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Nutritional support and hydration for critically and terminally ill elderly

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Title:
Nutritional support and hydration for critically and terminally ill elderly
Creator:
The Oley Foundation Inc.
Publisher:
U.S. Congress. Office of Technology Assessment
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Language:
English
Physical Description:
119 pages.

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Subjects / Keywords:
Critical care medicine -- United States ( LCSH )
Older people --medical care -- United States ( LCSH )
Critical care medicine -- United States ( LCSH )
Genre:
federal government publication ( marcgt )

Notes

General Note:
This report discusses the enteral or parenteral nutritional support as a therapy for anyone, including someone 65 or older, who is unable to meet his/her nutrition needs with meals and snack due to inadequate ingestion or impaired digestion or absorption.

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Source Institution:
University of North Texas
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University of North Texas
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This item is a work of the U.S. federal government and not subject to copyright pursuant to 17 U.S.C. §105.
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Y 3.T 22/2:2 L 62/v.2/pt.2/nutrit.-2 ( sudocs )

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IUF:
University of Florida
OTA:
Office of Technology Assessment

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NUTRITIONAL SUPPORT AND HYDRATION FOR CRITICALLY AND TERMINALLY ILL ELDERLY The Oley Foundation, Inc. 214 Hun Memorial Albany Medical Center Albany, NY 12208 November, 1985 Congressional Office of Technology Assessment Contract'# 533-5090.0

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ACKNOWLEDGMENTS This report was prepared by the following professional and technical staff: Principal Investigator Lyn Howard, M.B., M.R.C.P. Executive Director, Oley Foundation Professor of Medicine, Albany Medical College Oley Foundation Staff Lenore Heaphey, M.S. Associate Director, Oley Foundation Maryann Timchalk, B.S. Researc~ Assistant Joan Bishop Secretary Consultants Michael Wolff, M.D. Assistant Professor, Albany Medical College Jean Bigaouette, M.A.R.D. Instructor of Medicine, Albany Medical College John Jenks, M.D. Assistant Professor, Albany Medical College Chief, Nutrition Support Services, Veterans Administration Hospital, Albany, NY Liva Jacoby, Ph.D. Research Assistant, Albany Medical College In addition to the above, several members of the Oley Foundation Scientific Advisory Committee participated in Task S. These were: John Balint, M.D., Michael Caldwell, M.D., Ph.D., C. Richard Fleming, M.D.

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Task 1. The Technology Introduction ... CONTENTS ( -,. J t / :,.} 7 Enteral Technique .................. :-~ Parenteral Technique .......... 5-7 Patient Perspective ........... 7-8 Future Developments ......... 9-11 References ..................... 12-13 Figures 1-7 14-19 Tables I-V .. 20-25 Appendix A (Enteral tubes, pumps & formulas) . 26a-26h Appendix B (Parenteral catheters, pumps & solutions) .. 26i-26o Task 2. Utilization in the University Teaching Hospital Characteristics of the Patient ........... 27-29 Impact of the Nutrition Support ......... 29-30 Length of Stay anu Outcome. . . . .. 30-31 Indications for or Against the Cse of ~S ...... 31-33 Alternatives to NS. . . . . . . ..... 33 Consent. . 33-34 Supply and Equipment Storage ..... 24 Notes . ...... 3: Figure 1. . . . . . . 36 Task 3. Utilization in the Nursing Home 37-39 Notes. 39 Table I. . . . . . . . . . . . 40 Appendix A (Treatment Decisions in a Skilled Nursing Facility & Editorial Response)41a-4lf Task 4. Utilization in the Home Demographics. . 42-44 Cost. . . 44-45 "Indications for HPEN. .. 45-49 Medical Diagnosis Leading to HPEN .... 50 Duration and Mortality . 50-52 Morbidity and Rehabilitation 52-55 Procedures, Equipment, and Formulas .. 55-57 Provision of Service and Quality of Care ... 57-59 Notes. 60 Figures 1 & 2 . 61-62 Tables I-XIII ................. 63-78 Appendix A (Standards for NS, Home Patients) ... 79a-79h Task 5. Conclusions Priority Issues .. ~eeded Research .... o t es. . . . . . 30 SG-36 ,. jQ

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TASK 1. TECHNIQUES FOR NUTRITIONAL SUPPORT AND HYDRATION Introduction Enteral or parenteral nutritional support is an important therapy for anyone, including someone 65 or older, who is unable to meet his nutrient needs with meals and snacks due to inadequate ingestion or impaired digestion or absorption. Although "enteral," which theoretically means feed:Lng via the gut, includes normal eating, in the current context of very technical nutrition therapy, enteral feeding refers to the infusion of a liquid nutrient formula by tube into the upper gastrointestinal tract. "Parenteral," which means outside the gut, in this context refers to the infusion of nutrient solutions via a catheter into the bloodstream. Figures 1 and 2 show several patients receiving enteral or parenteral infusions and give a general picture of the technology. The following sections discuss these two nutritional techniques in more detail, outline some aspects of the technology from the patient perspective, and explore some issues for the future. 1.

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,) '_.: Enteral Techniques The first record of tube feedings is reported to be in the 16th century when Capivacceus introduced nutrients into the esophagus by tube.I Today enteral feeding tubes are placed either through the nose or through an ostomy, a medically created tract, into the gut. The development of small bore, pliable feeding tubes that remain soft with continued expo5ure to digestive juices has made long-term tube feeding possible. Figure 3 shows the most common placement sites and Figure 4 shows how a nasoenteric tube may be secured in an uncooperative patient. In Table I the placement techniques of the different tubes, thei~ clinical uses, and their advantages and possible drawbacks are summarized. (Also see Appendix A(l) for a listing of some brands of tubes currently on the market with their manufacturers, characteristics, and list price.) In addition to the feeding tube, enteral nutrition requires careful regulation of the nutrient infusion rate. Rapid infusion may provoke gastric regurgitation with aspiration into the lungs, vomiting, or diarrhea. Too slow an infusion may result in inadequate hydration and nutrient deficits. Enteral feeding pumps' assure the most uniform delivery of the formulas and Appendix A(2) lists some of the available models with their features. Pum~s are not always used for patients receiving tube feedings. If the distal end of the feeding tube (nasogastric or gastrostomy) is in the stomach and the gut is functioning 2.

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normally, bolus feeding (i.e., quantities of 300-400 cc . (; \ ,-... .~. i_/ administered in a single dose with a large syringe) ~ay be u s e d I n t h i s c a s e t h e s t o m a c h s e r v e s a s a '' r e s e : ,,. o i :" i J r : :--. e food which slowly passes into the intestine absorbed. . . :o Je c15estea anc "Gravity drip" is anoth~r method of administering tube feedings. In this method, the height the formula container is hung provides the force and a regulator clamp calibrated by counting the drips controls the flow rate. However with gravity drip, accurate regulation depends on hourly monitoring of the flow rate by a nursing attendant or, depending upon the setting, a family member or the patient himself. The duration of enteral infusion can range from one to 24 hours per day and the formulas are an excellent media for proliferation of bacteria from both internal and external sources. If a formula is to be infused over many hours without constantly refilling the container, it is important that the nutrient mixture be kept cool and protected from contamination. Complications arising from contamination of enteral formulas are diarrhea, enteritis, and bacteremia.2-6 Preventing these problems requires an infusion container that can hold a large volume of formula (1-3 liters), that is closed, to protect the solution from airborne contaminants, and is kept cool to limit the growth of any organisms. In the past, such containers used to be large glass burettes or metal chambers with a cooled stirring device. ~ecently such containers have been repl:ce~ j~ disposable plastic bags that are closed to the atmosphere and some have built-in icP. packs to keep the nutrient solution well 3.

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below room temperature. (Appendix A(2) includes brands_ off 1 .; enteral formula containers.) Another potential complication from tube feedings 1s aspiration pneumonia. Aspirating stomach contents that tave been regurgitated or vomited can bring on acute respiratory distress. Regurgitation can occur quite subtly, particularly in those with impaired mental status or with decreased ability to close their glottis (as in someone with a tracheostomy). One measure that can be taken to decrease potential aspiration is to make .sure the patient's head is elevated to 30 degrees at all times. Other measures include checking the tube's placement, checking gastric residuals, and initially diluting formulas to encourage gastric emptying.7 Enteral formulas cover a wide spectrum. They range from those that are produced at home by blenderizing normal table food to formulas that have a defined chemical composition tailored for a specific metabolic disorder, such as those enriched with branched chain amino acids and reduced in aromatic amino acids for patients with hepatic failure. Table II summarizes the various enteral formula categories, their clinical indications, and methods of administration. '(See Appendix A(3) for some of the commercially available enteral products with their manufacturers and price per liter.) 4.

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Parenteral Techniques "\ ,. t .,, ,.. f ; 3 I 1 _, I The development of an "artificial gut" or total ;are~teral :1 u t r i t i o :1 ( T ? :: ) b e g a n i n t h e 1 S 6 0 s .~ h e n D c. : i c '.z a :-: .. __ colleagues conducted the first experiments to show that g:o~th, development and positive nitrogen balance can be achieved in humans through parenteral feedings.8 Because of its complexity and potential risks, TPN was initially undertaken only in the hospital setting. In 1969 Shils and associates9sent the first patient home and in the past 10-15 years the experience of managing patients at home on parenteral nutrition has grown rapidly.10-13 As defined earlier, parenteral nutrition* is the tec~nology of infusing nutrients via a catheter direclty into a vein. Figure 5 shows examples of parenteral feeding catheters (also called "lines") and Appendix B(l) gives a more complete list of some brands that are currently on the market. Because parenteral nutrient solutions are highly concentrated solutions, they are not readily tolerated by small veins with low blood flow, hence the catheters must be threaded into large, high flow, central veins where the infused solution can be rapidly diluted. Figure 6 shows the veins that can be used for accessing the central venous system and Table III summarizes the various characteristics of the catheters, both the externalized lines and those with subcutaneous portals, and the technique of insertion. Figure 7 depicts a typical venous catheter placement. *'O:casi anally 1FN is referred to as hyperalimsntaticn, a fonner tem for the technique. 5.

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With parenteral feeding, a constant and accurate infusi~~-~. : '.' / I rate is even more critical than with enteral feeding and pumps have been developed to perform this task. Appendix B(2) lists some of the models currently available for parenteral feeGi~gs. Among their special features are a battery to insure that power failure does not interrupt infusion and alarm devices to warn nursing attendants or patients about air bubbles or occlusions (i.e., resistance to flow that could mean a kink in tubing or a clot). Each infusion formula provides several standard components: protein (amino acids), dextrose, fatty acids or lipids, electrolytes, trace elements, and vitamins. However, the formula must be adjusted to the specific needs of each patient and laboratory tests are necessary to monitor the adequacy of the therapy. For example, in a patient with renal failure, the amino acid component may be modified to provide principally the essential amino acids (the ones the body cannot manufacture) and restrict the sodium, potassium, phosphorous, and minerals; whose excretion is defective in renal impairment. Table IV presents a standard parenteral nutrition formula. This formula provides all the known nutrients except iron. Traditionally iron has not been included because of early reports of parenteral iron causing life-threatening anaphylaxis and because many hospitalized patients receive generous iron supplements from blood transfusions. In recent years there has been a growing experience with incl11ding small amounts of iron (l-3mg/day) in the daily solutions and this 3ppears to be safe.14,15 (See Appendix B(3) for a list of parenteral solutions, their manufacturers, and list prices.) 6.

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Because parenteral formulas usually provide the required caloties primarily as dextrose, they are highly osmolar I' J: ,, I soluticns. Ia the i~~ediate vicinity 0 the ca:~eter ti;, :hese that attack foreign particles by surrounding and er.gulfing them. Parenteral formulas are also potential growth media for contaminating organisms, bacterial and fungal. Since they are infused close to the heart and since local defense mechanisms are impaired by virtue of the osmclarity, it is easy to understand that the central danger of parenteral feecing is blood borne infection or sepsis. For this reason aseptic technique in compounding the formula, setting up che in~~sion system, and handling the venous catheter is mandatory. Table V summarizes the potential complications with parenteral nutrition, especially at the outset of instituting the therapy. For long-term patients at home on parenteral support, micronutrient deficiencies become a more significant issue and these complications will be discussed in the section on home utilization. Patient Perspective To accept and benefit from the techniques of enteral or parenteral nutritional support it is important that all aspects of the technology be discussed with the patient and the patient's family before therapy is instituted. The family discussion is particularly important if the patient is senile, comatose or if the patient must rely on family ~e~~ers to assist with the regimen. For both the long-term or short-term patient 7.

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and their families, this discussion should encompass: '. '-, ') I I .... 1. An explanation of why the specialized nutritional support is indicated what benefits can be anticipated, and ho\\. 1 on; it :n a:, Je necessary. 2. Information on catheter (line) or tube placement. This should include: a) the type of device to be used; b) site of entry and anatomical location inside the body; c) lubrication or type of anaesthetic used; d) position of patient during insertion and patient's role to ensure ease and safety of the procedure; e) potential discomfort and hazards associated with the line or tube; and f) how the line or tube is changed or removed. Particularly relevant for the long-term patient, especially one discharged to the home is: 1. What and who will be involved in the daily care of the tube (clean technique) or catheter (aseptic technique) and dressing changes. 2. Use of the pump and taking advantage of its special features to aid in controlling the infusion process. 3. Preparation and-storage of the nutrition formula. 4. Potential complications and how to manage them appropriately. 5. Inventory and reimbursement management, including supply ordering, cost and payment mechanisms. 6. Details ~f 24-hour emergency back up for medical complications or equipment breakdown. 7. Development of a plan for post-discharge medical follow up. 8.

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Future Developments The Small Pumo .f2.!. Greater ~obilit,, Since nutritional rehabilitatio~ is only tota::y s~c:~5s~~: if the ~atient is restcred to the ~axi~~m le~el cf ac:~~~:: :~a: he or she may be capable of, it is usual for patients discharged from the hospital on long-term parenteral or enteral therapy to obtain the nutritional support overnight. This permits the patient to be free from pump, tubes, and solutions during the day. In many patients with bowel disorders requiring therapy, there is an abnormal loss of gastrointestinal secretions sc t~at these patients are subject to severe dehydration. For t~is reason toward the end of their "off" period, they become ',o:ry dry and uncomfortable. Conversely, when the infusion restarts and hydration is restored, they start to produce urine and must get up and go to the bathroom several times during the night. Obviously this presents a dilemma in the older patient who ~ants daytime mobility but may require close supervision for the infusion period and need help in going to the bathroom when infusing. There is a "vest" with a small battery pump (see Appendix A(2)) that permits ambulatory parenteral infusion. So far this device has proven useful in extending the day for active adults, but has not been developed to the point where it is a true alternative to the large volume, noct~rnal infusion. Clearly, however, it is a step in the right direction. Si~plification of ili Parenter~l ~utrient Solution In the early years of developing intravenous fat solutivns 9, i

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there was a major problem of stabilizing the fat particles and t I .. ,4 1 avoiding their coalescence into large particles that could >II i t induce a sy~drome akin to fat embolisrn.1 6 Rece~tly a number of studies indicate that it it safe to premix the fat solution ~it~ the other parenteral compounds producing a "three-in-one" infusion (fat, dextrose, and amino acids in one mixture).17,18 More studies are needed to evaluate how long such solutions are stable for certainly using a "three-in-one" solution simplifies delivery, which is especially valuable for the older, less dexterous individual. Micronutrient Composition While the adequacy of calories, protein and fluids is fairly easy to assess clinically, the requirement for micronutrients such as trace elements, vitamins and essential fatty acids are harder to establish and more studies are needed. Since nutritional therapy utilizes plastic bags, tubing and filters, adherance of nutrients to these materials has to be evaluated. In addition, as parenteral feeding is into the systemic rather than the more physiologic portal system, nutrients may be presented more rapidly to the kidney than to the liver, the organ commonly involved with storage and metabolic activation of nutrients. For this reason, parenteral requirements may be higher than the amounts established for oral feeding. Also, as stated earlier, many gut disorders are associated with the abnormal loss of enteral secretions that can result in the abnormal endogenous loss of many nutrients and interruption of normal enterohepatic cycles (e.g., cobalamin, 10.

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folic acid, vitamin D, zinc, calcium, magnesium, copper, and t: perhaps other nutrient conservation is impaired). One future ap~roach to studies on trace ele~e~t require~ents ~ay be autopsy analysis oi the tissues 0~ ;atiants who have been on nutritional therapy for many years. Another approach to altered nutrient metabolism may be stable isotoRe tracer studies. Enteral Therapy Enteral therapy is clearly a less expensive form of nutritional support than parenteral therapy. With the advent of more comfortable feeding tubes and conviently packaged enteral formulas, there has been a greater use of enteral support in many gastrointestinal disorders. More information is required at both a basic and applied level about how to make enteral feeding truly successful. A key issue will be better reimbursement practice by third party payers. Currently the reimbursement for enteral therapy is so uncertain that it positively encourages the more expensive parenteral approach. From the patient and family perspective it is certain that no one would cooperate with either form of therapy if they did not experience substantial bgnefit. Both types of therapy are cumbersome and restricting so flagrant abuse of nutritional support is unlikely and a far cry from the era of "tonics." However, its widening application beyond the hospital setting requires that appropriate professional standards and quality of care be monitored. 11. I ' J

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References ,I I \ ... '" j. J ; J I ) 1 H i s W : A u r g s c h i c h t e d e ma g e n p u m p e :-1 e d K 1 i n :~ 1 3 9 1 -9 3 1925. 2. Anderson KR, Norris DJ, Godfrey LB, et al: Bacterial contamination of tube feeding formulas. JPEN 8:673-8, 1984. 3. Fagerman, KE, Paauw JD, Dean RE, Bacterial contqamination of enteral solutions. JPEN 9:318, 1985. 4. Schroeder P, Fisher D, Volz M: Microbial contamination of enteral feeding solutions in a community hospital. JPEN 7:364-8, 1983. 5. Allwood MC: Microbial contamination of parenteral and enteral nutrition solutions. Acta Chir Scand 147 [Supp]S07: 383-7, 1981. 6. Cataldi-Betcher EL, Seltzer MH, Slocum BA, et al: Complications occurring during enteral nutrition support: a prospective study. JPEN 7:546-52, 1983. 7. Bernard M, Forlaw L: "Complications and their prevention," Enteral and Tube Feeding, eds. Rambeau JL and Caldwell MD (Philadelphia: WB Saunders & Co., 1984), Chapter 29, pp. 553-55. 8. Dudrick SJ, Wilmore DW, Vars HM, et al: Long term total parenteral nutrition with growth, development and positive nitrogen balance. Surgery 64:134-42, 1968. 9. Shils ME, Wright WL, Turnbull A, et al: Long term parenteral nutrition through arteriovenous shunt. N 'Engl J ~ed 283:381-44, 1970. 12.

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. 13. 10 Br O Vi a C J N s Crib n er B H: pr O 10 n g e d parent er a 1 nut r it i~ n !1 ; 7 the home. Surg Gyncol Obstet 139:24-8, 1974. 11. jeejeebhoy T \T l'-.; Langer B, T~allas G, et al: Total nutrition at hooe: studies in patients survi~i~~ ~c~:~s :JS years. Gastroent 71:943-53, 1976. 12. Wesley JR: Home parenteral nutrition: indications, principles and cost effectiveness. Compr Ther April 9(4): 29-36, 1983. 13. Howard L, Michalek AV: Home parenteral nutrition. Ann Rev Nutr 4:69-99, 1984. 14. Norton JA, Peters MS. Wesley R, et al: Iron supplementation of total parenteral nutrition: a prospective study. JPEX 7: 457-61, 1983. 15. Sayers MH, Johnson DK, Schumann LA, et al: Supplementation of tatal parenteral nutrition solutions with ferrous citrate. JPEN 7: 117-20, 1983. 1 16. Silberman H, Freehauf M, Fong G, et al: Parenteral nutrition with lipids. JAMA 238: 1380-82, 1977. 17. Hardy G, Klim RA: Stability studies on parenteral nutrition mixtures with lipids. JPEN 5: 589, 1981. 18. Epps DR, Knutsen CV, Kaminski MV, et al: Clinical results with total nutrient admixture for intravenous infusion. Clin Pharm 2:268-70, 1983.

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FIG. 1. THREE PATIENTS RECEIVING ENTERAL FEEDINGS IN THREE SETTINGS. 14. BEST COPY AVAILABLE .l .. ---la.-Crohn's patient rece1v1ng feeding at home through nasogastric tube inserted daily by patient. lb. Hospitalized patient receiving enteral feeding for anorexia nervosa. le. Stroke patient ~eceiving feeding at nursing home through_gastrostomy (tub into stomach). Tube in throat is t racheos tomy to aid breathing .

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I Fig. 2 T\tlO PATIENTS RECEIVING PARENTERAL FEEDINGS IN T\JO SETTINGS. 15. 2b. Radiation enteriti~ patieni receiving parenteral infusion at home via subcutaneous reservoir catheter. (Above: catheter site and tubing; right: pump and nutrients.) ,"\ j~--+.,.._ ____ ~-2a. Crohn's patient receiving parenteral nutrition via indwel 1 ing--catnet-er (Hickman) in hospital

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Fl G. 3. COMMON PLACEMENT SITES FOR ENTERAL FEEDING TUBES. Nasc,vutnc Tuoe I 16. I _, --, [\-~, f\VA1LABLE FIG. 4. TECHNIQUE FOR SECURING NASOENTERIC TUBE IN AN UNCOOPERATIVE PATIENT.

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WEIi LOCK CAP FIG. 5. PARENTERAL NUTRITION CATHETERS. 1 7. Sa. Externalized catheters. -------------DACRON CU" INLARGID CATHITIII CIIOIS SECTION ,v--<:T r.o~y AVA.fLABt E ,. CATNfflll ................. lumen catheter ~hewing the lume~ -m, m-=t::=========r.,,;:ibc::::o:=:s===========tJ/============== CATHfflll LIMPIIOOP AOAPTlll1 11 ......... liliNM Sb. Catheters with subcutaneous portals. Lower right is a cross section of an implanted portal. ~Lock-Cdlet

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18. FIG. 6. ACCESS VEINS FOR PARENTERAL FEEDING. I; J : '\ :J :_, .. external jugular subclavian v. __. __ _,..li"~-, superior vena cava femoral v. __ __.._ ...

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DACRON CUFF OR GRAFT EXIT SITE OF CATHETER 19. FIG. 7. EXTERNALIZED CATHETER THREADED THROUGH THE SUBCLAVIAN VEIN TO THE SUPERIOR VENA CAVA. THE CATHETER IS TUNNELLED UNDER THE SKIN BETWEEN THE EXIT SITE AND THE ACCESS VEIN. (

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TA n I.,,: r En t er A l Feed in g Tu hes PLACF..MlrnT TJ~~ :_11 NI qu E ----------------Nc-tqi*n:-;Q r i ( Rxt.ernn.1 111,n~-:un~mP.nt: nostril, eRr to xiphistf'r1111111; placed by professionnJ or with i n s t r u c I i o n f a mi 1 y me m be r or pa t i e n t ; t u be s Ui f r P rH' d h y i c e w a t e r or a s t y l c' t ; po s i t i. on t <' s I P .1 eed ing and/or str.ict 11n~. Passing tt1h<' 1.hrough pylorus; pr(VP11ti11g the spontanrous 1,11 I 1 i ng back into stomnch; continuous drip required nnd tends to cause diarrhea; tubes stiffen wi.t.11 I ime; cnn lacerate py]or11s or gastroesophogPnl junction if pulled 0111 rnpidly. Aspiratlon if I uhr in stomach; phnryngenl scer r in g ca u s es ,I i s t o r ti.on of normal anntomy; rnuses swallowing lif firulty. Irritati.on n1 011nd tube site; aspi.rnl i(>n of regurgi tat-eel sl.onrnch con ten t s ; d .i ~: p I n c rm en t of tuhe i.nlo p<.'ri toneal cavity or if hPld jn situ by balloon; ohstruction of the pylon,~~. -------------------------------------------cclnt c>11 11( \ I I inge

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N ') TABLE I. Enteral Feeding Tubes (cont.) .. PLACEMENT TECHNIQUE Jejmosta11y 'Tube plocf'd surgically through abdominc:11 wall into proxjmal loop of jejunum, tethered to an t er i o r ,all l by s u t u re ; f in e bore t u he inserted hy d .i ngonal tract into bowel 1 umen or large horP with an anchoring suture. Canbined G1stro je junostany Tubes Tube placed surgically with jejuna! arm thread beyond the pylorus. CLINICAL USES Long-term access. Used for defective gastric emptying; fine bore tube recommended as postoperative backup where prolonged gastric atony may occur. Allows for simultaneous gastric suction and jejunal infusion; used where patient particularly at risk for aspiration of gastric contents. -2 I POTENTIAL IWBLEMS Irritation nt tube exit site, espec ic111 y large bore tube; clogging or displacement of tube continuous drip usually required; diarrhea common Not yet widely available.

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. N N 1' A IU. I~ I I I\ n t er n 1 Feed i n R For m u I a s BINMIPrbnl lic,111111lrn~ M:f.xt,11'(' of pun'f'fl meat, fruit, vegetnh I PH. ~wmeti.mes Added n on f a t I r y III i I I< f i. be r v i t am i n A and minf'rnl~:; ldghly viscous. Polyn1-i c Vi >rnn, I n.c:; M i x t u r e o f '" h o .I e pr o t e i n s po 1 y -s a c c Im r j ends on quantities of protein, C If O a n fl f n t II B c d CLIN.ICAI. INDICATIONS No nn a I. d i g es t i o n an d A b so r p t i o 11 n:1q11 i rrd; used with phnryngost omy, cervical esophogostomy or ga:=;t.rostomy tubes. N o r m n l d i g es t. i o n An d a b so r t> t i o n r<'(I'' ired; can he fed into C!-rnphngus, stomach, duodenum, or jPJunum. UsPd for inflnmmatory bowel disrnse, chronic pancreatitis, GI fJstula, radiation or chemotherapeutlc enteritis, pn11 maldigestion, pen malabsorption or transition feeding from parPnteral to enteral therapy. Us P. (I for re n a 1 fa i 1 u re hep e t i c encPphalopathy, stress, trauma And respiratory failure UsPd for specific metabolic nhnormalit:t.es, such .as glycogen stornge disease -------------------TUBE OF CHOICE Large bore 12-18 French Smell bore 8-10 French Small bore 5-6 French Small bore 5-6 French varies, depends on viscosity corn 11:N'rs I.oh,~~, rost; 2 01 more liters rHPcl('l1,~:, gravity, or pump Iii glHr rost than po I y m c r i c ; l 53 .Ii t Prs needed d n i I y; pump fl i g I I(' S t C OS t 2 1 il.Prs or mo 1 <' d n i. l y RrH\'ity or pump II i J~ Ii r c o s t t h en mo110111(ric; 1.5 or more> liters Of'(cl('d; bolus, grnvit.y or pump --.,_.

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TABLE III. Parenteral Nutrition Catheters TYPES OF CATHETERS A. Externalized 1. single, double or triple lumen; 2nd and 3rd channels used for intravenous medications or blood drawing B. Subcutaneous port 1. involves a small reservoir with an overlying rubber diaphram which is self sealing 2. port must be entered by a J-shaped needle 3. not all patients like the daily needle stick 4. if line is not in use, the buried port makes showers and swimming less hazardous CATHETER MATERIAL A. Polvvinylchloride, polyethylene, polyurethane.!. teflon 1 Advantages a. inherent stiffness allows easy threading into the vein 2 Disadvantages a. stiffness allows catheter to be in direct contact with vessel wall causing thrombosis b. stiffness increases over time, causing kinks or fractures B. Silicone Rubber 1 Advantages a. very pliable, less kinking b. less traumatic to vessel wall c. inert; inducing little reaction or adherence 2 Disadvantages a. difficult to thread into vein b. falls out more easily due to nonadherance c. potential for tearing SITES .Q[ VENOUS ACCESS A. Distal tip of catheter best placed in mid-portion of superior vena cava. B. Enters venous system via: 1. percutaneous stick into the subclavian, external jugular, or anterior cubital vein 2. cut down site on external jugular (via common facial vein) femoral, axillary or intercostal vein C. All catheters can be tunnelled superficially to a distal site which: 1. may provide a barrier to skin organisms ir.fecting the line 2. places exit site at convenient place for self care in patients going -home 23.

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TABLE IV. Standard Total Parenteral Nutrition Solution (24 Hours) for a 70 kg Adult Fluid 3 Liters Protein (amino acids) Calories* Essential fatty acids (lipids) Electrolytes Sodium Potassium Chloride Acetate/gluconate Calcium Magnesium Phosphorous Trace Elements Zinc Copper Iqdine Selenium Chromium Manganese Vitamins Ascorbic acid Thiamine Riboflavin Niacin Pantothenic acid Pyridoxine Biotin Folic acid Cobalamin Vitamin A Vitamin D Vitamin E Vitamin K *Provided prinicpally as dextrose. .:-.3 g nitrogen/~g 25-40 kcal/kg 2% of total calories 100 mEq 100 mEq 130 mEq 90 mEq 15 mEq 20 mEq 300 mg 5 :ng 1.5 mg 120 ug 100 ug 15 ug 2 mg 100 mg 3 mg 3.6 mg 40 mg 15 mg 4 mg 60 ug 400 ug 5 ug 4000 I.U. 400 I. U. 15 mg 200 ug 24.

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. I.I'\ N ( .. :) TABLR V. Chronological Occurrence of Complications from Total Parenteral Nutrition ( .. :: .... ---First 48 Hours First 2 Weeks Three Months Onward -------------------------------------------------------------------------------------------------Mechanicnl Metaboljc Infectious Complications from catheter insertion: cephalad displacement pneumothorax hemothorax Detachment of line at catheter hub with blood loss or air embolism Hy per glycemia Hypophosphatemia Hypokalemia Catheter coming out of vein, more common if silastic Detachment of line at catheter hub with blood loss or air embolism Hyperosmolar nonketotic hyperglycemic coma Hyponatremia Hypomagnesemia Hypopotassemia Hypocalcemia Acid-base imbalance Catheter-induced sepsis Detachment of ]J11e at catheter hub with hlood loss or air embo]jsm Fracture or tears in catheter Essen t i a 1 fa t t y cH j d cl e -ficiency Zinc, copper, chromium, s e 1 en i um mo 1 y b d <' 1111 m deficiency Iron deficiency Vitamin deficiency TPN metabolic bone disease TPN liver diseasp Ca thet er-ind ucecl sP 1>S is Tunnel infections

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ENTRIFLEX DOBBHOFF C0:1PA:1Y 3iosearch :led ical Prod uc ts APPENDIX A(l) ENTERAL FEEDING TUBES+ CO>IPOS ITIO:~ Polyurethane Polyurethane FE.-\TCRES Radiopaque ti? Mercury weighted Stylet included 36, 43" long, 8 Fr* Radiopaque tip Mercury weighted Uses Entriflex stylet 43" long, 8 Fr 26a. 18.00 19.00 -----------------------------------------------------~-----------------------~ IEOFEED SURGIFEED JEJUNOSTOMY IVAC Corporation Silicone Silicone Radiopaque tip Tungsten weighted Stylet included 36, 42" long, 5-8 Fr 18 '' 1 o n g j 8 F r 9.00 ., ,.., ,, ( ___ '-,._. -~~---------~------------------------~---------------------------------------DUO-TUBE VIVONEX FLEXIFLO TRAVASORB Argyle Norwich Eaton Silicone Polyurethane Ross C-Flex Laboratories Travenol Polyurethane Laboratories Radiopaque Mercury or silicone weighted 40" long, 5-8 -Fr Thinner tubing so greater inside diameter for.thicker formulas Radiopaque Tungsten weighted 45" long, 8 Fr Radiopaque Tungsten weighted Teflon coated stylet 36,45" long, 8,12 Fr Radiopaque Tungsten weighted Prelubricated stylet 45" long, 8 Fr 10.00 12.50 16.25 -----------~----~-~---------------------------------------------~------------+rnformtion supplied by manufacturer. ++List prices do not, of course, reflect actual purchase prices that may include volume discounts, special contracts, or what is actually paid by the third party payers. *Fr=French=0.33 cm. (a measure for the t~be's outside diameter). -:H: D = :: o D a ta ( i .:1 t :1 e ma t er i al av 3 i 1 a b 1 e fr 1J rr: the ::: a :1 :..1 a c t : re r : :-: e ;; :-:. -: .. :::: 3 :-: o : included).

PAGE 30

26b. (!, : p I ,\1 1 'I '_I ~ ,l_ APPENDIX A(l) ENTERAL FEEDING TUBES+ (cont.) TUBE FLOW THRU SAFE-T-FLEX CONVENTIOAL SAFE-T-FLEI MED-PRO CORPAI KANGAROO COMPANY Superior Plastic Products COMPOSITION Polyurethane Silicone Viera Corp. Silastic Corpak Co. Polyurethane Chesebrough Polyurethane Ponds, Inc. +Informtion supplied by manufacturer. FEATURES Radiopaque Silicone weighted 42" long, 9 Fr* graduated to 14 Fr Bolus tip Radiopaque Bronze spring weighted Braided wire stylet 42 in. long 6, 8, 10 Fr. PVC outer stent Radiopaque Tungsten weighted Braided wire stylet 36, 43" long 6, 8, 10 Fr Radiopaque stripe Tungsten weighted Braided wire stylet 43" long, 8 Fr PRICE++ 16.00 13.00 ND** 9.00 15.00 ++List prices do not, of course, reflect actual purchase prices that may include volume discounts, special contracts, or what is actually paid by the third party payers. *FrFrench=0.33cm. (a measure for the tube's outside diameter.) it*ND=No Data (in the material available from the manufacturer the price was not included).

PAGE 31

26c. APPENDIX A(2) EMTERAL FEEDING PUMPS+ !~' (; :_:. J ._: FLOW AUDIO/VISUAL WEIGHT & OTHER p C~! p ~:-~! A U F .\CT t! R ER ~ATE AL .-\R:!S FEATCRES :,orr=++ ". '""'._ -Dobchoff 3iosearch l-300 :: 0 flow ~.7j ., l. ::, s t... ;.anc ... e .;.1~:-::s >ledical ?rod. :nl/hr Low batte::: -.... a::1b1.r2.a~or:: -~ .I. Enteral 5-300 No flow./ ace. 4.5 1 b s. i-hr. 495-525 #14-7005 ml/hr Rate change battery operation Low battery ----------------------------------------------------------~-------------~-----Kangaroo 220 Iangaroo 330 Kangaroo 2 Home Care Corpak VTR 300 Chesebrough-Ponds, Corpak Company Inc. IV AC # 3000: IV AC Ieofeed Corporation Flexiflo Flexiflo-II Ross Laboratories 5-295 ml/hr 1-295 ml/hr 5-295 ml /hr 1-299 ml/hr 1-300 ml/hr Occ/empty rate change low battery Occ/empty Low battery Hold alarm Occ/empty Rate chang~ Low battery ace/empty Low battery Low battery Rate change 50-200 None ml/hr 20-250 ml/hr Occ/empty Low battery 4.2 lbs. 505-990** With pole clamp & power converter 5 lbs. 595-1090 3-hr. battery 3.5 lbs., optional 354-600 car lighter pl'.lg adapter---------------12.50 6.5 lbs. (with cord & pole clamp) Portable [Bag and pump set] Portable 8-hr. battery 275-300 595 305 550 -----------------------------------------------------------~---------------~--Superior Enteral Pump Superior Healthcare Group, Inc. 10-390 ml/hr Occ/empty Rate change Low battery Can be used on Table or IV stand Takes most tubing ---------------~-------------~------~--------~----~------~--------------------Enteral Delivery Pump #430 IMED Corporation 1-299 ml/hr Rate change Occ/empty Low battery 7.6 lbs. 8 hr battery Table or IV stand 650 ---~---------------------------------------~-~-----------~------~-------------Flo-gard 2000 Travenol Laboratories 5-300 ml/hr No flow Occ/empty Rate change Low battery 7 lbs. Portable 595 --------------------------------------~----------------------~-----------------+Information supplied by manufacturer. *Pumps run on AC current or can be used for short p~riod3, l-3 hours, Jn rechargable battery generally included with pu~p. ++Price ranges reflect discounts _or quantity purchases, contracts, e::. Pumps can also be rented on a monthly basis. **Price range reflects large contract prices for institutions to indivdual patient purchases for long-term home use. ***NDNo Data (in the material available from the manufacturer the price was not included).

PAGE 32

26d. APPENDIX A(2) ENTERAL FEEDING CONTAINERS+ ,) '~ t f ... ... "'l ;: ;y )) ,_; CONTAINER DOBBHOFF l:EOFEED VIVONEX FLEXIFLO TOP-FILL FLEXITAINER COMPANY Biosearch Nedical Products IVAC Corporation Norwich Eaton Ross Laboratories MATERIAL Vinyl Bag Vinyl Bag Bag Bag Plastic Bottle FEATURES Size: 1 liter 3 holes for hanging Universal outlet Disposable Includes pump set Size: .5 or 1.5 liter Delivery set avail. 1 hole for hanging Zip lock top Universal outlet Use with pump or drip Size: 1 liter 1 hole for hanging Side snap cap Universal outlet Disposable Use with pump or drip Size: l liter 1 hole for hanging Side screw on cap Universal outlet Disposable With pump set Use with pump or drip Size: .5, 1 liter 1 hole for hanging Self collapsing Disposable PRICE++ 4.12-5.65 2.52-3.10 4.80 2.92 6 .10 2.75 ~-----~--------------------------~--------------~-----~-----------------------SAFE-T-FLEX Superior Plastic Products Plastic Bottle Use with pump or drip Size: .75, 1 liter 1 hole for hanging Top screw on cap Universal outlet Self collapsing Reusable 2.25 --------------------------------------------------------~----------------------+Information supplied by manufacturer. ++List prices do not, of course, reflect actual purchase prices that may include volume discounts, special contracts, or what is actually paid by the third party payers. *ND=No Data (in the material available from the manufacturer the ~rice ~as not included).

PAGE 33

26e. i. I f-. I ""\ '; .i ~-! -, APPENDIX A(2) ENTERAL FEEDING CONTAINERS+ (cont.) EVA CORPAI TRAVASORB KANGAROO CO>!PA~Y G i 1-~!e d Industries Corpak Co. Travenol Laboratories Chesebr9ugh Ponds, Inc. >L.\ TERI AL Ethyl vinyl Acetate Bag Bag Tapered Bag FE:ATCRES L'se with pur:1p or Size: 1, 3 liter Top clamp J.. ,... .; ... .. ... Size: 1 liter 1 L 3 L Roberts valve flip top l hole for hanging 2 outlet ports Admin. set available Size: 1.3 liter Top fill, preattached cap, rigid neck 1 hole for hanging 2 outlet ports With admin. set With pump set Size: .5, l, 1.2, 1.6 liter Easy capclosure 1 outlet port includes pump set Without ice pouch With ice pouch (1 or 1.2 liter only) :,-; 7r:::-.;.--... ....,, 7.30 7.95 5.00 4.60 j.25 5.63-7.00 5.11-5.88 -------------~--~-~-------------~--~------------------------------------------~ +Information supplied by manufacturer. ++List prices do not, of course, reflect actual purchase prices that may include volume discounts, special contracts, or what is actually paid by the third party payers. *NDNo Data (in the material available frqm the manufacturer the price was not included).

PAGE 34

APPENDIX A(3) COMMERCIAL ENTERAL FORMULAS ,, ,-' "' ; J f j -I ,j PRODUCT COMPANY PRICE/LITER Blenderized Formulas VITANEED BIOSEARCH 6 .19 COMPLEAT-B SANDOZ 7.36 COMPLEAT MODIFIED 8.26 FORMULA NUTRI-1000 CUTTER ND* FORMULA-2 ND* Polymeric Formulas ISOCAL-HCN MEAD JOHNSON 5.62 SUSTAGEN 7.00 SUSTACAL 4 .17 ISOCAL 4.17 SUSTAGEN-HC 5.40 LONALAC 4.56 PORTAGEN 4.50 TWO CAL HN ROSS 3.98 ENSURE PLUS 2.90 ENSURE PLUS HN 3.19 ENSURE 2.53 ENSURE HN 2.10 ENRICH 3.60 OSMOLITE HN 2.22 OSMOLITE 2.02 TRAVASORB TRAVENOL 2.31 MAGNACAL BIOSEARCH 5.78 ENTRITION 5.17 RENU 3.50 RESOURCE CRYSTALS SANDOZ 2.45 MERITENE 3.69 CITROTEIN POWDER 3.82 ISOTEIN HN 16.60 *ND=No Data (in the material available from the manufacturer the price was not included). 26f.

PAGE 35

APPEND II A( 3) COMMERCIAL ENTERAL FORMULAS (cont.) ;'r. ' ~.., I_~ ', I '_I -' '' ?RODt:CT :!on om er i c For !'!1 u 1 as VIVONEX VIVONEX-HN PRECISION-LR PRECISION ISOTONIC PRECISION-HN CRITICARE VITAL SLD TR.-\VASORB STD TR..\VASORB NCT TR.l.v.l.SORB-H~ VIVEP Modular Formulas Protein: CO~P A~iY ~ORWICH EATON SANDOZ MEAD JOHNSON ROSS TRAVENOL CUTTER Powder form, reconsitituted with water P-ROPAC BIOSEARCH CASEC MEAD J.OHNSON RDP NAVACO NUTRISOURCE PROTEIN SANDOZ Carbohydrate (CHO): SUMACAL POWDER BIOSEARCH PURE CHO POWDER NAVACO LIQUID CHO NAVACO HYCAL BEECHAM CAL-POWER GM POLYCOSE LIQUID ROSS MODUCAL POWDER MEAD JOHNSON NUTRISOURCE LIQUID CHO SANDOZ PRICE/LITER 8.46 13.60 7.36 9.42 14.01 16.70 21.36 4.17 6.86 11.84 :2.so ND* 4.15/100 9.00/100 4.75/100 5.68/100 .69/100 .82/100 8.75 ND* ND* 7.15 1.15/100 7.66 gms gms gms gms gms gms gms *NDNo Data (in the material available from the manufacturer the price was not included).

PAGE 36

APPENDIX A(3) COMMERCIAL ENTERAL FORMULAS (cont.) PRODUCT Xodular Formulas (cont.) Fat: HIGH FAT POWDER MICROLIPID MCT OIL NUTRISOURCE MCT Disease-Related Formulas HEPATIC AID AMIN-AID TRAVASORB RENAL TRAVASORB HEPATIC PULMOCARE STRESSTEIN TRAUMACAL T.E.N. COMPANY NAVACO BIOSEARCH MEAD JOHNSON SANDOZ MCGAW TRAVENOL ROSS SANDOZ MEAD JOHNSON NORWICH EATON PRICE/LITER 1.76/100 gms 15.12 27.00 1.00 ND* ND* 22.80 43.20 3.98 25.06 7.08 21. 34 ,'\ ( '~ \ i ,_; I ~:' : *NDNo Data (in the material available from the manufacturer the price was not included). 3) 26h.

PAGE 37

CAT:ETER BROVIAC PEDIATRIC BROVIAC REPAIR KIT HICKMAN DUEL LUMEN HICIMAN REPAIR KIT APPENDIX B(l) PARENTERAL FEEDING CATHETERS*~: :-tA:~t:F .-\CTtR ER CO:lPO SI TIO~~ ~ver::1ed Sil:.cone Rubber Silicone Rubber Silicone Rubber rE..\TCR::s 9 C.c ::1 long :: 2:::::: 0:) ~:-~: Dacron cuff Barium impregnated Luer lock connector Teflon reinforced exterior portion 71cm long .9mm(.3Fr)or l.4mm(4Fr)OD ..................... 90cm long 3.2mmOD Dacron cuff lcuff, radiopaque 2cuff, cl.ear 90cm long 2.2mm, 3.2mm0D radiopaque Dacron cuff ..................... 36.00 49.00 45.00 50.00 36.00 26 i ----~----------------------------------~----------------------------------COOI DUEL LUMEN COOK PEDIATRIC COOK COOi: CATHETER ICIT REPAIR KIT Cook, Inc. Silicone Rubber Radiopaque Dacron cuff 90cm long, 7,lOFr OD 90cm long, 12 Fr OD 65cm long, 4Fr OD 1 lumen 2 lumen Includes wire guide, introducer needle, peel away sheath, and catheter 1 lumen 2 lumen 1 lumen .... 2 1 um en 31.50 43.50 41.50 53.50 45.50 55.50 32.jQ 38.50 *Information supplied by ~anufacturer. List prices do not reflect actu~l purchase prices that may include volume discounts, special contracts, etc. **ODOuter Diameter

PAGE 38

.. ,~ ', 1, t c I APPENDIX B( 1) PARENTERAL FEEDING CATHETERS (cont.) ' :.,' CATHETER SCRIB,NER TYPE TRIPLE LUMEN MANUFACTURER COMPOSITION FEATURES Extracorporeal Silicone 89cm long lmmID* Arrow International Rubber Radiopqaque Polyurethane Dacron cuff 20,30cm long 16,18,18guage lumens PRICE [1977] 30.0G Color coded hubs 180.00 INFUSE A PORT MEDIPORT DUAL LUMEN DUAL SEPTUM MEDIPORT CORCATH REPAIR KITS Infusaid Corp. Cormed *ID~Inner Diameter Polyether sulfone plastic Silicone Rubber Stainless steel +dacron/ silicone rubber Same Silastic Elastomer Base-4.7cm Port ht-l.58cm 50.8cm long 2.3mm0D Radiopaque Wt-12.lgms Uses Infusaid or Huber needles Base-36mm IIt-l.4cm 50cm long Radiopaque Wt-20gms Uses huber needles 2 or 3mmOD Base-35.5mm Ht-14mm Wt~45gms OD-4mm(12Fr) 50cm long Dacron cuff Latex oversheath Luer lock Radiopaque 1)2.lmm(6Fr)OD 84cm long 2)3.0mm(9Fr)OD 90cm long 3)1.Smm(4Fr)OD 72cm long 4)Duel Lumen 4mm(12Fr)OD 91.5cm long color coded hubs .................. 250.00 325.00 475.00 35.00 37.00 45.00 48.00 40.00 26j

PAGE 39

C..\T:!ETER HE~ED CATHETER INTRODUCER CATHETER IIT REPAIR KIT PORTACATH QUINTON RAAF DOUBLE LUMEN SINGLE LUMEN PEDIATRIC SINGLE LUMEN REPAIR KI\ APPENDIX B( 1) PARENTERAL FEEDING CATHETERS (cont.) ., ~A~UFACTURER CO~POSITIO~ FEATURES Gish Biomedical Pharmacia Nu Tech Quinton Instrument Silicone lubber Stainless steel port Silastic catheter Silicone Rubber Silicone Rubber Silicone Rubber Luer lock, r3~io~a~~e Dacron cuif 5 sizes .. 1 lumen 2 lumen For placement of catheter Introducer, Tunneller Catheter .. 1 lumen 2 lumen ...... 1 lumen ........ 2 lumen Base-24mm, Ht-13mm 2 catheter sizes: 2,2.Smm OD Uses huber needles 84cm long, 4.SmmOD Dacron cuff Color coded lumens Radiopaque 89cm long Radiopaque Dacron cuff 2 lumen sizes 78cm long l.3mm0D --:: ,-..... .L l.., P;\rc::: 38-48.00 52.00 25.50 69-79.50 83.50 30.00 :iD* 330.00 55.00 35.00 45.00 60.00 *NDNo Data (in the material available from the manufacturer the price was not included). 26k.

PAGE 40

261. APPENDIX B(2) PARENTERAL INFUSION PUMPS+ ) I '' iJ. _!, 0 J_ PU:IP* MANUFACTURER LifeCare Abbott Model 4 Laboratories Cormed II Cormed, Inc. Ambulatory ML 6-8 (includes 2 rechargable power packs, plug in flow rate meter & power pack charger) IMED !MED #927, 928, Corporation 929 FLOW RATE 1-999 ml/hr 600-3000ml/ 24 hrs. AUDIO/VISUAL ALARMS Occlusion Dose complete Dose limit Air in line KVO* Low battery Low battery Low flow High flow Elec. prob. range: No data l-299to 1-1599 ml/hr WEIGHT & OTHER FEATURES PRICE++ 13 1 b s. 8-hr. 2,900 battery at jQ ml/hr.; cassette type 17 oz.; 48-hr. 1,425 5V rechargable battery; Vest-type support harness 150 Administra. set 6 Extension set 5 13 lbs. range: 2,600-3,950 -----------~-------------~-------------------------~-------~----------~-------IVAC #560, IV AC 565 Corporation Sigma 6000 Infutrol 6000 Infutrol 7000 SIGMA Valleylab, Inc. 1-999 Low battery .1-99.9 Low flow ml/hr Occlusion respectively .1-999 ml/hr 1-499 ml/hr .1-699.9 ml/hr Air/occ. Low battery KVO, high/ low rate, Cassette not in; Air/occ. Low battery System fail. KVO Above plus KVO off +Information supplied by manufacturer. 14 lbs. 10.2 lbs., separate piggyback settings 4-hr. battery 9.2 lbs., 10-hr. batt. life at 99.9 ml/hr Admin. set 11 lbs., 7-hr. battery ,pt. occ. monitor 2,795 2,495 1,895 7.45 2,495 *Pumps run on AC current or can be used on rechargable battery generally included with pump. In additi~n to pump an IV pole is required and several "disposables" --a filter, an IV administration set and casette, and an extension set of tubing so patient can have some freedom of movement (particularly important if sleeping). ++List prices do not, of course, reflect actual purchase prices that may include volume discounts, special contracts, or what is allowed and actually paid by third party payers. Pumps can also be rented on a monthly basis. **KVO=Keep Vein Open.

PAGE 41

SOLUTIONS DEXT~OSE AMINO ACIDS APPENDIX B(3) PARENTERAL SOLUTIONS* COMPANY TRAVENOL 10-i0~ ... lL ..... glass . . . . . . . . . '.,, i a l. e :( 5% w/.9%NaCl lL 1 0 % w / 9 % N aC 1 5% w/RINGERS 5% w/LYTES 5% w/ 40mEq KCl ABBOTT 10-70% part fill(500ml/1) 50% lL glass plastic 70% lL glass plastic 5% w/ .9% NaCl 5% w/ LACTATED RINGERS IONOSOL-10% w/LYTES s: w/40mEq KCl AMERICAN MCGAW 5,10,20,50% ....... SOOml 5% w/20,40mEq KCl ....... 11 5 % w / 9 % Na C 1 : 1 L 10% " ......... lL 5% w/.45% NaCl,'.40mEqKCl ... lL Lactated Ringers ... lL ... w/5% dex Ringers ..... .............. lL TRAVENOL TRAVASOL ........... lL 5.5% AMINO ACIDS w/ LYTES 8 5 % 10 % 8.5% TRAVASOL KIT incl. 50% dex-500ml/1000ml transfer set, additive cap .... w/ LYTES ....... w/o LYTES ABBOTT AMINO SYN .......... 1 L 3.5% AMINO ACIDS w/LYTES 8.5% ............ (l/2L) 8.5% AMINO ACIDS,NO LYTES 10 % AMERICAN MCGAW 26m. PRICE r 9 1 :. .l. ..... -.-, ~.:~-l .. ,,. :; C.i. ,.., J 5.42 6.li 6.16 7.68 7.46 5.77-14.85 14.33 17.54 17.82 21.80 5.49 6. 18 8.i2 7. 12 [.l.,-:-..-.;;~1 .. --.. 5.51 7.75 5.97 6.85 7.75 6.21 6.74 6". 19 (1984] :50.02 66.00 74.70 47.69 44.69 25.33 33.57 63.94 72.95 Freamine III Kit 8.5%,l/2L freamine, lL w/ 500ml 5% dex, trans set, add. cap 46. 71 Freamine III 8.5~ ....... lL 10% lL Procalamine 6S.43 78.0i 3% AA, 3% glycerin w/LYTES .. lL *Information supplied by manufacturer. 30.47

PAGE 42

FAT EMULSIONS -TRACE ELEMENTS APPENDIX B( 3) PARENTERAL SOLUTIONS (cont.) ;; !~ .:. 0 :] TRAVENOL TRAVAMULSION ........ SOOml ABBOTT LIPOSYN 10% SAFFLOWER; 1.2% EGG PHOSPH AT!DES, 2.5% GLYCERIN IN H20 10% ... SOOml 20% ..... 500ml [ABIVITRUM INTRALIPID 10% 10% soybean .. 250,SOOml AMERICAN MCGAW IV FAT 10% .. SOOml 20% . 250ml AMERICAN QUININE MTE ....... lOml Znlmg,Cu.4mg,Cr4mcg,Mn.lmg/ml MTE CONCENTRATE 10ml ZnSmg,Culmg,CrlOmcg,Mn.Smg/ml PEDIATRIC MTE 10ml Zn.5mg,Cu.lmg,Crlmcg,Mn.03mg/ml ZINC SULFATE Smg/ml ........ 5ml lmg/ml ... lOml TRAVENOL MTE 3ml . 10 ml ZINC lmg/ml ...... lOml ABBOTT MULTIPLE TRACE METALS Zn4mg,Mn.8mg,Culmg,Cr10mcg 5ml AMERICAN MCGAW MULTIPLE TRACE ELEMENTS Znlmg, Cu.4mg, Mn.lmg, Cr4mcg .. 10 ml ZINC SULFATE lmg/ml lOml LYPBOMED MTE-2 (Znlmg,Cu.4mg) 10ml MTE-3 (+Cr4mcg) .. 10ml MTE-4 (+Mn.Smg) lOml MTE-5 (+Se60mcg) .. 10ml MTE-6 (+Iodine75mg) 10ml Neotrace 4 ........ 2ml PTE-4 (s1 higher) .... lOml ZINC SULFATE [1984] 32.36 30.78 46.11 ND* 30.75 28.47 6.60 9.60 7.60 2.80 1 12 [1984] 2.02 5.94 1.84 2.14 5.94 1.89 3.30 4.40 5.50 12.75 14.86 4.32 11 45 Smg/ml. .............. lOml 6.86 lmg/ml ............... lOml 1.45 26n. *ND=No Data (in the material supplied by the manufacturer the price was not included).

PAGE 43

ELECTROLYTES SPECIAL FORMULAS APPENDIX B(3) PARENTERAL SOLUTIONS (cont.) ;_~ :_ (:_ C~ ARMOUR PHARMACEUTICALS :I'CLTITRACE ~-i ULT IT RACE CO )i C :IUL TI TRACE PED ~lU LT I TR ACE -5 :-; J ~:AMERICAN QUININE POT CHLORIDE . 20 mEq/lOml .. 40 mEq/ 20ml CA GLUC 10%(.465 mEq/ml)lOml MAG SULFATE 50%(500mg/ml)2ml LYPHOMED CA GLUC.10% .. lOml LYPHOLYTE-mult. lytes 20ml MAG SULFATE 50% ... 2ml POT CHLORIDE .... 40mEq/20ml TRACELYTE lytes/trace elements ..... 20ml ARMOUR PHARMACEUTICALS MVI-12 2-5ml vials MVI-12 LYOPHILIZED reconstitute with 5ml water MVI-PEDIATRIC 10ml MVI higher formulation for 9 4.00 5.70 5.00 2.40 .75 4.70 .42 5 2 8.iO vitamins 10ml ND* ROCHE SYNKAVITE Synthetic H20 soluble Vit K analog .... Smg/ml-lml . lOmg/ml-lml .... 75mg/ml-2ml ND* AMERICAN MCGAW 6.9% FREAMINE-HBC 45% BCAA (12:1 BCAA:AA ratio) for trauma, sepsis 750ml/1000ml 8.0% HEPATAMINE 36% BCAA (37:1 BCAA:AA ratio) for liver disease .... 500ml 5.4% NEPHRAMINE for renal disease ... 250ml TRAVENOL RENAMIN for renal disease ........ 250ml 54.50 62.50 41.59 39.38 260. *ND=No Data (in the materials available by the manufacturer the price was not included). l/0

PAGE 44

TASI 2. UTILIZATION OF NUTRITION SUPPORT (NS) {i~ 0 __ OJ THE UNIVERSITY TEACHING HOSPITAL From February to June of 1984, a sex and age stratified random sample of inpatients age 65 and over was studied at the 725-bed Albany Medical Center Hospital, the principle teaching hospital of Albany Medical College, Union University. Data was collected on 96 subjects, 64 women and 32 men. Twenty-five percent (24) of these patients received tube delivered enteral feeding or intravenous (IV) nutrient solutions* or both. Specifically this included: 71% (17) t~be feeding only 17% ( 4) tube feeding and IV nutrient solution 12% ( 3) IV nutrient solution only Characteristics of the Patients Who Received Nutrition Support There was no evidence that NS was determined by payment status for: 67 had Medicare only or Medicare plus private insurance and of this group, 16 (24%) received NS 28 had Medicaid or were Medicaid eligible and of these, 8 (29%) received NS *The IV support included peripheral and central line infusions. In general, peripheral infusions can only be done for a short term and the intravenous solutions must be of low concentration. However, central vein infusion can be done indefinitely and the solution can be more concentrated (see Task 1, Parenteral Techniques). ~, 27.

PAGE 45

,"\ i; : There was a trend toward decreased utilization with age: Age 63-69 70-74 29 (31!) received NS 19 (21~) received XS i5+ 48 (21%) received NS However this trend was not statistically significant. The 96 patients were evaluated on 4 different functional rating scales from the Functional Assessment Inventory (FAI).l r: ( r~ .-, I I As can be seen in Figure 1 the social resources of those receiving ~Sand those not receiving NS were rated to be similar; however mental health, physical health, and the activities of daily living, a scale which measures the ability to live independently --all showed greater impairment among those receiving NS as compared to those who did not. (A FAI economic assessment of these patients was not done because of concern about confidentiality.) The diagnoses in the 24 patients receiving NS were: 11 (46%) central nervous system damage 7 cerebrovascular accidents 1 brain hemorrhage due to head injury 1 spinal cord injury 2 brain tumors 5 (21%)-carcinomas with local or metastic bowel involvement 8 (33%) --complex medical (4) or surgical (4) conditions .... In comparison only 4 ( ,..':'7\ J 0 ,0 / rec ei : e c no .,~ ::au central nervous system damage (2 had cerebrovascular accidents, 1 28.

PAGE 46

(; I '' r~ ,. .. ) , -/ I had Parkinson's disease and 1 had a brain tumor). Fifteen (21%) had carcinomas of various types. Diagnoses that appeared markedly more prevelant among this group than the NS receivers were heart and respiratory diseases and mental disorders. Impact of the Nutrition Support In 61 of these 96 patients, anthropometric studies were done allowing us to calculate a ~ody mass index (BMI)2 which is thought to be the single best measurement for determing desirable weight (weight in kg/height in cms2). Of the 15 patients receiving nutritional support in this sample of 61, 1/3 were within the normal BMI rang~, 1/3 were above and 1/3 were below. Thus only 1/3 of the group receiving NS were malnourished as determined by BMI. In the 46 patients not receiving support, most (56%) were within the pccmal range and just 11% were malnourished. Since nutritional assessment was done once and not at the onset and conclusion of NS, this descriptive study cannot determine if there was any benefit from the therapy as demonstrated by improvement in body composition. Half of the 24 patients who received NS died within one year of the study. Their average survival time from the beginning of their hospitalizations (which did not necessarily coincide with the beginning of the study) was 184 days (SE 39) and ranged from 11 to 530 days. A breakdown of the amount of nutrient support ordered for 22 of these 24 patients indicated that 45% were prescribed mere than 1 5 0 0 ca 1 o r i e s of n u t r i en t s u p p o r t v i a tu b e o r c e n t r a 1 \' e i n T !1 e 29.

PAGE 47

:' I , t' : \ f_j : t ,J I ) remainder were prescribed less than 1500 calories via tube or ?eripheral vein. Specifically, the patients' records indicated: 41~ (9) prescribed <1500 calories via tu~e 9% (2) prescribed <1500 calories via tube and peripheral IV 5% (1) prescribed <1500 calories via peripheral IV 27% (6) prescribed >1500 calories via tube 9% (2) prescribed >1500 calories via tube and central IV 9% (2) prescribed >1500 calories via central IV Length of Stay and Outcome Hospital stays for these 96 patients had a bimodal distribution with a cutoff between the curves at about 40 days. Looking at. the patients in terms of long and short hospital stays shows: Short stay (40 days or less): No NS 42 (58%) average stay 17 day NS 4 (17%) average stay 26+4 days Long stay (41 days or more): No NS NS 30 (42%) range 41-730 20 (83%) range 41-772 These differences are highly significant (p<0.002) and like the ~unctional ratings point to the fact that patients who received NS were tn general sicker. None of these patients were discharged on nutrition support. One tube fed patient had been in the hospital for 722 days at the time of study, reflecting the frequent difficulty in ~ew York State of transferring a patient 30.

PAGE 48

:'. ,~ ,~ ,, t' 'J ii J .I J ..,I with extreme need for physical care from an acute to a chronic health facility. Outcome for the nutritionally supported looked as follows: 14 (58%) were discharged home 6 (25%) died in the hospital 4 (17%) were discharged to a nursing home Of those 18 who left the hospital, 5 (27%) had at least one further hospitalization and 6 (30%) died during the one year followup period. Discharge data was avialable for 54 of those not receiveing :{S Of this group: 39' (72%) were discharged home 9 (17%) were discharged to a nursing home 4 ( 7%) were discharged to another hospital 2 ( 4%) were discharged to a hospice During the follow-up per.iod, of those so who left an acute care setting, 23 (43%) had at least one more hospitalization and 7 (14%) died. Indications for or Against the Use of NS in Elderly Patients In general the indications for use of NS in the hospitalized elderly are the same as for younger patients and can be summarized as follows: 1. Evidence that the patient is malnourished or is at risk for developing malnutrition and cannot be restored or sustained by simpler oral feeding approaches. 2. Evidence that the patient would benefit physically and/or psychosocially from aggressive nutritional support. 31.

PAGE 49

{'\! .'' ,~ I "\ In other words it should be possible to demonstrate tha~ tti patient stands to benefit from this expensive intervention and it is not an excercise in futility. On occasion benefit is not easy to gauge at the outset and NS is begun to prevent worsening of the prognosis until the clinical picture is clearer to the patient, their family and the health team. At the point that outcome can be assessed it may be appropriate to "back off" from NS, if the benefit is perceived by all involved to be negligible. Cost is never, in our experience, a determining factor. What does happen, particularly with tub~ enteral feeding, is that it can switch from being a treatment that is medically indicated for rehabilitation to being baseline support or a hygienic measure. In the terminally ill bed-ridden patient it helps prevent bed sores and by maintaining immune function prevents intercurrent infections. Since an intercurrent infection may be the "natural" event leading to death in severely ill patients, the concept of "preventing" such an outcome is a difficult ethical decision which probably should bea reflection of the patients and their families wishes on a broad societal basis. It is not truly a physician decision. From the data currently available from this university hospit~l study it seems likely that: 1) NS was instituted in the more chronically debilitated, sicker patients. 2) The XS may have been used in a variety of illnesses ~here nutritional intake was at least acutely a problem, rather than 32.

PAGE 50

n I' ,, _', I \. ',.1 -..t 1. the more specific gastrointestinal disorders characteristic of long-term NS in home patients. Presumably in such far-reaching treatment decisions there is a more precise defir.ition of clinical benefit. 3) NS via a central line was a more certain medical decision that was done with planning and follow through, whereas tube feeding and peripheral IV feeding was more often token (under 1500 calories). This study did not clarify whether the nutritional support truly influenced outcome. Alternatives to NS Encouraging the patient to eat a general or modified (full liquids, mechanically soft) diet is usually tried before resorting to parenteral or enteral feedings. Often the help of family or friends is elicited, especially if hand feeding is necessary or home cooked food is more appealing to the patient. Obviously this approach breaks down if there are no family available, for hand feeding is highly labor intensive and can easily fail because of staffing shortages. Staffing limitations may therefore dictate the introduction of tube feedings or even peripheral vein NS. It is unlikely that staffing considerations determine the more major decision of initiating central vein feeding, except in so far as this can only be safely undertaken in some areas of the hospital and moving the patient to such a location may depend on availability of beds and trained staff. Consent The need for consent of the patient does vary according to the method of feeding used. Nasogastric feeding generally 33.

PAGE 51

requires only tacet consent. Intravenous lines placed in limbs similarly requira on:y tacet consent and ca~ acco~~odate ~~:=~e~c solutions of low concentration. Central lines a~d :~ta: parenteral nutrition does require written consent of the patient, next of kin, or legal guardian, as does surgical placement of a gastrostomy or jejunostomy feeding tube. Supply and Equipment Storage The supplies, equipment and storage requirements related to nutritional support do not present any special procedures beyond the customary hospital rules and protocols. At the Albany Medical Center Hospital parenteral sol~tions arestored in the pharmacy. Typically they are mixed according to a patient-specifi~ formula by the pharmacist on a daily basis under appropriate procedures in the pharmacy IV area: transported to the floor, and stored in a refrigerator and administered by nursing staff during that 24-hour period. Tubing and cassettes are stored on the floor with additional stock stored in the pharmacy (tubing) or central supply (cassettes). Pumps are stored in central supply and ordered by the floor as needed. Occasionally there are spot shortages of pumps as they are used for infusing other solutions or are not returned to central supply but kept by floor personnel to make sure a pump is available if needed. In some institutions IV controllers (devices that control number of drops) are used to regul~te the infusions when volumetric pumps are not available. Enteral formulas are treated ~ore as food a~d stored in a kitchen on the floor. Formulas that come ready to use from the 34.

PAGE 52

{', .' ft '. = ") 3 5 1.,,,, __ .i.,;;J can are opened and administered by nursing staff. Those that need to be mixed are prepared on a daily basis by hospital dietary staff in clean, disposable containers and then transferred into the enteral feeding containers by nursing staff. Both the canned and powdered enteral products need to be mo~itored for shelf life. Enteral pumps are ordered from central supply and in the Albany Medical Center Hospital the supply seems sufficient to cover the demand. Notes 1. Pfeiffer E, Johnson T, Chiofolo, R: Functional assessment of elderly subjects in four service settings. J Am Ger Soc 29:433-437, 1981. 2. Thomas AE, McKay DA, Cutlip MB: Monograph for body mass indes (kg/m2). Am J Clin Nutr 29:304, 1976. -Y?

PAGE 53

1-'ig. 1. Functional Slatus Ruting Scale Scores of Paticul ! Kcndving aud Nol keccivg N:; PERCENT LO !JO 40 JU tJ ,~--, u PERCENT LO -J(j I I i .JI / . / / ', / 1 / /;,; L ..... -MENTAL HEALTH I PHYSICAL HEALTH !i W1 I, b j ",/ / / I / :,'. -_~l !I ,., I, PERCENT l,O JO PERCENT 40 Ju ,'U [j ~10 1-1 I lll:H, .i111:,,H IN -I ii ~)-:JuEu 1~11, 1 t 1 ,1_141~ L '. ~lll'PIJII I tfl ''Ii ... SOCIAL RESOURCES ] I::: -1 ACHV I TIES OF OA IL Y LIV I Nt, I I I : ,,. >.

PAGE 54

,, ' : l'L, ; I I_ -A.. ,J TASI 3. UTILIZATION IN THE NURSING HOME Systematic data regarding use of enteral feeding supplements and intravenous nutritional support in nursing homes are unavailable. However, information from a single 200-bed skilled nursing facility will be presented here along with the nutrition support results from a systematic study of nurses attitudes toward use of this and other medical interventions. Currently, 7 of 200 patients of the Daughters of Sarah Nursing Home in Albany, New York are receiving gastrostomy or jejunostomy feeding. None are receiving intravenous nutrj~ional support or continuous hydration. Two of the patients are young women, ages 52 and 57, who have severe multiple sclerosis, one of whom is within apd the other above a calculated ideal body weight range (based ?n figures from Master et al).1 The other 5 individuals are between 77 and 91 years of age with severe dementin~ .llness, tubes having been placed at the time of acute hospitalizations for strokes, septicemia, and in one case surgical removal of meningioma. In the last year, one of the authors (M. Wolff) is aware of 4 cases where the family of a severely demented individu~l declined to consent to the placement of a feeding gastrostomy. In all cases, the family consulted a clergyman as well as health care professionals before deciding against tube placement. The legal and ethical questions regarding nutritional support were reviewed in a series of three articles in the Archives of 37.

PAGE 55

', .. ft : .! '"' \_, :~ _._ l. u Internal ~edicine.2-4 Opinion generally divides based on ~hether artificial feeding is considered a raedical in~er~e~t~0n, analogous to medication use, or a custodial duty, a~al~g~~s co the provision of basic hygienic conditions. In the former argument, futile treatment may be withheld or withdrawn. In the latter, basic sustenance must always be provided regardless of prognostic or quality of life considerations. A revealing survey was completed at the Daughters of Sarah Nursing Home (see Appendix A) by Wolff et al. Head nurses of the facility were asked to complete questionnaires regarding whic~ ~ed~c:l interventions they considered too ag;ressi~e ~or ~CC 0~ the 200 patients. Questionnaires were returned for 98 patients. Similar questions were asked regarding 20 patients who had died in the p~ior year. The data pertinent to this report are displayed in Table I. The nurses considered intravenous therapy too aggressive in 42% of the current residents, increasing to 47: if these residents were hypothetically to become immobile and to 66% if they were hypothetically to become comatose. Nasogastric feeding was less frequently considered inappropriate: 31: of current residents, 32% if permanently immobile, 46% if comotose. Basic nasogastric hydration was considered inappropriate only rarely: 11% of current residents, 11% if permanantly immobile, 22% if permantly comotose. Although tube feeding is ofte~ given via permanent gastrostomy or jejunostomy tubes, the figures for nasogastic feeding would probably be c:rnparable with some positive bias toward use of the treatment. 38.

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. i / : ,, . n. 7 I _,:_ .l. Looking in detail at 11 patients whom the nurses would not wish to give even nasogastric hydration and 3 others in the group of deceased patients, all had chronic neurological failure. The most common feature was the perception by nurses that these individuals were depressed (12 of 14, 86%). Hence, a qualityof-life based preference was being enunciated by the nurses. It is interesting, and important from a governmental perspective, that if these findings are extrapolated to this nursing home's entire patient population, the 11 living patients to whom the nurses would prefer not to provide nasogastric hydration represent only a small fraction, 18%, of the home's intellectually impaired individuals. Notes: 1. Master AM, Lasser RP, Beckman G: Tables of average weight and height of Americans ages 65 to 94 years. JAMA 114: 125-128, 1985. 2. Dresser RS, Boisaubin EV: Ethics, law, and nutritional support. Arch Intern Med 145:122-124, 1985. 3. Meyers DW: Legal aspects of withdrawing nourishment from an incurbly ill patient. Arch Intern Med 145:125-128, 1985. 4. Seigler M, Weisbord AJ: Against the emerging stream: should fluids and nutritional support be discontinued? Arch Intern Med 145:129-131, 1985. 39

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;_, ,-, .' ,... ,_. -..l. :J TABLE I Percent of patients where treatment is considered "too aggressive" for nursing home patients based on their current status and in hypothetical circumstances of total immobility or total .unresponsiveness (n=93) Current Status If Immobile If Unresponsive Nasogastric 11 11 22 Hydration Nasogastric 31 32 46 Feeding Intravenous 42 47 66 Fluid or Medication 40.

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Appendix A 41 a. J\lledical Ethics and Humanities Treatment Decisions in a Skilled-nursing Facility: Discordance with Nurses' Preferences Michael L. Wolff, MD, Susan Smolen, BS, and Linda Ferrara, AN Hospitalization transfers from a skilled-nursing facility were studied. A hierarchically arranged questionnaire on acute medical deterioration and treatment aggressiveness was used to study the degree of discordance between the transfers actually made and the preferences of nursing home head nurses. According to the nurses, 37 per cent of the patients involved should not have been hospitalized even under the most compelling circumstances; however, 76 per cent of this subgroup had in fact been hospitalized under physician's orders. The nurses would have refrained from instituting any new treatment in 14 per cent of the cases, all of which involved chronic neurological impairments; 36 per cent of this subgroup had nevertheless been hospitalized in the 12 months prior to the study. J Am Geriatr Soc 33:440, 1985 The transfer of nursing home residents from nursing home to hospital is the key step in determining the extent of medical intervention. There has been very little published on the ethical issues involved, although Besdine raised the issue systematically at the 1983 annual meeting of the American Geriatrics Society and subsequently in that society's journal. 1 Case law is rather confusing to the practitioner, 2 and the extent to which legal guidance must be sought varies from state to state and is inconsistent in application. Attempts have been made to anticipate acute illness and to designate treatment status of patients in nursing homes. 3 In addition, ethics committees have been used to make decisions in difficult cases, allowing interaction of staff members, family members, clerics, and lawyers in the consideration of subacute and chronic treatment. 4 Hilfiker has de scribed the physician's dilemma poignantly, and the spirited letters written in response to his de scription outline many of the limitations of our cur rent health care system. 5 6 Recently, an affiliation between the Daughters of Sarah Nursing Home, a voluntary, nonprofit skilled-nursing facility, and Albany ~ledical College has been formed. This has allowed the collection of information from charts and from questionnaires Assistant Professor and Head. Section ot Geriatric Medic:ne. "lbany Medical College. and Daughters of Sarah Nursing !-tome. Albany, New York. Address correscondence and reprint ~eQuests to Dr. Wolff: Section of Geriatric Medicine. Albany Medical College. Albany, NY 12208. completed by nurses and families regarding deci sions to transfer patients to a hospital or to refrain from transferring patients with acute medical deterioration. This study was undertaken as a review of practices during the year prior to the affiliation of the institutions. The purpose was both to perform a systematic audit and to provide a standard against which to compare future practices in terms of documentation, family satisfaction, health out come, and hospital utilization. It was also necessary to develop a base of information on recent practices in anticipation of both life-protective and utiliza tion-minimizing constraints, which are certain to create increasingly grave ethical conflicts for the medical practitioner in the years ahead. \Vhile very few decisions were made to treat life threatening illnesses in the nursing home setting, the decisions to hospitalize patients appeared to conflict frequently with attitudes expressed by the five head nurses of the facility. This area of dis agreement is the focus of this report and is of par ticular importance because nurses are the profes sionals charged with identifying any deterioration of patients and initiating the transfer process. :\Iethods SUBJECTS The Daughters of Sarah Nursing Home is a vol untary, nonprofit skilled-nursing facility that ac cepts patients without regard to source of payment. There are 200 beds divided into five nursing units. ,,, J:S.

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June 1915 BEST COPY AVAILABLE One hundred fifty residents are classified as requiring total care. and 125 residents ,1re dia~nose
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I ...S WOLFF:TAL. TABLE 1. Hospitatization Considered Appropriate by Head Nurses Current Patients (N 98) Current If If Condition Immobile Unres0ons1ve Symptom n(o/o) /1 (%) ,"J (%) GI bleeding 62 (63) 53 (54) 13 (13) Unresponsiveness 45 (46) 37 (38) NA Aspiratton 36 (37) 31 (32) a (Bl Joint pain/swetling 36 (37) 17 (17) 4 (4) Seizure 31 (32) 19 (19) 4 (4) Fever 24 (24) 10 (iO) 3 (3) Htmaturta 21 (21) 9 (9) 3 (3) Arrest 19 (19) 12 (12) 3 (3) Hypotension 16 (16) 4 (4) 3 (3) =; n : .-, l_. ; ,} -...... 1. gressive for .55 per cent of patients at their current ability levels, for 72 per cent if immobile, and for 95 per cent if unresponsive, suggesting that he modvnamic stabilization without transfusion ,~uld be the nurses' goal for hospital transfer m a fr~dft,h of instances. The scores for treatment aggressiveness similarly declined with hypothetically decreasing functional status. On average, he:.1d nurses felt that the pa tients either at current functional status (interven tion score = 3. 9i, range 1-10) or immo~ilized (3.39, range 1-6, x2 = 4.90, p < 0.03 versus current status) should receive intravenous fluids or medication, if necessary, but not transfusions, and that they should not receive even intravenous fluids if rendered unresponsive (2. 75, range 1-5, x2 =6.54, p < 0.01 versus immobilized). Only the of nonterminal illnesses for the living and the deretrospectively considered deceased patients who ceased subjects was trivial. Overall. the organ syswere hypothetically unresponsive were consistems affected were as follows: musculoskeletal (25 tently judged as not warranting nasogastric nutriper cent), cardiovascular (19 per cent), gastrointestion, though the head nurses felt that even these tinal (1 i per cent), respiratory (16 per cent), and individuals shculd bP given nasogastric hydration. others in smaller proportion. In approximately 30 For only 31 living patients could head nurses conper cent of instances, discussious with family memceive of an instance in which termination of treatbers were not recorded in the nursing home charts. ment would be appropriate. However, dialysis was All of these instances were accounted for by the considered inappropriate in 97 per cent of cases at fact that notification occurred after hospitalization, current functional status, and bronchoscopy, en-according to the families. Spouses were rarely condoscopy, and intubation were considered;approsulted, and offspring were frequently consulted. priate in 82 per cent. All four of these procedures The family's reaction to treatment decisions was not were considered universally inappropriate in the recorded in 78 per cent of instances. There were retrospectively considered deceased individuals. three instances in which family disagreement was Nurses considered themselves and the physicians noted in the charts, and families reported an ad-to be the best judges in 23 cases, and the family ditional four instances of disagreement (3.3 per members-in consultation with nurse and physicent). In only seven instances was a choice made cian-to be the best judges in 17 cases. For half to keep a subject in the nursing home, and in only the cases, the nurses stated they would advocate four instances was a decision made not to institute their position, if in disagreement with the family's, new treatment. The head nurse o{ the home was to the physician, and for an additional fifth of cases the most frequent notifier of families. they said they would advocate their position to both The nursing questionnaire was remarkable for the family and the physician. Only one patient had _revealing a more conservative treatment orientaa formally designated "do not resuscitate" status. tion than was apparent in actual treatment activiThis patient also should not have been hospitalized, ties. Because of change in head nurse stair, this according to the family, although she was hospitalquestionnaire was answered regarding only 98 of ized on one occasion against the family's wishes. the living and 1 i of the deceased patients. Table 1 Transfer appropriateness and treatment intensity shows that of the living patients, a maximum of 62 opinions did vary from unit to unit. This appeared subjects (63 per cent) were considered to require to reflect the prevailing functional status of patients hospitalization under the circumstances described. on the individual unit. Three of the five units have Conversely, for 37 per cent of living patients, the consistently had patients with greater-than-normal head nurses considered hospitalization inapprocare requirements admitted. This is reflected in priate under the circumstances described; this proaverage D~lS-1 scores ranging from ,316 = 5.3 SD portion increased to 46 per cent with the hypoon the most intensively staffed unit to 320 = 1~8 thetical circumstance of total immobility and to 87 SD on the least intensively staffed unit. Of interest, per cent with the circumstance of unresponsiveagain, is the fact that hospitalization was sometimes ness. At all three disability levels, gastrointestinal felt appropriate even though the specific treat-bleeding provided the most compelling impetus for ments likely to occur in hospital were felt to be too hospitalization. Transfusion was considered too agaggressive. dt-.Sf COPY AVAILAtiLE . ... ,--. "' --. 41 C.

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::: --'""r "()PY AVAJ LA3LE Of 3i living patients whom the nurses would not have hospitalized under the most compelling cir cumstances, 28 (:"6 per cent) had in fact been hos pitalized for acute illness occurring in the nursing home. Eleven I JO ~e!" cen t.1 of these hospitalizations were for falls and acute ~usculoskeletal ~rauma. inciuding two for orthopedic surgery and :1ve :or ~recautionary :<-rays on.iy despite opposing opin ions on the .. joint pain1swelling .. item). ~ine of the 36 individuals whom nurses would not have hos pitalized for gastrointestinal bleeding had, in fact, been hospitalized for gastrointestinal bleeding. Of 14 patients for whom nurses would have fa vored no new therapy (score of l on the treatment intensity scale), all had chronic neurological failure and 9 (64 per cent) were incontinent. On the DMS-1 behavioral scale, ten (il per cent) were some times agitated, five (36 per cent) were sometimes assaultive, eight (57 per cent) were verbally abu sive, and 12 (86 per cent) were depressed. Overall, the results for deceased patients ap ;eared to be similar. but ehe retrospective data were feit to be potentially so influenced by the known prognosis (i.e., death), that they are not reported here in detail. Discussion The results of this survey are interesting on sev eral counts. The relative concordance of treatment decisions with family wishes is reassuring, as is the good reporting, by family members, of appropriate notification by the staff. The fact that spouses were rarely consulted before hospitalization was principally a reflection of the fact that the overwhelming majority of the home's patients are widowed females. The contrast between actual practice and nurses' perceptions of what would be the appropriate in tensity of care is a matter of concern. It reflects a prevalent ethical disquiet on the part of tlie health professionals who provide most of the daily supervision of elderly nursing home residents. It is unclear whether the physicians involved felt similar conflicts, but the fact that onethird of transfer de cisions had been made before consultation with families implies that physicians continue to pre sume in favor of more intensive treatment and that families, subsequently, concur in such a presump tion. Since head nurses were queried retrospec tively. it is quite possible that :hey would have acted as the nurse on duty acted. i.e., that they would have notified the physician and accepted the decisions made without documented disagree ment. Whether staff nurses or nurse's aides would concur with the head nurses has not been studied. These data do demonstrate, however, that the conTREATMENT OECISICNS !NA s1~t;7u~t~ ;~c:L1i'f 4 l d l I ,. .. ~"" sidered preferences of the senior nurses of this fa. cility were at variance with many of the actions taken. In many instances :t appears :~at ~hese :1ur.ses oppose hospi taliz:ition oer ;e. J..S evicenced oy the ~ac .. "'h..,t .:l\en ,.'no fT~ -i ~,., .. ,~ .. ,__ ,-,:::. ~t., ........ ,.-:.._,. .. ~. I.; ,. u~.:.i .... e inc-:-. :,.,.-Jr _:i .. .;' .. : appropriate b~: the nurses :s ;er1er:ili> ~~~:one :::e use oi intravenous substances. :he nurses .vould not wish to transfer roughly one-third of this pa tient group. The converse was true in other cases. perhaps reflecting a perceived need for bedside monitoring (tii:, gastrointestinal bleeding), which is difficult to provide on a low-intensity unit. Since the diagnostic and laboratory technology and staffing levels required to support intravenous ther apies are among the distinctions behveen nursing homes and hospitals, lower-technology hospital set tings or higher-technology nursing :iome settings may be appropriate for selected ;,atients. In lddi tion, falls and trauma a.ccoun teci :or a :hirci oi hos pitalizations that the nurses mig.:,1 Jthe. vis.> hav,e opposed. Half of ~hese were :er ~recaucionary xrays and might well have been r,revented had a physician or physician-extender been available a.t the nursing home at the time of injury. The lower preference for intervention in the presence of immobility or unresponsiveness demonstrates that the nurses of this facility do consider quality of life when forming opinions about appropriate treatment. However, the high rate of perceived depression in individuals for whom nurses wish no new treatm'ent implies that the nurses' views are motivated by their perception of indi vidual suffering rather than judgments as to individual worth. As Avom has pointed out, such ~econdary judgments regarding quality-adjusted'' life may be hazardous and may seriously underestimate the patienf s own perception of life's worth even when life entails substantial suffering. 7 There has been no formal attempt, as yet, to validate the scales used. These results have been presented to the head nurses and stat!' nurses in the nursing home. They unanimously agree that the findings presented herein do reflect their feelings. They concur that nurses have in fact not expressed disagreement with decisions. despite the implication made by the results of the questionnaire that they would have done so. They also express ~he belief that many unnecessary hospitc1iizations occur. after diagnostic work-up is compiete. because of a lack of knowiecige on :he ;,art :Jr emer gency room personnel JS :o :he inter:ent1oris pos sible and the quality of personnel available in the skilled-nursing facility. In addition. the question naire item relating to "termination'" of care was felt to be ambiguous (see Appendi-<:). The selection of the patients for less intensive JC'."" '.'I'"""--~---.... -.:,f

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treiitment is the nuh of the <1uestion. It is unfor tunate that we w~re unable to question the patients, but ,lpproaching even family members is dif ficult. \Ve ,ire currently convening a panel to con sider what approach may be appropriate in the future .. -\ systematic survey of the patients will require careful consideration. :\-1any of the mentally fit nonagenarians have spontaneously said that they do not wish to go to hospital, but others have found these questions to be abstract, even in. the midst of a situation in which the decision must be made expeditiously. \Vith regard to families, more intensive education on the ramifications, in terms of help and suffering, of high-technology interventions and a systematic approach to treatment intensity issues on or shortly after admission may prove beneficial. J Anecdotally, adult children of intellectually im paired patients appear hesitant to request that technological inte~ention be limited and generally do so with fear of criticism from the medical staff. There are no systematic data available to suggest whether families or staff members might feel differently in a nursing facility drawing more heavily on an impoverished population. We were also unable to poll the physicians on a patient-by-patient basis, but it is clear from discus sion that all of the current and past physicians of this facility have felt uncomfortable, in certain instances, with the intensity of treatment toward which they felt impelled. The current setting is illsuited to the formal study of physicians attitudes because of the small staff and the fact that, since the academic affiliation of the home began, one of the authors (~1'V) either has had or currently main tains medical responsibility for nearly two-thirds of the home's patients. There has been some evidence in the literature regarding an increasing tendency of academically ba!ed physicians to omit life-prolonging treatment for terminally ill patients. 8 TI1ere is also evidence that some 6 per cent of febrile patients in community nursing homes have had antibiotics omitted, with frequently fatal outcome, apparently by intent, in severely debilitated individuals. 9 Wanzer and colleagues have taken a clearly stated position with regard to the "levels" of treatment that mav be delineated for individual patients.10 They emphasize a physician's responsi bilities and relative autonomy. Their assertions are not, however, universally agreed on or c:.irefully buttressed by philosophical argument. They do provide soma solace to members of the medical profession, for whom these issues are not abstract but rather the subject of daily concerned applica tion. 41d. Summary This study quantifies the discordance between treatment locus decisions actually made on behalf of patients in a skilled nursing facility and treat ment locus preferences subsequently expressed by head nurses. Such discordance is of substantial magnitude, as demonstrated by use of a hierar chical questionnaire technique. Aclmowledgments The authors wish to acknowledge the int !rest and suoport ~f a,e nurses ot the Daughters of Saran Nursing Home: Sheldon Tocin, PhO, and Liva Jacoby, PhO, for their helpful advice on the mar,uscript: Mr. David Phillips and the University of Cincinnati tor :omputing support: and Ms. Eugenia Van Zorge for her excert :1ericat and grammatical assistance. References 1. Sesdine ?.W: Dec:s1ons to withhold treatment from riurs1r.g nome residents. J Am Geriatr Soc 3, 602. i 983 2. Doudera AE. Peters JO (ecs): LegaJ ano :~h1ca1 Ascec:s :r Treating C:it1ca1ly and Term,natly Ill P3t1erits. Ann Arcor ~v11. Hea1th Aom1nistration ?ress. 1982 3. Levenson SA. List DL. Zaw-w1n S: Etti1ca1 cor,s1cerat1ons -n crit ical and terminal 1ilness in the elderly. J Am Gerratr Sec 29:563, 1981 4. Weisman S: A nursing home's exoerience with an ethics committee. Nurs Homes 29 (5):2. 980 S. Hilfiker 0: Allowing the oeb1litated :o die: fac:ng our eu,,cat choices. N Engl J Med 308: 716, 1983 6. Letters on "Allowing the debilitated to die and authOr's re sponse. N Engl J Med 309: 862. 1983 7. Avom J; Benefit and cost analysis ,n geriatnc care: turning age discrimination 1nto health policy. N Engl J Med 310: 1294 1984 e. Noyes R Jr. Jochimsen ?Ft Davis TA: The cr.ang,ng attitudes of physicians toward prolonging lives. J Am Geriatr Soc 25.470, ,977 9. Brown NK, Thomcson DJ: Nontreatment of fever ,n extended care facilities. N Engl J. Med 300: 1246, 1979 10. Wanzer SH, Adelstein SJ. Cranford RE, et al: The physician s responsibility toward nope!ess1y :ii patients. N =~gr j Mee Ji0:955, 1984 Appendix: Nurse's Questionnaire I. Patient's Name ------------Unit---------Date ____ II. If this patient developed one of the following findings, would you think it appropriate to hospitalize him/her if necessary for diagnosis or treatment? FINDING DECISIO~ ~o Yes ai Fever bl l" nresponsiveness c) Seizure d) Hematuria e) GI bleeding 0 Aspiration BEST COPY A'!/1, H r: 1 r VI, I L. ( : \... r

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June,. III. g) H ypotension h) Joint pain & sweilin!,t i) Cc1rcliopulmonary .irrest If this ~,er~on were to recuv~r from ,111 ,ic:ute dl ness. vet be rendered cmni,letelv immobile i.e .. in ne~d Jt ,:u11stant stmer.iswn :~nc.i c;:1re1 woui
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---.....-'.". -. f 41f. ,"\ ; I I (s ,' ~: .... 'I t' ~-t) Editorials Treatment Dichotomies This is!iue contains an a,tide entitled "Treatment Decisions in a Skilled N ursin~ Facility: Discor dance with Nurses' Preferences,' by 'Wolff, Smolen, ,md FerrJra. The research the authors c.:onducte<.-curs in every long-term care institution. The tragedy is com pounded not only hy the unnecessary expense borne bv the home residents. their families. their estates, ~nmes are obscure. Nurses who have been respon sihle for the c-'1re of such resit.Jen ts consider it th.eir duty to weigh the realities of continued life against the benefits of such interventions. Because the au thors the second point. In addition to requiring all ,esitlents (or their families) to give a pop11bt1nn "ill force us to establish more strin~t'llt polil'tt.-"s about the kinds of crises that woulnt' when appropriate on the hasis of. this ddt~rmina tion, and tum from intervention to <:01111\>rt wlu. .. n the prolongation of lite suits 1witlwr 11s 11or ~od,t~. A .. doctor" coul
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,-, I \: TASI 4. UTILIZATION IN THE HOME Solid national statistics regarding the utilization, cost and outco~e c~ ho~e parenteral and enteral n~:riticn .. -, .. --... ... -' in the developmental stages. Much in this area will depend on the success of OASIS, the Oley/A.S.P.E.N. Information System scheduled to get off the ground in 1986. A goal of this system is to develop for the first time a national patient-specific registry that will track the home patient over time so that variables such as underlying diagnosis or duration and outcome can be aggregated for a specific age group such as the elderly. In the meanti~e, the Oley Foundation has looked at utilization samples from several existing data sources as shown in Table I.l Since the absolute number of patients on home parenteral and enteral nutrition is unknown (estimates vary from 2,000-5,000 on parenteral support and 15,000-20,000 on enteral support) ,2 it is important to realize that the patients in tte sample groups used here are not distinct patients or groups of patients, for a particular patient may be included in at least two of the data sources, the "registries" (including the Oley/LifelineLetter sample) and the commercial services (see Figure I). At this point in time this is the only data available. Demographics li.2.!!!.!, Parenteral Nutrition (HPN) --In terms of age distribution these samples show a similar picture. Roughly 10-20% of the patients are below 20, about half are 50 years or alder, and 20~ are over 65 (see Table II). A?pl~ing t~~s 42.

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,\ .._ I '; , , ,...., J : I percentage to the national estimates means that there are approximately 400 to 1,000 people 65 and over on parenteral support at home. This percentage in the oldest age category demonstrates a significant shift from earlier home utilization. In 1978 the New York Academy National Home TPN Registry reported that of 358 patients 30% were over SO and only 5% were over 65. This suggests that the use of HPN has extended as experience has grown and also as the long-term survivors have reached an older age. As shown in Table III in 4 out of the 5 HPN patient series there are more women than men, especially in the later age groups. This could reflect the greater life expectancy of women generally or that the diseases which lead to HPN are more common in women, for example, radiation enteritis following cancer of the cervix or ovary, or the professional and family perception that older women can be more readily rehabilitated than men to a functioning level that justifies the complex HPN undertaking. Home Enteral Nutrition (HEN)--HEN data show more frequent use of this kind of therapy in older patients (see Table II). If ss: of enteral patients are over 65 and there are indeed 15,000 to 20,000 HEN patients nationally as has been "guesstimated," then 8,000 to 11,000 elderly (65+) people are receiving tube enteral feedings. It is likely that the majority of these patients are at home but a small proportion may be in health related facilities. Unfortunately there is no previous database with which to co~pare these figures, however one cun assume that t~e~ 43.

PAGE 67

:' I J l' '' would show a growth as the elderly population has increased and as advances have been ~ade in HE~ technology and its ap~lica:ion t=-: ere see::1s to )e .: a r: e ; .: ::i. 1 s e x ,i i s t r :. :; '..l t :. : :-. -patients on HEN (Table III). The only exception to this generalization occurred in one small commercial series (CH~S III) where maies predominate. Cost There are currently no figures readily available. It is thought that HP~ costs, on the average, 30%-50% of the cost of providing such therapy in the hospital and HE~ costs about iG~-15~. ~hile so~~ facts regarding cia:3es (as dis:inc~ ~==~ cost) do exist, these are difficult to analyze because they vary considerably and various service components (e.g., delivery of supplies, nursing visits, inventory and reimbursement management) may be included in the charges for solutions and supplies. On an annual basis, charges for an adult on HPN range from $50,000 to $100,000 and for HEN from $3,000 to $12,000. Table IV summarizes the payment mechanism of patients reported from 5 different sources. The majority of patients had more than one type of coverage, but only the principle payer is given. The high proportion of Medicare funding in the Oley group may be due to the fact that this sample includes those longer-term patients who have exhausted their private insurance and become Medicare eligible. In regard to the older patient, the Oley Foundation loo~ed

PAGE 68

1985.3 Of those 60-64 (n=16), 16% reported basic Medicare coverage only, 26%. reported Medicare plus supplemental, and 58% reported coverage by private carrier. Among those 65 and over responding to this survey (n=26), 4% reported >Iedicare coverage alone, 88% Medicare plus supplemental, and 8% Medicare plus supplemental and Medicaid. Indications for HPEN In initiating long-term nutrition support the issues as discussed under Task 1 "The Patient Perspective" are very important. The criteria commonly used for selection of HPN patients are listed below: 1. Potential for meaningful rehabilitation. 2. Patient's desire and ability to accept responsibility for aseptic infusion techniques. 3. Ability of family or friends willing to support patient. 4. Availability of medical backup both for acute problems and long-term supervision. 5. Financial resources so the patient can afford HPN without great distress or anxiety. Obviously in older patients the question of what is "meaningful rehabilition" may be harder to resolve, especially if there is likely to be great dependence on the family for managing the technical aspects. It must be stressed that few patients can afford full-time nursing support at home and nursing ho~es or 45.

PAGE 69

"' .. -... other health related facilites rarely accept patients on HPN. .__, Thus, relative self-sufficiency or a strong fa~ily commit~e~t are essentia:. ":Ieaningful rehabilitation" usually i;:;?lies :reejJ;:-i from severe pain and the li~elihood of returning to nor~al age-related activities. In the Albany program a great effort is made to evaluate patients and their home situation before HPN is openly discussed and then to have a patient and family conference where the pros and cons are forthrightly presented. If the decision is made to "go ahead," we have found it very valuable to arrange a visit from o~e or more experienced home patients, if possible c:Jse i~ age, sex, diagnosis, and home area to the starting patient. In our experience, the majority of older patients are settled into their routine in two or three weeks, especially if the move from hospital to home is smoothly planned. This involves coordinating the delivery of the supplies 24 hours in advance, having them conveniently arranged in the patient's bedroom, installing an extra refrigerator if necessary, and making sure that a nurse who is familiar to the patient in the hospital is at their home when they first arrive back. All of these services are usually provided by the commercial pharmacy service. Most HPN patients, both young and old, accept the technological dependence well and are full of pride for their medical sophistication and independence. However, about 25: of patients, ~ost co~monly t~ose ~ho are elder, jeco~e ~eJres5e~ 46.

PAGE 70

,") I -, 1 I anxious; while they may recognize their good physical rehabilitation, the real quality of this high tech existence is clearly in doubt. In such situations, a great deal of SU?portive "listening," small nighttime doses of an antidepressent (50-i0 mg Imipramine or 100 mg Desyrel), and frequent visits from the home nurse, can cause dramatic improvement. If the anxiety depression persists, then it is often wise to firmly present the option of discontinuing HPN, even though that usually means death. This allows patients to reaffirm their sense of control and accept more actively a decision to live. In many clinical situations, particularly with older patients, the "meaningful rehabilitation" may finally dwindle to "existing" but not "living"; especially if the underlying disease is progressing. At these junctures, the decision is gradually made to back off from complete nutrition to more limited fluid support. This decision process involves the patient, doctor, and the close family; and is quite easily recognized and moved through. In Albany and many other large programs, patients with cancer and bowel obstruction may be considered for HPN if they are comfortable and can be expected to live several months. In such situations, the hospital training period is shorter and the technical burden simplified by using a modified nutrient solution from the onset. Such .solutions do not meet the patient's calorie and protein needs but they keep the patient hydrated and comfortable. It is an option which many patients and families choose, even though they know gradual weakness and ~eight loss 47. (, 7

PAGE 71

are inevitable as their cancer progresses. ( S e e b e 1 ow _, "Du r a t i o n and >Iortality" for :!P~r outcome in relatic:1 to diag:1osis.) F in a n c i a 1 .; c r :-y es p e c i a 11 y a s i :-e : a : 2 s t o t :-: :. 3 : 2 r : expensive therapy, is a major concern ~or most H?~ patients a:1: their families. Fortunately, at this time, it is possible to reassure Medicare patients that most of their costs will be covered and that their home service will assist them with their billing problems. Relieving patients of these worries is a major contribution to their welfare. While the decision to use HEN may be very similar to a :1 d t~e .ehabilitation potential the same or brighter because gastrointestinal tract is only partially compromised, there are other circumstances in which the HEN is more akin to provision of baseline support as, for example, in a patient with irreversible brain damage. The majority of such cerebrally impaired patients would probably be discharged to a healt~ related facility rather than home because they .require around-the-clock nursing and the neurological deficit contributes to psychosocial detachment. The ethical decision to maintain good nutrition in patients with severe neurological impairment is best determined by a societal viewpoint, not a medical judgement. In the situation where gastrointestinal dysfunction is borderline, for example the adoles~ent with infammatory bowel disease who maintains his weight but has impaired linear growth, HEN may be the necessary boost to restore growth. In these circu;7:stances :::1e nc~: is usually take:1 overr.i5:-:t. o:: self 48.

PAGE 72

intubation. This type of indication is rare in older patients, but can occur in chronic disorders such as cirrhosis, renal failure, or chronic pulmonary disease where nutritional support by overnight feedings restores a level of well being that allo~s the patient to resist intercurrent infections and maintain reasonable health and function. Since older patients are less adept at learning.self intubation, a small bore gastrostomy or jejunal tube may be more acceptable. Although it is always a possibility that in borderline situations HPEN could be overused by clinical enthusiasts, a natural and substantial break on such abuse is the strong patient preference to live free of tubes and complex technology. Only when patients and their families experience a quantam leap of better health and well being will they persist with such complex endeavors. On occasion an HPN patient may "graduate" to HEN once severe malnutrition has been corrected and an impaired gut is beginning to work a little better. However, once a patient has learned HPN they find intravenous infusion rather simple and the prospect of switching to self intubation or a permanant gastrostomy or jejunostomy is not attractive, especially if they have an ostomy and greater use of the gut can provoke greater ostomy output and the complication most feared, that of the ostomy bag overfilling and leaking. Thus in general, patients accept HEN better if they use the gut from the outset, even if more constant infusion is necessary while the patient and their bowel improve. As rehabilitation occurs, faster and more restricted infusion hours are usually possible.

PAGE 73

so. Medical Diagnosis Leading to HPEN Table V summarizes the ~ain dia~nostic groups ~-?c:i=~:s dischar;ed on 2?~. From all series exce?t one, ~est s:~~:~ diagnosis was malignancy. This exc~ption was patients responding to the Oley/LifelineLetter questionnaire. This again reinforces the idea that patients who request this newsletter are disproportionately long-term survivors on HPN, probably without active cancer. Table VI summarizes the very limited diagnostic data on HE~ patients. Swallowing disorders due to a malignancy or a neurological deficit due to stroke predominate exce~t in the Oley sample were once again more begni~, less ter~i~al dia~~cse~ ~==~~. In regard to specific diagnoses for the elderly, data is even scanter. Data available from three sources is presented in Table VII. Two sources (the commercial registry and the Oley consumer sample) show radiation enteritis and Crohn's as major diagnoses with the.commercial registry also showing several patients 6j+ with malignancy. In the A~C 65+ group, diagnoses are fairly evenly dispersed while in the younger group malignancy predominates as this group includes several patients who were receiving basically just fluid and electrolytes. Duration and Mortality Specific information regarding duration of therapy in the elderly has not been documented. Data from the New York Academy Registry shows that just over half of all the patients starting HP~ are still on therapy at the end of one year, that a .quarter 70

PAGE 74

,\ I [ ....... &, ; j i .'j .-, are dead and the rest are alive but off HPN. Many of the larger, more established HP~ programs have patients who have survived over 10 years on therapy at home. Average survival ti~e obviously depends greatly on the underlying diagnosis and the population surveyed. Thus, in the Oley/LifelineLetter sample respondents have lived on HPN or HEN for an average of 3 years. Looking at the older patients who answered the consumer survey, those between the ages of 60-64 (n=l5) had survived an average of 4.4 years (including one enterally supported patient on therapy for 61 months) and those 65+ (n=25) had survived an average of 3.18 years (including one enteral patiant who had been on therapy for 17 months). These samples, however, do not include any deceased patients so obviously do not give the true picture regarding duration and mortality. The commercial registry shows the average duration of enteral therapy to be 1.1 years and parenteral therapy to be 2.5 years with no specific figures for the elderly. One industry source (CHNS II) described 33% of their HPN patients as on therapy for three months, 8% as on for 4-12 months, and 59% as on for more than a year, again without age breakdowns. Looking more closely at diagnosis in terms of duration and mortality, an analysis had been done of the AMC program's adult patient experience with HPN. Since 1973, this program has discharged and followed 82 HPEN patients. Sixteen of these patients had cancer and bowel dysfunction, their average age was 58.9 years, ranging from 30-73 ~ith seven 60 or olner. 51. 71

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f'. r, _. ....... ,_, ,, ., --;_; ,, Thirty-six of the patients had extreme short bowel syndrome due co Crohn's, mesenteric infarct or radiation e~teritis. ~o~e ~= :~is last category ~ad any evidence of re:~rrent ca~cer; t~s~: average age was 55.6 years, ranging from 21-8~ with ourceer. 6C or older. (For this analysis all patients under 20 years and those with normal bowel length such as pseudo obstruction or severe hyperemesis gravidarum were excluded.) As shown in Figure 2, 50% of the cancer patients survived only six months and 15% survived a year. All deaths were due to the underlying malignancy. In contrast, over so: of the patients ~ith ~o malignancy iave survived 3 years aJd 15~ are still a::~e at 8 ye~rs. While all the malignancy patients have died, only 10 of these 35 non-malignant patient~ have died. Th e r e i s no a. v a i 1 a b 1 e d a t a f o r c a n c e r v er s u s n o n c a n c e r outcome for HEN patients. The Albany experience with HEN adults is too small (8 patients) for a meaningful comparison. Morbidity and Rehabilitation The frequency of hospital readmissions is one way to gauge the morbidity of patients on home nutritional support. However, this information has not been specifically compiled for the elderly nor for patients on HEN. In 1983 the New York Academy found that three quarters of all HPN patients had no HPN related readmissions during that year. Fifteen percent had one reaqmission and 11% had two readmissions or more. The commercial registry data for 1984 shows a similar picture. Steiger and Sr~4 found that over five years (1976-21) their ~P\ ?ati~~ts with Crohn's, radiation enteritis, and mesenteric infarct spent 52.

PAGE 76

,, I .... : ,!J l : j on the average about 13% of their time in the hospital. About a quarter of this hospital time was related to HPN complications. One in five of their patients was not rehospitalized at all during the j-year study period. This low rehospitalization rate attests to the efficacy of HPN, since home management is obviously cost saving compared to institutional care. As shown in Table VIII sepsis or suspected sepsis is clearly the most common reason for readmission. In 80% of the patients with suspected sepsis, infection was confirmed by blood culture. A bacterial infection was six times more frequent than a fungal infection. In that same year (1983) 1 out of 8 patients with suspected sepsis was managed. as an outpatient. Potential complications for both enteral and parenteral feedings were outlined in Task 1, Tables I and VII, respectively. Very long-term nutrition support with a defined formula diet does have some rather far-reaching implications in terms of completeness of the artificial diet. Even in healthy individuals nutrient requirements are only firmly established for some trace elements and even some vitamins are only ap~roximately agreed upon. From a reasonable variety of foods and by metabolic regulation of absorption and excretion, it would seem that healthy subjects meet their requirements. However disease and diet restriction alter this set of assumptions and for patients dependent upon long-term enteral or parenteral therapy more data is needed about their nutrient requirements and the influencing variables. Table IX lists some of the potential factors that Ga~ operate in these circumstances. In fact HPN has lead to a number 53.

PAGE 77

" .t :-.. r1 ~; ~-; -.j .. of obscure deficiency syndromes, which in some instances have helped to clarify the metabolic role of several micronutrients. 7hese syn~romes are listed in Ta~le X, alon~ ~ith re~ere~:es :J the articles where they are discussed. Table XI gives the rehabilitation status of HPEN patients as reported in S sources. Unfortunately the method of describing rehabilitation is not uniform from one series to another, which may explain some of the discrepancies. However, generally it would seem that 50-60% of HPEN patients are able to work part time or full time, 15-20% are retired or of preschool age and 20-30% are unable to work. Forty-two percent of those res;c~i~n~ to the Oley survey described themselves as carrying on normal activity for their age. Of those 60-64 (n=l9) from this sample, 37% reported that they were able to carry on normal activity for their age and 44% of those 65 and over (n) reported the same. The majority of specific comments from these older respondents indicated satisfaction with their quality of life and a very positive rehabilitation. The most frequent comment was appreciation for the ability to be at home and the energy nutritional support gave them for activities such as entertaining, camping, volunteer work and other community activities. One older respondent (age 64) continued to work full-time outside of the home. Forty-four perc~nt of those 60 and over also thought that respite care was or would be important if they or their family caregiver became incapable. One spouse felt t~at ~er ~ei::~ was going ''down hi 11" because of a 1 a ck of respite This 54.

PAGE 78

percentage among the elderly is higher than the sample as whole which registered 32% as seeing a need for such relief. Procedures, Equipment, and Formulas Currently there are no special ~daptations of the technology tailored to the needs of the elderly HPEN patient; they or their caregivers, as with all patients, must learn the technology. In terms of HPN patient training, New York Academy Registry data from 1981 show the mean training time required before discharge is longer for patients learning home mixing (30.4 17.8 hours) than for those being prov~ded with pre-mixed solutions (21.6 16.9 hours). Also hospital readmissions tended to last 7 days longer for the home-mixing patient. Under the DRG reimbursement system 5 days are allowed for HPN patient training. The Albany experience indicates that 10 days to 2 weeks is a more realistic time span. Patients are usually ill prior to their catheter insertion and their underly~ng illness coupled with soreness from the insertion procedure make it difficult for them to concentrate immediately. Stiffness in the joints and decreasing vision make it more difficult to measure additives with syringes so the older patient may need to have pre-mixed solutions. They also frequently require a family member or some other person to help connect tubing and administration sets to complete an HPN "hookup." As mentioned in Task 1, going to the bathroom while infusing may be particularly difficult for the older person and nessitate the availability of a bedside commode. From the HPEN patient point of view the availability of 55.

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t'. ~-r 56 . premix formulas and the development of a pump with better mobility are extre~ely important. I3 the Oley cons~cer survey ~atients rated use of ?remix solutions as the ~ost i~;ort2~: ~:~e service o~tion (see 7able XII).3 This held true for those 6C and over who gave it a 1.03 on a scale of 1 (important) to 3 (least important). One could assume that with the infirmities of age any features that make home nutritional support less complex and more manageable are particularly desirable. Indeed, as one 66-year-old homemaker wrote, "I like the pre-mixed as home mixing is very time consuming and hard to rlo when your fingers are stiff." Since most people judge according to their own experience, the experience of respondents was also asked in the consumer survey. Table XIII shows that experience greatly influenced the patient's preference. For this reason perhaps the mast objective ranking was from the patients who had experienced more than one type of service. Patients who had home mixed their own solution and received pharmacy premixed solution, clearly preferred the convenience of premix. On the issue of nursing visit, most patients thought the first visit was important particularly if they had met the same nurse in the hospital prior to discharge. Home delivery of supplies was widely appreciated especially when it involved the home care service itself rather than a common carrier. However, there were several comments about the lack of consumer control of the time of delivery and delivery of wrong items. Inventory keeping ~as a controversial issue a~ong the respondents as a whole. ~ost thought it may be necessary and

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,, I ; : n : ,, '-t : helpful to have the supplier do the inventory at first, but after a while patients felt they kept their own inventory better. Those 60 and over generally agreed wit~ this and rated ::.~ven:or~ by the service as just "somev-hat important" ( :2 .0), some re:.:ari--:in~ that "we work together on it" and "on 1 y I know how much I use '' Reimbursement seemed to be a constant headache for most patients, particularly when multiple carriers were involved. Those 60 and over agreed with this and rated reimbursement management as an "important" 1.18. Provision of Service and Quality of Care In the early years, services provide~ to HPEN patients were bareboned. The patients picked up their infusion supplies from the hospital pharmacy in boxes and crates and transported these supplies home in their cars and carried them in and stacked them. If the parenteral solutions were supplied premixed this usually required a weekly trip to the hospital and a second refrigerator at home for solution storage. In general, patients or their families were taught the infusion technique by the hospital staff and post discharge visits from the V~A or other domicillary nursing services were discouraged, since these professionals had not been trained to administer parenteral infusions and did not have much experience with tube feedings their involvement tended to provide more confusion than benefit. As HPEN became more established commercial services offering special support mushroomed. Pharmacists and the pharmaceutical i n u s t r :: r e c ,J s n z e ,J t h i s ,.: : n a :.1 s o n e : o r o t '= n t i
PAGE 81

;". (1 . 'I I _. ,. .a great many specialized nutrition service companies developed. ~ome ~ere divisions of large na:ic~al ~har~ac~~:ical sol~:=-~~ The services patients receive are considerably more excensive than those provided by the early no-frills-attached programs. Delivery of supplies and stacking them on shelves is usually included, as are follow-up visits by specially trained nurses, help with inventory keeping, and supply ordering. The companies in large measure take over all the third party billing problems for their home ~atients and protect them as ~uch as ~ossible :~J~ : ::. :1 a n c i a l. :1 a r r a s s e n t 0 :J c c :i. s :. c s t :1 :. s :-: a s :i: e 3 :1 : ': :: c : ::-: : :--. : absorbing losses where coverage ~as inadequate or non existent. While reimbursement for HP~ has been largely met, reimbursement for HEN services has been far less assured and many companies have withstood heavy losses in this area. In some instances the nursing support services can be billed and are paid directly by third parties, but in many instances such services are not rei~bursable and so the cost of this service component has to be buried in the solution charge. This explains in part the marked cost increase in HPEN when patients switched from hospital-based programs to commercial programs. Further, the commercial services also extended the use of HPEN by offering physicians the services of nurses and pharmacists to train and monitor their home patients, spreading the availability of this therapeutic option to many physicians ~ho ~ere not -:: :,: ::., e r i .-~ :1 ,: '= i . ., ',v l t '.1 '."l '.!:: r l t l \~ n 3 3 ;J; \j r:: 58.

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59. ,; _-_(.,; Recognizing the proliferation of home support beyond major hospital-based programs, the American Society for Parenteral and Enteral ~utrition in 1984 adopted minimal acceptable standards of care for the home patient and they are included in Appendix A. These standards spell out the areas of responsibility, stressing that there be a clearly defined physician initiating and coordinating home nutritional support, and emphasize the need for the documentation and monitoring of the therapeutic plan. While these standards provide the foundation, their implementation on a national scale needs to be monitored. This w o u 1 d not on 1 y he 1 p e.n sure the safe de 1 iv er y of ho r.1 e n,, tr it ion a 1 support but also help establish a national referral network for primary care physicians needing linkage to physicians with expertise in management of the home patient.

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t. :~ o t es 1 n o w a r d L n e a p h e y LL T i m c h a 1 k > r : A r e v i e 1 .: o r t h e current national status of home parenteral and enteral nutrition (HPEN) from the provider and consumer perspective, Oley Foundation, August 1985 (submitted for publication). Tables, figures a~d other information from this review have been adapted by the authors for inclusior. in this report. 2. Various sources such as Homecare, >Iay 1934; Parenteral and Enteral Nutrtion, USA, 1984, C. H. Kline and Co. 3. A consumer questionnaire was mailed to 418 LifelineLetter patient subscribers in June, 1985. In the subsequent 6 weeks, 172 patients r~turned the questionnaire. --.:: J 4. Steiger E, Srp F: ~orbidity and mortality related to home parenteral nutrition in patients with gut failure. Am J Surg 145:102-5, 1983. 60.

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, Fig. I. THE OVERLAPPING DATA SOURCES.* CHNSI n = 493"+ CHNSM n = 2.00 Commercial Registry n = 250 National Registry n = 945 Oley Foundation LifellneLetter n = 159 Drawn to conceptualize how a particular patient may appear In one or more data source. Not drawn to scale. CHNS Commercial Home Nutrition Service 61. I -_,:_ ? .~

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fllgure 2. Survival Time In Months of Albany Medical Center Patients on HPN With MaUgnant and Non-Malignant 01 Percent of Patients 70 60 50 40 30 20 10 Patients who died during time interval Patients alive and on H PN at start of interval Malignant disease (n 16) o--.,w,,;w...~--,:~ ..... ~....,Q,~..A,;li.:,,,.~..,.-o 3 8 9 12 15 20 30 100 90 80 70 60 50 40 30 20 10 Non maUgnant disease ( n = 35) 0 .._~ ..... ~-....a..,.,._~ ..... ...... ~~~~""-"',;;~~:M,.,~,L..C~ 12 15 20 30 40 50 60 70 Survival in Months .. 62

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TABLE I Source and characteristics of the utilizution data Source Sample and Time Frame Comment -----------------------------------------------------------------------------------~-------------National Registry New York Academy 945 patients-all HPN. Data from 93 programs, collected Jan-Dec 1983. Data supplied by MD or d e s i g n e e sup e r v i s i n g p r o g n1111 i 11 aggregate numbers. ----------------------------------------------------------------------------------------------------Oley Foundation/ LifelineLettcr Respondents 159 patients-153 HPN, 6 HEN. Data collected Feb-Apr 1985. Data supplied by patients responding to a questionnaire. ----------------------------------------------------------------------------------------------------Commercial Registry Commercial ll0111e Nutrition Servi.ce I Commercial llo111e Nutrition Service II Commercial ll0111e Nutrition Slrvice III 250 patients-224 HPN, 26 HEN. Data collected Jan 1984-Apr 1985. 4934 patients-2244 HPN, 2690 HEN. Data collected Jan 1984-Apr 1985. 268 patients-all HPN. Data collected Mar & Apr 1985. 200 patients-89 HPN, 111 HEN. Data collected Jan-Dec 1984. Data supplied by MD or designee supervising program receiving suppl i.es from one national pharmaceutical service. Data supplied by home nutritio11 s(~rvice compa11y. Data supp1ied by home nutriti.011 ~;crvice compa11y. Data supplied by home nutritiu11 st..rvice companv.

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TABLE II A g e ti "i s t ri h u t i on o f pa t i en t s u l i 1 i z i n g H PEN e x p r e s s e d i II d t. < il ti e s a 11 d a s p e r c e II t ct g e of total number of pa Lieu Ls report etl Agt. a)Parenteral 0-10 11-10 'l.1-'HJ b) Entera l 0--1 U Jl--LO ll--w ] 1 -LdJ ( j I) t National Registry (n=465) 9 6 13 14 14 27 17 Oley Foundation (n=l53) 12 2 6 19 17 24 15 17 0 0 17 1] 17 17 *CIINS=--C:0111111('<" iul llome Nutrition Service Commercial Registry (n;;224) 16 7 1 1 10 1 l 25 20 (n=26) 4 0 12 12 15 CIINSi~ I ( n;: 1 :u. 4) 6 9 13 14 29 ') 'j ] 19 CIINS II (n-268) 18 7 17 32 26 CIINS Ill (n=89) 16 18 9 3 2 24 27 (n:;;:)11) 16 6 0 6 16 -)

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65. TABLE III Sex distribution of patients utilizing HPEN expressed as percent in each decade from five sources on Table I Age a)Parenteral 0-10 11-20 21-30 31-40 41-50 51-60 61-64 65+ Total b)Enteral 0-10 11-20 21-30 31-40 41-50 51-60 61-64 65+ Total :-iational Registry (n=465) M F NA* 43 57 Oley Foundation (n=148) M F so 50 0 100 67 33 40 57 45 35 44 ** 33 67 60 43 55 65 56 Commercial Registry (n=248) M F NA* 46 54 (n=26) NA*. 50 so CrIXS I (n=2244) M F 52 58 43 43 43 42 43 38 42 48 42 57 57 57 57 62 58 (n=2690) 56 58 49 41 58 55 60 48 51 44 42 51 59 42 45 40 52 49 CH:,; S III (n=89) M F 50 44 37 33 50 43 58 5.1 50 56 63 67 so 36 57 42 49 (n=lll) 59 100 0 50 71 78 67 61 65 41 0 0 50 29 22 33 39 35 ~l); A = ; ; o t a v a i 1 a b 1 e s e x b y d e c a d e s a n d t h e r a p y c o u 1 d n o t b e a s r e ;; ::1 t e d **Sample of 6 was too small to include.

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TABLE IV Major 11111diug mechanism for IIPEN patients. expreBsed HS Pl:lC:t>lll. of the total number ul patients in each group F u n d i u g !-; o u r c e National Registry8 Oley Foundation CommcHial CIINS II Registry Medicare Medicaid Privute ius. or other C<>Vc.Jraged None No re:::; I' 11 t.ie 36 47 3 47 5 39 4 5 32 8 SH 2 8Data collected in 1980 from 63 programs and 374 patients bAlhauy Medical Center HPN progrctm-82 patients; 1973-85 CMe, etc.

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Diagnosis TABLE V Percentage of HPN patients in different diag11ostic categories from all of the reporting sources listed in Table I and the AMC Program National Registry (n=465) Oley Foundation (n=l53} Commercial CHNS l* Registry (n=224) (n=2244) CHNS II (n=268) CHNS Ill (n=89) AMC** (n=82} --------------------------------------------------------------------------------------------------------Malignancy Crohn's diseuse Ischemic bowel (mesenteric infarct) Motility disorder Congenital bowel disorders Other (includes SBS unrelated to above, immune disorders and hyperemesis grav idarum) 42 19 9 5 4 17 10 40 9 7 4 30 *CHNS=Comrnercial Home Nutrition Service 25 20 7 14 9 25 28 26 2 ND 44 41 12 ND 3 ND 44 48 9 1 4 2 34 **AMC=Albany Medical Center IIPN Program, includes patients from 1973 to August, 1985 ***ND=None diagnosed as such. 32 22 16 4 9 18 ... .. : .. <:.: r .... '.

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TABLE VI Percentage of HEN patients in different diagno.sli(' c.dtcgories from three reporting sources Diagnosis M_a 1 i gnu I a c y Neurological disorders of swallowing Other (incJuding metabolic disorders l ead.i.ng to non-malig11uut fistulas, growth failure "ii, iuflammatory bowel disease, etc.) Oley Foundation* ( n:::6) 0 17 83 CIINS I *it( u;2690) 'h 14 CHNS II (n::111) 46 21 33 *Oley F~rn1,dation Consumer Survey, June 1985. Among 172 rc~q,ondcuts, 13 were on en t e r a l !-; 11 I' po r t **CHNS=Ct1111111crcial Home Nutrition Service .--. : ...

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TABLE VII : f. ' --~ ') ""_....,. J Percentage of HPEN patients 61 and over in different dia~~ostic categories from three data sources Diagnosis a)Age 61-64 Radiation Enteritis Crohn's Disease Mesenteric Vascular Disease Malignancy Other*** b)Age 65+ Radiation Enteritis Crohn's Disease Mesenteric Vascular Disease Malignancy Other*** Albany Medical Center* (n=13) 15 8 15 54 8 (n=14) 21 21 29 21 7 Oley F o u n d a t i on .,} (n=16) 18 25 19 0 38 (n=25) 24 24 16 4 32 Co:::::iercial Registry (n=18) 16 22 6 6 50 (n=63) 16 8 6 13 57 *Albany Medical Center (AMC) Clinical Nutrition HPEN program, 1973-1985. **Patients responding to Oley Foundation Consumer Survey, June 1985. ***Other includes, for example, scleroderma, pseudo-obstruction, trauma, motility disorder, etc. 69

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TABLE VIJI Reasons for IIPN related hospital readmissiousit National Registry 198'..i Ad111i88ions Total Per 100 patient mouths Sepsis, suspected or conf inned 2]7 3.1 Catheter related problems 62 0.8 Change of catheter J 1 Q.4 Fluid/electrolyte problems 24 0.3 Organ failure/dysfunction l l 0 .1 Metabolic bone disease B 0 .1 Retraining in HPN technique 7 0. 1 Patient/family unable to cope 5 o.o Iron therapy ' 0.05 Other causes ) 4 0.2 ~U.J 6 read mi s s ions f or an a v er age 1 en g th o f 8 ta y o 1 I 9 d a y s Av er a g e o f O 1. 1,admission8 per patieut per year. ._..,, '4-'' <':,. r

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,\ I r &J ,L, 71 0 i q ~. V ,rJ TABLE IX Factors that may influence nutrient requirements for patients ~it~ gastrointestinal disorders receiving enteral or parentera! feedin~ 1. Adherence of nutTients to the containers, tubes or filters used for their delivery. 2. Impaired digestion and absorption of nutrient. 3. Loss of abnormal amounts of endogenous nutrients because of interrupted enterohepatic cycles (Bl2, folate ?, fat soluble vitamins, zinc, copper, magnesium, calcium) that normally lead to nutrient conservation. 4. Abnormal metabolism because of systemic infusion rather than portal delivery in parenteral nutrition, leading to immediate renal excretion rather than hepatic storage of nutrients and their conversion to a functional form. 5. Altered nutrient utilization because of nighttime infusion with changed diurnal rhythms.

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T.-\BLE X : : t r-:.. e n t -: e f i c :.. -= ;1 c i e s : e s c ri e ,: :. :-. ; 2. : : e :-'. : s ., long-term parenteral ieedin; Nutrient References* Essential fatty acids Calcium Phosphorus Zinc Copper !1anganes e Chromium Molybdenum Selenium Biotin Folic Acid Vitamin A Vitamin D Vitamin E 1 2 3,4 5,6 -I 9 10 11 12 13 14 15 16, 1 7 18 i; (, .... --~ *Refer to numbers on following 2 pages for articles describing the specific nutrient deficiencies. 72

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,) ..., .... 73. i~ .. u ,' Table X (cont.) 1. Riella MC, Broviac JW, Wells M, et al: Essential fatty acid deficiency in human adults during total parenteral n u t r i t i o n A n n I n t ~i e d 8 3 : 7 8 6 -7 8 9 1 9 7 5 2. ~ene JD, Connor WE, DenBeste L: The development oi essential fatty acid deficiency in healthy men fed fat-free diets intravenously a~d orally. J Clin Invest 56:127-134, 1975. 3. Klein GL, Ament ME, Bluestone R, et al: Bone disease associated with total parenteral nutrition. Lancet 2:1041-44, 1980. 4. Shike M, Harrison JE, Sturtridge WC, et al: Metabolic bone disease in patients receiving long-term total parenteral nutrition. Ann Int Med 92:343-50, 1980. 5. Gaddock PR, Yawata Y, Van Santen L, et al : Acquired phagocytic dysfunction: A complication of the hypopho3phatemia of parenteral hyperalimentation. XEJ~I 290:1403-1407, 1974. 6. Travis SF, Sugerman HJ, Ruberg RL: Alterations in red cell glycolytic intermediates and oxygen transport as a consequence of hypophosphatemia in patients receiving intravenous hyperalimentation. NEJM 285:763-768, 1971 7. Okada A, Takagi Y, Irakura, T, et al: Shin lesions during intrav~nous hyperalimentation zinc deficiency. Surgery, 80:629-635, 1976. 8. Heller RM, Kirchner SA, O'Neil JA, et al: Skeletal changes of copper deficiency in infants receiving prolonged parenteral nutrition. J Pediatr 92:947-949, 1978. 9 Doi s y EA : ".Effects of def i c i enc. y in manganese upon p 1 as ma levels of clotting proteins and cholesterol in man". In: Trace Element Metabolism in Animals. Hoekstra, WG, et al eds. 2:668-70, Baltimore:Baltimore Univ. Press, 1974. 10. Jeejeebhoy KN, Chu RC, Marliss EB, et al 4: A Bruce Robertson chromium deficiency, glucose intolerance and neuropathy reversed by chromium supplementation in a patient receiving long-term parenteral nutrition. Am J Clin Nutr 30:531-538,1977. 11. Abumrad NN, Schreider AJ, Steele D, et al: Amino acid intolerance during prolonged total parenteral nutrition reversed by molybdenum. Clin Res 27:621A,1981.

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n: r1 Table X (cont.) l .2 \"an~ i j .-\ ~-1 Tho rr: p son CD ~!c ~en~ i e J >! et 2 : 5 -2: :-: ::. ..: :-:: 1~f~cie~:~ i~ tctal ;arenteral nutr!:~Jn. ~= :1~~ ~~er 3::2C76-2035,1979. l ..__, 13. ~ock DM, deLorimer AE, Liebman WM, et al: Biotin deficiency an unusual complication of parenteral alimentation. ~EJM 3C4:820-822,1981. 14. Wardrop CAJ, Lewis MH, Tennant GB, et al: Acute folate deficiency associated with intravenous nutrition with amine acid sorbitol ethanol: Prophylaxis with intravenous folic acid. Br J Hematol 37:521-526,1977. 15. Howard L, Chu R, Feman S, et al: Vitamin A deficiency from long-term parenteral nutrition. Ann Int ~1ed93: 576-577, 198C. 16. Klein GL, Horst RL, Norman AW, et al: Reduced serum levels of 1,25 ~ihydroxyvita~i~ D during long-ter~ :ccal par en t er a 1 nu tr i ti o n Ann I n t :-1 e d 9 4 : 6 3 3 -6 .. +3 l 9 5 i 17. Shike M, Hanson J, Sturtridge W, et al: ~etabolic bone disease in patients receiving long term total parenteral nutrition. Ann Int Med 92:343-350, 1980. 18. Howard LB, Chu R., Ovesen L: Vitamin E requirements for patients on home parenteral nutrition. JPEN 3:315, 1979. (Abstract) 74.

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TABLE XI l{ehabilitation status of HPEN patients expressed as% of patients respondiug Full-time employed, in school or college, homemaker Part-time worker, student Unable to work or go to school Retired National Registry (n=615) 32 12 24 13 Oley Foundation (n=165)8 52 7 11 19 Commercial Registry (n=l52) 32 7 30 14 Albany Medical Center HPN Program (n=82) 32 23 18 15 Univ~ Washington HPN Programb (n=4L) 21 Lt: NJJC 26.L 16.7 -----------------------------------------------------------------------------T------------------------Preschool child Able to work but unemployed due to inability to find a job or insurance restrictio11 on working 6 10 9 ND ND 5 10 NU 4 35. 7d aTotal number of 172 respondents answering the rehabilitation section of a consumer (patleut) survey conducted in June, 1985. bRobb R, Brakebill J, Ivey M, et al: Subjective assessment of patient outcomes on home p,11c!nleral nutrition. Am J Hosp Pharm 40:1646-50, 1983. dao% because they feared loss of coverage 20% because of time in HPN involvement .... ......., \J1

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TABLE XII Consu~er (patient) overall ra~kin~ on Home ~utrition Service (~~S) C?tio~sa Option 1. Premix rather than home mix 2. Home delivery rather than self pick up 3. Reimbursement management by HNS 4. Initial nurse visit 5. HNS delivery rather than common carrier 6. Home mix rather than premix 7. Respite care 8. Inventory management 9. Follow-up nursing visits Scoreb 1.15 1.18 1.19 1. 4 7 1. 55 1. 71 1. 92 2.04 2.04 77. aThis overall ranking does not take into account the patients' experience bscore: limportant 2somewhat important 3not important

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TABLE Xlll Tabulation of consumer (patient) r1nking of home services Score: l=important 2=somewhat important 3=not important SERVICE Solutions Home visits from nurse CONSUMER EXPERIENCE Premixed (n=87) Home mix (n=37) Both (n=45) None (n=44) Some (n=l27) PREFERENCE Premixed h pharmacy 1.01 1. 73 1.01 Initial visit 1.89 ~.38 Delivery mechanism HNS* delivery .Y.... patient pick .!!.E. HNS delivery (n=59) 1.10 Common carrier (n=22) 1.09 Both (n=76) 1.13 Reimbursement Reimbursement IINS & inventory collected vs self management All handled by HNS -1.13 (n=l06) Some managed by HNS 1. (n=22) None managed by HNS 2.00 (n=l6) *HNS=llo111e Nutrition Service Home mixed h pnli.ent 2.37 1.18 2.37 Periodic follow-up visits 2.27 1.98 HNS delivery vs common carrier delivery 1. 08 2.31 1.68 Inventory h IINS vs self 1.92 2.50 1.97 C .... .. '-J CX)

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Appendix A AMEfUCAN SOCJETY FOR PARENTERAL ANO ENTERAL NUTRITION STANDARDS FOR NUTRITION SUPPORT Home Patients 79a. .. January 1985

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A.S.P.E.N. is a professional society whose members are health care professionals-physicians, nurses, dietitians, pharmacists and nutritionists-dedicated to optimum nu trition support ofpatients during hospitalization and rehabilitation. A.S.P.E.N.'s diverse professional membership reflects the basic importance of good nutrition to good medical prac tice and the multidiscipline team appro~ch to sound nu trition support. A.S.P.E.N. has developed these standards to promote the health and welfare of those patients in need of enteral and parenteral nutrition. The standards represent a con census of A.S.P.E.N.'s members as to that minimal level of care which should be given in order to assure sound and efficient enteral and parenteral nutrition. A.S.P.E.N. disclaims any liability to any health care provider, patient or other persons affected by these standards. Copyright, 1985 '; (i .-,. : ,_ .. V .J American Society for Parenteral and Entera1 :\Jutrit1on 8605 Cameron Street Silver Spring, MO 20901 (301) 587-6315 All rights reserved. Copies of this publication may not be made without the explicit written consent of this Society. 79b

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;'. : {: .' .. ,, t~-iBEST COPY AVAi LAB LE Dear Colleague: This publication contains minimal standards of care for home patients to ensure that malnutrition is recognized and effectively and safely tre:iced. The Standards are presented in a tbrmat similar to those published for hospitalized patients. Each Standard is usually followed by an explanatory paragraph. Each of these Standards represents minimal acceptable levels of care and should be subscribed to by home health care providers. Specific diagnostic tests. treatment modalities and protocols have not been detailed. but are presented in the broadest. most generic terms so chat these can be specifo:d by ~ach patient's home health c:ire ;,ro\'ider. These Stlndards are ~volutionlry :md will be reviewed. upd:ued :ind lmended JS needed tc keep ;,ace ,.,ith advancemems in medical science and changes Ln the delivery of he:J.lth ~~re. The A.S.P.ES Committee on Standards. a multidisciplinary group. prepared chese final standards liter receiving comments on an earlier dr:ift from A.S.P.E.~. members. \\e welcome your comments. Ezra Steiger, M.D. Chairman, Committee on Standards 3 79c.

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STANDARDS FOR HOME NUTRITION SUPPORT '. Enteral nutrition nutrition provided throughl30~ST COPY AVAILABLE via the gastrointestinal tract oral enteral nutrition taken through or via the mouth tube-enteral nutrition provided through a tube that delivers nutrients distal to the oral cavity Feeding formulation -a ready to administer mix ture of nutrients Home -a patient's residence excluding chronic care and extended care facilities Malnutrition any disorder of nutrition, usually a deficiency of nutrient intake or impaired nutrient metabolism Nutrient protein, carbohydrate, lipids, vitamins, electrolyt~s, minerals, and water Nutrition-the sum of the processes by which one takes in an1~1 utilizes nutrients Nutrition support service-a multidisdplinary group of health care professionals who aid in the provision of specialized nutrition support Parenteraf nutrition nutrients provided by means other than the gastrointestinal tract central parenteral nutrition delivered through a large diameter vein, usually the subcla vian or superior vena cava, that empties directly into the heart peripheral parenteral nutrition delivered through a smaller vein, usually in the hand or forearm Provider-a physician with expertise in specialized nutrition support who is medically responsible for the patient's home nutrition care Specialized nutrition assessment -a physician with expertise in specialized nutrition support who is medically responsible for the patient's home nutri tion care Specialized nutrition assessment -a comprehensive approach to defining nutrition status that em ploys clinical and dietary histories, physical ex amination, anthropometric measurements, and laboratory data Specialized nutrition support -provision of specially formualted and/or delivered intravenous or enteral nutrients to prevent or treat malnutrition Vendor -an organization that supplies aqu,oment and p-roducts and proviaes services to the patient reQuiring specialized home nutrition support under the direction of the provider 4 /IJ I 79d.

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BEST COPY AVAILABLE 2. Organization .... ,-. : '"' : ~' L , a) PROVtDcRS OF SP:ClAL!ZeO HOME NUTRITION SUPPORT Sc~VICeS SHALL se CLeARL y OEFiNcD. 7he :rovicer -~f soec:alized home nutrition suc~crt =s tne ~nvs:c:an wno is ;:,rimar:ly resocnsib1e :er :~e :at?:nt' s ~ucmicn :are anc snou1d ::e ass;stea oy 3 l"egisterec r.urse, a :-eg:stered oietit1an and a registered ,:,harmacist eacn Maving accro priate education, specialized training and expe rience in the discipline of specialized home nutrition support. Specialized home nutrition support services shall be initiated and coordinated by the provider. There shafl be a clear understanding among the pro vider, the vendor and the patient specifying re sponsibilities of each including; the manner in which services shall be cooroinated and evalu ated; the role of the provider, the vendor and the ~atient in the ~stablishment and monitcr;ng of patient care; and the mechanism and responsi bility for ~avment for services, !Quioment and oroduc:s. :, "."'HE :,RCVlC:;:;s :F S?:C:ALJZEO HOME \JL TF11TION SWPPCR7 SSFMCSS SHALL SE G~IOED BY WRITTEN ?OL1ClES ANO PROCEDURES. There shail be written policies and procedures concerning the scope and provision of specialized nomenutrition support services. These shall be devef oced oy the provider. Concurrence shall be obtained from the medical,surgical, dietetics, nursing, pharmacy and other staff as appropri ate. These shall be reviewed annuaHy and re vised as appropriate to reflect optimal standards of care. The policies and procedures shall inctude but not be limited to the following: 1. The rotes, responsibilities and 24 hour avail abiiity of provider care. 2. Criteria for patient eligibility and selection should be defined. These criteria should ;n clude medical suitability; rehabilitative po-_ tential; social and economic factors; educa ble, psychological and emotional factors pertinent to the patient and others who are signiflcantty included in this care. 3. A mechanism for patient monitoring (e.g. fre quency of follow-up contact. laboratory studies, and physical examinations). 4. Availability of consultative medical services and services of other professionals such as psychologists and social workers and non professionals, such as patient sucport groups as appropriate. S. Reimbursement mechanisms for services. ~cui::>ment ano suoo1ies. o .. ..\cou,sitiOn of gnterai ~r :nr:-avenor...s :-,i..trients, eouioment ana suop1ies for home =elivery. 7. Educational materials for patient and family training and use at home. ,. 5 8. ?reparation and:or storage of enteral formulas or intravenous nutrient solutions in the ~ome: :ec~r.,cwas ;or ~:,e acmir.rst:-at1on Jf enteral for~u,as :r ~t:-avenous :iwt:-:er.t 30 i..;tions. f~ecir:; sc:--ecu!~S. :;3re :f ::ecir; ::..oes :c:-:at::r:s -~ca,,r; =r-,rera1 ;cr~~ .3s. and :are :f :ac::e:ers 3~,::: :..;:irig ::r :at. ~:-:s receiving :ntravencus .~uc:-:t:cn. 9. Prevention and management of comoiica tions in the home, and emergency consu1-tation with professional staff. 10. Mechanisms for Quality assurance. c) SPECIALIZED HOME NUTRITION SUPPORT SERVICES SHALL SE DCCUMt:NTED Medical recoras shall be maintained for every patient receiving specialized home nutrition support services and snail include: 1. Designation of .:,nysician having ~rimary :-e sponsibility for tne ~atient's ho~e r,utrtt:or. care. 2. All :,ertinent ;:atier.t ciagr.cses 3nc :=r~g r.oses ric:ucing er.,; Jr.c S:"' ... r:-rer~ :::~C rives of :reatr:-:ant. 3. Initial and follow-up .:,nys1cal examinations. 4. Sc e and resuits of training and retraining. S. Plan of care including tyces and frequencv of services to be provided, functional :imitations of the patient. activities :erminec, osvcno social needs of the ~atient, su1taciiitv ar.o adaptability of the patient's residence for tne provision of home nutrition services and ,,ame of other individuaHs, who will assi.st in ~he care of the patient if required. a. Composition, rate, and mode of aoministration of feeding formu1ation and all :1"1edica tions. 7. Signed and dated progress notes for eac:i home visit and clinic visit 3nd teieonor.e c-:,, tact. These progress notes snouid inc:uce iesponse to therapeutic regimen :nclucir.g :-e sults of serial monitoring, complications anc revisions in the therapeutic regimen. 8. A summary statement at termination of nutrition therapy which includes results of ther apy, complications, outcome and disoosition of patient. d) SPECIALIZED HOME NUTRITION SUPPORT RENDERED SH.~LL BE REVIEWED ANO :VALU ATEO REGULARLY TO DETERMINE OVERAL!. EFFECTIVENESS AND SAFETY. Evaluation of the oatient's neec: fo:-anc :-esoonse i:o s0ecia1izec ho~e ~ut:-ition 3u:oor: sila1l :d :he res::or.s1b11itv :f :ne .:Jr::vcers. ---= -~e., 3na :va1:..at:on 3ria11 :e Jer-:.--ec .3r:: ::c.:~ 'i1enteo at ,east ever, 90 ::avs. :Jef:c:enc:es ;J1...rc in the review snould ::,e :orrec:ea 'Jv ~ocifv1r.g services. orotocols, proceoures ana ecucat1or.a1 programs. i9e.

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3. Patient Selection ;,--, :, f1 ; ,.., a) Indications and Contraindications for Special ized Home Nutrition Support -PATIENTS SHALL ee CAREFULL y EVALUATED PRIOR TO SELEC TlON FOR SPECIALIZED HOME NUTRITION SUP ?ORT Candidates for specialized home nutrition suo ;:,ort are those patients unaore to meet nutrient requirements by ora1 e~teral nutrition. In addi tion, the patient's clinical status and quality of life must be such that treatment at home would be appropriate. Specialized nutrition support being given at home should be designed to achieve the nutrition objectives. The patient's home envi-, ,1 .-0,, ronment should be appropriate fo1 the safe use of home nutrition supoort. b) Determination of Nutrition Requirements AN EVALUATION OF THE 1\JUTRIENi NEEDS CF TME ?ATIENT S~ALL ae ?~~FCR;viEJ ?Q:CR 70 "'."~: IMTIATiON OF SPEC:.:i.uz:~ T91~:c,'-l Si..Fl PORT. Nutrition requirements will :Je a ~unc:1on .Jf ::ie special disease state, the patient's nutrition sta tus, growth requiremel"'!ts ana the duration of anticipated intake. The type and amount cf nutrition needed by the patient shall be determined. 4. Therapeutic Plan a) Objective -THE OBJECTIVE(S) OF SPECIAL IZEO NUTRITION SUPPORT SHALL BE DETERMINED ANO DOCUMENTED. The objectives of home nutrition support should address the short and long term needs of the home patient. Short term needs might include resolution of disease progression. wound heal ing, progression to enteral support and recovery from nutrition depletion. Long term needs in clude maintenance of normal nutrition and re habilitation to physical and social independence. These objectives should be developed prior to the institution of nutrition support. b) Mode-iHE ROUTE(S) SELECTED TO PROVIDE SPECIALIZED NUTRITION SUPPORT SHALL BE APPROPRIATE TO MEET ASSESSED NUTRIENT REQUIREMENTS ANO ACHIEVE THERAPEUTIC GOALS AND OBJECTIVES. The safest, most cost effective route which meets the patient's needs should be utilized. The gas trointestinal tract should be used whenever pos sible. It should be recognized that as the patient's therapy progresses the optimal mooe of feeding mav change and may, at times, utilize ootl"I en teral and parenteral feedings. c) Prescription -THE SELECTED ~==~ING ~CRMULA ilONS SHALL SE ~PP~OP~IAT2 ~c 7~E DISEASE PROCESS, COMPATIBLE WITH THE ACCESS ROUTE, AND MEET NUTRIENT NEEDS. The formulation selection and modification snould be under the direction of the provider and should consider availabl~ products and their costs 3nd knowledge of the patient and of his, her specific clinical disease processes. The most cost effec tive therapy compatible with the access route should be utilized. The patient should oe given a prescription copy of the feeding formulation and other medications. 5. Implementation a) Establishment of Access THE ACCESS ROUTE{$) SHALL BE APPROPRIATE FOR HOME USE. The type of device used should be placed, rec ommended or approved by the provider and doc umented in the patient's medical records. Access should be placed by, or their placement direct_!y supervised by, a physician, nurse or specially trained health care professional who is proficient in their placement. Selected pati~nts or respon sible others who have been trained may insert enteral feeding tubes. Standard techniques or protocols should be established for gaining access. The access selected must be appropriate for the type of therapy to be delivered and should be as simple as oossible for home care and use. offer appropriate durability for the anticipated duration of therapy, and minimize the potential for occurrence of complications. b) Patient Education 1. THE PATIENT ANO:OA RESPONSIBLE OTHER SHALL RECEIVE EDUCATION ANO DEMON STRATE COMPETENCE IN FEEDING FOR 6 MULATION PREPARATION ANO ADlvlll'JIS TRATION. Patients should be aducated in the following areas: knowledge of appropriate formulation components, determination of proper dosages, aseptic (parenteral) or clean (enteral) technique, manipulation and maintenance of equipment and infusion method. Patients receiving enteral nutrition must be instructed in clean techniques of feeding formulation preparation, storage and infusion. Closed containers should be used for feeding formulation storage and administration. in gen eral, enteral formulations should not be :eft hanging for !onger tnan i 2 hours but hanging time may oe ~ore :imitea :or soec:f:c :;roc ucts. Adm,xeo oarenteral ormL.1ar1ors snci..;ic not be left at room temperature for .cnger than 24 hours. Patients receiving oarentera, nutrition should be taugnt to check the integ rity of the feeding formulation containers, to inspect for abnormalities in appeaiance. oroper storage of the feeding formulation. and fil-79f.

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BEST COPY AVAl!.ri; .~ n: (1 ,~ _,.. tering techniques, if used. For cvctic er.teral STRATE COMPETENCE lN 7'HE. ~EC"OcrNrand parenteral infusion methods, specific inTION AND A?F'ROP~IATE ~ES?ONSE iO struction should be given. Control of the in COMPLJCATIONS ~NO :CL.-I?",lE:'f: .'11.-l.lN fusion rate ro maintain an accurate flow rate TENANCE ~ND vlALFL;NC~!CNS. ~eQuires an infusion control device whic~ the ~at1ent or "esoonsibIe other .,,us, ::e :augr.t :o ;.Se. ... -:-: .:)A 7':i:N~ ~ND CR ~ES?CN$SL.: c:-:~ .Si-.~L~ =:C::VE ::'.:l..'C.~ "'.":CN ~ND JE:\IC \iS'7'~~ TE COMP:7:NCE :N ~C:ESS RCL.;7: CARE. The patient receiving parenteral infusions must be trained in aseptic technique of dressing care, connecting and disconnecting the intra venous tubing to the catheter and post in fusion flushing to prevent catheter occtusion. The enteraUy fed patient must be trained in ctean techniques for handling the tube, maintaining the accesa site and ff ushing the tube to maintain patency. 3. THE F'ATIENTANO:CR RESPCNSiBLE Oi'r-4ER SHAL:. ~ECEIVE :OUCAi1CN ~ND DE:\'10N-:--crr,e :nr:r:11 3~C :a~r-::, -.. :-: :r :5 ::erlts aric --1 .. s: :: :',a. ac.-= ==~--= ::-: :.::-: :o aov,se anc. ~r n~er'.1ene f :cr:r-::a::'1 3S rious comoIicat1ons 3rise. C~mmcn. -~ocrtant clinical complications :r.c:uce seOSiS, glucose intolerance. fluio ano eiectroivte :,,-,. b~l=3nce, catheter or tube occius.1cn ana breakage and ec;uipment malfunction. 4. EDUCATIONAL ~1ATERIALS SHOULD 9E PROVIDED TO THE ,:,A ilENi OR .~ES?C,\JSIBLE OTHERS. 5. PATIENT EDUCATION SHALL INCLUDE ?: RIO0IC REASScSSMENi ANO ~E7RAlMNG AS NE:OED. 6. Patient Monitoring 31 THE PATIENT SHALL SE MONITORED FOR THERAP!UTtC ANO ADVERSE EFrECTS ANO CLINICAL CHANGES THAT MA V INFLUENCE SP!CJAUZED NUTRmON SUPt'OAT. F'rotocols snould be developed for ::,eriodic review of the patient's c1inical and biochemical sta tus. Routine monitoring should include nutrient intake; review of current medications; signs of intoierance ~o ther3oy: Ne!gr.r ::'!ar;es: :1: chem,cal. hemato1og1c anc ocr~er :::iert:r.ent ::ata including clinical signs of .,utnent oefic:er.c:es and excesses as weil as acjustment to ~:ieraov. changes in lifestyle, osvchosoc:al ::,robte~s ar.o changes in the home ,nvironment. ~ssessrrer.t of the patient's major organ func:ions sncuI0 oe made periodical! 7. Termination of Therapy a) THE PATIENT SHALL CEMONSTrlATE THEASIL ITY TO INGEST AND ABSORB At EQUATE NU 1rllENTS BY THE ENT!RAL ROUTE PRIOR TO DISCONTINUING PARENTERAL NUTrlmON. Parentera1 nutrition should not be discontinuea by the crovider orver,aor until estimated nutrient reQuirements are tolerated by the gastrointes tinal tract. Parenteral nutrient formulations should be decreased over time while enteral feedings are increased. Documentation of ingestion and absor0tion of adeQuate nutrients via the gas trointestinal tract should be made in the medical records . b) ADEQUATE ORAL ENT!RAL NUTRITION SHALL BE DEMONSTRATED PRIOR TO CISCONT1NU ANCE OF ENTERAL NU~ITION. c) SPECIALIZED NUTRITION SUPPORT SHALL BE OISCONTINUEO WHEN COMPt.JCATtONS SO IN DICATE. 7 Complications which are uncontroIIaoIe and. or life-threatening reQuire immediate assessment of the patient by the orovider ~nvsician. ana :r necessary, :mmediate discont:nuanon ,r :ne specialiZ!d nutrition suo~ort ~r.eraov -~aat:r.g emergent life-threatening -:oncitions :a1
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Chairman :zra Steiger, M.D. Staff Surgeon Cleveland Clinic Foundation Cleveland, OH Oougl11 WIimore, M.D. Brigham & Women's Hospital Boston, MA John P. Grant. M.D. Associate Professor of Surgery Oirec:tor-NutritionaJ Support Service Ouke University Medical Center Durham, NC Steven B. Heymsfleld, M.0. Associate Profeesor of Medicine Director, Division of Nutrition :mory University Scriool of ~edicine Atlanta, GA President Ezra Steiger, M.O. Staff Surgeon Clevefand Clinic Foundation Cleveland, OH President-Elect John M. Daly, M.O. Associate Professor of Surgery Oepartment of Surgery Memorial Sloan-Kettering Cancer Center New York, NY Vice-President John P. Grant, M.D ..,. Assistant Professor of Surgery Oirec:torNutrition Support Service Duke University Medical Center Durham, NC Secretary Calvin Long, ?!i.D. Baptist Meaical Center Birmingham, ~L Treasurer Albert Bothe, Jr., M.O. -Associate Director Nutrition Support Service Harvard Medical School New England Deaconess Hospital Boston, MA .1 COMMITTEE ON STANDARDS 1984 bL~.d ~UP}' li~i11Litu~i. Philip J. Schneider, M.S. Clinical ~ssistant ?rofessor and Associate Director Department of Pharmacy Ohio State University Hospitals Columbus, OH Christine Kennedy Caldwetl, R.N., M.S.N. Pediatric Nutritionist-Clinical Nurse Spec. Nutrition Support Service Rhode Island Hospital Oepartment of Surgery Providence, RI Anne Marie Hunter, M.S., R.D. Director Clinical Nutrition Services St. John's Regional Medical Canter Joplin, MO Loretta Forlaw, R.N., M.S.N., A.N.C. (Walter Reed Army Medical Center) (Washington, O.C.) Olney, MO BOARD OF DIRECTORS, 1984 Immediate Past President Terry W. Hensle, M.O .,. Director of Pediatric Urology Babies Hospital New York, NY Chairman-Continuing Education Brian J. Rowlands, M.O., F.R.C.S. Department of Surgery University of Texas Medical School of Houston Houston.TX Chairman-Membership Gordon P. Buzby, M.O. Assistant Professor of Surgery Univ. of Pennsylvania School of Medicine Philadelphia, Pa Chairman-Publications Howard Silberman, M.D. Associate Professor of Surgerv Department of Surgery use Los Angeles, CA Dlrector-atl.arge-Dietitians Emma L. Cataldi-Betcher, R.D., M.S. Emerson. NJ Murray H. Seltzer. ~.O. 'Jirec:or of .'n .. tr:::or S1..:::ccr: Ser,.c~ St. 3arnaoas .',lec:ca1 C~r.!~r Livingston, NJ Wanda Hain-Howell Tucson, AZ Lyn Howard, M.D. executive Di rector Oley Foundation Albany Medical College Albany, NY Richard Baptista, M.S., R.Ph. Clinical Pharmac:st Nutrition Support Services New England Deaconess i"'iO!;Oitat Boston, Massac:iusens Staff Oeobrah Parham, RN Rockville, MO Directoratl.arge-Nurses Kathleen Crocker. R.N .. M.S.N. Clinical Nurse Spec1a1ist Nutrition Intervention Team St Vincent Charity Hoscital Cleveland. OH OirectoratLarge-Pharmacists Philip J. Schneider, M.S. Clinical Assistant ?rofessor Associate Director Department of Ptiarmacv Ohio State Universitv Hospitals Columbus. OH Oirectoratl.arge Robert L. Ruberg, M.O. Associate Professor of Surgery Oh,o State University of Hospitals Columbus. OH Director-at-Large ';larvin ~ment. '.-1.J. Department of ?eo:atrcs UCLA Center Los Angeles. C~ Olrectorat-Large C. Richard Fleming, M.D. Mayo Clinic Rochester, MN 79h.

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TASK 5. CONCLUSIONS Tt-.::..: ,, -~ ...... ---.1 ... _o_ ... J,..,1 5 1.s~ues of :ieeded research .,,er e developed and prioritized froo the material presented i~ Tas~s 1-4 and discussions with the Oley Foundation Scientific Advisory Committee. Consistent with much of the previous material, the issues that impact on the elderly are frequently the most pressing for the therapy as a whole so future investigations in these areas will generally benefit the entire field of nutritional support. Priority Issues 1. Third-party reimbursement of nutritional support. 2. Establishing the nutritional requirements of the elderly, both enterally and parenterally, in health and disease. 3. Determining the cost effectiveness of nutritional support: a) in different disease. states; b) under both modes of administration. 4. The need for ongoing data collection to evaluate changes in utilization of the technology in both inpatient and outpatient settings. 5. The need to develop mechanisms for disseminating. information related to nutrition support research and monitoring its application. Needed Research I. As indicated above, a major area for needed research pertains to the econo~ics of nutritional su?port, joth in ter~s Bo.

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of third-party reimbursement and cost effectiveness* of the therapy. This need holds true for all settings and will be discussed as it relates to each. n: ... 4 ,, I, "' 1._ A). Hospital Setting: It is clear that nutritional support in hospital patients typically involves the sicker, more debilitated long-stay patient. While there are ICD-9. co-morbidity or complication codes for protein~calorie malnutrition (PCM), as seen in the university hospital study described in Task 2 PCM was only an accompanying diagnosis 30% of the time. In other words, not infrequently and quite appropriately, NS is initiated before PCM has developed. Further since NS is needed for a wide array of conditions, theoretically factoring it into a few specific diagnoses or procedures like "Crohn 's disease" or "bowel resection" is untenable. It seems clear that adequate procedure codes for specialized nutrition support procedures need to be developed so they can be factored in as a "severity index" for a broad range of disorders. To ensure that nutritional support is appropriate and not an abused therapy to increase reimbursement, a number cf studies are required: 1. Studies which test the cost effectiveness of NS as an adjunct therapy in different disease states, particularly in older patients with limited life ex~ectancy. -if,Cost. effectiveness is used in the sense of "what is the least costly way to produce a desired effect or outcome." Ill/ 81.

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. Studies that determine mechanisms for cost-effective monitoring and proper use of this therapy. In ether words, real and needed nutritional support versus token and unnecessar? nutritional support. while data exist to show safer and ~ore effective NSl in hospitals with a nutritional support team, no study has yet demonstrated that hospitals which develop and underwrite NS teams save money while providing essential NS. It would be desirable to design studies to see if families and friends, with the advice and supervision of a nutritionist, can stimulate greater oral intake of food by the patient, avoiding the necP~sity for ex?ensive parenteral or e~tera: nutrition. In less developed countries such family support, in all aspects of nursing, is very important and mechanisms are developing in the U.S. to limit hospital costs by offering various options for family versus professional nursing care. 3. Parenteral peripheral vein nutritional support (PVNS) can be almost as expensive as parenteral central vein nutritional support (CVNS). PVNS frequently involves less professional decision making. To date there is no academic consensus that PVNS is cost effective. Until such evidence exists, it would seem appropriate to create financial disincentives for such token nutritional support while encouraging necessary nutritional support, either CVNS if required or enteral NS. 4. Studies that evaluate simplifying in-hospital NS to r e d u c e c o s t s s u c h a s u s e o t h e t h r e e i n -o :1 e I \' s c l :.: t i c n s (premixed glucose, amino acids and fat); the mixing of a several 82.

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., i ; :~' ; .' .. I t.J liter, 24-hour supply, in one bag; less costly and more reliable infusion pumps; and less expensive, well-tolerated enteral formulas. B). Nursing Home (NH) Setting: There needs to be further clarification of whether NH nutritional support can truly be separated into adjunctive medical therapy, i.e., treatment of limited duration which can be started or withheld according to medical benefit, in contrast to the hygenic maintenance of patients with chronic disorders, in whom the level of supportive care is more "truly" a societal than a medical decision. Research needs are: 1. Studies to design simpler, more cost-effective NHNS. 2. Studies to evaluate initiating NS at the NH (e.g., nasogastric tubes placed by nurses, NH percutaneous gastrostomies). What would be the medical indications for such therapy? Does such NHNS avoid a more expensive hospitalization because it prevents the complications of malnutrition, e.g., decubitus ulcers, infections, loss of strength resulting in immobilization? 3. Should parenteral support become more available for NH pa~ients? Currently few nursing homes will accept any patients requiring IV infusions. Is this a safeguard against potential abuse~of IVNS or is this an option which should be available to patients and their families for long-term or respite care? It is the personal opinion of some of our consultants that the availability of long-term CV~S could lead to serious abuse of this expensive therapy since the goal of meaningful 83.

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rehabilitation would probably be set in only very limited terms. Conversely short-stay respite centers have relevance for families ~anaging older relatives and needing vacations. C). Home Setting: As ~hown by data from the Oley Foundati~n review of HPN, there seem to be two separate groups of patients, a long-term HPN group (chronic, "benign" GI dysfunction) and a short-term HPN group (GI obstruction from a malignancy). Further investigations should determine if it is appropriate to separate these uses by applying different funding mechanisms to underline the differences in training, the c .., .n p 1 e x :. : :: o : :i u t r i e n t s o 1 u t i o n a n d t h e p o s t d i s c :-. a r g e :1 e e d s a s discussed under Task 4, such as the nursing support needed once home. Thus long-term patients could be funded by the current mechanism, Medicare Part B "prosthetic device," and short-term patients could be funded by Part A "hospice care" or by a DRG-type of mechanism that includes a severity factor determined by including specialized nutrition procedures. Additional studies should include: 1. Cost-containment studies on the realistic training time and components of home equipment (premix versus homemix, "three-in-one," infusion vests, etc.). 2. Studies on the role of home enteral nutrition versus the more costly home parenteral nutrition. This would include questions on how frequently HEN could be used instead of HPN and does reimbursement promote HPN over HEN. Comparative studies should investigate their relative complication rates, ~0s~ital readmissions, and rehabilitative efficacy. //IJ ., .. 84.

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I, .. t ,', i; :_, t, -~-; II. A second important research need can be summarized as the evaluation of new developments prior to tbeir widespread use. This seems an obvious requirement and yet throughout medical care generally, improvisation and theoretical benefit have often preceded any clear, scientific cost-effective evaluation. This laissez-faire ambience is probably expensive and unethical and should be replaced by formal testing of medical innovations prior to their widespread dissemination. In the nutritional support arena this requires: 1. Good data Colle.ction on new develpments in the use and outcome of NS, such as that information which is to be collected by OASIS. 2. Support for formal testing of new products and their appropriate application, for more information about parenteral versus enteral requirements and how the requirements change with age. 3. Mechanisms for disseminating nutcition support research knowledge and testing for micronutrient levels on a regional basis. III. A third important need exists in regard to standards of care. What mechanlsms are needed in all three settings to ensure quality of care? Technically a vehicle exists for this in the hospital setting by the Joint Commission o~ Accreditation of Hospitals (JCAH). Thus far the JCAH supervision has not carefully delineated in-hospital standards for NS. Outside the hospital, no general standards exist. As mentioned earlier, /11 as.

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":. 86. i :,' I ' I -' ., ASPEN has provided a baseline for standards of care for home (and hospital) NS and they are currently working on area. However such standards require for=al a~C?tion :ati0~~-!~e and credentialing mechanisms to be sure they are upheld. Notes: l. ~ehme AE: ~utritional support of the hospitalized ;atie~:; the team concept. JAMA 243:1906-1908, 1980. dEST COPY AVAILABLE ,, /1:J-


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