.I Chron Dis Vol. 36. No. 6. pp. 433-438. 1983 Prmted !n Cire;it Brikn. All rights reserved
OUTPATIENT REGULATION OF THE INSULIN-REQUIRING PERSON WITH DIABETES (AN ALTERNATIVE TO HOSPITALIZATION)* F. W. WHITEHOUSE, I. J. WHITEHOUSE, M. S. Cox, J. GOLDMAN, D. M. KAHKONEN, J. 0. PARTAMIAN and R. C. TAMAYO Division
of Metabolic
Diseases,
Henry
Ford
Hospital.
Detroit.
MI 48202. U.S.A
Abstract- One hundred and six insulin-requiring diabetic patients were randomly recruited to a pllot out-patient diabetes regulation and self-care program. The program was designed to offer an alternative to hospitalization. 89 patients completed the 5-day program. Fasting plasma glucose values at 5 days were significantly lower than initial levels (263 ) 73 mg,‘dl vs 156 + 60 mg/dl; p-value < 0.001). Long-term diabetic control was similarIT improved at 6 months after entry levels were signlticantly lower than initial values when total glycosylated hemoglobin (13.8 i_ 2.8”” vs Il.1 + 2.4”“; p-value < 0.0005). I7 patients failed to complete the program. Only four patients of the 89 were subsequently hospitalized with diabetes-related conditions. 445 hospital days were saved during the study period wzith calculated total dollar savings over $90,000. It is suggested that a structured out-patient program for diabetes regulation and self-care can be successfully developed and carried out at a significantIF lower cost than hospitalization. Third party payers should take cognizance of these programs and appropriately include them in their health care coverage.
INTRODUCTION FOR SEVERALyears it has been our custom
to initiate insulin therapy in diabetic
patients
in an out-patient setting in lieu of hospitalization. Under the direction of a diabetes teaching nurse (DTN), these patients learn to give themselves insulin and to self-monitor their diabetes by testing urine and blood for glucose. They receive individual diet instruction from a dietitian and are encouraged to attend scheduled diabetes classes. They learn to deal with insulin reactions and intercurrent illnesses. Each patient is given return appointments with the DTN and the dietitian for follow-up assessment and for further instruction in the details of self-care of their diabetes. In a loosely structured program, we found that many patients did not take advantage of these learning opportunities. Some visited the dietitian only once for initial diet instruction or met with the DTN only until they felt confident enough to measure and inject insulin. Attendance at scheduled diabetes classes was variable. Reasons for missed visits included the personal expense of the visit, the demands of daily living and the lower priority of diabetes in their life. Hospitalization of these patients would be an alternative choice which has been an accepted medical practice but which increases the cost of regulation and education of the diabetic patient. Even though patients who are hospitalized incur minimal personal cost, indirect insurance cost to all subscribers will be affected. We believe that patients with uncomplicated diabetes in need of metabolic regulation should be managed in an out-patient setting. With a structured program these patients can be offered intensive individual attention in self-care. In a hospital setting, too often *Supported in part by a generous grant from the Michigan Department of Public Health. All correspondence should be addressed to: Dr F. W. Whitehouse. 2799 West Grand Boulevard. Metabolic Diseases. Henry Ford Hospital. Detroit, MI 48202, U.S.A. 433
Division
of
434
F. W. WHITEHOLSF: d trl TABLE 1. DEMOGKAPHIC I~ATA oh X9 PAIILNTS IN THL OUrPATIkNT KEGL'LATION PROGRAM a.
b. c. d.
Age: 19-79yr (avg.55 yr) Sew: men 32; women 57 Race: Black 50: White 39 New to insulin: 56
the care of other patients with more urgent medical problems prevents the ward nursing personnel from giving the diabetic patient needed attention. In addition these personnel have neither the specialized training nor the available time to give diabetic patients what they need. In a structured out-patient program, diabetic patients can receive initial insulin and diet therapy, can learn self-care of their diabetes and can have key family members intimately involved in the learning process. However, this approach will only succeed if personal expenses are minimized as they are during a hospital stay. In Michigan. this would require the underwriting support of third party payors, a position that does not now exist. In order to demonstrate the inherent possibilities of a structured out-patient program to interested third party payors, we developed in 1979 a one year pilot program for the regulation and education of insulin-requiring diabetic patients in an out-patient setting. As this program was designed to simulate a hospital stay, we hoped that results would show that diabetic patients could be managed more economically and as successfully in an office setting as in the hospital. We speculated that if the pilot program succeeded, third party payors might support similarly structured programs in Michigan and elsewhere.
MATERIALS
AND
METHODS
We offered our pilot program from 1 July, 1979 to 30 June, 1980. Only insulinrequiring diabetic patients who met accepted criteria * for non-emergent hospitalization were accepted into the study. Some patients needed insulin for the first time while others required a readjustment of their insulin program. Table 1 records the demographic data. As if hospitalized, each patient had a complete history and physical examination including a chest roentgenogram and an electrocardiogram. The usual laboratory studies were done including measurement of total glycosylated hemoglobin. 89 patients completed the program. The diabetic patient and family members met with members of the health care team for 7 hr daily, Monday through Friday. The program was held in the out-patient clinic where our diabetic patients come for continuing care. The patients attended the usual daily classes offered to all diabetic patients and their families. Participants ate breakfast and lunch as a group in the hospital cafeteria with food selection and quantitation supervised by teaching dietitians. Throughout the 5-day period, patients had learning sessions with the diabetes teaching nurse and with the nutritionist. These sessions covered details of self-care, including individual advice on nutrition, home monitoring of diabetes control, insulin injection techniques, appropriate foot care and ways to cope with hypoglycemia and acute illnesses. Daily adjustments of insulin dosage were made by an attending physician. Ten days after the initial 5-day session, our patients returned to the DTN and to the dietitian for assessment of their progress. All patients visited the DTN at 4-6 weeks and at 6 months. Some patients also met with the dietitian at these times. Follow-up visits appropriate to individual needs were scheduled with a physician. An identical written test incorporating simple cognitive information about diabetes was given to each patient at the beginning of the program, 5 days later and at 6 weeks and 6 months. Data on these tests will be reported separately. *Local review (PSRO) criteria include: symptomatic hyperglycemia without ketosis, fasting plasma glucose over 200 mg/dl or random plasma glucose over 300 mg/dl, a need for insulin initiation or readjustment of dosage.
Outpatient
Regulation
TARL~ ?(A). FASTING PLASMA GLUCOSE (mg/dl
+ SE) AT C\TRY AND S DAYS LATER (SHORT-TERM aI,c;I’l.ArIo\) Day
N Patients new to insulin: Patients previously on insulin: Total group:
TALM 2(B). TOTAL GLYCOSYLATED
HEMOGLORIN
*Normal
at Henry
Ford
Hospital:
I
264 + 1I 254 + I2 263 + 8
56 33 89
Patients new to insulin: Patients previously on insulin: Total group:
475
of Diabetics
Day 5 I56 + 7 158 + I2 157 * 6
p-value
VALVES* AT EUTRY ANU .A,6 MONTHS OR MORF MILK
rb~R\
h
Initial
Final
p-WIUC
51 29 80
13.8 f 0.4”,, 13.7 + 0.4”,, 13.8 + 0.3”,,
10.4 f 0.3”,, 12.3 + 0.3”,, I I.1 & 0.3”,,
< 0.0005 10.01 < 0.0005
5.9%%7”,, (7.3 i 0.7”,,).
RESULTS
One hundred and six persons with insulin-requiring diabetes were enrolled. 89 persons completed the 5-day program. 12 of the remaining 17 patients either failed to keep their initial appointments or cancelled them. Their reasons included transportation problems, pressing home responsibilities or an inability to be absent from work. Three other patients left the program after 1 or 2 days stating that they were not willing to follow the required protocol. Two patients were disenrolled because of their inability to keep pace with the program. They were offered individual help. In those 89 patients who completed the 5-day schedule, we monitored short term diabetic control by comparing the fasting plasma glucose level initially and 5 days later. These data are shown in Table 2 and indicate a significant decrease in plasma glucose on the fifth day of therapy. Levels of total glycosylated hemoglobin at 6 months or more similarly showed a statistically significant decrease from initial levels which reflect continuing improved control of the diabetes. Analysis of plasma total cholesterol levels in X9 patients at entry into the program and after 6 months failed to show any significant change (Table 3). 21 patients had initial and follow-up measurements of fasting serum triglyceride levels which showed a small but not statistically significant decrease after 6 months of diabetic control (192 mg/dl to 150 mg/dl, p-value > 0.15). The body weight of our patients expressed as percent ideal body weight was recorded initially, and at 6 or more months after completing the period of initial regulation. Normal weight and obesity were defined as less and more than 120:,; of ideal body weight respectively. The patients were divided into four subsets according to body weight and prior insulin therapy (Table 4). Weight increased only in that subset of the 23 patients new to insulin therapy who were initially at normal weight. Neither subset of obese patients lost weight over the 6 month period. However. within the subsets of obese patients (47 persons), two individuals successfully decreased weight and lost their need for insulin. Eleven participants who completed the program subsequently required hospitalization. Four of them had diabetes-related problems and seven had unrelated illnesses. Four
TARL~ 3. PLASMA TOTAL CHOLESTEROL (mg/dl
+ SE) AT PNTRY INTO STIIIIYAUU AT SIX MONTHS OR MORI. .
Patients new to insulin: Patients previously on insulin: Total group:
IV
Initial
Final
56 33 89
263 f I8 231 f 8 251 * 12
232 k 7 221 * 8 228 + _ 5
p-value < 0.20 < 0.40 < 0. IO
436
F. W. WHITEHDUSE
PC al
TABLE 4. COMPARISON OF PERCENTAGE IDEAL BODY WEIGHT (IBW) AT ENTRY AND AFTER 6 MONTHSIN 81 PATIENTS A. NORMAL WEIGHT(ATOR BELOW 12o",,or;IBW + SE)
Group
h’
New to insulin: Previously on insulin:
23 11
Initial 10s f 2(‘,<, 108 i 2”,,
Final
p-value
11I + 2”,,
<0.025 NS
107 * 3”,,
B. OBESE (ABOVE 120:,, IBW f SE) Group
N
New to insulin: Previously on insulin:
29 18
Initial 142 f 4”,, 137 * 3””
Final
p-value
144 * 4”,, 139 + 4”,,
NS NS
pateints have died during the follow-up period, three following a myocardial and one from a cerebrovascular accident.
infarction
DISCUSSION
We wanted to know whether it was feasible to treat a selected group of diabetic patients in an out-patient milieu rather than in a hospital. Avoiding the hospital would lower the cost of care. If one could achieve the desired therapeutic goals, it would then be clear that this approach would effectively help the patient’s medical problem and also contribute to cost containment. Metabolic regulation of diabetes and education of the patient in its self-care seemed an appropriate way to test this thesis. Often diabetic patients with hyperglycemia but without ketosis are admitted to the hospital for 5-10 days for regulation of the diabetes and education in self-care. These patients are only moderately symptomatic and in need of medical care which does not demand an in-patient stay. A day-care center would provide daily contact between the patient and health care professionals permitting therapy to be adjusted frequently and self-care to be taught. Critics might argue that we should have developed a randomized control study in which similar patients would have been admitted to the hospital for management or treated in our out-patient program. We rejected this option, reasoning that the regulation of the diabetic patient in a hospital is clearly an accepted and feasible practice. The question to be explored was; can this regulation and self-care education be achieved effectively in an office setting? Our data indicate that one can achieve short-term (5 days) and long-term (6 months) regulation of diabetic patients when they are offered an out-patient alternative to hospitalization. 89 patients were managed without hospital care. Follow-up analysis indicates that subsequent hospitalization for diabetes-related problems is insignificant. The use of expensive hospital beds was avoided. We believe this out-patient approach is feasible for the insulin-requiring diabetic patient who fulfills the usual criteria for hospital admission and would ordinarily be hospitalized. Most patients prefer day-care management to in-hospital care. This positive experience might encourage others to adopt a similar protocol. Our approach is not novel. Tridec, the Tri-Hospital Diabetes Education Center, is a shared service of three Toronto hospitals which offers out-patient education to diabetic patients Cl]. Their 1978-79 report demonstrates the continuing effectiveness over an 8-yr period of out-patient education of diabetic patients [2]. During 1978-79, 72 diabetic patients attended this program for insulin initiation. Serving these 72 patients in an ambulatory setting putatively saved 605 hospital days and $123,614 in revenues. Similar experiences have been reported by King and colleagues from a diabetic day-care program at McMaster University Medical Center [3] where Spaulding and Spaudling showed that 15 diabetic patients could be regulated with insulin equally well in a daycare unit when compared with 14 hospitalized patients [4]. Costs for the latter group were nine times greater than for the ambulatory group.
Outpatient
Regulation
of Diabetics
337
Though substantive similarities will exist between programs, the style and content of any out-patient diabetes regulation and self-care program should be determined locally. The approach should be patient-centered and modified to help the individual patient. We conducted our pilot program over 5 days to match a work week and to approximate the time for the average hospitalization of a person with uncomplicated insulin-requiring diabetes. We enrolled 2-4 patients at each session and included relevant family members. In practice, a group of 4 patients including some family members was easily managed by one teaching nurse and one dietitian. While we do not view a 5-day stint as mandatory, it does give the physician the opportunity to stabilize insulin therapy and the DTN and dietitian’s time to help the patient and family with the many details of self-care. Our urban patient population varies in educational achievement from people who are functionally illiterate to individuals with advanced university degrees. Teaching people who easily integrate new procedures provides a satisfying experience for the teacher and for the student. Low achievers learn and adjust more slowly to new, strange and, at times, undesired information. The latter attitude places additional demands on the time and patience of both the health care provider and the student. We have found that small groups function better when homogeneous. The goals of one patient may vary from those of another participant within the group. The goals of a patient may vary from the goals of the health care provider. We learned that whenever a physician enrolled a patient in our program without a prior commitment of the patient, a drop-out was more likely to occur. It is clear that we cannot tell a patient what to do; the patient must understand why the advice is appropriate. Reluctant patients or patients who deny the need for insulin are best instructed individually. Some patients may refuse all offers of help. Among our patients we found some who were initially reluctant to participate but who became enthusiastic with their progress once they were involved in the program. Frequently an esprit dr corps developed within the group that bolstered the morale of all members. Though cognitive knowledge about diabetes may not correlate closely with the quality of self-care, we tested all patients on knowledge of self-care of their diabetes. They were retested at intervals to determine continued learning or loss of recall. We agree with Travis [S] that one should “test to do. not test to know”. To those patients who were functionally illiterate, we read the test questions in as neutral a manner as possible. mindful that voice inflection, body movements or gestures could bias their answers. Unless the patient revealed reading-learning disabilities through his questioning. difficulties in taking a test often were not detected until the first test was corrected or until the second test was reviewed. Excepting the first test, we discussed the results of each test with the patient at the time it was taken so that we could reinforce the correct answer. Only 4 of 89 patients required hospitalization for diabetes-related problems during the follow-up period ending 1 January, 1981. One patient became depressed, stopped her insulin and developed acute hyperglycemia. Another spent a short time in a hospital following a severe episode of hypoglycemia. A third patient suffered an infected blister on her foot and required a brief hospital stay. A fourth patient developed insulin resistance during the initial phases of a leukemic state. Diabetic persons requiring insulin initiation or adjustment usually have been admitted to a hospital. Close hospital monitoring of diabetes care has been deemed necessary because of the variable individual responses to insulin therapy. As medical care costs soared, alternatives to hospitalization have been sought for treatment of uncomplicated diabetes. Though the National Blue Cross-Blue Shield Association encouraged its Member Plans to support the concept of patient education [6]. it has failed to persuade these state Plans to support ambulatory diabetes regulation and self-care programs. The Maine Blue Cross-Blue Shield has agreed to support ambulatory diabetes education through either a cost reimbursement formula or a fee for service at hospitals where these programs are extant [7]. Escalating hospital costs, the availability of experienced diabetes educators and the recognition by consumers that an out-patient atmosphere is more conducive to achieving
43x
F.
Personnel Supplies Laboratory Other
W.
WHITFHOUS~
costs charges
Total direct costs Indirect costs (space. utilities. etc)
$53.2xX.00
Total costs
ShX.552.00
IS.264.00
self-care in diabetes has persuaded many professionals that an office setting is the best place to initiate diabetes care. Lagging third party support for out-patient regulation and self-care has slowed its growth. Perhaps the results of pilot programs like ours will encourage third parties to look more favorably on similar out-patient programs and offer underwriting support. Table 5 details the budget for our pilot program. Average cost per patient (89 patients served) was $599. If indirect costs are included (43.2”,, of direct costs), the average patient cost increases to $770. This compares with an average cost for a 5-day in-patient stay on the Medical Service at Henry Ford Hospital during 1979 of $1775.* Most of our outpatient costs were fixed since we followed a prospective protocol designed to mimic a patient’s in-hospital experience. If charges for a complete history and physical examination and “routine” laboratory costs are modified to include only basic laboratory charges and a daily professional fee, the average cost per patient is decreased to $342 (or $513 with indirect costs included). It is not surprising that out-patient costs are lower than in-hospital charges. Calculations show that savings achieved in this pilot program range from $89.000 to $104,000 for the 89 patients depending on which out-patient cost figures are used. Assuming a 5-day in-hospital stay, 445 hospital days were saved by offering these X9 patients the out-patient alternative. Physicians, diabetes educators and their patients should make third party payors aware of out-patient programs which are effective 4ternatives. It is our thought that out-patient programs of similar nature, structured to regulate diabetic patients on insulin and to educate them in self-care, will offer the uncomplicated diabetic patient a desirable alternative to in-hospital care. It seems only reasonable that third party payors would recognize the value of this type of program to their consumer-clients. It would be to the advantage of all parties concerned to emphasize out-patient care for the uncomplicated diabetic person and de-emphasize the use of an expensive hospital bed in patients where only diabetic control and self-care is planned. Treatment of the uncomplicated insulinrequiring diabetic patient exemplifies a medical situation ideally suited for out-patient care. REFERENCES Laugharne E, Steiner G: Tri-Hospital Diabetes Education Center (Trldec): a cosl effective. cooperative venture. Can Nurse 70: 14 19, 1977 Tri-Hospital Diabetes Education Center: Annual Report, pp. I 21. lY78 79 King B, Spaulding WB. Wright AD: Problem-oriented diabetic day care. Can Nurse 73: lY_22. 1974 Spaulding RH. Spaulding WB: The diabetic day-care unit. II. Comparlaon of patients and costs 01 initiating insulin therapy in the unit and a hospital. J Can Med Assoc 114: 7X0-783, 1976 Travis LB: University of Texas Medical School. Galveston. (Personal communication) White Paper. Patient Health Education: National Blue Cross Association, Chicago. pp. I- 7. 1Y74 Willhoite B. Lacasse J: Reimbursement of an outpatient diabetes education program. Diabetes 30 (suppl. I): 13A. 1981 (abstr) *While costs do not equal charges in hospital care, expenses charged to the patient or to his third party are used for fiscal reference, as determined by 1979 third party cost reports.
carrier