Development of randomized patient education experiments with urban poor hypertensives

106

DEVELOPMENT OF RANDOMIZED PATIENT EDUCATION EXPERIMENTS WITH URBAN POOR HYPERTENSIVES LAWRENCE W. GREEN, Dr. P.H., DAVID M. LEVINE, M.D. Sc.D., JOAN WOLLE, Ph.D. and SIGRID DEEDS, Dr. P.H.

Health Services Research and Development Center, and Division of Health Education, The Johns Hopkhzs Medical Institutions, Balthnore, Maryland

INTRODUCTION

The purpose of the three-year study, "Health Education Strategies for Hypertension Control," was to assess the relative cost-effectiveness of different educational strategies in achieving patient compliance and control of blood pressure. Four hundred diagnosed hypertensive patients in general medical and hypertension clinics in a large inner-city teaching hospital were assigned to eight combinations of three educational interventions (exit interviews, home visits with family members, and small group meetings) in a randomized factorial design. The logic and design, as well as some preliminary results of the study, have been previously presented. 1 A basic assumption in the design is that the compliance behavior of patients is affected not only by their own demographic, disease-specific, and psychosocial characteristics, but also by their interaction with the providers and with the system of care. Therefore, the clinical trials of educational strategies directed initially at the patient population will be followed by education and training directed at the providers in the same health-care system. This paper describes the empirical basis for the development of educational interventions as derived from baseline surveys of patients and providers to test their knowledge, attitudes, and behaviors. Also presented are methods developed to measure and score compliance behavior, blood pressure control, and beliefs and knowledge related to hypertension. The actual educational interventions are then outlined.

BACKGROUND

The plan for randomized clinical trials of health education for hypertensive outpatients in East Baltimore proposed baseline surveys of providers and patients to determine the kinds of education needed by staff and patients? The process by which findings from the survey of 311 patients have dictated a number of decisions on the design, phasing, and evaluation of educational interventions is presented first. The supporting results from the survey of 103 providers comment further on clinical considerations behind these decisions. -° The patient characteristics in this study, as indicated by the baseline survey, were 87% black, 69% female, with an age range between 27 and 84 (50% of the patients between 46 and 65) and a median age of 55. Median income was in the $3,000-$3,400 range, with 37% having less than $2,000 annually. Approximately 69% were unemployed or retired; 56% were receiving public Medical Assistance benefits. The majority, nearly 60%, had less than 10 years of formal schooling. BLOOD PRESSURE AND ITS CORRELATES

There were no significant differences in blood pressure control between General Medical and Hypertension specialty clinics of the Johns Hopkins Hospital, between those who kept their last appointment and those who did not, 3 between males and females, between blackg and whites, or between groups with different levels of knowledge or belief in benefits of treatment. In all Of these groups the percentage of patients with uncontrolled blood pressure was not significantly different from 50%. The only significant correlates of blood pressure control at the time of the baseline survey were complexity of drug regimen (the more drugs the patient was prescribed, the less likely he was to meet the criterion of blood pressure control) (Figure 1), and an overall compliance score based on verbal reports by the patient (Figure 2). The association with corn-

PATIENT COUNSELLING AND HEALTHEDUCATION

107 N

(26)

(95)

(102)

%

(67)

70-

70 60

% of Patients with Controlled Blood Pressure

61.5

50

60" 56.8 46.1 '

40

40.3

Controlled Blood Pressure

:

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30-

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Compliance Score

Figure 1. Blood pressure control by complexity of regimen.

Figure 2. Blood pressure conlrol by verbal compliance index.

plexity of drug regimen was the first indication of an educational problem.

everybody was noncompliant, yet 50% of the patients had controlled blood pressure. By the "history" or interview method, we were able to obtain a measure of compliance from responses to five questions which indicated tendencies to take or not take medications under various circumstances. An added question on appointment keeping at the clinic provided us with a six-item scale of compliance with a reliability coefficient of r=0.66. As shown in Figure 2, this measure of compliance has predictive validity in its direct, linear relationship with blood pressure control. The scale consists of the following questions to which respondents could respond yes, no, or not sure, where the "correct" response indicating compliance is "no" in each case:

COMPLIANCE MEASURES The problems in verbal reports by patients of their compliance with medical regimens are well known? The preferred alternatives of pill counts, urine tests, blood tests, and other "hard measures" proved to be largely impracticable because of the inconsistent records on these variables in this situation. This will likely be so in most health education and compliance studies except in prepaid plans where all medical, laboratory, and pharmaceutical services and records are uniform for all hypertensive patients. Pill counts were meaningless for the hospital outpatients because (a) the patients have numerous pharmaceutical sources of their drugs, (b) their bottles are frequently refilled before the previous supply is exhausted, (c) pharmacies do not consistently label the vials, and (d) with frequent changes made in the composition and dosage of hypertension regimens, it is exceedingly difficult to match the right prescription in the medical record (if any) with the current prescription the patient is supposed to be following. In a pilot study of pill counts in the homes of 64 patients (September 1974 through January 1975), a pill-count criterion of compliance was much too severe. It failed to distinguish between the patient who is generally very compliant but missed a day or two of pills because of an illness or other circumstances and the noncompliant patient who throws away unused pills, overdoses, or refilled the prescription recently. By the pill-count criterion in our pilot study, virtually

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Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better, do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Are there any reasons why you might not follow your doctor's advice? Did you miss your last appointment to see the doctor or nurse here about your high blood pressure? The scores for the responses are as follows: correct responses = 1, incorrect = 0, and "not sure"= 0.5. The total score range was 0 to 6, and rtt equalled 0.66. The total scores on this scale tend to skew, so that a normal distribution is best achieved by a trichotomy

108 collapsing scores 0-3 as "low," 4-5 as "medium," and score 6 as "high" compliance. Furth4r work on the scaling properties and validation of this index is needed, but we believe it is now a practical, efficient, and reliable measure for use in large-scale studies of home compliance with hypertension regimens, other than diet. Except in situations where patients have a sole source of highly standardized pill supplies, as in a military dispensary, or where tracers can be put in the pills to enable urine tests of compliance, we believe this measure is preferable to the "harder" alternatives. C O R R E L A T E S OF COMPLIANCE We have reported previously ' on the very high levels of knowledge found in this diagnostic-baseline survey of patients, relative to the national survey of adults in the general population, ~ and relative to a study completed nearly two years earlier a in the same Hopkins clinics. We also find (Table I) that the correlation between knowledge and compliance is negligible and possibly even slightly negative. The 18 items used to measure knowledge are listed in the Appendix. This index of patient knowledge about hypertension had a reliability coefficient of 0.91, indicating considerable internal consistency of responses. In addition, we found little correlation between elements of the Health Belief Model and compliance. Neither belief in the seriousness of hypertension nor belief in the benefits of therapeutic and preventive measures for hypertension and stroke was sufficiently associated with compliance or blood pressure control to warrant directing educational programs at changing these beliefs. Although black patients had much less confidence in the efficacy of treatment (belief in benefits) than whites, this difference was not reflected in compliance behavior. The belief indices, based on the items shown in the Appendix, had reliability coefficients of 0.76 and 0.88, respectively. The percentage of patients responding correctly to most of the specific questions in the Appendix was greater than 80%, with very few items having less than 50% correct-response rate? The few exceptions were not items from which the correction of misconceptions could be expected to influence compliance

significantly. It may well be, then, that the National High Blood Pressure Education Program and other sources of publicity about hypertension had already had an additive effect with increased medical interest to cause most hypertensive patients to be well informed, r It .appears also that these new levels of knowledge and beliefs had not had time to influence behavioral changes, or else there were other barriers to compliance to which health education needed to be addressed. We found in our diagnostic-baseline data three other sources of possible influence on patient compliance that shaped our decisions on the structure and phasing of educational interventions. One was evidence of patient confusion with his or her own regimen despite general understanding. A second was variable support for the patient from his or her own family or household members. A third was a tendency for patients to express some defeatism and dismay at not being able to comply or to control their blood pressure. These three findings will be reviewed briefly here and their implications for the design and structure of our educational interventions will be discussed. Patient Confusion About Regimen

While the general level of knowledge about hypertension and its treatment was high in this population of patients, they were frequently confused or uncertain about specific aspects of their own medical regimen. Their number of pills, doses per day, hours or timing in relation to meals, and the specific dietary restrictions were often distorted. They could correctly recognize facts about their treatment, but they had difficulty recalling specific instructions and operationally defining their compliance task. We concluded from these observations that a first-stage intervention should be a highly individualized educational session with each patient immediately after he has received his latest medical instructions from his- physician or nurse practitioner. This would be distinct from the usual patient educational session employed in compliance experiments 8 in that the message would be personalized and flexible rather than standardized and rigid.

Table I. Correlations (gamma coefficients) between scores from hypertension baseline patient survey (n---307). Complexity

Complexity Compliance Knowledge Belief in seriousness Belief in benefits Minimum diastolie blood pressure at same visit

0.21 0.05 0.12 -- 0.02 0.24

Compliance

-- 0.10 0.09 0.12 -- 0.15

Belief in Knowledge seriousness

0.43 0.37 0.09

0.43 0.07

Belief in benefits

-- 0.04

PATIENT COUNSELLING A N D HEALTH EDUCATION

109 Family Support

Patients were asked in the baseline survey whether they expected or generally received any help from family members in complying with their medical regimen. There were major differences in positive responses, for example, between males ( 8 3 % ) and females ( 6 5 % ) , and between patients on sodium restriction regimens ( 6 4 % ) and those on weight reduction regimens ( 8 2 % ) . From a review of literature on family-member roles in compliance of patients, we were convinced that this was a neglected dimension of health education with considerable potential for improving compliance, especially with long-term regimens in which a supportive and reinforcing social environment is critical to the maintenance of a behavior. 9 Locus of Control

The final aspect of our analysis concerned the more fully internalized sources of resistance or motivation than either of the above. There was a note of fatalism or at least disbelief in the attitudes of many patients toward their regimen and its efficacy. Following the clarification of the compliance task and the provision of support from family members, a strategy was conceived which would bring to bear a learning experience designed to increase self-confidence in dealing with the difficulties of the regimen? ° In summary, we had generated hypotheses from the diagnostic-baseline survey that there were three levels of problems that could be addressed through three correspondingly stratified levels of patient education: 1) clarification, 2) social support, and 3) self-confidence or locus of control training. PHASING THE EDUCATIONAL STRATEGIES The original plan of the project was to follow the diagnostic-baseline surveys of patients and providers with continuing education programs directed at staff, in order to inform them of what patients needed to know and of what they needed to do to educate their patients. It turned out that most of what the diagnosticbaseline surveys measured were things patients and staff already knew. There was little that these surveys revealed that staff did not already suspect; and that which was new would need more convincing evidence to change their own medical care practices. Our revised plan, then, was to conduct our experimental patient education trials to test our hypotheses about the three levels of need and the three strategies of health education. On the basis of the findings from these experimental interventions, a final clinical package would be constructed and introduced to the clinic

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staff in a final round of evaluation with random assignment of both providers and patients to experimental and control groups. The phasing of the three patient education trials was designed to proceed in a sequential factorial design from the least complex intervention to the most complex intervention. The flow of patients through the experimental phases is illustrated in Figure 3. The randomization at each stage divides the samples in halves, so that there are 200 patients in each of the two groups in Phase 1, 100 in each of the four groups at Phase 2, and 50 patients in each of the eight groups at Phase 3. Phase 1: ReteachingmReinforcement Exit Interview in the Clinic

Individualized reteaching and reinforcement sessions following the patient-practitioner encounter in general medical and hypertension clinics were provided to 200 patients during March to May, 1975. The purpose of the 20-minute session was to go over the specific instructions given by the provider relative to medication schedules, diet, and return visits. The patient's medication regimen was adapted to his own daily schedule through the use of clock and calendar aids by interviewers who were trained, graduate healtheducation students. Referral to other hospital resources was used for problems introduced by patients if they were nonclinical, personal, or financial matters, ix Phase 2:

Household Reinforcement

This intervention combined the characteristics of a home visit and a social-learning approach through an outreach effort to members of the patient's household. Patients from Phase 1 control and experimental groups were interviewed concerning their knowledge, atti-

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Experimental combinations All three 1 and 2 only I and 3 only 1 only 2 and 3 only 2 only 3 only None

110 tudes, treatment regimens, and compliance behavior about hypertension. In addition they were asked to identify the person in the household with whom they were most frequently in contact, who might be expected to provide the most potential for behavioral reinforcement upon the patient. The householder was sought out for a separate interview and given specific information on hypertension, what the patient is to do, and how that person can aid the patient in his or her adherence efforts. Phase 3: Small Group Discussions

The purpose of this intervention was to provide support through group discussion in the areas of hypertension management and compliance in which patients lack self confidence. Random sets of 16 patients were recruited to group discussions and asked to return for a total of three 1I/2-hour sessions. The content of the discussion group series will be specified and analyzed in future reports so that the intervention is made replicable for discussion leaders from several disciplines and at other times. The group sessions encompass a broad range of short-term procedures, mostly action-oriented (role playing, behavioral rehearsal, problem clarification, cognitive restructuring). They are organized to move the patient toward more selfdirection in dealing with his medical situation. The theoretical process that will guide our measurement of intermediate outcomes for this intervention is locus of control of reinforcement.1° The intermediate goal of this phase is to move patients from external to internal locus of control by helping them believe that they can cope with and control their own problems related to blood pressure. SUMMARY

This paper raises some of the measurement issues identified in our baseline studies because we think these issues are fundamental to hypertension education research, and to the ultimate credibility of health education research. We have also presented the procedures by which we generated a set of hypotheses from baseline diagnostic surveys and a series of interventions to be tested in small-scale, but carefully con-

trolled, randomized trials before training medical staff to employ them in their clinical routines. There has been a tendency in the medical and nursing literature to oversimplify the problems of hypertension management and of health education interventions ' and evaluation in this kind of setting. Some investigators have assumed that physicians' instructions were followed. Others presumed too much about the transferability to hypertension of educational technology, behavior modification, and cognitive theories from other health problems and populations in which they had successfully employed them. Many expect too much of blood pressure readings, clinic records, the possibility of pill counts, and even of survey methodologies to yield hard outcome data. Some have attempted or proposed to use the same dependent variables as the earlier Veterans Administration studies, which were not primarily concerned with patient compliance. The realities of inner-city clinic management of the typical hypertensive patient do not allow investigators simply to import educational or behavior modification strategies and prevail uponexisting clinic staff to implement them. Neither the strategies nor the instrumentation to measure their effects have been sufficiently developed and field tested to justify their immediate, large-scale application in clinical trials that disrupt clinic routines, impose on the time of staff and patients, and are of unknown efficacy. Our approach to these issues hasbeen to presume as little as possible and to build on a series of exploratory, methodological, and feasibility studies before imposing new procedures on overburdened clinics. ACKNOWLEDGMENTS This research is supported by Grants NCHSRD 5-P50-H51964-2, 1R25-HL-17016-01 and 1T32HL0710-02 from the U.S. Department of Health, Education and Welfare. We are indebted to the support and consultation of Drs. Carol Johns, Mohammad Raza, and Patterson Russel of the Johns Hopkins Hospital; Judy Chwalow, Brian Flynn, Michael Gross, Peter LeBrun, Pat Mulligan and Sam Shapiro of the Health Services Research and Development Center and the School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland.

REFERENCES

t. Green, L. W., Levine, D. M. and Deeds, S. G. (1975): Clinical trials of health education for hypertensive outpatients: Design and baseline data. Prey. Med. 4, 417425. 2. Levine, D. M., Green, L. W., Chwalow, A. J. et al. (1979): Behavioral and clinical effects of health educa-

tion for hypertensive patients. J. A m . Med. Assoc. In press. 3. Fletcher, S. W., Appel, F. A. and Bourgeois, M. A. (1975): Managementof hypertension: Effect of improving patient compliance for follow-up care. I. A m . Med. Assoc. 233 (July 21), 242-244.

PATIENT COUNSELLINGAND HEALTH EDUCATION

111 4. Gordis, L., Markowitz, M. and Lilienfeld, A. M. (1969): The inaccuracy of using interviews to estimate patient reliability in taking medications at home. Med. Care 7, 49-54. 5. Harris, L. et al. (1973): The PubUc and High Blood Pressure: A Survey Condttcted ]or the National Heart and Lung Institution. Louis Harris and Associates, New

York. 6. Inui, T. S. (1973): Effects o] Post-Graduate Physician Educat{on on the ltlanagement and Otttcomes o] Patients with Hypertension. Master of Science Thesis. Johns Hop-

7. 8.

9.

10. I1.

kins University School of Hygiene and Public Health, Baltimore. Apostolides, A., Hebel, J. R., McDilI, M. S. et al. (1974): High blood pressure: Its care and consequences in urban centers. Int. J. Epidemiol. 3 (June), 105-118. Sackett, D. L., Gibson, E. S., Taylor, D. W., Haynes, R. B. et al. (1975): Randomized clinical trials of strategies for improving medical compliance in primary hypertension. Lancet (May 31), 1205-1207. Becker, M. H. and Green, L. W. (1975): A family approach to compliance with medical treatment: a selective review of the literature. Int. J. Health Edttc. 18 (July-September), 173-182. MacDonald, A. P. (1972): Internal-external locus of control techniques. Rehabil. Lit. 33, 44--47. Chwalow, A. J., Green, L. W., Deeds, S. G. and Levine, D. M. (1975): Task clarification as a first stage in patient education to improve compliance with hypertension regimens. Presented at the American Public Health Association, Chicago, November 19.

APPENDIX Items Measuring General Knowledge about Hypertension. "What do you think high blood pressure ( H B P ) means? Tell me in your own words" (number of correct responses). Number of incorrect responses to preceding question subtracted. "If a person has HBP, what things will make it w o r s e ? " (number of correct responses). N u m b e r of incorrect responses to preceding question subtracted. Yes, no, or not sure A person can always tell when he has HBP. It can cause cancer. H B P can cause tuberculosis. Another name for H B P is hypertension. Doctors tell people with H B P to eat more salty foods. People with H B P are told to gain weight. Sometimes the doctor changes medicine for some people. People with H B P are told not to exercise and to stay in bed. All people with HBP take the same medicine. Smoking cigarettes lowers blood pressure. Some people feel worse when they first start taking medicine for HBP.

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Do you think overweight is related to HBP? Do you think underweight is related to HBP? Do you think having too much salt in diet is related to HBP? Do you think H B P runs in the family? Do you think too much exercise is related to HBP? Total score range = 0 - 2 2 ; rft = 0.91

Item-Content of Scale Measuring Belief in Seriousness of llypertension. "In your own words, tell me what you think high blood pressure could do to your body" (number of correct responses). Number of incorrect responses to preceding question subtracted. Yes or no High blood pressure can harm a person's kidneys. High blood pressure can lead to a stroke. It can harm a person's eyes. It can damage a person's heart. How long do you think you will need to take medicine for high blood pressure? If a person with H B P is going to have a stroke, it will probably happen right away. Bad feelings, like headaches or dizziness, will always warn a person before he has a stroke. Do you think H B P is a serious disease? Total score r a n g e = 0 - 1 0 ; r t t = 0 . 7 6

Item Content of Scale Measuring Belief in the Benefits of Treatment. Yes, no, or not sure There are ways to control high blood pressure. H B P will eventually go away on its own Without treatment. H o w well do you think the medicines work for treating HBP? What about controlling HBP by the foods you eat? "Tell me if you think this is a way to help prevent a stroke: Exercise; Stop smoking; T a k e vitamin pills; Watch weight, don't gain too much; Wear a copper bracelet; T a k e H B P medicine if you have HBP; Eat garlic or drink garlic water." Total score r a n g e = 0 - 1 1 ; rtt--'0.88