Special Article
A Randomized Trial of a Program to Reduce the Use of Psychoactive Drugs in Nursing Homes
N Engl J Med 1992; 327:168-173July 16, 1992
- Abstract
- Abstract
Background.
Although psychoactive medications have substantial side effects in the elderly, these drugs are used frequently in nursing homes. Few interventions have succeeded in changing this situation, and little is known about the clinical effects of such interventions.
Methods.
We studied six matched pairs of nursing homes; at one randomly selected nursing home in each pair, physicians, nurses, and aides participated in an educational program in geriatric psychopharmacology. At base line we determined the type and quantity of drugs received by all residents (n = 823), and a blinded observer performed standardized clinical assessments of the residents who were taking psychoactive medications. After the five-month program, drug use and patient status were reassessed.
Results.
Scores on an index of psychoactive-drug use, measuring both the magnitude and the probable inappropriateness of medication use, declined significantly more in the nursing homes in which the program was carried out (experimental nursing homes) than in the control nursing homes (decrease, 27 percent vs. 8 percent; P = 0.02). The use of antipsychotic drugs was discontinued in more residents in the experimental nursing homes than in the control nursing homes (32 percent vs. 14 percent); the comparable figures for the discontinuation of long-acting benzodiazepines were 20 percent vs. 9 percent, and for antihistamine hypnotics, 45 percent vs. 21 percent. In the experimental nursing homes residents who were initially taking antipsychotic drugs showed less deterioration on several measures of cognitive function than similar residents in the control facilities, but they were more likely to report depression. Those who were initially taking benzodiazepines or antihistamine hypnotic agents reported less anxiety than controls but had more loss of memory. Most other measures of clinical status remained unchanged in both groups.
Conclusions.
An educational program targeted to physicians, nurses, and aides can reduce the use of psychoactive drugs in nursing homes without adversely affecting the overall behavior and level of functioning of the residents. (N Engl J Med 1992;327:168–73.)
Media in This Article
Figure 1
Proportion of Residents Whose Drug Regimens Were Changed in Nursing Homes in the Experimental and Control Groups.Figure 2
Change in the Number of Days of Use of Psychoactive Medications in Nursing Homes in the Experimental and Control Groups.Article Activity
- Article
DESPITE reports over more than a decade documenting a high level of use of psychoactive drugs among elderly residents in nursing homes, the use of such drugs continues to be a source of concern.1 2 3 4 In an earlier study,1 we found that over half the residents in a group of nursing homes were receiving some psychoactive medication; a fifth were receiving two or more such drugs concurrently. Although these medications can be of benefit to selected elderly patients when used judiciously, some disturbing patterns emerged from our research. Antipsychotic drugs were used frequently; such agents were received by a quarter of all residents. Two of every five residents were prescribed a hypnotic agent, and 82 percent of these received it regularly, although such agents often lose their efficacy with long-term use.5 , 6 Problems were also found in the choice of a therapeutic agent within a class. Amitriptyline was the most frequently prescribed antidepressant, although it is the most likely to cause anticholinergic side effects and sedation. Benzodiazepines with long half-lives were often prescribed, despite data that demonstrate an association between such agents and a higher frequency of hip fracture.7 , 8
In nursing homes, frail patients often receive intensive drug therapy with minimal supervision by a physician. Few well-controlled studies have evaluated ways to address this problem, however; even less is known about the clinical consequences of such interventions.9 We and others demonstrated improvements in patterns of drug prescription after the institution of an educational program for practitioners (a method referred to as "academic detailing").10 11 12 The present study was designed in an attempt to reduce the excessive use of sedating drugs by means of an educational program for health care providers in nursing homes. We used a randomized, controlled design, with drug use and clinical status as outcome measures.
Methods
We evaluated patterns of psychoactive-drug use by residents of nursing homes in eastern Massachusetts; facilities with atypically high or low levels of use were excluded. Details of the screening procedure were presented previously.1 The 12 nursing homes identified for inclusion in the study were grouped into six pairs matched on the basis of size, type of ownership, and level of drug use. We sought to ensure that the facilities in each pair were similar in terms of base-line drug use but were geographically distant enough to minimize the spread of information by staff members affiliated with both an "experimental" and a "control" nursing home. One institution in each pair was then randomly assigned to receive the experimental program.
Drug Use
Software was written for a laptop computer and used to record all medications received by each of the 823 residents of the 12 study facilities on a day-by-day basis during each of two 30-day periods, one before and one after the intervention program. For drugs prescribed to be given "as needed," we recorded each instance in which the medication was actually received.
Psychoactive agents were divided into those whose use would generally be discouraged ("nonrecommended" drugs) and those recommended if an agent of this type was indicated ("acceptable" drugs). Some benzodiazepines fell into neither category and were designated as "other" (Table 1Table 1
Classification of Psychoactive Drugs.). This category included triazolam, the use of which in the elderly had already been the subject of adverse reports. For each drug, we defined a daily dose above which use would be considered high. To test the effectiveness of the educational intervention, a psychoactive-drug-use score, according to which points were assigned for the use of a nonrecommended drug, for high doses, or for both (Table 2Table 2
Indicators of Potentially Inappropriate Use of Psychoactive Drugs.*), was developed before the program began.Clinical Assessments
A combination of measures was developed to evaluate changes in patients' level of functioning that might be associated with changes in drug use. We gathered information from three sources, in order to reduce the bias or limitations inherent in any single source. The measures we used were as follows: (1) the results of objective, standardized testing of a resident's performance by a research assistant blinded to the study design and the nursing home's group assignment; (2) assessment of the resident's functional status and behavior and the level of distress generated in the staff by him or her, as reported by nursing home staff members who knew the resident13; and (3) the resident's own report of his or her functional level and symptoms. (Tests are listed in Table 4Table 4
Changes in Measures of Clinical Outcome in the Experimental and Control Nursing Homes.*.)All clinical assessments were obtained throughout the study by the same research assistant, who worked from written procedures to ensure consistency. Over the course of the study, this research assistant was observed to standardize her assessments and prevent change over time. Permission was sought to assess all residents who had taken psychoactive medication during the month before the intervention.
Experimental Intervention
After measuring base-line drug use and performing clinical assessments, we initiated a comprehensive educational-outreach program in the six nursing homes randomly assigned to the experimental group. This program, which focused on geriatric psychopharmacology, was designed to reduce the overall use of psychoactive drugs by improving the selectivity of their use. Alternatives to sedation were proposed for behavior problems or insomnia. If a benzodiazepine was used, short-acting drugs were recommended over long-acting drugs. Reliance on antipsychotic drugs such as haloperidol and thioridazine was generally discouraged, although it was acknowledged that these drugs might be appropriate for limited use for specific patients. Although there is controversy surrounding the use of the antihistamine diphenhydramine as a hypnotic agent in the elderly, we judged that its known anticholinergic effects made it less desirable than a short-acting benzodiazepine. Diphenhydramine accounted for most of the drug use in the nonrecommended category (Table 1).
The educational intervention was based on the principles of "academic detailing" described elsewhere.10 , 14 Before producing any educational materials we interviewed nurses, nursing assistants, and physicians working in nursing homes that were not included in the study and inquired about factors that influenced them in prescribing psychoactive drugs for residents in long-term care facilities. We also conducted systematic reviews of the literature in psychopharmacology and geriatric medicine, oriented around such specific problems in long-term care as the management of insomnia, confusion, and agitation. The educational messages in our program were presented in six topical summaries of the literature, designed to be visually engaging in the style of drug advertisements. These printed materials were disseminated in three mailings to all the physicians caring for patients in the six experimental homes and were used as discussion aids in face-to-face educational sessions.
Physicians were chosen for these special sessions if their prescriptions for psychoactive drugs exceeded the threshold level during the base-line evaluation. After an introductory call by a geriatrician to explain the program, three interactive visits were scheduled by a clinical pharmacist with each physician. The pharmacist emphasized that the program was not connected with any pharmaceutical company or governmental agency but, rather, was a foundation-sponsored educational program conducted by faculty members from the Harvard Medical School Division on Aging. Because earlier educational programs for physicians only did not decrease the use of psychoactive drugs in nursing homes,15 we invited nurses and nursing assistants (in separate groups) to participate in four training sessions at each facility in the experimental group. In these sessions direct patient care, alternatives to psychoactive drugs, and recognition of adverse drug reactions were emphasized. An additional session was held for nurses and aides on the night shift, focusing on the use of hypnotic agents. After the conclusion of the educational program, data on the use of all medications were again collected at both the experimental and the control nursing homes. The same blinded research assistant returned to each facility to administer the clinical-assessment battery again to each resident who had been assessed previously.
Statistical Analysis
To assess changes in patterns of medication use, we used methods that accounted both for potential bias due to clustering and for the paired design.16 , 17 We computed the mean change in each measure of drug use for each nursing home, calculated the differences in the mean changes in each pair of nursing homes, and then averaged these differences for all six pairs. Comparing data from paired nursing homes rather than considering each one separately effectively reduced the sample to six pairs. This conservative approach lowered the power of the study to detect small differences, but it adhered closely to the experimental design, in which the nursing home pair was the unit of randomization.
For clinical-outcome variables, the changes in scores were not distributed normally, and the degree of variability in test scores for individual residents over time was high. We therefore divided the residents into two groups according to outcome: those with deterioration in performance and those with stable or improved performance. In each nursing home, we identified all residents who had received antipsychotic medication in the month before the intervention. A second study group comprised residents who had received benzodiazepine or hypnotic drugs and who had psychoactive-drug-use scores ≥1 (Table 2). Residents in the first group (those who had received antipsychotic drugs) were excluded from the second group to prevent overlap. Clinical outcomes were compared between the experimental and the control facilities for all residents in these defined risk groups. Rate-ratio estimates and 95 percent confidence intervals were used to assess differences between the two groups of facilities in the numbers of residents whose functional status deteriorated as compared with those whose status improved or who maintained their scores on each clinical measure.
Results
Medication Use
At base line, the use of psychoactive medication was comparable in the experimental and control nursing homes (Table 3Table 3
Use of Psychoactive Drugs in Experimental and Control Nursing Homes in the 30-Day Periods before and after the Intervention.*). The proportions of residents remaining in the two groups of homes after the intervention were also quite similar: 349 of 431 (81 percent) in the experimental nursing homes and 329 of 392 (84 percent) in the control facilities. Overall, the intervention was associated with a significant reduction in the psychoactive-drug-use scores of all residents with potentially inappropriate drug use (base-line psychoactive-drug-use score, ≥1) in the experimental nursing homes as compared with the control nursing homes. In the six experimental facilities, the mean psychoactive-drug-use score for these residents was reduced by 27 percent, from 1.87 to 1.36, whereas in the control facilities the change was only 8 percent, from 1.74 to 1.60 (mean difference in risk reduction, -0.37; 95 percent confidence interval, -0.08 to -0.67; P = 0.02).In the experimental nursing homes, more than twice as many of the residents who had received antipsychotic medications in the month before the intervention had these drugs discontinued as in the control facilities (32 percent vs. 14 percent; difference, -18 percent; 95 percent confidence interval for the difference, -3 percent to -33 percent) (Fig. 1Figure 1
Proportion of Residents Whose Drug Regimens Were Changed in Nursing Homes in the Experimental and Control Groups.). This difference was also reflected in a reduction in the number of days of antipsychotic drug therapy per patient per month in the experimental group that was nearly twice that in the control group (-7.1 vs. -3.7; mean difference, -3.5; 95 percent confidence interval for the difference, -10.6 to 3.6) (Fig. 2Figure 2Change in the Number of Days of Use of Psychoactive Medications in Nursing Homes in the Experimental and Control Groups.).More than twice as many residents in the experimental facilities had the nonrecommended hypnotic agent diphenhydramine discontinued and were instead given an acceptable agent or no hypnotic agent at all (45 percent vs. 21 percent; mean difference, -24 percent; 95 percent confidence interval, -54 percent to 5 percent). Shifts to no drug or to an acceptable drug were also observed among residents receiving either long-acting benzodiazepines or other benzodiazepines (20 percent vs. 9 percent; mean difference, -11 percent; 95 percent confidence interval, -38 percent to 15 percent). Although the educational program also addressed the use of antidepressant agents, these were the least frequently prescribed type of psychoactive agent at base line (received by 13 percent of residents), and the intervention dealt with the underuse as well as the overuse of these drugs; little change occurred in this category.
Clinical Outcomes
Clinical outcomes were compared for patients who had received antipsychotic drugs or any benzodiazepine or hypnotic agent in the month before the intervention and who had a psychoactive-drug-use score ≥1 at base line. Loss to follow-up was comparable for such patients in the experimental and control nursing homes. For example, of the 236 residents who were assessed with the Folstein mental-status examination18 at base line and were still in the facility after the intervention, follow-up assessments were performed for 78 percent of those in the control nursing homes and 73 percent of those in the experimental facilities. Loss to follow-up tended to be greater for other tests and among the more impaired residents with higher base-line drug use (Table 4), but it remained similar in the experimental and control nursing homes.
On the detailed test of memory (delayed-recognition-span test),19 among experimental nursing home residents who had received antipsychotic drugs before the intervention, 69 percent maintained or improved their scores and 31 percent had a deterioration in function. By contrast, among comparable residents in the control nursing homes, 46 percent maintained or improved their score, and 54 percent had deterioration (Table 4); the resulting rate ratio was 0.6 (95 percent confidence interval, 0.3 to 1.0). These results suggest that such residents in control nursing homes were only 60 percent as likely to maintain or improve their performance on memory testing as comparable patients in the experimental nursing homes. There was also a trend toward less deterioration on other measures of cognitive function in the facilities where the intervention was carried out (Table 4). We also measured clinical outcomes that might have worsened with a reduction in the use of psychoactive drugs. Among residents who had received antipsychotic agents, twice as many in the experimental nursing homes reported worsening depressive symptoms after the intervention as in the control nursing homes (56 percent vs. 27 percent; rate ratio, 2.0; 95 percent confidence interval, 1.1 to 3.9).22 , 23 No such differences between residents who had received antipsychotic agents in the two groups of facilities were found for other components of the assessment. When the data were analyzed as continuous rather than dichotomous variables, residents in the experimental facilities who had received antipsychotic agents had significantly less deterioration than those in the control facilities on the letter-cancellation test, a measure of attention (P = 0.04), but the differences in other outcomes did not reach statistical significance. Despite the reductions in drug use, experimental and control nursing homes were similar in measures of disruptive behavior and staff distress after the intervention.24 There was a somewhat greater frequency of sleep-related complaints among residents in the experimental nursing homes who had received benzodiazepines or hypnotic agents, but this difference did not reach statistical significance.
Paradoxically, residents in the experimental nursing homes who had received benzodiazepines or hypnotic agents reported stable or improved anxiety levels22 , 23 more frequently than such residents in the control nursing homes (77 percent vs. 48 percent; rate ratio, 0.4; 95 percent confidence interval, 0.2 to 1.0), despite the reduction in the use of sedating medications (Table 4). Nurses who regularly cared for residents reported more improvement in functional status among those who had received benzodiazepines or hypnotic agents in the experimental nursing homes than among comparable patients in the control nursing homes (67 percent vs. 45 percent; rate ratio, 0.6; 95 percent confidence interval, 0.4 to 1.0), although this effect was not evident in the ability to perform self-care activities as observed by the research assistant, indicating the possibility of observer bias.20 , 21 There was a significantly greater frequency of deterioration in scores on the delayed-recognition-span test in this cohort in the experimental than in the control facilities (62 percent vs. 29 percent; rate ratio, 2.1; 95 percent confidence interval, 1.1 to 4.2). These changes were not significant when the outcomes were measured as continuous variables across pairs of nursing homes. No differences were seen in the rates of hospitalization, mortality, or change in the level of care.
Discussion
Several conclusions can be drawn from the findings of this randomized controlled study involving more than 800 patients in 12 nursing homes. First, it is possible to reduce the use of psychoactive medications in such facilities through educational efforts, without reliance on regulatory penalties or economic incentives. Such reduction in drug use does not appear to result in more disruptive behavior or greater dysfunction among the residents or in increased levels of distress among staff members. Considerable evidence exists of the adverse effects of overuse of such medications, and the current levels of use of antipsychotic medications, benzodiazepines, and other hypnotic agents in long-term care facilities in the United States are probably excessive. The magnitude of the change in patterns of drug use in this study was similar to that observed in our earlier study of drug use among outpatients.10 The program we describe is not inexpensive, and like most educational or quality-assurance programs, it would be most effective if repeated and updated periodically. Additional economic studies will be needed to relate the costs of such programs to changes in the costs of drugs and long-term reductions in adverse drug reactions (such as a reduced frequency of hip fractures attributable to the use of sedatives7 , 8). It may be that greater changes could occur with the added impetus of changes in regulation, such as those recently implemented, in conjunction with the educational method reported here.25 Federal regulations that went into effect in 1991 imposed penalties for "incorrect" use of antipsychotic drugs in nursing homes, but offered little guidance to clinicians on how to address behavioral problems in long-term care. Drug-use policies that are merely restrictive may change physicians' prescribing practices in ways that ultimately defeat the purpose of the regulation.26
Although the effects of our educational program on drug use are clear, the consequences of reduced drug use were not uniformly positive. We identified trends suggesting greater improvement (or less deterioration) in some cognitive functions, such as memory, among residents who had received antipsychotic drugs in the nursing homes where the educational program was carried out than among comparable residents in the control nursing homes. The reduction in drug use was associated with a significant increase in residents' reports of depression, however. The clinical outcomes for residents who had been taking benzodiazepines or hypnotic agents are difficult to interpret. Contrary to our expectations, there was a trend toward reduction in the level of anxiety, as reported by the residents, in the experimental group as the use of benzodiazepine and other hypnotic agents was reduced, but these residents' performance on memory tests deteriorated. Further research is needed to determine whether such observations are chance findings or result from the effects of benzodiazepine withdrawal in patients with dementia. Because of our small sample, the statistical significance of the findings related to clinical outcomes in our study was not robust across different analyses, and larger clinical studies of these issues are needed.
In spite of the reduced use or discontinuation of psychoactive drugs for many residents in the experimental nursing homes, there was no substantial increase in reports of behavior disorders among the residents or distress on the part of the staff in either group of facilities. The limited sample size makes it impossible to rule out negative effects completely. Yet these findings provide some reassurance to those who are attempting to reduce the use of drugs that act on the central nervous system in nursing homes, whether for therapeutic reasons or for purposes of research.
All the facilities that participated in this study had undergone routine monitoring of medication use by consultant pharmacists, as well as by the physicians and nurses responsible for the care of each resident. Nevertheless, the base-line level of use of psychoactive medications was high, and the choice of agents and dosage were frequently less than optimal. The experimental intervention brought about an apparent improvement in the patterns of use of these drugs. Our results probably indicate a lower limit for the efficacy of such an approach since our study lasted only a few months, did not benefit from the reinforcement and long-term follow-up that would accompany an ongoing program, and was undertaken before the implementation of new federal regulations aimed at reducing such drug use. Nonetheless, comparable evidence does not exist for most other methods of improving the use of drugs in long-term-care facilities.9 With the number of elderly patients in nursing homes projected to exceed 2 million by the end of this decade,27 such educational programs could enhance attempts to counter the overuse of psychoactive drugs in the vulnerable residents of these facilities.
Supported by a grant from the Medications and Aging Program of the John A. Hartford Foundation of New York City.
We are indebted to the residents and staff members at the participating facilities, without whose help this work would not have been possible; to Elin Griesbach, who performed all the clinical assessments; to Christina Casteris, M.S., for her assistance in programming and data analysis; to Sharon Hawley, who abstracted the medication-use data; to Marilyn Albert, Ph.D., for guidance in the use of the expanded test of memory; to Susanne Bellavance for administrative support; to Barbara Arsenault and Rita Bloom for assistance in the preparation of the manuscript; and to Stephen Rappaport, M.D., for assistance in the early stages of the project.
Source Information
From the Program for the Analysis of Clinical Strategies, Harvard Medical School (J.A., S.B.S., D.E.E., D.R.-D., M.H.B., D.S., S.R.S.-S., D.F.); the Departments of Medicine of the Beth Israel and Brigham and Women's hospitals (J.A., D.E.E., M.H.B., D.F.); the Department of Social Medicine, Harvard Medical School (S.B.S., D.R.-D.); the Geriatric Research, Education, and Clinical Center of the BrocktonWest Roxbury Veterans Affairs Medical Center (D.E.E.); and the Harvard Geriatric Research and Training Center (J.A., D.E.E.) — all in Boston. Address reprint requests to Dr. Avorn at the Program for the Analysis of Clinical Strategies, Gerontology Division, Brigham and Women's Hospital, 221 Longwood Ave., Boston, MA 02115.
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