Predictors of antipsychotic withdrawal or dose reduction in a randomized controlled trial of provider education.

OBJECTIVES: To evaluate the effects of an educational program to reduce antipsychotic use in nursing homes that had high use rates post-OBRA-87 and to identify factors that predicted antipsychotic withdrawal or 50% or greater dose reduction. DESIGN/SETTING: A randomized controlled trial (RCT) of the educational program (nursing home the unit of randomization and analysis) was conducted in 12 Tennessee nursing homes (6 education/6 control). Cohort analysis in baseline antipsychotic users identified factors predicting withdrawal or dose reduction. SUBJECTS: The RCT analysis included 1152 patients in the homes at baseline and 6 months. The cohort analysis included 133 baseline antipsychotic users in the five education homes able to implement the recommendations of the educational program. OUTCOME MEASURES: Change in days of antipsychotic use per 100 days of nursing home residence, withdrawal from antipsychotics, reduction in antipsychotic dose by 50% or more. RESULTS: Following the educational intervention, use of antipsychotics in the six education homes decreased from 25.3 days per 100 at baseline to 19.7 days per 100 by month 6, a 23% reduction relative to control homes (P = .014). In the withdrawal analysis, 44 (33%) of 133 baseline antipsychotic users were withdrawn. Factors at baseline predicting successful withdrawal were low antipsychotic dose, no use of benzodiazepines or antidepressants, and behavioral symptoms score below the median. However, although an additional 22 patients had dose reductions > or = 50%, none of the predictors of withdrawal were associated with dose reductions. CONCLUSIONS: Focused provider education programs may facilitate antipsychotic reduction above and beyond that attributable to regulatory changes. Patients who are poor candidates for total antipsychotic withdrawal may tolerate substantial dose reductions, which should reduce their risk of adverse antipsychotic effects.

Clinical and biomechanical measures of balance as fall predictors in ambulatory nursing home residents.

BACKGROUND: We evaluated the capacity of biomechanical and clinical measures of balance to predict future risk of recurrent falls in a cohort of frail, elderly ambulatory residents of 12 Tennessee community nursing homes. METHODS: Baseline measurements of balance and other potential fall risk factors were obtained in 303 ambulatory nursing home residents. Balance measures included biomechanics force platform measurements of postural sway (area ellipse and mean velocity) and clinical measures, which included functional reach, Tinetti balance subscale (adapted from Tinetti's Performance Oriented Mobility Index), timed chair stands, and 10-foot walk. Residents who fell two or more times during follow-up (mean of 11 months) were identified from nursing home incident reports and nursing notes. The predictive value of the balance measures was evaluated by the incidence density ratio (IDR) estimated from proportional hazards models. RESULTS: There were 118 recurrent fallers (54.2 per 100 person-years). Rates of recurrent falls increased with increasing quintiles of both the biomechanical and clinical measures of balance, with unadjusted IDRs (95% CI) per quintile change of 1.22 (1.07-1.39) for area ellipse, 1.12 (0.98-1.27) for mean velocity of postural sway, 1.29 (1.13-1.47) for the Tinetti balance subscale, 1.24 (1.08-1.41) for timed walk, 1.24 (1.09-1.42) for timed chair stands, and 1.12 (0.98-1.28) for functional reach. Controlling for age, gender, height, and weight did not materially affect the linear relationship between the balance measure quintiles and subsequent recurrent falls. However, after controlling for additional fall risk factors, only area ellipse of postural sway and the Tinetti balance subscale remained independently predictive of subsequent recurrent fall rates, with IDRs of 1.16 (1.02-1.36) and 1.17 (1.01-1.34), respectively. In an analysis where subjects were stratified by tertiles of each of these two measures, each measure appeared to independently predict future rates of recurrent falls. The independent predictive capacity of each measure persisted after controlling for other fall risk factors in a multivariate analysis with IDRs of 1.15 (1.00-1.32) for area ellipse and 1.15 (1.00-1.32) for the Tinetti balance subscale. Inclusion of both balance measures in a model with other fall risk factors to evaluate their relationship did not materially alter IDR point estimates of these risk factors. CONCLUSIONS: In this cohort of frail, nursing home residents, both area ellipse of postural sway and the Tinetti balance subscale independently predicted risk of future recurrent falls. However, the predictive value of other independent fall risk factors on risk of future recurrent falls persisted and was not explained by these two measures. Thus, assessment of patient fall risk based on surrogate endpoints, for either research or clinical practice, may need to include multiple measurements.

Excess costs from gastrointestinal disease associated with nonsteroidal anti-inflammatory drugs.

OBJECTIVE: To quantify medical care costs for the diagnosis and treatment of gastrointestinal disorders attributable to use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than aspirin in elderly persons. DESIGN AND SETTING: Retrospective cohort study of 75,350 Tennessee Medicaid enrollees at least 65 years of age. MEASUREMENTS: The cohort was classified by baseline NSAID use as nonusers (no use preceding 1988), occasional users (< 75% of days) or regular users (> or = 75% of days). For the follow-up year (1989), we calculated annual rates of utilization of and Medicare/Medicaid payments for: medical care for NSAID-associated gastrointestinal disorders; hospitalizations/emergency department visits for peptic ulcers, gastritis/duodenitis, and gastrointestinal bleeding; outpatient upper and lower gastrointestinal tract radiologic and endoscopic examinations; and histamine2 (H2)-receptor antagonist, sucralfate, and antacid prescriptions. Rates were adjusted for demographic characteristics and baseline health care utilization. RESULTS: Among nonusers of NSAIDs, the adjusted mean annual payment for all types of medical care for study gastrointestinal disorders was $134. This increased to $180 among occasional users, an excess of $46 (p < .001); and to $244 among regular users, an excess of $111 (p < .001, comparison with both nonusers and occasional users). Cohort members with any baseline year NSAID use had an adjusted mean annual payment of $191, $57 (p < .001) higher than that for nonusers. In both users and nonusers of NSAIDs, medications and inpatient care accounted for the largest component of costs. Among regular NSAID users, excess payments increased with baseline NSAID dose: $56, $120, and $157 for less than 1, 1 to 2, and more than 2 standard units per day, respectively (p < .01, linear trend). CONCLUSIONS: Nonsteroidal anti-inflammatory drug (NSAID) use in elderly patients was associated with substantial excess costs and utilization of medical care for gastrointestinal disorders.

Injurious falls in nonambulatory nursing home residents: a comparative study of circumstances, incidence, and risk factors.

OBJECTIVE: To determine the circumstances of, incidence of, and risk factors for falls resulting in serious injuries in nonambulatory nursing home residents compared with those for ambulatory residents. DESIGN: Prospective cohort study with 1-year follow-up. SETTING: Twelve community nursing homes in Tennessee. SUBJECTS: A total of 1228 residents, 65 years of age or older, of whom 725 (59%) were nonambulatory and 503 (41%) were ambulatory. MEASUREMENTS: Baseline data were obtained for potential risk factors for injurious falls. These included demographic characteristics, mental and physical function, vision, hearing, incontinence, and use of mechanical restraints and psychotropic drugs. Data were obtained from direct resident assessment, care provider interview, and the nursing home Minimum Data Set (MDS) (validated in a sample of residents). OUTCOME: There were 111 first falls resulting in serious injury (head injury with altered consciousness, fracture, joint dislocation or sprain, or sutured laceration) that received medical treatment (hospitalization, emergency room visit, physician visit, or on-site radiological examination), ascertained from facility incident reports and nursing home charts. RESULTS: Nonambulatory residents had a substantially greater prevalence of mental and physical impairment. Circumstances of injurious falls in nonambulatory (n = 39 falls) and ambulatory (n = 72 falls) residents differed; those in the former groups were more likely to involve equipment (87% vs 45%, P < .0001), occur while seated or during transferring (82% vs 21%, P < .0001), and from a chair/bed level (54% vs 6%, P < .0001). The incidence of injurious falls in nonambulatory residents (6.7 per 100 person-years) was less than half that in ambulatory residents (17.0 per 100 person-years, P < .0001). After controlling for other factors, the nonambulatory residents at highest risk were those not bed-bound and with capacity for independent transfer (incidence density ratio (IDR) = 2.02, 95% CI = 1.07-7.99); the ambulatory residents at highest risk were baseline users of psychotropic drugs (IDR = 2.49, 95% CI = 1.43-4.33). CONCLUSIONS: In the study cohort, nonambulatory residents had 35% of injurious falls. Because the circumstances and risk factors of these events were substantially different from those for ambulatory residents, separate prevention strategies may be needed for this group. These data suggest that increasing the safety of transferring and of equipment are appropriate targets for interventions.

Psychotropic drugs and risk of recurrent falls in ambulatory nursing home residents.

Although psychotropic drug use has been associated with increased risk of falls in long-term care settings; this association may be confounded by the high prevalence of dementia and depression and other fall risk factors. This question was addressed in a prospective cohort study of recurrent falls among 282 ambulatory residents of 12 Tennessee nursing homes during 1991-1992. Eligible subjects were > or = 65 years of age, ambulatory, able to provide study data, and expected to remain in the nursing home for > or = 3 months. Baseline data collected for each cohort member included symptoms of dementia (cognitive impairment and behavior problems) and depression, medication use, and other potential fall risk factors. Falls were ascertained from facility incident reports and nursing home charts. During follow-up, 111 residents had > or = 2 falls, an incidence rate of 54.9 recurrent falls per 100 person-years. With the use of Cox proportional hazards modeling, the authors found incidence density ratios (95% confidence intervals (Cl)) showing that the following risk factors were independently associated with recurrent falls: age > or = 75 years (1.66 (1.01-2.72)); > or = 4 assisted activities of daily living (1.94 (1.09-3.47)); middle (2.08 (1.20-3.61)) and upper (2.54 (1.44-4.49)) tertiles of balance impairment; fall in the 90 days preceding assessment (2.01 (1.32-3.06)); and upper tertile of behavior problems (1.65 (1.03-2.64)). The rate of recurrent falls increased tenfold as the number of these risk factors increased from 0 to 5 (21.4 to 231.5 per 100 person-years, p < 0.0002). After controlling for symptoms of dementia and depression and other fall risk factors, the incidence density ratio for recurrent falls in baseline regular psychotropic drug users (n = 178) compared with nonusers (n = 104) was 1.97 (95% Cl 1.28-3.05). Within groups defined by number of other independent fall risk factors present, regular psychotropic users had a recurrent fall rate that was greater than that for nonusers: 44.1 versus 22.9 per 100 person-years (p = 0.03) in the low risk (< or = 2 factors) group and 98.7 versus 64.3 (p = 0.08) in the high risk (> 2 factors) group. The attributable risk of recurrent falls for regular psychotropic drug users was 36%, which suggests optimal management of psychopharmacotherapy is an essential component of fall prevention programs for ambulatory nursing home residents.

Effect of a prior-authorization requirement on the use of nonsteroidal antiinflammatory drugs by Medicaid patients.

BACKGROUND: Prior authorization--mandatory advance approval for the use of expensive medications--is now the primary method by which Medicaid programs control expenditures for drugs. However, whether this policy reduces expenditures for specific drugs without causing the unwanted substitution of other drugs or medical services has been largely unstudied. We evaluated the effects of a prior-authorization policy involving nongeneric nonsteroidal antiinflammatory drugs (NSAIDs) in the Medicaid program in Tennessee. METHODS: We compared monthly Medicaid expenditures that were potentially affected by the policy change during the year before and the two years after its implementation. We studied prescriptions for NSAIDs, other analgesic or antiinflammatory drugs, and psychotropic drugs, as well as outpatient services and inpatient admissions for the management of pain or inflammation. RESULTS: At the midpoint of the base-line year, 495,821 people were enrolled in Medicaid. During that year, mean annualized Medicaid expenditures for NSAID prescriptions amounted to $22.41. Expenditures decreased by 53 percent (95 percent confidence interval, 48 to 57 percent) during the next two years, for an estimated savings of $12.8 million. The reduction in expenditures resulted from the increased use of generic NSAIDs, as well as from a 19 percent decrease in overall NSAID use (95 percent confidence interval, 13 to 25 percent). There was no concomitant increase in Medicaid expenditures for other medical care. Regular users of nongeneric NSAIDs, those most affected by the policy change, had similar reductions in NSAID expenditures and use, with no increase in expenditures for other medical care. CONCLUSIONS: Prior-authorization requirements may be highly cost effective with regard to expenditures for NSAIDs, drugs that have very similar efficacy and safety but substantial variation in cost.

Comparison of clinical and biomechanical measures of balance and mobility in elderly nursing home residents.

OBJECTIVE: To compare biomechanics force platform measurements of postural sway with clinical measures of balance and mobility, in frail elderly residents of community nursing homes, in terms of feasibility, correlation with other known risk factors for falls, and intercorrelation with each other. DESIGN: Cross-sectional study. SETTING: Twelve Tennessee community nursing homes. SUBJECTS: Of 1315 residents 360 (> or = 65) could stand independently (> or = 10 seconds). Of these eligible subjects, 303 (84%) provided informed consent and were assessed. MEASUREMENTS: The biomechanics force platform measurements were postural sway during quiet standing characterized as elliptical area and mean velocity. The clinical measures were functional reach, mobility maneuvers (adapted from Tinetti's Mobility Index), timed chair stands, and 10-foot walk. Resident characteristics and function were also obtained. RESULTS: Balance measurements were obtained on most (100% for postural sway to 67% for chair stand) consenting residents and were reliable on test-retest (intraclass correlation from .56 to .98). Performance in both groups of balance measures deteriorated with increasing musculoskeletal disability. Functional reach and mobility maneuvers correlated with height, and mobility maneuvers with depressive symptoms. Elliptical area correlated with mean velocity of postural sway (Pearson's r = 0.72; P < 0.001), and the clinical measures of balance (functional reach, mobility maneuvers, timed chair stands and walk) were modestly intercorrelated (r from 0.35 to 0.65; all P values < or = 0.05). However, the biomechanical measures were not correlated with the clinical measures. CONCLUSIONS: Standard measures of balance were obtained reliably from nursing home residents who could stand independently for > or = 10 seconds. However, in this group, further research is needed to determine which measures best predict falls. Further research is also needed to identify predictors of falls in the majority of residents who were too frail to undergo these standard assessments.

Effects of antipsychotic withdrawal in elderly nursing home residents.

OBJECTIVE: To study the effects of antipsychotic withdrawal in elderly nursing home residents. DESIGN: Longitudinal prospective study. SETTING: 12 community nursing homes that participated in a randomized controlled trial of an educational program designed to reduce antipsychotic use. SUBJECTS: 271 residents receiving antipsychotics at baseline and remaining in the home for approximately 6 months thereafter. These were placed into two groups: those with continued use of antipsychotics at follow-up (n = 207) and those with drug discontinued (n = 64). MEASUREMENTS: Change between baseline and follow-up for several standard measurements. These included behavior problems, as reported by both regular care providers (Nursing Home Behavior Problem Scale) or a blinded study rater (items from the Brief Psychiatric Rating Scale), observer-rated psychiatric symptoms (subset of the Brief Psychiatric Rating Scale), and other standard tests of function (Activities of Daily Living, Mini-Mental State Examination, Geriatric Depression Scale, and Abnormal Involuntary Movements Scale). RESULTS: The frequency of behavior problems did not increase in residents with antipsychotics discontinued. For these residents, observer-rated psychiatric symptoms decreased by 21% (P = 0.003), which resulted from a 27% decrease in adverse affective symptoms (P = 0.0002). Residents with drug discontinued had no deterioration in any of the measures of function. CONCLUSION: In this sample, nursing home residents whose antipsychotics were discontinued had significantly improved affect and no discernable adverse effects.

Changes in antipsychotic drug use in nursing homes during implementation of the OBRA-87 regulations.

OBJECTIVES: To describe the changes in antipsychotic drug use in nursing homes during the period surrounding the implementation of federal legislation designed to reduce unnecessary use (the Omnibus Budget Reconciliation Act of 1987 [OBRA-87]) and to identify nursing home characteristics associated with such changes. DESIGN: Longitudinal study of 9432 Tennessee Medicaid enrollees 65 years of age or older who continuously resided in Tennessee from April 1, 1989, to September 30, 1991, a 30-month period surrounding implementation of OBRA-87. MAIN OUTCOME MEASURES: Changes in the use of antipsychotic and other psychotropic drugs. RESULTS: During the 30-month period, antipsychotic drug use decreased from 23.9 to 17.5 days per 100 days of residence, a 26.7% decline (P < .001), which resulted from both a decrease in new users (P < .001) and a reduction in long-term use of antipsychotic drugs (P < .001). There was no concomitant increase in other psychotropic drug use. A multivariate analysis revealed that changes in antipsychotic use were strongly associated with baseline antipsychotic use (P = .001) and third-shift staffing levels (P = .003). Nursing homes with baseline antipsychotic drug use and third-shift staffing above the median reduced antipsychotic drug use by 41%, compared with a 2% increase in nursing homes where both of these factors were below the median (P < .0001). CONCLUSIONS: A substantial decrease in antipsychotic drug use coincided with the implementation of OBRA-87. Although this decrease is consistent with an improvement in quality of nursing home care, further research is needed to determine the effects of this legislation on resident outcomes.

Reducing antipsychotic drug use in nursing homes. A controlled trial of provider education.

OBJECTIVE: In the United States, 20% or more of nursing home residents receive antipsychotic drugs, primarily for the behavioral manifestations of dementia. This high level of use of drugs with substantial toxicity has engendered a strong and persistent controversy and recently has led to explicit regulatory measures to curtail use (Omnibus Budget Reconciliation Act of 1987). We developed and tested a comprehensive program to reduce antipsychotic use through education of physicians, nurses, and other nursing home staff. The primary elements of the program were instruction in use of behavioral techniques to manage behavior problems and encouragement of a trial of gradual antipsychotic withdrawal. DESIGN: In a nonrandomized controlled trial, the program was implemented (beginning in August 1990) in two rural Tennessee community nursing homes with elevated antipsychotic use; two other comparable homes were selected as concurrent controls. PATIENTS: Throughout the study 194 residents were in the education homes and 184 were in the control homes. Residents in both groups of homes had comparable demographic characteristics and functional status, and each group had a baseline rate of 29 days of antipsychotic use per 100 days of nursing home residence. MAIN OUTCOME MEASURES: The primary end points were postintervention changes in administration of antipsychotics and other psychotropic drugs, use of physical restraints, and frequency of behavior problems. RESULTS: Days of antipsychotic use decreased by 72% in the education homes vs 13% in the control homes (P < .001). No significant changes were noted in the use of other psychotropic drugs in either group. Days of physical restraint use decreased 36% in the education homes vs 5% in the control homes (P < .001). Behavior problem frequency did not increase in either group, even among the 48% of baseline antipsychotic users in the education homes who had antipsychotic drug regimens discontinued for 3 or more months. CONCLUSIONS: The educational program led to a substantial reduction in antipsychotic use with no increase in the frequency of behavior problems. This suggests that for many antipsychotic drug users benefits may be marginal and that programs to reduce such drug use among the 250,000 US nursing home residents receiving these drugs should have high priority.

Black-white differences in fracture rates.

To compare the incidence of all nonvertebral fractures between elderly blacks and whites, the authors conducted a retrospective cohort study among Tennessee Medicaid enrollees aged 65 years or more from 1987 through 1989. A previously validated computer algorithm identified 6,802 persons of black or white race with 7,645 new nonvertebral fractures. The incidence of all nonvertebral fractures in blacks was only half of that in whites. This finding persisted after the authors controlled for sex, age, and nursing home residence (relative risk = 0.4, 95% confidence interval 0.4-0.5). Rates were consistently lower among blacks within subgroups defined by these factors and for each of the 13 different fracture sites examined. The magnitude of the difference between blacks and whites in rates of all fractures combined and most site-specific fractures is similar to that previously reported for hip fractures. These consistent racial differences suggest a common underlying factor(s).

Psychoactive drugs and the risk of injurious motor vehicle crashes in elderly drivers.

To determine whether commonly used psychoactive drugs increase the risk of involvement in motor vehicle crashes for drivers > or = 65 years of age, the authors conducted a retrospective cohort study. Data were obtained from computerized files from the Tennessee Medicaid program, driver's license files, and police reports of injurious crashes. Cohort members were Medicaid enrollees 65-84 years of age who had a valid driver's license during the study period 1984-1988 and who met other criteria designed to exclude persons unlikely to be drivers and to ensure availability of necessary study data. There were 16,262 persons in the study cohort with 38,701 person-years of follow-up and involvement in 495 injurious crashes. For four groups of psychoactive drugs (benzodiazepines, cyclic antidepressants, oral opioid analgesics, and antihistamines), the risk of crash involvement was calculated with Poisson regression models that controlled for demographic characteristics and use of medical care as an indicator of health status. The relative risk of injurious crash involvement for current users of any psychoactive drug was 1.5 (95% confidence interval (CI) 1.2-1.9). This increased risk was confined to benzodiazepines (relative risk = 1.5; 95% CI 1.2-1.9) and cyclic antidepressants (relative risk = 2.2; 95% CI 1.3-3.5). For these drugs, the relative risk increased with dose and was substantial for high doses: 2.4 (95% CI 1.3-4.4) for > or = 20 mg of diazepam and 5.5 (95% CI 2.6-11.6) for > or = 125 mg of amitriptyline. Analysis of data for the crash-involved drivers suggested that these findings were not due to confounding by alcohol use or driving frequency.

Identification of fractures from computerized Medicare files.

Study of non-hip fractures, which are a serious public health problem for persons greater than or equal to 65 years of age, has been hindered by the absence of an economical method for case identification. We assessed the utility of computerized Medicare inpatient, emergency room, hospital outpatient department and physician claims for identifying fractures in an elderly Tennessee Medicaid population. We used these files for 1987 to identify 3086 possible fractures and reviewed medical records for a sample of 1440. Using this sample, we developed a definition of probable fractures that excluded claims unlikely to represent newly diagnosed fractures. For all fractures, this definition had a positive predictive value of 94%, which for individual fracture sites, ranged from 79% (tibia/fibula) to 98% (hip). Of fractures in the reviewed sample, 91% were identified as probable fractures; this upper bound for sensitivity varied between 75% (femoral shaft) and 100% (patella). These data suggest that computerized Medicare files can be used for rapid and economical fracture ascertainment among persons greater than or equal to 65 years of age. However, further work is needed to obtain better estimates of sensitivity.

Methodological issues in evaluating expanded Medicaid coverage for pregnant women.

In a recent effort to lower the US infant mortality rate, Congress has expanded the Medicaid coverage options that states may offer pregnant women. Careful evaluation of changes in perinatal outcome associated with this expanded coverage is needed. The linkage of Medicaid enrollment files of mothers and infants to birth, death, and fetal death certificates is an initial step in assessing the effectiveness that Medicaid coverage expansions have had on pregnancy outcome. Creation of such a database for Tennessee for 1984-1987 revealed that complete information on mother, delivery, and child is available for only three quarters of Medicaid-reimbursed births. Furthermore, Medicaid-reimbursed births that had all three data components had different characteristics and lower mortality rates than did births with missing elements. Those persons seeking to evaluate expanded Medicaid coverage for pregnant women need to be aware that consideration of only those births for whom there is information on mother, delivery, and child may lead to serious underascertainment of fetal, perinatal, and neonatal mortality rates.