The purpose of this study is to evaluate the effectiveness and efficiency of withdrawal, reduction or substitution of fall-risk increasing drugs in older fallers (65 +) presenting at the A+E Department. Based on the results of this study, a clinical protocol will be developed for assessment and modification of drug use among older fallers at the A+E.The research questions are the following: 1. To what extent can fall-risk increasing drugs be controlled in older fallers? 2. Does control of fall-risk increasing drugs lead to a reduction of further falls and an improvement in generic health-related quality of life (HRQOL)? 3. Does control of fall-risk increasing drugs lead to increased health risks? 4. What is the cost-effectiveness of the control of fall-risk increasing drugs in older fallers?
Objective/ research questions:To evaluate the positive and negative effects, and the cost-effectiveness of a systematic assessment of drug use and drugs modification in older fallers presenting at the Accident and Emergency (A+E) Department. Based on the results of this study, a clinical protocol will be developed for assessment and modification of drug use among older fallers at the A+E.Study design:RCT with one intervention and one control group, and with a single intervention.Study population:Older fallers (65+) presenting at the A+E of the Erasmus MC or VUmc, and on 1 or more fall-risk increasing drugs, are eligible. We will randomise 620 (2x310) patients. The intervention group will receive a systematic drugs assessment. Fall-risk increasing drugs will be stopped, reduced or substituted by safer drugs where possible. The control group will receive usual care. During 1 year of follow-up, fall incidence, fall-related injuries, medication use, recurrence of (disease)symptoms, and health care consumption (costs) will be registered.Intervention:Single intervention (i.e., fall-related drugs assessment + drugs modification + follow-up) in older fallers.Outcome measures:Primary outcome parameters will be the incidence of further falls and the possible negative health outcomes of drug withdrawal.Secondary outcome measures will be fall-related injuries, generic health-related quality of life (HRQOL), compliance and quality adjusted life years.Sample size calculation:All consecutive persons of 65+ who visit the A+E of the Erasmus MC and VUmc because of a fall and who use one or more fall-related drugs (n=about 1500-2000 in one year for both UMCs together) will be asked to participate. Based on previous studies, we may assume an annual cumulative incidence of further falling of 50% without intervention, a 15% drop-out (including death), drug withdrawal being possible in 50% of the participants in the intervention group, and a 52% decrease of further falls among participants with successful withdrawal. Under these assumptions, a sample size of 616 would have 80% power to detect a 26% decrease of respondents reporting further falls in the intervention group, with an alpha of 0.05.Data analysis:The intention-to-treat principle will be followed. The hazard ratio (HR) for falling will be calculated with Cox-regression analyses using the time between the intervention till the first/second fall as the outcome measure.Economic evaluation:Cost-effectiveness analysis, including costs per prevented fall as primary outcome measure, and costs per prevented fall-related injury and costs per QALY as secondary outcome measures. |
