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Results from the Improving Medication Prescribing to reduce Risk Of FALLs ( IMPROveFALL ) Study A Randomized Controlled Trial

Importance: Fall incidents represent a public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs (FRIDs). Objectives: To investigate the effect of withdrawal of FRIDs versus ‘care as usual’ on reducing falls in community-dwelling older men and women. Design: Randomized multicenter trial. Setting: Community, Primary care, Geriatric care. Participants: 612 older adults who visited an Emergency Department due to a fall. Interventions: A structured medication assessment including withdrawal of FRIDs. Main Outcomes and Measures: A 3-monthly falls calendar was used for assessing the number of falls and associated injuries during 12 months of follow-up. Primary outcome was incidence of falls. Secondary outcome measures were falls requiring a general practitioner consultation or Emergency Department visit, and possible health effects of medication withdrawal. Data were analyzed using an intention-totreat (primary) and a per protocol (secondary) analysis. Both overall FRID withdrawal as well as major subgroups (psychotropic and cardiovascular drugs) were assessed. The hazard ratios for time-to-fall were calculated using a Coxregression model. Differences in cumulative incidence of falls were analysed using Poisson regression. Results: During the 12 months follow-up, 91 (34%) of the control participants and 115 (37%) of the intervention participants experienced a fall. FRIDs withdrawal did not have a significant effect on the time to the first fall (hazard ratio [HR] 1.17; 95% confidence interval [CI] 0.89-1.54), the time to the second fall (1.19; 0.78-1.82), the time to the first general practitioner consultation due to a fall (0.66; 0.42-1.06), or the time to the first Emergency Department visit due to a fall (0.85; 0.43-1.68). Cardiovascular FRID withdrawal increased the time to the first general practitioner consultation due to a fall (0.57; 0.34-0.93). Per-protocol analyses did not alter the results. Conclusions and Relevance: The risk of falls did not differ between the usual care and intervention groups. There was a trend towards fewer healthcare visits in the intervention group, and this was significant in the cardiovascular-drugs withdrawal subgroup. Surprisingly, no effect of psychotropic drug withdrawal was seen, possibly due to the group size and low compliance. Trial Registration: Netherlands Trial Register NTR1593 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1593).