• Klaas A Hartholt, Nicole D A Boyé, Nathalie Van der Velde, Van Lieshout Esther M M EM, Suzanne Polinder, Oscar J De Vries, Albert J H Kerver, Gijsbertus Ziere, Milko M M Bruijninckx, Mark R De Vries, Francesco U S Mattace-Raso, André G Uitterlinden, Ed F Van Beeck, Paul Lips, Peter Patka, and Tischa J M Van der Cammen.
• Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P,O, Box 2040, 3000 CA Rotterdam, The Netherlands.
• BMC Geriatr. 2011 Aug 21; 11: 48.

BackgroundFall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall.Methods/DesignA prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis.DiscussionThe successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction.Trial RegistrationThe trial is registered in the Netherlands Trial Register (NTR1593).

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