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Open Access Study protocol

[Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study)

Klaas A Hartholt12, Nicole DA Boyé12, Nathalie Van der Velde1, Esther MM Van Lieshout2, Suzanne Polinder3, Oscar J De Vries4, Albert JH Kerver5, Gijsbertus Ziere16, Milko MM Bruijninckx7, Mark R De Vries8, Francesco US Mattace-Raso1, André G Uitterlinden9, Ed F Van Beeck3, Paul Lips4, Peter Patka2 and Tischa JM Van der Cammen1*

Author Affiliations

1 Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

2 Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

3 Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

4 Department of Internal Medicine, VU university medical center, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands

5 Department of Surgery-Traumatology, Sint Franciscus Gasthuis, Kleiweg 5003045 PM Rotterdam, The Netherlands

6 Department of Geriatric Medicine, Harbour Hospital Rotterdam, Haringvliet 23011 TD, Rotterdam, The Netherlands

7 Department of Surgery-Traumatology, IJsselland Hospital, P.O. Box 690, 2900 AR Capelle a/d IJssel, The Netherlands

8 Department of Surgery-Traumatology, Reinier de Graaf Groep, P.O. Box 5011, 2600 GA Delft, The Netherlands

9 Department of Internal Medicine, Erasmus MC, University Medical Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

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BMC Geriatrics 2011, 11:48  doi:10.1186/1471-2318-11-48

Published: 21 August 2011

Abstract

Background

Fall 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/Design

A 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.

Discussion

The 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 Registration

The trial is registered in the Netherlands Trial Register (NTR1593)