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

BMC Geriatrics

Study Protocol

Nathalie Van der Velde¹  Tischa JM Van der Cammen¹  Francesco US Mattace-Raso¹  Gijsbertus Ziere²  Klaas A Hartholt³  Nicole DA Boyé³  André G Uitterlinden⁴  Paul Lips⁵  Oscar J De Vries⁵  Suzanne Polinder⁶  Ed F Van Beeck⁶  Esther MM Van Lieshout⁷  Peter Patka⁷  Milko MM Bruijninckx⁸  Mark R De Vries⁹  Albert JH Kerver^1,10 

[1] Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Geriatric Medicine, Harbour Hospital Rotterdam, Haringvliet, 23011 TD, Rotterdam, The Netherlands;Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Internal Medicine, Erasmus MC, University Medical Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Internal Medicine, VU university medical center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Surgery-Traumatology, IJsselland Hospital, P.O. Box 690, 2900 AR, Capelle a/d IJssel, The Netherlands;Department of Surgery-Traumatology, Reinier de Graaf Groep, P.O. Box 5011, 2600 GA, Delft, The Netherlands;Department of Surgery-Traumatology, Sint Franciscus Gasthuis, Kleiweg, 5003045 PM, Rotterdam, The Netherlands;

关键词: Quality Adjust Life Year;    Healthcare Consumption;    Fall Incident;    Emergency Department Attendance;    Full Cost Price;   

DOI  :  10.1186/1471-2318-11-48

 received in 2011-07-05, accepted in 2011-08-21,  发布年份 2011

来源: Springer

【 摘 要 】

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)

【 授权许可】

Unknown   
© Hartholt et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.