title: [Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial is registered in the Netherlands Trial Register (NTR1593).
authors.affiliation: Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P,O, Box 2040, 3000 CA Rotterdam, The Netherlands.
authors.forename: Klaas A
authors.initials: KA
authors.lastname: Hartholt
authors.forename: Nicole D A
authors.initials: ND
authors.lastname: Boyé
authors.forename: Nathalie
authors.initials: N
authors.lastname: Van der Velde
authors.forename: Esther M M
authors.initials: EM
authors.lastname: Van Lieshout
authors.forename: Suzanne
authors.initials: S
authors.lastname: Polinder
authors.forename: Oscar J
authors.initials: OJ
authors.lastname: De Vries
authors.forename: Albert J H
authors.initials: AJ
authors.lastname: Kerver
authors.forename: Gijsbertus
authors.initials: G
authors.lastname: Ziere
authors.forename: Milko M M
authors.initials: MM
authors.lastname: Bruijninckx
authors.forename: Mark R
authors.initials: MR
authors.lastname: De Vries
authors.forename: Francesco U S
authors.initials: FU
authors.lastname: Mattace-Raso
authors.forename: André G
authors.initials: AG
authors.lastname: Uitterlinden
authors.forename: Ed F
authors.initials: EF
authors.lastname: Van Beeck
authors.forename: Paul
authors.initials: P
authors.lastname: Lips
authors.forename: Peter
authors.initials: P
authors.lastname: Patka
authors.forename: Tischa J M
authors.initials: TJ
authors.lastname: Van der Cammen
mesh_terms: D000058:Accidental Falls / Q000191:economics* / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis / Q000191:economics; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations / Q000191:economics*; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D004364:Pharmaceutical Preparations