title: Prevention of fall incidents in patients with a high risk of falling: design of a randomised controlled trial with an economic evaluation of the effect of multidisciplinary transmural care.
abstract: BACKGROUND
  Annually, about 30% of the persons of 65 years and older falls at least once and 15% falls at least twice. Falls often result in serious injuries, such as fractures. Therefore, the prevention of accidental falls is necessary. The aim is to describe the design of a study that evaluates the efficacy and cost-effectiveness of a multidisciplinary assessment and treatment of multiple fall risk factors in independently living older persons with a high risk of falling.
  
  
  METHODS
  The study is designed as a randomised controlled trial (RCT) with an economic evaluation. Independently living persons of 65 years and older who recently experienced a fall are interviewed in their homes and screened for risk of recurrent falling using a validated fall risk profile. Persons at low risk of recurrent falling are excluded from the RCT. Persons who have a high risk of recurrent falling are blindly randomised into an intervention (n = 100) or usual care (n = 100) group. The intervention consists of a multidisciplinary assessment and treatment of multifactorial fall risk factors. The transmural multidisciplinary approach entails close cooperation between geriatrician, primary care physician, physical therapist and occupational therapist and can be extended with other specialists if relevant. A fall calendar is used to record falls during one year of follow-up. Primary outcomes are time to first and second falls. Three, six and twelve months after the home visit, questionnaires for economic evaluation are completed. After one year, during a second home visit, the secondary outcome measures are reassessed and the adherence to the interventions is evaluated. Data will be analysed according to the intention-to-treat principle and also an on-treatment analysis will be performed.
  
  
  CONCLUSIONS
  Strengths of this study are the selection of persons at high risk of recurrent falling followed by a multidisciplinary intervention, its transmural character and the evaluation of adherence. If proven effective, implementation of our multidisciplinary assessment followed by treatment of fall risk factors will reduce the incidence of falls.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN11546541.
authors.affiliation: Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands. g.peeters@vumc.nl
authors.forename: Geeske M E E
authors.initials: GM
authors.lastname: Peeters
authors.forename: Oscar J
authors.initials: OJ
authors.lastname: de Vries
authors.forename: Petra J M
authors.initials: PJ
authors.lastname: Elders
authors.forename: Saskia M F
authors.initials: SM
authors.lastname: Pluijm
authors.forename: Lex M
authors.initials: LM
authors.lastname: Bouter
authors.forename: Paul
authors.initials: P
authors.lastname: Lips
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000203:Activities of Daily Living; D000368:Aged; D003362:Cost-Benefit Analysis; D003627:Data Interpretation, Statistical; D005500:Follow-Up Studies; D006801:Humans; D009426:Netherlands; D010348:Patient Care Team / Q000191:economics*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012008:Recurrence; D012107:Research Design; D018570:Risk Assessment / Q000379:methods; D016896:Treatment Outcome