BACKGROUND: Falls occur frequently in older people and strongly affect quality of life. Guidelines recommend multifactorial, targeted fall prevention. We evaluated the effectiveness of a multifactorial intervention in older persons with a high risk of recurrent falls. METHODS: A randomized controlled trial was conducted from April 3, 2005, to July 21, 2008, at the geriatric outpatient clinic of a university hospital and regional general practices in the Netherlands. Of 2,015 persons identified, 217 persons aged 65 years or older were selected to participate. They had a high risk of recurrent falls and no cognitive impairment and had visited the emergency department or their family physician after a fall. The geriatric assessment and intervention were aimed at reduction of fall risk factors. Primary outcome measures were time to first and second falls after randomization. Secondary outcome measures were fractures, activities of daily living, quality of life, and physical performance. RESULTS: Within 1 year, 55 (51.9%) of the 106 intervention participants and 62 (55.9%) of the 111 usual care (control) participants fell at least once. No significant treatment effect was demonstrated for the time to first fall (hazard ratio 0.96; 95% confidence interval 0.67 to 1.37) or the time to second fall (1.13; 0.71 to 1.80). Similar results were obtained for secondary outcome measures and for per-protocol analysis. One intervention participant died versus 7 in the control group (hazard ratio 0.15; 95% confidence interval 0.02 to 1.21). CONCLUSION: This multifactorial fall-prevention program does not reduce falls in high-risk, cognitively intact older persons. TRIAL REGISTRATION: isrctn.org identifier ISRCTN11546541.

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