Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial
Abstract
Background: Each year, half of all long-term care (LTC) residents will sustain a fall, and many will sustain a fall-related fracture. Fifty percent of all fractures in this vulnerable cohort occur at the hip, which is a life-changing health event leading to hospitalization, impaired physical functioning, and increased risk of premature mortality. National osteoporosis guidelines for the prevention of fractures are not consistently used in LTC homes. Improving osteoporosis guideline implementation may prevent hip fractures and other fractures. This study will examine whether the PREVENT (Person-centered Routine fracture prEVENTion) model can reduce hip fracture rates over one year compared to usual care in LTC homes.
Methods: Our study design is a pragmatic, cluster, randomized controlled trial. We will recruit 122 for-profit and not-for-profit LTC homes across Ontario, Canada. Homes will be randomized in a 1:1 ratio to intervention (PREVENT model) or control (usual care) arms. Eligibility criteria include a minimum of 50 occupied beds and access to the PointClickCare (PCC) electronic medical record system. One or two local opinion leader(s) and a leadership team consisting of five to ten healthcare providers will be recruited within each LTC home to support the implementation of the fracture prevention knowledge translation (KT) intervention. Generalized estimating equations (GEE) will be used to examine the effect of the PREVENT intervention vs usual care on hip fracture…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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