Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial

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 incidence (primary outcome), adjusting for important resident and LTC home characteristics; and secondary outcomes, including new osteoporosis medication prescriptions, non-hip fracture rates, falls, hospitalizations, death, LTC quality indicators, pain, mobility, responsive behaviors, and healthcare utilization costs. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement was used to guide the development of this study protocol. DISCUSSION: Preventing hip fractures in LTC has significant health, economic, and personal benefits. To our knowledge, the PREVENT trial is the first KT study of its kind in LTC to measure hip fracture as the primary outcome. If the PREVENT trial successfully improves hip fracture rates, it may lead the way for implementing a standardized approach to preventing hip fractures in LTC homes across Canada and internationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT04947722. Registered on July 1, 2021.