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The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

NCT04947722 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3060

Last updated 2025-07-01

No results posted yet for this study

Summary

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

Conditions

Interventions

BEHAVIORAL

PREVENT Program

A standardized PREVENT educational program will be offered to each intervention LTC home and health-care staff. The curricula includes video modules with fracture-prevention care recommendations and an orientation to the Fracture Prevention Toolkit. Using the Fracture Risk Scale (i.e., a clinical decision support tool embedded in the RAI-MDS 2.0), the LTC team will identify residents at high-risk for fracture and will implement the fracture prevention recommendations into care plans on an individual resident basis.

Sponsors & Collaborators

Principal Investigators

  • Alexandra Papaioannou, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947722 on ClinicalTrials.gov