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

NCT04947722 | Recruiting

• 1 other identifier: 13622
• Study Type: interventional
• Target: 3,060
• Locations: 1 country
• Sites: 1

Brief 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

Fracture; Fractures, Hip; Osteoporosis

Keywords

Long-Term Care; Fracture Risk; Falls; Knowledge Translation

Outcome Measures

Primary Outcomes (1)

• Number of hip-fractures

  Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.

  One year

Secondary Outcomes (10)

• Number of non-hip fractures (wrist, spine, pelvis, humerus)

  One year

• Number of hospital transfers (emergency department and admissions)

  One year

• Number of deaths

  One year

• Change in number of falls

  Baseline, 3, 6, 9 and 12 months

• Change in level of pain

  Baseline, 3, 6, 9 and 12 months

Study Arms (2)

PREVENT Program

EXPERIMENTAL

PREVENT model

Behavioral: PREVENT Program

Control Group

NO INTERVENTION

Residents in homes allocated to the control group will receive usual care as provided within their home.

Interventions

PREVENT Program BEHAVIORAL

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.

PREVENT Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Both profit and non-profit long-term care homes in Ontario, Canada.
• Homes must have a minimum of 50 occupied beds to participate; there is no maximum home size for participation.
• For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.

You may not qualify if:

• Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University - St. Peter's Hospital

Hamilton, Ontario, L8M 1W9, Canada

RECRUITING

Related Publications (1)

• Papaioannou A, Feldman S, Katz P, Costa AP, Kennedy CC, Adachi JD, Boyd H, Giangregorio L, Heckman G, Hewston P, Hirdes J, Holroyd-Leduc J, Howard M, Ho J, Jaglal S, Kaasalainen S, Kristof L, Lau A, Lee J, McArthur C, Marr S, O'Donnell D, Rodrigues IB, Shankardass K, Siu H, Straus S, Thrall S, Tarride JE, Thabane L, Hafid S, Tung J, Hillier LM, Kane LL, Azizudin AM, Desinghe TD, Ioannidis G. Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial. Trials. 2026 Jan 9. doi: 10.1186/s13063-025-09398-1. Online ahead of print.

  PMID: 41507969 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Hip Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexandra Papaioannou, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Kane, MSc, BSc

CONTACT

905-521-2100; kanela@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, GERAS Centre for Aging Research, Hamilton Health Sciences

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: June 19, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)