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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis; Fracture; Fractures, Hip
• Intervention / Treatment: Behavioral: PREVENT Program

• Study Type: Interventional
• Enrollment (Estimated): 3060
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Kane, MSc, BSc; Phone Number: 77866 905-521-2100; Email: kanela@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1W9
      • Recruiting
      • McMaster University - St. Peter's Hospital
      • Principal Investigator: Alexandra Papaioannou, MD, MSc
      • Contact: Sherri Smith; Phone Number: 77715 905-521-2100; Email: smithsher@hhsc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Residents in homes allocated to the control group will receive usual care as provided within their home.
Experimental: PREVENT Program; PREVENT model	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of non-hip fractures (wrist, spine, pelvis, humerus)	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.	One year
Number of hospital transfers (emergency department and admissions)	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.	One year
Number of deaths	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.	One year
Change in number of falls	Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0. Scored as occurred: yes, no and number of falls.	Baseline, 3, 6, 9 and 12 months
Change in level of pain	Assessed by the MDS 2.0 Pain Scale. Scored on a scale from 0-4 where higher scores indicate more severe pain.	Baseline, 3, 6, 9 and 12 months
Change in mobility	Assessed by the MDS 2.0 Activities of Daily Living (ADL) Hierarchy Scale. Scored on a scale from 0-6 where higher scores indicate more impairment in ADL performance.	Baseline, 3, 6, 9 and 12 months
Change in responsive behaviours	Assessed by the MDS 2.0 Aggressive Behaviour Scale. Scored on a scale from 0-12 where higher scores indicate greater frequency and diversity of aggressive behaviour.	Baseline, 3, 6, 9 and 12 months
Change in health related quality of life	Assessed by the MDS 2.0 Health Status Index. Scored on a scale from 0-1 where a score of 1 indicates full health.	Baseline, 3, 6, 9 and 12 months
Change in medications	Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication(s).	Baseline, 3, 6, 9 and 12 months
Health quality indicators	Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0 or health quality indicators for falls, pressure ulcers, pain, physical function and depression.	Baseline, 3, 6, 9 and 12 months.

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Alexandra Papaioannou, MD, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Knowledge Translation; Long-Term Care; Falls; Fracture Risk
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Metabolic Diseases; Leg Injuries; Bone Diseases, Metabolic; Femoral Fractures; Hip Injuries; Fractures, Bone; Osteoporosis; Hip Fractures
• Other Study ID Numbers: 13622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No