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

NCT ID: NCT04947722

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fracture Fractures, Hip Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PREVENT Program

PREVENT model

Group Type EXPERIMENTAL

PREVENT Program

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Papaioannou

Executive Director, GERAS Centre for Aging Research, Hamilton Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra Papaioannou, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University - St. Peter's Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lauren Kane, MSc, BSc

Role: CONTACT

905-521-2100 ext. 77866

Facility Contacts

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Sherri Smith

Role: primary

905-521-2100 ext. 77715

Other Identifiers

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13622

Identifier Type: -

Identifier Source: org_study_id

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