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

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McMaster University

Status

Enrolling

Conditions

Osteoporosis
Fracture
Fractures, Hip

Treatments

Behavioral: PREVENT Program

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

3,060 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

3,060 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Lauren Kane, MSc, BSc

Data sourced from clinicaltrials.gov

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