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

Not Applicable

Recruiting

• Conditions: Fracture; Fractures, Hip; Osteoporosis
• Interventions: Behavioral: PREVENT Program

• Registration Number: NCT04947722
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-01
• Status Verified: 2024-01
• Study Start: 2024-06-19
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3060

Inclusion Criteria

• Both profit and non-profit long-term care homes in Ontario and Alberta.
• Homes must have a minimum of 70 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREVENT Program	PREVENT Program	-

Primary Outcome Measures

Name	Time	Method
Number of hip-fractures	One year	Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.

Secondary Outcome Measures

Name	Time	Method
Change in responsive behaviours	Baseline, 3, 6, 9 and 12 months	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.
Number of non-hip fractures (wrist, spine, pelvis, humerus)	One year	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Change in number of falls	Baseline, 3, 6, 9 and 12 months	Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0. Scored as occurred: yes, no and number of falls.
Change in health related quality of life	Baseline, 3, 6, 9 and 12 months	Assessed by the MDS 2.0 Health Status Index. Scored on a scale from 0-1 where a score of 1 indicates full health.
Number of deaths	One year	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Change in level of pain	Baseline, 3, 6, 9 and 12 months	Assessed by the MDS 2.0 Pain Scale. Scored on a scale from 0-4 where higher scores indicate more severe pain.
Number of hospital transfers (emergency department and admissions)	One year	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Change in mobility	Baseline, 3, 6, 9 and 12 months	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.
Change in medications and supplements	Baseline, 3, 6, 9 and 12 months	Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication, calcium and vitamin D supplements.

Trial Locations

Locations (1)

McMaster University - St. Peter's Hospital; 🇨🇦 Hamilton, Ontario, Canada