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

Study Overview
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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.

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

Conditions
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Fracture, Fractures, Hip, Osteoporosis

Intervention / Treatment
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* Behavioral: PREVENT Program


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREVENT Program<br> | Behavioral: PREVENT Program<br>* 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.<br>|
| No Intervention: Control Group<br>Residents in homes allocated to the control group will receive usual care as provided within their home. | |

What is the study measuring?
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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 and supplements | Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication, calcium and vitamin D supplements. | Baseline, 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-Term Care, Fracture Risk, Falls, Knowledge Translation