The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
Primary Purpose
Fracture, Fractures, Hip, Osteoporosis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PREVENT Program
Sponsored by
About this trial
This is an interventional prevention trial for Fracture focused on measuring Long-Term Care, Fracture Risk, Falls, Knowledge Translation
Eligibility Criteria
Inclusion Criteria:
- Both profit and non-profit long-term care homes in Ontario and Alberta.
- Homes must have a minimum of 70 residents 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PREVENT Program
Control Group
Arm Description
Residents in homes allocated to the control group will receive usual care as provided within their home.
Outcomes
Primary Outcome Measures
Number of hip-fractures
Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.
Secondary Outcome Measures
Number of non-hip fractures (wrist, spine, pelvis, humerus)
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Number of hospital transfers (emergency department and admissions)
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Number of deaths
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04947722
Brief Title
The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
Official Title
The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Fractures, Hip, Osteoporosis
Keywords
Long-Term Care, Fracture Risk, Falls, Knowledge Translation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3060 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PREVENT Program
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Residents in homes allocated to the control group will receive usual care as provided within their home.
Intervention Type
Behavioral
Intervention Name(s)
PREVENT Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of hip-fractures
Description
Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of non-hip fractures (wrist, spine, pelvis, humerus)
Description
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Time Frame
One year
Title
Number of hospital transfers (emergency department and admissions)
Description
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Time Frame
One year
Title
Number of deaths
Description
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Time Frame
One year
Title
Change in number of falls
Description
Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0. Scored as occurred: yes, no and number of falls.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in level of pain
Description
Assessed by the MDS 2.0 Pain Scale. Scored on a scale from 0-4 where higher scores indicate more severe pain.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in mobility
Description
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.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in responsive behaviours
Description
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.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in health related quality of life
Description
Assessed by the MDS 2.0 Health Status Index. Scored on a scale from 0-1 where a score of 1 indicates full health.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in medications and supplements
Description
Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication, calcium and vitamin D supplements.
Time Frame
Baseline, 3, 6, 9 and 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both profit and non-profit long-term care homes in Ontario and Alberta.
Homes must have a minimum of 70 residents 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).
12. IPD Sharing Statement
Learn more about this trial
The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
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