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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
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fracture focused on measuring Long-Term Care, Fracture Risk, Falls, Knowledge Translation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 24, 2021
    Last Updated
    September 2, 2022
    Sponsor
    McMaster University
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    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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