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NCT Number: NCT04947722

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

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.

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Key information

Conditions

Fracture Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Fractures, Hip Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University - St. Peter's Hospital

Hamilton, Ontario, L8M 1W9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PREVENT Program

Behavioral

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 outcomes

  1. Number of hip-fractures

    Time frame: One year

    Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.

Secondary outcomes

  1. Number of non-hip fractures (wrist, spine, pelvis, humerus)

    Time frame: One year

    Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.

  2. Number of hospital transfers (emergency department and admissions)

    Time frame: One year

    Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.

  3. Number of deaths

    Time frame: One year

    Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.

  4. Change in number of falls

    Time frame: 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.

  5. Change in level of pain

    Time frame: 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.

  6. Change in mobility

    Time frame: 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.

  7. Change in responsive behaviours

    Time frame: 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.

  8. Change in health related quality of life

    Time frame: 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.

  9. Change in medications

    Time frame: Baseline, 3, 6, 9 and 12 months

    Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication(s).

  10. Health quality indicators

    Time frame: Baseline, 3, 6, 9 and 12 months.

    Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0 or health quality indicators for falls, pressure ulcers, pain, physical function and depression.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Acronym: PREVENT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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