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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04947722
Acronym
PREVENT
Enrollment
3060
Registered
2021-07-01
Start date
2024-06-19
Completion date
2027-03-31
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture, Fractures, Hip, Osteoporosis

Keywords

Long-Term Care, Fracture Risk, Falls, Knowledge Translation, Osteoporosis

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.

Interventions

BEHAVIORALPREVENT Program

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.

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of hip-fracturesOne yearData extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.

Secondary

MeasureTime frameDescription
Number of non-hip fractures (wrist, spine, pelvis, humerus)One yearData extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Number of hospital transfers (emergency department and admissions)One yearData extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Number of deathsOne yearData extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Change in number of fallsBaseline, 3, 6, 9 and 12 monthsAssessed by the Minimum Data Set (MDS) (standardized assessment) 2.0. Scored as occurred: yes, no and number of falls.
Change in level of painBaseline, 3, 6, 9 and 12 monthsAssessed by the MDS 2.0 Pain Scale. Scored on a scale from 0-4 where higher scores indicate more severe pain.
Change in mobilityBaseline, 3, 6, 9 and 12 monthsAssessed 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 behavioursBaseline, 3, 6, 9 and 12 monthsAssessed 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 lifeBaseline, 3, 6, 9 and 12 monthsAssessed 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 medicationsBaseline, 3, 6, 9 and 12 monthsData extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication(s).
Health quality indicatorsBaseline, 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.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORAlexandra Papaioannou, MD, MSc

McMaster University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026