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

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04947722

Collaborator

(none)

3,060

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fracture Fractures, Hip Osteoporosis	Behavioral: PREVENT Program	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3060 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PREVENT Program

Behavioral: PREVENT 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.

No Intervention: Control Group

Residents in homes allocated to the control group will receive usual care as provided within their home.

Outcome Measures

Primary Outcome Measures

Number of hip-fractures [One year]
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) [One year]
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Number of hospital transfers (emergency department and admissions) [One year]
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Number of deaths [One year]
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Change in number of falls [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.
Change in level of pain [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.
Change in mobility [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.
Change in responsive behaviours [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.
Change in health related quality of life [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.
Change in medications and supplements [Baseline, 3, 6, 9 and 12 months]
Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication, calcium and vitamin D supplements.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).