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

McMaster University3,060 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

3,060

Conditions

Fracture Fractures, Hip

Interventions

PREVENT ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

McMaster University - St. Peter's Hospital

Hamilton, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Number of hip-fractures

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 Outcomes

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

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

Time frame: One year

Number of hospital transfers (emergency department and admissions)

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

Time frame: One year

Number of deaths

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

Time frame: One year

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.