Clinical trial NCT04947722: 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
Overall status: RECRUITING
Phase: NA
Conditions: Fracture
Fractures, Hip
Osteoporosis
Keywords: Long-Term Care
Fracture Risk
Falls
Knowledge Translation
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 3060
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Both profit and non-profit long-term care homes in Ontario and Alberta.
* Homes must have a minimum of 70 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).

Primary outcomes:
measure: Number of hip-fractures
timeFrame: One year
Secondary outcomes:
measure: Number of non-hip fractures (wrist, spine, pelvis, humerus)
timeFrame: One year
measure: Number of hospital transfers (emergency department and admissions)
timeFrame: One year
measure: Number of deaths
timeFrame: One year
measure: Change in number of falls
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in level of pain
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in mobility
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in responsive behaviours
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in health related quality of life
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in medications and supplements
timeFrame: Baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University - St. Peter's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: