Partnership for Applied Research in Fracture Prevention Programs for the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Université de Sherbrooke
- Enrollment
- 631
- Locations
- 20
- Primary Endpoint
- Incidence of secondary fragility fracture
Study Overview
Brief Summary
During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will experience at least one fracture due to bone fragility (FF). Evidence is growing regarding prevention programs' effectiveness to prevent falls, but prevention of fractures through fall prevention programs has enjoyed limited success. Falls prevention programs and post-fracture screening programs leading to pharmacological treatment are very different strategies, with a shared ultimate goal. Coordination between those who repair fractures and those who manage the patient to prevent the next fracture is critical. The overarching aim of this proposal is to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an integrated FF prevention program, as well as a portrait of the barriers and facilitating factors for such programs. More specifically, the objectives are: 1) to combine existing fall prevention and post-fracture management programs in the province of Quebec into integrated FF prevention programs; 2) to compare the performance of these integrated programs to control sites, using a pragmatic study design; 3) to identify barriers as well as factors that improve effectiveness across different implementation milieu; and 4) to develop and engage in active knowledge transfer activities in Quebec regions where integrated FF prevention programs are neither adequately nor successfully implemented. Drawing upon the literature on integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF program can reduce the risk of a subsequent fracture by at least 30% in the population of interest. The proposed team is poised to develop new interdisciplinary collaborations among healthcare practitioners and decision makers involved in the prevention of FFs. The program is built upon existing healthcare and structures and programs and in turn, will truly measure the effectiveness of an integrated FF prevention program. The results will ultimately lead to improvements in the existing knowledge base, address policy-relevant and health systems problems, and assist in the design and implementation of FFs prevention programs.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •50 years of age and over
- •must have a primary care physician
- •must be able to follow simple instructions
- •must have sustained a fragility fracture within three months of the recruitment date.
Exclusion Criteria
- •severe kidney insufficiency (grade 4 or 5)
- •advanced stage of cancer
- •fracture to sites not commonly associated with osteoporosis such as toe, finger, hand, foot, ankle, patella, head, and cervical spine.
Arms & Interventions
Control group
Integrated program
Participants will be involved in an integrated interorganisational fragility fracture prevention program, which combines both post-fracture management as well as fall prevention strategies. The intervention will last up to 18 months.
Intervention: Integrated program (Other)
Outcomes
Primary Outcomes
Incidence of secondary fragility fracture
Time Frame: 18 months post recruitment
Secondary Outcomes
- Incidence of secondary fragility fractures.(At 24, 36, 48 and 60 months post recruitment)
- Fall-related hospitalizations(At 18, 24, 36, 48 and 60 months post recruitment)
- Time to first fall event(Within the first 18 months post recruitment)
- Fragility fracture-related death(At 18, 24, 36, 48 and 60 months post recruitment)
- Participants' quality of life(At 18, 24, 36, 48 and 60 months post recruitment)
- Initiation of osteoporosis treatment by the primary care physician(At 6, 12, 18, and 60 months post recruitment)
- Practice of physical activities(At 6, 12, 18, 24, 36, 48 and 60 months post recruitment)
- Admission to a long-term care facility(At 18, 24, 36, 48 and 60 months post recruitment)
- Participants' perceptions of care integration(At 12 months post intervention)
- Intervention participant's satisfaction with the fragility fracture prevention program(At 12 months post intervention)
- Number of clinically significant fall events.(At 18, 24, 36, 48 and 60 months post recruitment)
- Compliance with osteoporosis treatment.(At 6, 12, 18, and 60 months post recruitment)
- Fragility fracture-related costs(At 18 and 60 months post recruitment)
Investigators
Isabelle Gaboury
Assistant professor
Université de Sherbrooke