Partnership for Applied Research in Fracture Prevention Programs for the Elderly

Not Applicable

• Conditions: Osteoporosis With Current Fragility Fracture
• Interventions: Other: Integrated program

• Registration Number: NCT01745068
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-07
• Study Start: 2013-01
• Primary Completion: 2016-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 631

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated program	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.

Primary Outcome Measures

Name	Time	Method
Incidence of secondary fragility fracture	18 months post recruitment

Secondary Outcome Measures

Name	Time	Method
Time to first fall event	Within the first 18 months post recruitment
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	Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.
Fragility fracture-related death	At 18, 24, 36, 48 and 60 months post recruitment	Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).
Participants' quality of life	At 18, 24, 36, 48 and 60 months post recruitment	Euro-QOL
Initiation of osteoporosis treatment by the primary care physician	At 6, 12, 18, and 60 months post recruitment	Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.
Practice of physical activities	At 6, 12, 18, 24, 36, 48 and 60 months post recruitment	CHAMPS
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	All participants' perceptions of care integration will be captured 12 months after the beginning of the intervention period, or following an early withdrawal from the study.
Intervention participant's satisfaction with the fragility fracture prevention program	At 12 months post intervention
Compliance with osteoporosis treatment.	At 6, 12, 18, and 60 months post recruitment	The data collected from the participant will be validated with the participant's pharmacist through the medication possession ratio. The medication possession ratio is measured from the first to the last prescription, with the denominator being the duration from index to the exhaustion of the last prescription and the numerator being the days supplied over that period from first to last prescription and the numerator being the total number of days in the interval.
Number of clinically significant fall events.	At 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related costs	At 18 and 60 months post recruitment	Medical costs from the participant's hospital record include: medical assessment, prescription and non-prescription drugs; and resource use related to the management of the fragility fracture and/or long-term complications, including hospitalization. As well, lost days of work, annual income (if the participant is in the labour force), travel to the hospital and/or rehabilitation facilities, parking, and out-of-pocket expenses for drugs and rehabilitation devices (e.g. splint) will be compiled. Protocol-driven costs will be excluded, with the exception of the costs related to the participants' fall prevention program.

Trial Locations

Locations (10)

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Hôpital Charles Lemoyne; 🇨🇦 Greenfield Park, Quebec, Canada

CSSS de St-Jérôme (Hôpital régional de St-Jérôme); 🇨🇦 St-Jérôme, Quebec, Canada

Hôpital de Hull; 🇨🇦 Gatineau, Quebec, Canada

Hôpital Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Centre hospitalier Hôtel-Dieu d'Amos; 🇨🇦 Amos, Quebec, Canada

CSSS du Roché Percé (Centre hospitalier de Chandler); 🇨🇦 Chandler, Quebec, Canada

Centre hospitalier régional de Lanaudière; 🇨🇦 Saint-Charles-Borromée, Quebec, Canada

Hôpital Jean-Talon; 🇨🇦 Montreal, Quebec, Canada