Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)

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 Overview

• Status: Unknown
• Conditions: Osteoporosis With Current Fragility Fracture
• Intervention / Treatment: Other: Integrated program

• Study Type: Interventional
• Enrollment (Actual): 631
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Amos, Quebec, Canada, J9T 2S2
      • Centre hospitalier Hôtel-Dieu d'Amos
    • Chandler, Quebec, Canada, G0C 1K0
      • CSSS du Roché Percé (Centre hospitalier de Chandler)
    • Gatineau, Quebec, Canada, J8Y 1W7
      • Hôpital de Hull
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles LeMoyne
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Sacre-Coeur de Montreal
    • Montreal, Quebec, Canada, H2E1S6
      • Hôpital Jean-Talon
    • Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
      • Centre Hospitalier Régional de Lanaudière
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Centre hospitalier universitaire de Sherbrooke
    • St-Jérôme, Quebec, Canada, J7Z 5T3
      • CSSS de St-Jérôme (Hôpital régional de St-Jérôme)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: 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.	Other: Integrated program; Each participant's primary care physician will receive written information containing a presumed osteoporosis diagnosis, investigations to be performed, correct interpretation of any bone densitometry results in the context of a fragility fracture, and treatment options. The study coordinator will be responsible for orienting the participant to an appropriate local fall prevention program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of secondary fragility fracture	18 months post recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of osteoporosis treatment by the primary care physician	Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.	At 6, 12, 18, and 60 months post recruitment
Compliance with osteoporosis treatment.	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.	At 6, 12, 18, and 60 months post recruitment
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
Number of clinically significant fall events.		At 18, 24, 36, 48 and 60 months post recruitment
Fall-related hospitalizations	Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.	At 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related death	Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).	At 18, 24, 36, 48 and 60 months post recruitment
Participants' quality of life	Euro-QOL	At 18, 24, 36, 48 and 60 months post recruitment
Practice of physical activities	CHAMPS	At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related costs	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.	At 18 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	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.	At 12 months post intervention
Intervention participant's satisfaction with the fragility fracture prevention program		At 12 months post intervention

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Merck Sharp & Dohme LLC; Novartis; Canadian Institutes of Health Research (CIHR); Amgen; Ministere de la Sante et des Services Sociaux; CSSS-IUGS Estrie
• Investigators: Principal Investigator: Isabelle Gaboury, PhD, Université de Sherbrooke; Principal Investigator: Hélène Corriveau, PhD pht, Université de Sherbrooke

Publications and helpful links

General Publications

• Gaboury I, Corriveau H, Boire G, Cabana F, Beaulieu MC, Dagenais P, Gosselin S, Bogoch E, Rochette M, Filiatrault J, Laforest S, Jean S, Fansi A, Theriault D, Burnand B. Partnership for fragility bone fracture care provision and prevention program (P4Bones): study protocol for a secondary fracture prevention pragmatic controlled trial. Implement Sci. 2013 Jan 24;8:10. doi: 10.1186/1748-5908-8-10.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 7, 2012

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: osteoporosis; evaluation; Canada; controlled clinical trial; fall prevention; fragility fracture; integrated program; interorganizational collaboration
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis
• Other Study ID Numbers: CIHR grant # 267395