Open Access Study protocol

Partnership for fragility bone fracture care provision and prevention program (P4Bones): study protocol for a secondary fracture prevention pragmatic controlled trial

Isabelle Gaboury12*, Hélène Corriveau34, Gilles Boire25, François Cabana25, Marie-Claude Beaulieu1, Pierre Dagenais6, Suzanne Gosselin17, Earl Bogoch89, Marie Rochette10, Johanne Filiatrault1112, Sophie Laforest111314, Sonia Jean15, Alvine Fansi166, Diane Theriault17 and Bernard Burnand18

Author Affiliations

1 Department of Family Medicine and Emergency Medicine, University of Sherbrooke, Sherbrooke, QC, Canada

2 Centre de recherche clinique Étienne-Le Bel, Sherbrooke, QC, Canada

3 School of Rehabilitation, University of Sherbrooke, Sherbrooke, QC, Canada

4 Centre de recherche sur le vieillissement, Sherbrooke, QC, Canada

5 Department of Medicine, University of Sherbrooke, Sherbrooke, QC, Canada

6 Institut national d’excellence en santé et en services sociaux, Montreal, QC, Canada

7 Health and Social Services Center- University Institute of Geriatric of Sherbrooke, Sherbrooke, QC, Canada

8 Keenan Research Centre, Toronto, ON, Canada

9 St Michael’s Hospital, Department of Surgery, University of Toronto, Toronto, ON, Canada

10 Ministère de la Santé et des Services sociaux du Québec, Québec, QC, Canada

11 School of Rehabilitation, University of Montreal, Montreal, QC, Canada

12 Centre de recherche de l’Institut universitaire de gériatrie de Montreal, Montreal, QC, Canada

13 Centre for Research and Expertise in Social Gerontology (CRESG), CSSS Cavendish-Centre affilié universitaire, Montreal, QC, Canada

14 Institut de recherche en santé publique de l’Université de Montréal (IRSPUM), Montreal, QC, Canada

15 Institut national de santé publique du Quebec, Québec, QC, Canada

16 Department of Health Community Sciences, University of Sherbrooke, Longueuil, QC, Canada

17 Osteoporosis Canada, Toronto, ON, Canada

18 University of Lausanne, Lausanne, Switzerland

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Implementation Science 2013, 8:10  doi:10.1186/1748-5908-8-10

Published: 24 January 2013

Abstract

Background

Fractures associated with bone fragility in older adults signal the potential for secondary fracture. Fragility fractures often precipitate further decline in health and loss of mobility, with high associated costs for patients, families, society and the healthcare system. Promptly initiating a coordinated, comprehensive pharmacological bone health and falls prevention program post-fracture may improve osteoporosis treatment compliance; and reduce rates of falls and secondary fractures, and associated morbidity, mortality and costs.

Methods/design

This pragmatic, controlled trial at 11 hospital sites in eight regions in Quebec, Canada, will recruit community-dwelling patients over age 50 who have sustained a fragility fracture to an intervention coordinated program or to standard care, according to the site. Site study coordinators will identify and recruit 1,596 participants for each study arm. Coordinators at intervention sites will facilitate continuity of care for bone health, and arrange fall prevention programs including physical exercise. The intervention teams include medical bone specialists, primary care physicians, pharmacists, nurses, rehabilitation clinicians, and community program organizers.

The primary outcome of this study is the incidence of secondary fragility fractures within an 18-month follow-up period. Secondary outcomes include initiation and compliance with bone health medication; time to first fall and number of clinically significant falls; fall-related hospitalization and mortality; physical activity; quality of life; fragility fracture-related costs; admission to a long term care facility; participants’ perceptions of care integration, expectations and satisfaction with the program; and participants’ compliance with the fall prevention program. Finally, professionals at intervention sites will participate in focus groups to identify barriers and facilitating factors for the integrated fragility fracture prevention program.

This integrated program will facilitate knowledge translation and dissemination via the following: involvement of various collaborators during the development and set-up of the integrated program; distribution of pamphlets about osteoporosis and fall prevention strategies to primary care physicians in the intervention group and patients in the control group; participation in evaluation activities; and eventual dissemination of study results.

Study/trial registration

Clinical Trial.Gov NCT01745068

Study ID number

CIHR grant # 267395

Keywords:
Fragility fracture; Osteoporosis; Fall prevention; Integrated program; Interorganizational collaboration; Canada; Controlled trial; Evaluation