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

Implementation Science

Bernard Burnand⁴  Diane Theriault^1,11  Alvine Fansi¹  Sonia Jean⁷  Sophie Laforest²  Johanne Filiatrault^1,13  Marie Rochette³  Earl Bogoch^1,12  Suzanne Gosselin⁹  Pierre Dagenais¹  Marie-Claude Beaulieu⁵  François Cabana⁸  Gilles Boire⁸  Hélène Corriveau⁶  Isabelle Gaboury^1,10 

[1] Institut national d’excellence en santé et en services sociaux, Montreal, QC, Canada;Institut de recherche en santé publique de l’Université de Montréal (IRSPUM), Montreal, QC, Canada;Ministère de la Santé et des Services sociaux du Québec, Québec, QC, Canada;University of Lausanne, Lausanne, Switzerland;Department of Family Medicine and Emergency Medicine, University of Sherbrooke, Sherbrooke, QC, Canada;Centre de recherche sur le vieillissement, Sherbrooke, QC, Canada;Institut national de santé publique du Quebec, Québec, QC, Canada;Department of Medicine, University of Sherbrooke, Sherbrooke, QC, Canada;Health and Social Services Center- University Institute of Geriatric of Sherbrooke, Sherbrooke, QC, Canada;Centre de recherche clinique Étienne-Le Bel, Sherbrooke, QC, Canada;Osteoporosis Canada, Toronto, ON, Canada;St Michael’s Hospital, Department of Surgery, University of Toronto, Toronto, ON, Canada;Centre de recherche de l’Institut universitaire de gériatrie de Montreal, Montreal, QC, Canada

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

Others  :  813821
DOI  :  10.1186/1748-5908-8-10

 received in 2012-12-10, accepted in 2013-01-16,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Gaboury et al.; licensee BioMed Central Ltd.

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