Clinical trial NCT01745068: Partnership for Applied Research in Fracture Prevention Programs for the Elderly
Official title: Partnership for Applied Research in Fracture Prevention Programs for the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis With Current Fragility Fracture
Keywords: fragility fracture
osteoporosis
fall prevention
integrated program
interorganizational collaboration
Canada
controlled clinical trial
evaluation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ministere de la Sante et des Services Sociaux
name: Merck Sharp & Dohme LLC
name: Novartis
name: Amgen
name: CSSS-IUGS Estrie
First posted: 2012-12-07
Enrollment: 631
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of secondary fragility fracture
timeFrame: 18 months post recruitment
Secondary outcomes:
measure: Initiation of osteoporosis treatment by the primary care physician
timeFrame: At 6, 12, 18, and 60 months post recruitment
measure: Compliance with osteoporosis treatment.
timeFrame: At 6, 12, 18, and 60 months post recruitment
measure: Time to first fall event
timeFrame: Within the first 18 months post recruitment
measure: Incidence of secondary fragility fractures.
timeFrame: At 24, 36, 48 and 60 months post recruitment
measure: Number of clinically significant fall events.
timeFrame: At 18, 24, 36, 48 and 60 months post recruitment
measure: Fall-related hospitalizations
timeFrame: At 18, 24, 36, 48 and 60 months post recruitment
measure: Fragility fracture-related death
timeFrame: At 18, 24, 36, 48 and 60 months post recruitment
measure: Participants' quality of life
timeFrame: At 18, 24, 36, 48 and 60 months post recruitment
measure: Practice of physical activities
timeFrame: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
measure: Fragility fracture-related costs
timeFrame: At 18 and 60 months post recruitment
measure: Admission to a long-term care facility
timeFrame: At 18, 24, 36, 48 and 60 months post recruitment
measure: Participants' perceptions of care integration
timeFrame: At 12 months post intervention
measure: Intervention participant's satisfaction with the fragility fracture prevention program
timeFrame: At 12 months post intervention
Other outcomes:
Locations:
city: Amos
country: Canada
facility: Centre hospitalier Hôtel-Dieu d'Amos
state: Quebec
city: Chandler
country: Canada
facility: CSSS du Roché Percé (Centre hospitalier de Chandler)
state: Quebec
city: Gatineau
country: Canada
facility: Hôpital de Hull
state: Quebec
city: Greenfield Park
country: Canada
facility: Hôpital Charles Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Jean-Talon
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Sacré-Coeur de Montréal
state: Quebec
city: Saint-Charles-Borromée
country: Canada
facility: Centre hospitalier régional de Lanaudière
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: St-Jérôme
country: Canada
facility: CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Isabelle Gaboury, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Hélène Corriveau, PhD pht
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.