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脆性骨折护理提供和预防计划伙伴关系(P4Bones):二次骨折预防实用对照试验的研究方案。

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

机构信息

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

出版信息

Implement Sci. 2013 Jan 24;8:10. doi: 10.1186/1748-5908-8-10.

DOI:10.1186/1748-5908-8-10
PMID:23343392
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3564742/
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.

摘要

背景

老年人与骨脆弱相关的骨折表明可能发生继发性骨折。脆性骨折常导致健康状况进一步恶化和活动能力丧失,给患者、家庭、社会和医疗保健系统带来高昂的费用。骨折后及时启动协调、全面的药物性骨骼健康和防跌倒计划可能会提高骨质疏松症治疗的依从性;并降低跌倒和继发性骨折的发生率,以及相关的发病率、死亡率和成本。

方法/设计:这项在加拿大魁北克八个地区的 11 家医院进行的实用、对照试验,将招募年龄在 50 岁以上、发生脆性骨折的社区居住患者,根据所在医院的情况,将他们纳入干预协调计划或标准护理组。各研究地点的研究协调员将为每个研究组招募 1596 名参与者。干预组地点的协调员将促进骨骼健康护理的连续性,并安排防跌倒计划,包括体育锻炼。干预团队包括医学骨骼专家、初级保健医生、药剂师、护士、康复临床医生和社区项目组织者。该研究的主要结果是在 18 个月的随访期间发生继发性脆性骨折的发生率。次要结果包括骨健康药物的起始和依从性;首次跌倒和有临床意义的跌倒次数;跌倒相关住院和死亡率;身体活动;生活质量;脆性骨折相关成本;入住长期护理机构;参与者对护理整合的看法、对该计划的期望和满意度;以及参与者对防跌倒计划的依从性。最后,干预组地点的专业人员将参加焦点小组,以确定综合脆性骨折预防计划的障碍和促进因素。该综合计划将通过以下方式促进知识转化和传播:在综合计划的制定和实施过程中,让各种合作者参与;向干预组的初级保健医生和对照组的患者分发有关骨质疏松症和防跌倒策略的小册子;参与评估活动;最终传播研究结果。

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