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临床试验/NCT04377529
NCT04377529已完成不适用

Evaluating the Impact of a Champion on Implementation of the Back Skills Training (BeST) Program in Canada: a Mixed Methods Feasibility Study Protocol

Memorial University of Newfoundland1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
% of target recruitment reached (champions)

研究概览

简要总结

There is global recognition in clinical guidelines and governing bodies that low back pain (LBP) should be managed with a biopsychosocial approach. Despite this, research indicates that physiotherapists, who treat the majority of LBP patients in the community, do not feel confident in using this treatment approach. Previous work to support implementation in this field has resulted in low uptake and has highlighted several barriers to implementation, including the need for additional ongoing support. The use of a local champion to support implementation has been successful in other fields and thus, represents a viable strategy to explore. Before undertaking a fully powered trial to evaluate the effectiveness of a champion for implementation, a pilot study is being conducted to determine the feasibility of the intervention as well as determining the feasibility of using a cluster randomised controlled trial to evaluate it.

In this study, a pragmatic cluster randomised controlled trial design will be used with an embedded qualitative interview study. Physiotherapists will be recruited who manage LBP in any publicly funded physiotherapy departments within Newfoundland and Labrador, Canada. Individual sites will be grouped into clusters based on their number of full-time physiotherapists, geography, and organisational relationships. All participants will be asked to complete a previously developed online training course to upskill them to deliver a biopsychosocial evidence-based intervention for LBP. Clusters randomised to receive a local champion will receive additional support from their champion. A basic champion training package has been developed based on known barriers in the literature. This will be tailored by co-developing aspects with study champions based on a comprehensive assessment of perceived implementation barriers using the Theoretical Domains Framework (TDF) and the Capability, Opportunity, Motivation and Behaviour (COM-B) model. A range of physiotherapist-level outcomes pre-post training will be measured and implementation of the evidence based biopsychosocial intervention will be monitored during a 6-month period after completion of the online training. After this 6-month period, a purposive sample of physiotherapists from each cluster who had both implemented and failed to implement the biopsychosocial intervention will be interviewed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Any publicly funded physiotherapy department within Newfoundland and Labrador working with adult patients with LBP are eligible to participate.
  • •Clinical leads need to be able to identify at least one champion at each site should they be allocated to the champion arm. We defined a champion as a physiotherapist in the musculoskeletal outpatient department who i) could commit the additional time for training, ii) would be willing to provide support to their peers at the sites within their cluster and iii) demonstrates enthusiasm about intervention to manager.

排除标准

  • •Physiotherapy departments who do not treat adult patients with LBP will be excluded.

研究组 & 干预措施

Back Skills Training Champion

Experimental

In additional to access to the online provider Back Skills Training course, participants in clusters randomised to this arm will receive additional support from a local champion. The local champion will have received additional training and support on the implementation of the Back Skills Training intervention from the study team.

干预措施: Local Champion (Behavioral)

No Champion

Active Comparator

Participants in clusters randomised to this arm will not receive any additional training or support beyond access to the online provider Back Skills Training course.

干预措施: Local Champion (Behavioral)

结局指标

主要结局

% of target recruitment reached (champions)

时间窗: 6 months post-intervention

We aim to recruit at least 1 champion from each cluster.

次要结局

  • Usefulness of the champion training(Immediately post-intervention and at 6-months post-intervention)
  • % of physiotherapists implementing the Back Skills Training intervention(6-months post intervention)
  • Satisfaction with champion training(Immediately post-intervention and at 6-months post-intervention)
  • % of champions remaining at the end of the study follow-up period(6-months post intervention)
  • Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention(6-months post intervention)
  • % of patients with low back pain who received the BeST intervention in each cluster(6-months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amanda Hall

Assistant Professor

Memorial University of Newfoundland

研究点 (1)

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