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Completed

NCT Number: NCT04377529

Evaluating the Impact of a Champion on Implementation of the Back Skills Training (BeST) Program in Canada

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science Centre

St. John's, Newfoundland and Labrador, NL A1B 3V6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Local Champion

Behavioral

Local champions (physiotherapists) will co-develop the champion training support based on a comprehensive behavioural analysis, previous implementation work and evidence-based theory. The study team will provide this training and support to the champions, who will then provide additional support to their peers participating in the study.

Primary outcomes

  1. % of target recruitment reached (champions)

    Time frame: 6 months post-intervention

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

Secondary outcomes

  1. % of physiotherapists implementing the Back Skills Training intervention

    Time frame: 6-months post intervention

  2. Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention

    Time frame: 6-months post intervention

    Individual semi-structured interviews

  3. Satisfaction with champion training

    Time frame: Immediately post-intervention and at 6-months post-intervention

    A single item satisfaction score on a 5-point scale with 1=very unsatisfied and 5=very satisfied

  4. Usefulness of the champion training

    Time frame: Immediately post-intervention and at 6-months post-intervention

    A single item usefulness score on a 5-point scale with 1=very unacceptable and 5=very acceptable

  5. % of champions remaining at the end of the study follow-up period

    Time frame: 6-months post intervention

  6. % of patients with low back pain who received the BeST intervention in each cluster

    Time frame: 6-months post intervention

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 6, 2020
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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