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

NCT ID: NCT04377529

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-08-30

Brief Summary

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Back Skills Training Champion

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.

Group Type: EXPERIMENTAL

Local Champion

Intervention Type: 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.

No Champion

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.

Group Type: ACTIVE_COMPARATOR

Local Champion

Intervention Type: 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.

Interventions

Local Champion

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

Amanda Hall

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Science Centre

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

References

Hall A, Richmond H, Bursey K, Hansen Z, Williamson E, Copsey B, Albury C, Asghari S, Curran V, Pike A, Etchegary H, Lamb S. Evaluating the impact of a champion on implementation of the Back Skills Training (BeST) programme in Canada: a mixed methods feasibility study protocol. BMJ Open. 2020 Nov 30;10(11):e040834. doi: 10.1136/bmjopen-2020-040834.

Reference Type: DERIVED

PMID: 33257487 (View on PubMed)

Other Identifiers

20190025

Identifier Type: -

Identifier Source: org_study_id