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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04377529
• Other study ID #: 20190025
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2023
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Health Science Centre	Saint John's	Newfoundland and Labrador

Sponsors (1)

Lead Sponsor	Collaborator
Memorial University of Newfoundland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of target recruitment reached (champions)	We aim to recruit at least 1 champion from each cluster.	6 months post-intervention
Secondary	% of physiotherapists implementing the Back Skills Training intervention		6-months post intervention
Secondary	Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention	Individual semi-structured interviews	6-months post intervention
Secondary	Satisfaction with champion training	A single item satisfaction score on a 5-point scale with 1=very unsatisfied and 5=very satisfied	Immediately post-intervention and at 6-months post-intervention
Secondary	Usefulness of the champion training	A single item usefulness score on a 5-point scale with 1=very unacceptable and 5=very acceptable	Immediately post-intervention and at 6-months post-intervention
Secondary	% of champions remaining at the end of the study follow-up period		6-months post intervention
Secondary	% of patients with low back pain who received the BeST intervention in each cluster		6-months post intervention