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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Local Champion
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain focused on measuring implementation, behaviour change wheel, physiotherapy, cognitive behavioural therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Science Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Back Skills Training Champion

No Champion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

% of target recruitment reached (champions)
We aim to recruit at least 1 champion from each cluster.

Secondary Outcome Measures

% of physiotherapists implementing the Back Skills Training intervention
Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention
Individual semi-structured interviews
Satisfaction with champion training
A single item satisfaction score on a 5-point scale with 1=very unsatisfied and 5=very satisfied
Usefulness of the champion training
A single item usefulness score on a 5-point scale with 1=very unacceptable and 5=very acceptable
% of champions remaining at the end of the study follow-up period
% of patients with low back pain who received the BeST intervention in each cluster

Full Information

First Posted
April 22, 2020
Last Updated
October 19, 2023
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT04377529
Brief Title
Evaluating the Impact of a Champion on Implementation of the Back Skills Training (BeST) Program in Canada
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
implementation, behaviour change wheel, physiotherapy, cognitive behavioural therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Back Skills Training Champion
Arm Type
Experimental
Arm Description
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.
Arm Title
No Champion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Local Champion
Intervention Description
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 Outcome Measure Information:
Title
% of target recruitment reached (champions)
Description
We aim to recruit at least 1 champion from each cluster.
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
% of physiotherapists implementing the Back Skills Training intervention
Time Frame
6-months post intervention
Title
Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention
Description
Individual semi-structured interviews
Time Frame
6-months post intervention
Title
Satisfaction with champion training
Description
A single item satisfaction score on a 5-point scale with 1=very unsatisfied and 5=very satisfied
Time Frame
Immediately post-intervention and at 6-months post-intervention
Title
Usefulness of the champion training
Description
A single item usefulness score on a 5-point scale with 1=very unacceptable and 5=very acceptable
Time Frame
Immediately post-intervention and at 6-months post-intervention
Title
% of champions remaining at the end of the study follow-up period
Time Frame
6-months post intervention
Title
% of patients with low back pain who received the BeST intervention in each cluster
Time Frame
6-months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Health Science Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
NL A1B 3V6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33257487
Citation
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.
Results Reference
derived

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

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