Low Back PainNCT04377529
Evaluating the Impact of a Champion on Implementation of the Back Skills Training (BeST) Program in Canada
A study testing Local Champion in people with Low Back Pain, run by Memorial University of Newfoundland at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Local Champion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Physiotherapy departments who do not treat adult patients with LBP will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Science Centre
St. John's, Newfoundland and Labrador, NL A1B 3V6
About this study
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
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
- Being tested
- Local Champion
- Keywords
- implementation, behaviour change wheel, physiotherapy, cognitive behavioural therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local ChampionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Local Champion |
| 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. Receives: Behavioral: Local Champion |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of target recruitment reached (champions)
We aim to recruit at least 1 champion from each cluster.
Measured: 6 months post-intervention
Secondary outcomes (6)
% of physiotherapists implementing the Back Skills Training intervention
Measured: 6-months post intervention
Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention
Individual semi-structured interviews
Measured: 6-months post intervention
Satisfaction with champion training
A single item satisfaction score on a 5-point scale with 1=very unsatisfied and 5=very satisfied
Measured: Immediately post-intervention and at 6-months post-intervention
Usefulness of the champion training
A single item usefulness score on a 5-point scale with 1=very unacceptable and 5=very acceptable
Measured: Immediately post-intervention and at 6-months post-intervention
% of champions remaining at the end of the study follow-up period
Measured: 6-months post intervention
% of patients with low back pain who received the BeST intervention in each cluster
Measured: 6-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Sep 2019
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Hall, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377529
- Sponsor's protocol ID
- 20190025
- Status last verified
- Oct 2023
- First submitted
- 22 Apr 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33257487
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04377529
- Acronym / sponsor ID
- 20190025
- Conditions
- Low Back Pain
- Keywords
- implementation, behaviour change wheel, physiotherapy, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back Skills Training Champion | Experimental | Behavioral: Local ChampionIn 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. |
| No Champion | Active comparator | Behavioral: Local ChampionParticipants in clusters randomised to this arm will not receive any additional training or support beyond access to the online provider Back Skills Training course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Physiotherapy departments who do not treat adult patients with LBP will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local ChampionLocal 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. | Behavioural | Back Skills Training Champion, No Champion |
Primary outcome
% of target recruitment reached (champions)
Time frame: 6 months post-intervention
We aim to recruit at least 1 champion from each cluster.
6 secondary outcomes
% of physiotherapists implementing the Back Skills Training intervention
Time frame: 6-months post intervention
Qualitative analysis of barriers to both the champion training intervention and the Back Skills Training intervention
Time frame: 6-months post intervention
Satisfaction with champion training
Time frame: Immediately post-intervention and at 6-months post-intervention
Usefulness of the champion training
Time frame: Immediately post-intervention and at 6-months post-intervention
% of champions remaining at the end of the study follow-up period
Time frame: 6-months post intervention
% of patients with low back pain who received the BeST intervention in each cluster
Time frame: 6-months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 33257487Hall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Champion in people with Low Back Pain, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of target recruitment reached (champions) (time frame: 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.