Promoting the use of a self-management intervention among chiropractic students treating individuals with back pain
| ISRCTN | ISRCTN17077842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17077842 |
- Submission date
- 09/03/2021
- Registration date
- 12/03/2021
- Last edited
- 22/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Clinical practice guidelines recommend that chiropractors offer self-management strategies (SMS) to patients with back pain. SMS consists of helping patients participate in the decisions and activities that will lead to healthy behaviours, such as increasing their level of physical activity. However, SMS is not routinely used as part of chiropractors’ practice. To address this gap between what is recommended and what is currently done in clinical practice, the researchers collaborated with Canada’s largest chiropractic training institution, the Canadian Memorial Chiropractic College (CMCC), to plan the implementation of an SMS during professional training. They previously identified some barriers to using SMS by conducting surveys and interviews with CMCC patients with back pain, students and their clinical supervisors (e.g., chiropractors' lack of knowledge, skills and time; feeling anxious about using SMS; the influence of supervisory clinicians; and patients' lack of resources; the difficulty of remembering SMS recommendations, and feeling anxious about using SMS). Taking these factors into account, the researchers designed a knowledge translation (KT) intervention consisting of webinars and an online educational module on how to use an SMS. This project aims to support chiropractic students’ use of self-management support strategies when treating individuals with back pain.
Who can participate?
Supervisory clinicians and students at CMCC and patients aged 18-65 receiving treatment from a consenting chiropractic student
What does the study involve?
The 16 patient-management teams of CMCC are randomly allocated to two groups, one receives the intervention and the other one is put on the waiting list (controls). The intervention includes webinars and an online educational module on how to use the self-management strategy (SMS). Participants in this study are asked to complete online questionnaires at different timepoints in the study. The questionnaires related to students’ use of the SMS and to patients’ health (e.g., levels of pain, disability, activation) are collected before and after the intervention using medical charts and questionnaires. To evaluate the feasibility of conducting a larger study, recruitment rate and adherence to the study’s duties are assessed, along with completing the study questionnaires and adherence to the KT intervention components. In addition, to evaluate the effects of the KT intervention, measures related to students’ use of SMS and to patients’ health (e.g., levels of pain, disability, activation) are collected before and after the intervention using medical charts and questionnaires.
What are the possible benefits and risks of participating?
This study may allow the researchers to gain an in-depth understanding of how best to transfer new knowledge strategies to chiropractors. This in turn may be of benefit to future patients. There are no known risks to chiropractors, interns, and patients.
Where is the study run from?
Canadian Memorial Chiropractic College in collaboration with McGill University (Canada)
When is the study starting and how long is it expected to run for?
June 2017 to June 2019
Who is funding the study?
1. Canadian Chiropractic Guidelines Initiative (Canada)
2. McGill University (Canada)
Who is the main contact?
1. Dr André Bussières
andre.bussieres@mcgill.ca
2. Dr Owis Eilayyan
owis.eilayyan@mail.mcgill.ca
Contact information
Scientific
King Khaled Road
Skaka
72341
Saudi Arabia
 ORCID ID |
0000-0001-6191-8745 |
|---|---|
| Phone | +966 (0)544750627 |
| owis.eilayyan@mail.mcgill.ca |
Study information
| Study design | Pilot quasi-clustered randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Theory-based intervention promoting the use of a self-management strategy among novice chiropractors treating individuals with spine pain: a mixed-methods pilot cluster-randomized control study |
| Study acronym | KT SMS |
| Study objectives | It is hypothesized that it is feasible to implement a full trial to implement evidence-based theory to promote the use of a self-management strategy among novice chiropractors treating individuals with spine pain. |
| Ethics approval(s) | Approved 25/09/2017, Research Ethics Board of McGill University (#633 - 3655 Promenade Sir William Osler, Montreal, Quebec H3G 1Y6, Canada; +1 (0)514 398 3124, +1 (0)514 398 8302; ilde.lepore@mcgill.ca), ref: McGill IRB: A09-B53-17B Approved 13/11/2017, Research Ethics Board of Canadian Memorial Chiropractic College (6100 Leslie St, North York, ON M2H 3J1, Canada; +1 (0)416 482 2340; mfillery@cmcc.ca), ref: 1711X01 |
| Health condition(s) or problem(s) studied | Spine pain |
| Intervention | The 16 patient-management teams of Canadian Memorial Chiropractic College (CMCC) are assigned to two groups, one receiving the intervention and the other one on the wait list (controls). The intervention includes webinars and an online educational module on how to use the self-management strategy (SMS). Participants are asked to complete online questionnaires at different timepoints in the study. The questionnaires related to students’ use of the SMS and to patients’ health (e.g., levels of pain, disability, activation) are collected before and after the intervention using medical charts and questionnaires. To evaluate the feasibility of conducting a larger study, recruitment rate and adherence to the study’s duties are assessed using calculating the ratio of participated people to all eligible people to the study, completing the study questionnaires and adherence to the knowledge translation (KT) intervention components. In addition, to evaluate the effects of the KT intervention, measures related to students’ use of SMS and to patients’ health (e.g., levels of pain, disability, activation) are collected before and after the intervention using medical charts and questionnaires. |
| Intervention type | Behavioural |
| Primary outcome measure | Clinicians and interns: 1. Recruitment rate, measured as a proportion of clinicians and interns potentially eligible for participating. It is the number of clinicians and interns agreeing to participate divided by the number of eligible clinicians and interns. 2. Retention rate: the number of clinicians or interns who completed follow-up of all outcome measures at 6 months divided by the number of clinicians, interns or patients who were randomized 3. Adherence to the knowledge translation intervention: for those randomized to the intervention arm, measured through the rates of attendance of the online training (baseline), practice and feedback session (3 months), and workshop training (3 months) Patients: Retention rate: the number of patients who completed follow-up of all outcome measures at 2 months divided by the number of patients who were randomized |
| Secondary outcome measures | Clinicians and interns: 1. Perceived skills measured using the BAP skills survey at four timepoints: baseline, immediately after the online training, 3 and 6 months. 2. Self-efficacy measured using the BAP Tool Experience at four timepoints: baseline, immediately after the online training, 3 and 6 months. 3. Perceived importance related to the brief action planning measured using the BAP Tool Experience at four timepoints: baseline, immediately after the online training, 3 and 6 months Patients: 1. Level of confidence with SMS measured using the Brief Action Planning Survey at three timepoints: baseline, 2 and 8 weeks 2. Compliance with their action plan measured using the Patient Activation Measure at three timepoints: baseline, 2 and 8 weeks 3. Pain intensity measured using the Numerical Rating Scale at three timepoints: baseline, 2 and 8 weeks 4. Disability measured using the Bournemouth Questionnaire at three timepoints: baseline, 2 and 8 weeks 5. Self-efficacy measured using the Patient Activation Measure at four timepoints: baseline, immediately after the online training, 3 and 6 months 6. Quality of life measured using the PROMIS Global Health Questionnaire at three timepoints: baseline, 2 and 8 weeks 7. Satisfaction with care measured using the Patient Activation Measure at three timepoints: baseline, 2 and 8 weeks |
| Overall study start date | 01/06/2017 |
| Completion date | 01/06/2019 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 55% of eligible clinicians and interns would agree to participate (i.e. clinicians: 11, interns: 140) |
| Total final enrolment | 65 |
| Key inclusion criteria | Clinicians: Supervisory clinicians are eligible to participate if they: 1. Are licenced chiropractors 2. Work either part-time or full-time at one of the participating clinics Interns: The interns are eligible to participate if: 1. They are in their final year at Canadian Memorial Chiropractic College 2. In one of 16 "patient management teams" who accept to participate in the study 3. Provide chiropractic treatment to a least two adults (age 18-65 years) with spine pain each week Patients: Patients are deemed eligible if they are: 1. Between 18-65 years 2. Receiving treatment by a consenting chiropractic intern 3. Able to read English and hold a conversation in English |
| Key exclusion criteria | Interns: Interns are excluded from the study if they have already attended the BAP webinar or educational online module Patients: Patients are excluded in the presence of: 1. 'Red flags' (i.e. indicators of serious pathologies including malignancy, infection, fracture, inflammatory disease) 2. Pregnancy |
| Date of first enrolment | 13/11/2017 |
| Date of final enrolment | 17/04/2018 |
Locations
Countries of recruitment
- Canada
Study participating centre
North York
North York
M2H 3J1
Canada
Sponsor information
University/education
845 Sherbrooke St W
Montreal
H3A 0G4
Canada
| Phone | +1 (0)5143988302 |
|---|---|
| ilde.lepore@mcgill.ca | |
| Website | http://www.mcgill.ca/ |
"ROR" |
https://ror.org/01pxwe438 |
University/education
6100 Leslie St
North York
North York
M2H 3J1
Canada
| Phone | +1 (0)4164822340 ext 267 |
|---|---|
| mfillery@cmcc.ca | |
| Website | https://www.cmcc.ca/ |
|
"ROR" |
https://ror.org/03jfagf20 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- McGill, Université McGill, Universitas McGill, MGU
- Location
- Canada
No information available
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The protocol of the study is not published and not available online. The paper will be submitted in April 2021 to the Implementation Science journal for publication. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication as an additional file. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 22/05/2023 | No | No | ||
| Dataset | 22/05/2023 | No | No | ||
| Dataset | 22/05/2023 | No | No | ||
| Results article | 21/01/2022 | 22/05/2023 | Yes | No |
Editorial Notes
22/05/2023: The following changes were made to the trial record:
1. Publication reference added.
2. Links to datasets were added.
12/03/2021: Trial's existence confirmed by the Research Ethics Board of McGill University.
