SWAP - Study of Work And Pain
| ISRCTN | ISRCTN52269669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52269669 |
| Secondary identifying numbers | 13183 |
- Submission date
- 25/10/2012
- Registration date
- 26/10/2012
- Last edited
- 10/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Recent government reviews highlighted that primary care is a key arena to address work-related issues in patients who experience pain. However, such a service has not been implemented in primary care before. The aim of this study is to test the clinical and cost-effectiveness of introducing a vocational advisor into GP practices to provide a structured approach to managing work-related issues in primary care patients with musculoskeletal pain problems.
Who can participate?
Adults aged 18 to 70 struggling with work or off sick from work due to musculoskeletal pain
What does the study involve?
Participating GP practices are randomly allocated to either the control group or the intervention group. Practices in the control group provide the best current care while the intervention practices provide the best current care and also access to the vocational advisory service. All participants are followed up at 4 and 12 months. Interviews are conducted with about 20 patients who have accessed the vocational advisory service.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Four GP practices in the Primary Care Research West Midlands North area of South Staffordshire (UK)
When is the study starting and how long is it expected to run for?
July 2012 to January 2014
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Sarah Lawton, Study Coordinator
s.a.lawton@keele.ac.uk
Contact information
Scientific
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
| j.gray@cphc.keele.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Primary care management of work related issues in patients with musculoskeletal conditions |
| Study acronym | SWAP |
| Study objectives | This study is a pilot randomised controlled cluster trial that will include up to 6 GP practices within Primary Care Research West Midlands North. We aim to recruit 360 patients aged between 18 and 70, 180 patients in each group. Information about the characteristics (pain, disability, psychological factors, employment, other health conditions) of these patients will be collected on postal questionnaires at baseline, and during one-year follow-up. This pilot trial will inform us about the feasibility and acceptability of running a full-scale randomised trial, including information about the recruitment and response rates. In addition, the pilot involves interviewing GPs, Nurse Practitioners, patients and vocational advisors to assess their feedback and an early assessment of the costs of the vocational advice service and issuing GPs a brief questionnaire to explore experiences of the sickness certification process. More details can be found at: https://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=3230 |
| Ethics approval(s) | Staffordshire Research Ethics Committee, First MREC approval date 18/04/2012, ref: 12/WM/0020 |
| Health condition(s) or problem(s) studied | Musculoskeletal pain |
| Intervention | Vocational Advice Service. Intervention Practices will consist of best current care as determined by the GP practice. In addition, a vocational advice service will be provided at each GP practice allocated to the intervention arm. GPs and Nurse Practitioners will be able to refer patients to the vocational advisor. All patients (in both arms) will receive the same information about the research evaluation indicating that this consists of completing questionnaires at baseline, four months and twelve months from the date of identification." |
| Intervention type | Other |
| Primary outcome measure | Work absence at baseline, 4 months and 12 months follow up |
| Secondary outcome measures | Measures of pain at baseline, 4 months and 12 months follow up |
| Overall study start date | 03/07/2012 |
| Completion date | 31/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 360; UK Sample Size: 360 |
| Key inclusion criteria | 1. Primary care consulters with musculoskeletal pain 2. Adults 18 to 70 years of age 3. Currently employed (paid) 4. Current sickness absence of less than 6 months duration, (either GP or self-certified absence) due to musculoskeletal pain OR 5. Patients assessed by the GP (or a nurse practitioner), during the consultation, as struggling with work due to musculoskeletal pain |
| Key exclusion criteria | 1. Patients with symptoms of possible serious pathology, requiring urgent medical attention 2. Patients unable to read and speak English (Information sheets, cover letters and questionnaires are in English). The postal questionnaires will have a contact name and telephone number that participants can call to discuss any difficulties or help required with completion of the consent form or the questionnaire. Potential participants will need to be able to understand the cover letter and information sheet which explains the study to them, before they can consent to take part. People who can speak English but not write English will however be included and their questionnaires will be completed by telephone. In addition, all interviews will be conducted in English. 3. Patients with serious mental health problems who are vulnerable and for whom participation in the study would be detrimental (at the GP's discretion) 4. Current pregnancy or those patients on maternity leave |
| Date of first enrolment | 03/07/2012 |
| Date of final enrolment | 31/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ST5 5BG
United Kingdom
Sponsor information
University/education
Arthritis Research UK Primary Care Centre
Newcastle-Under-Lyme
ST5 5BG
England
United Kingdom
"ROR" |
https://ror.org/00340yn33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publications are planned for Spring 2017. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/07/2014 | Yes | No | |
| Results article | results | 01/01/2018 | Yes | No | |
| Other publications | development and content of the intervention and training package | 01/06/2019 | Yes | No |
Editorial Notes
10/07/2018: Publication reference added.
05/10/2017: Publication reference added.
15/02/2017: Recruitment and trial end date changed from 02/07/2013 to 31/01/2014. Publication plan and data sharing plan added.
26/11/2013: During the progress of this study, it has become apparent that the pilot trial will not proceed to a main trial. After consultation with the Trial Steering Committee and Data Monitoring Committee, it was decided to proceed with the study and report as a full trial.
