Plain English Summary
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 will be randomly allocated to either the control group or the intervention group. Practices in the control group will provide the best current care while the intervention practices will provide the best current care and also access to the vocational advisory service. All participants will be followed up at 4 and 12 months. Interviews will be 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
Trial website
Contact information
Type
Scientific
Primary contact
Ms Jacqueline Gray
ORCID ID
Contact details
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
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j.gray@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13183
Study information
Scientific title
Primary Care Management of Work Related Issues In Patients With Musculoskeletal Conditions
Acronym
SWAP
Study hypothesis
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
Updated 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.
Ethics approval
Staffordshire Research Ethics Committee, First MREC approval date 18/04/2012, ref: 12/WM/0020
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Work absence at baseline, four months and 12 months follow up
Secondary outcome measures
Measures of pain at baseline, 4 month and 12 month follow up
Overall trial start date
03/07/2012
Overall trial end date
31/01/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 360; UK Sample Size: 360
Participant 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 GPs discretion)
4. Current pregnancy or those patients on maternity leave
Recruitment start date
03/07/2012
Recruitment end date
31/01/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Arthritis Research UK Primary Care Centre
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Funders
Funder type
Government
Funder name
NIHR (UK) - Programme Grants for Applied Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
30/06/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25012813
Publication citations
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Protocol
Bishop A, Wynne-Jones G, Lawton SA, van der Windt D, Main C, Sowden G, Burton AK, Lewis M, Jowett S, Sanders T, Hay EM, Foster NE, , Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669)., BMC Musculoskelet Disord, 2014, 15, 232, doi: 10.1186/1471-2474-15-232.