Musculoskeletal (MSK) Pathways Study
| ISRCTN | ISRCTN38924614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38924614 |
| IRAS number | 326002 |
| Secondary identifying numbers | IRAS 326002, CPMS 56279 |
- Submission date
- 17/05/2023
- Registration date
- 25/09/2023
- Last edited
- 20/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Musculoskeletal pain (affecting bones, joints, ligaments, tendons or muscles) is very common, accounting for a large number of GP appointments. NHS staff often have to make assessment and treatment decisions for these conditions in short consultations. Whilst national guidelines for MSK conditions are available, they are complex and cover many different conditions separately. Therefore, there is often variability in the care patients receive. Orthopathway is a system that is installed onto GP practice computers for use in appointments to help clinicians make these decisions. Pathways are built for each pain site that contain best practice national guidelines adapted by local experts. This means that all clinicians in the local area follow the same high-quality guidance. The aim of this study is to find out whether using Orthopathway in primary care has an effect on patient outcomes, clinical decision-making, is cost-effective, and reduces carbon emissions.
Who can participate?
Patients aged 18 years and over who consult for neck, shoulder, elbow, wrist/hand, back, hip, knee, or foot pain
What does the study involve?
Participating GP practices are randomly allocated to one of two groups. GPs in the intervention group will use the Orthopathway system in eligible consultations, while GPs in the control group will continue delivering care as usual. After the consultation, patients will be asked to complete questionnaires at the start of the study and after 6 weeks and 3 months to monitor their outcomes. Consent will be sought to review the medical records of participants to see what healthcare usage there was after the consultation. Some clinicians and patients from the intervention arm will be asked to take part in interviews to talk more in-depth about their experiences.
What are the possible risks and benefits of participating?
There are no direct benefits to taking part in this study. This is considered a low-risk study; no new treatments are being tested.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
February 2023 to March 2024
Who is funding the study?
SBRI Healthcare Grant (UK)
Who is the main contact?
Dr Hollie Birkinshaw and Pro. Jonathan Hill, research.mskpathways@keele.ac.uk
Contact information
Public
School of Medicine
Keele University
Keele
ST5 5BG
United Kingdom
 ORCID ID |
0000-0003-0853-2995 |
|---|---|
| research.mskpathways@keele.ac.uk |
Scientific
School of Medicine
Keele University
Keele
ST5 5BG
United Kingdom
| ORCID ID |
0000-0003-0853-2995 |
|---|---|
| research.mskpathways@keele.ac.uk |
Principal Investigator
School of Medicine
Keele University
Keele
ST5 5BG
United Kingdom
| research.mskpathways@keele.ac.uk |
Study information
| Study design | Non-inferiority cluster randomized controlled trial with embedded health economic, carbon reduction, and qualitative analyses |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic, Other, Treatment, Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparing usual care vs CrossCover Orthopathway clincial decision support system in primary care: a non-inferiority cluster randomized control trial |
| Study objectives | That the intervention (Orthopathway) does not cause worse outcomes for patients' health and wellbeing (measured using the MSK-HQ) than usual care. |
| Ethics approval(s) |
Approved 01/06/2023, Yorkshire & The Humber – Sheffield Research Ethics Committee (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle-upon-Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8388; sheffield.rec@hra.nhs.uk), ref: 23/YH/0105 |
| Health condition(s) or problem(s) studied | Painful musculoskeletal conditions |
| Intervention | Orthopathway is a clinician decision support system to be used by clinicians in consultations with patients to reduce variability in care. Orthopathway enables patient-facing clinical staff to follow best practice national guidelines adapted by local experts. The platform facilitates clinical experts to edit existing pathways, or build new easy pathways to follow, with fully illustrated interactive flowcharts and relevant clinical information. The innovation is designed to standardise decision-making among front-line clinicians and follow best-practice patient care. Participating GP practices are randomly allocated to one of two groups. GPs in the intervention group will use the Orthopathway system in eligible consultations, while GPs in the control group will continue delivering care as usual. After the consultation, patients will be asked to complete questionnaires at the start of the study and after 6 weeks and 3 months to monitor their outcomes. Consent will be sought to review the medical records of participants to see what healthcare usage there was after the consultation. Some clinicians and patients from the intervention arm will be asked to take part in interviews to talk more in-depth about their experiences. Practices will be randomized in a ratio of 1:1 to intervention or control using stratified block randomization based on practice patient list size using a computer-generated random sequence and concealment by ensuring that each practice has an anonymized code. The randomization sequence and stratification will be carried out by the senior trial statistician. The block randomization will follow Keele CTU’s randomization SOP, and the data sequence will be held on a secure server. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CrossCover Orthopathway Clinician Decision Support System |
| Primary outcome measure | Musculoskeletal health, as measured by the Musculoskeletal Health Questionnaire (MSK-HQ) at baseline and 3 months |
| Secondary outcome measures | 1. Clinician confidence in MSK decision-making as measured by a clinician survey at baseline, 6 weeks and 3 months 2. Participant pain intensity as measured by 0-10 visual analogue score (VAS) at baseline, 6 weeks and 3 months 3. Participant quality of life as measured by the EQ5D at baseline, 6 weeks and 3 months 4. Participant experience of consultation and care as measured by Keele Patient Experience Measures at baseline 5. Participant ability to work as measured by modified Work Productivity and Activity Impairment (WPAI) at baseline and 3 months 6. Participant healthcare utilisation measured using self-reported questionnaire data at 3 months, and medical record review data at 3 months 7. Acceptability and experience of Orthopathway explored using qualitative interviews with patient participants and clinicians at 3 months 8. Health economic and carbon reduction analyses using self-reported healthcare utilisation questions and medical record review data at 3 months |
| Overall study start date | 01/02/2023 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | 1. Aged 18 years and over 2. Registered with a participating GP practice during the study period 3. Clinician determined suitability at the point-of-care for trial inclusion 4. Presenting with an MSK problem and a pain intensity score of ≥4 on a 0 to 10 numerical rating scale at the index consultation |
| Key exclusion criteria | 1. Patients considered vulnerable by their GP (including those on the severe and enduring mental health register, with a diagnosis of dementia, with a recent diagnosis of a terminal illness, who have experienced recent trauma or bereavement, and nearing the end of their life) 2. Patients unable to communicate in English (both in reading and speaking) |
| Date of first enrolment | 01/10/2023 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wesleyan
Colmore Circus Queensway
Birmingham
B4 6AR
United Kingdom
Sponsor information
University/education
Keele University
Keele
ST5 5BG
England
United Kingdom
| research.governance@keele.ac.uk | |
| Website | https://www.keele.ac.uk/research/raise/governanceintegrityandethics/ |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| 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 | Planned publication in a high impact journal, dissemination to GPs. |
| 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? |
|---|---|---|---|---|---|
| Other unpublished results | 20/05/2025 | No | No | ||
| Statistical Analysis Plan | 23/09/2024 | 20/05/2025 | No | No |
Additional files
Editorial Notes
20/05/2025: The following changes were made to the trial record:
1. An unpublished results summary was uploaded as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
04/10/2023: Internal review.
23/06/2023: Study's existence confirmed by Yorkshire & The Humber – Sheffield Research Ethics Committee.
