- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842915
The National Musculoskeletal Audit and Research Database
Developing and Testing a Musculoskeletal National Audit in Community/Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Roanna Burgess, Dr
- Phone Number: 01782733900
- Email: r.m.burgess@keele.ac.uk
Study Locations
-
-
Staffordshire
-
Keele, Staffordshire, United Kingdom, ST5 5BG
- Recruiting
- Keele University
-
Contact:
- Roanna Burgess, Dr
- Phone Number: 01782 733900
- Email: r.m.burgess@keele.ac.uk
-
Contact:
- Jonathan Hill, Prof
- Phone Number: 01782 733900
- Email: j.hill@keele.ac.uk
-
Principal Investigator:
- Jonathan Hill, Prof
-
Sub-Investigator:
- Roanna Burgess, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(MSK Services)
- MSK service seeing adult (+18 years) set in community care
- MSK service with at least 10 WTE HCPs
- System in place for digital collection of PROM/PREM data
(FCP Services)
- FCP service seeing adult (+18 years) in primary care
- FCP service with at least 1 WTE FCP seeing MSK patients
- Use of EMIS or SYSTMONE
- Able to implement Midlands FCP template
- System in place for digital collection of PROM/PREM data
(For patients)
- +18 years
- Active phone number or verified email address to participate in the patient questionnaire
- Able to provide informed consent
Exclusion Criteria:
(MSK Services)
* Secondary care MSK services
(For patients)
- Has declined for data to be part of research as part of consent process
- Unable to complete surveys due to health issues including severe or terminal illness, severe learning difficulties or psychological disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
First Contact Practitioner (FCP)
A continuous routine-data cohort study involving FCP primary care services aiming to recruit a minimum of 25patients per service from 10 FCP services, with complete data from at least 25 patients at baseline and 3-month follow up per service for each 12-month period. Data collection will involve: Patient survey (to collect outcomes and experiences) Organisational characteristics (collected via a survey to service leads and via publicly available national sources) Electronic health record (EHR) data (collected via a standardised FCP template and search within EHR systems) |
Baseline and 3 month questionnaire
|
|
MSK Community Services
A continuous routine-data cohort study involving MSK Community Services, aiming to recruit a minimum of 250 patients per service from a minimum of 10 MSK services, with complete data from at least 250 patients at baseline and 3-month follow up per service for each 12-month period. Data collection will involve: Patient survey (to collect outcomes and experiences) Organisational characteristics (collected via a survey to service leads and via publicly available national sources) |
Baseline and 3 month questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To provide a secure national MSK research database for participating MSK providers to upload their routinely collected data.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To develop a standard dashboard and reporting system that supports an ongoing automated process to analyse and present the data for quality improvement purposes.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG-0359-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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