Hill, JC ORCID: https://orcid.org/0000-0001-6246-1409, Garvin, S, Chen, Y, Cooper, V, Wathall, S, Saunders, B, Lewis, M, Protheroe, J, Chudyk, A, Dunn, KM ORCID: https://orcid.org/0000-0002-6202-2606, Hay, E ORCID: https://orcid.org/0000-0002-9545-4296, van der Windt, DA ORCID: https://orcid.org/0000-0002-7248-6703, Mallen, CD ORCID: https://orcid.org/0000-0002-2677-1028 and Foster, NE ORCID: https://orcid.org/0000-0003-4429-9756 (2020) Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial. BMC Family Practice, 21.

FAMP-D-19-00434_R2.pdf - Accepted Version
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Background: Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decisionmaking is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations.

Methods: The design was a pragmatic pilot, two parallel-arm (stratified versus nonstratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician
and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP
point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making.

Results: GPs screened 3063 patients (intervention=1591, control=1472), completed the EMR template with 1237 eligible patients (intervention=513, control=724) and 524 participants (42%) consented to data collection (intervention=231, control=293). Recruitment took 28 weeks (target 12 weeks) with >90% follow-up retention (target >75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved “complete success”.

Conclusions: A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.

Item Type: Article
Additional Information: This is the accepted author manuscript (AAM). The final published version (version of record) is available online via BioMed Central at https://doi.org/10.1186/s12875-019-1074-9 - please refer to any applicable terms of use of the publisher.
Subjects: R Medicine > RC Internal medicine > RC925 Diseases of the musculoskeletal system
Divisions: Faculty of Medicine and Health Sciences > Primary Care Health Sciences
Depositing User: Symplectic
Date Deposited: 18 Dec 2019 09:55
Last Modified: 04 Mar 2020 11:19
URI: http://eprints.keele.ac.uk/id/eprint/7419

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