Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial

Abstract

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 decision-making 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-ofconsultation for these five most common MSK pain presentations. Methods:The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified 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.

Stratified primary care versus non-stratified care for musculoskeletal pain: qualitative findings from the STarT MSK feasibility and pilot cluster randomized controlled trial

“…Amendments to the tool and matched treatment options were informed by bringing together the qualitative findings reported here with the quantitative findings from the feasibility and pilot trial, which are reported elsewhere (see Hill et al [17]). The changes, as outlined below, were made following a series of discussions amongst the broader TAPS trial team, as well incorporating input from members of the TAPS Trial Steering Committee and the study's PPIE group.…”

“…2, below). Prior to a main trial that compares the clinical-and cost-effectiveness of stratified primary care for patients with the five most common MSK pain presentations, versus usual, non-stratified care, a feasibility and pilot RCT was needed to test the The STarT MSK feasibility and pilot RCT (ISRCTN 15366334) was a pragmatic, two parallel arm, cluster RCT and is fully described in a separate publication [17]. In brief, 8 general practices were randomised (4 to stratified care, 4 to usual care) and patients consulting with the five most common MSK pain presentations were invited to participate in data collection over 6 months.…”

Neck pain patterns and subgrouping based on weekly SMS-derived trajectories

“…In addition, patients with NP and LBP have several similarities in psychosocial prognostic factors and comorbidities, clinical guidelines for best practice, and lack of specific pathoanatomic causality [11][12][13][14]. While the models for clinical management of musculoskeletal complaints to date have mainly been condition specific, there have recently been calls for management based on characteristics within the biopsychosocial model regardless of pain condition [14][15][16][17]. Studies have also demonstrated that patients with trajectories of NP display similar on most health-related factors as for LBP [5,6].…”

Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model?

“…Also, we identified one published pilot study and protocol for a trial testing stratified care in musculoskeletal conditions including OA. 39 , 40 No trials or protocols were identified on head-to-head comparisons of stepped and stratified models of care. Although there is limited research to inform whether models of care could be the same for OA and LBP or if one model should be chosen rather than the other, a recent focus group study indicated that practitioners consider a generic stratified model to be relevant across 5 musculoskeletal conditions.…”