Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial

Abstract

<jats:sec> <jats:title>Background</jats:title> <jats:p>Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain–related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with &gt;5000 MSK consultations available for anonymized medical record data comparisons.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial Registration</jats:title> <jats:p>ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334.</jats:p> </jats:sec> <jats:sec> <jats:title>International Registered Report Identifier (IRRID)</jats:title> <jats:p>DERR1-10.2196/17939</jats:p> </jats:sec>

Integrating clinician support with intervention design as part of a programme testing stratified care for musculoskeletal pain in general practice

“…• WP3 -pilot/feasibility cluster randomised controlled trial of stratified care in general practice [15,16] • WP4 -main cluster randomised controlled trial of stratified care in general practice [17] packages (see Table 1,below). Several of the studies from these work packages have previously been published in this journal [4,15,16].…”

“…Final results of the clinical trial are yet to be published. The stratified care intervention is described in detail elsewhere [12,17] and comprises two components: the use of the prognostic risk tool (Keele STarT MSK Tool) and the selection of an appropriate clinical treatment, matched to the patient's prognostic risk group. In brief, the key components for intervention practices were: • To ensure that the GP engages with the EHR to trigger the stratified care template whilst the patient is still present…”

Testing Stratified Care for Musculoskeletal Pain in General Practice: Integrating Clinician Support and Intervention Design

“…The strati ed care intervention is described in detail elsewhere [14,17] and comprises two components: the use of the prognostic risk tool (Keele STarT MSK Tool) and the selection of an appropriate clinical treatment, matched to the patient's prognostic risk group. In brief, the key components for intervention practices were:…”

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.…”