JMIR Publications

ABSTRACT

Background:

Musculoskeletal (MSK) pain from common conditions such as back pain and osteoarthritis is a major cause of pain and disability. We previously developed a prognostic tool (STarT Back Tool) specifically for use in primary care to guide the management of patients with low back pain. Prognostic stratified care models involve matching treatments to the patient’s prognostic profile to support clinical decision-making in an effort to maximize treatment benefits, reduce harm and increase health care efficiency. A logical next step is to determine whether a similar model of prognostic stratified care might also have benefits for primary care patients with a much broader range of MSK pain presentations (back, neck, knee, shoulder and multi-site pain).

Objective:

The primary objective is to determine, in patients presenting with one of the five most common MSK pain presentations in UK primary care, whether stratified care involving 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 more clinically and cost effective compared to usual non-stratified primary care.

Methods:

We are conducting a pragmatic, two parallel-arm (stratified versus non-stratified care), cluster RCT, with a linked health economic analysis and mixed methods process evaluation. The setting is UK primary care, and the trial will include approximately 24 average-sized general practices randomized (stratified by practice size) in a ratio of 1:1 (approx. 12 practices per arm) with blinding of trial statistician and outcome data-collectors. The units of randomization are the general practices and the units of observation are adults consulting for MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records will be tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention is supported by an 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. The primary outcome using intention-to-treat analysis is patient-reported pain intensity, measured monthly over 6-months. Secondary outcomes include measures of physical function and quality of life and an anonymized EMR audit will capture clinician decision-making. The economic evaluation will focus on the estimation of incremental quality-adjusted life years (QALYs) and MSK pain-related healthcare costs. A mixed-methods process evaluation is planned to explore a range of potential factors that might influence differences between trial arms, as well as to better understand how stratified care is used and perceived by patients and clinicians involving quantitative analyses focussing on a priori hypothesized intervention targets, and qualitative approaches using focus groups and interviews. The sample size target is 600 patients per arm (1200 in total) from 24 general practices.

Results:

Recruitment to the trial commenced on 18th May 2018 and ended on 15th July 2019, after a recruitment period of 14 months in 24 GP practices. It is anticipated that all follow-up and interview data collection will be completed by February 2020.

Conclusions:

This study protocol describes the detail of the STarT MSK trial, which aims to investigate the clinical and cost effectiveness of stratified primary care for patients with the five most common MSK pain presentations compared to usual non-stratified care. The intervention was designed to improve patient outcomes including pain intensity, physical function and quality of life, and also clinician decision-making in order to reduce treatment variability and improve adherence to best practice. 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. Clinical Trial: ISRCTN15366334