Title: Stratified Primary Care for Musculoskeletal Pain
Funder: Department of Health and Social Care

Abstract: The programme has 4 linked Workpackages. Workpackages 1 and 2 run in parallel and inform Workpackages 3 and 4. Workpackage 1 aims to confirm the validity and optimise the predictive performance of the STarT-Musc screening tool and determine the cut-points for each patient risk strata. We plan an observational, prospective cohort of 1800 adults with one or more of the five most common musculoskeletal pain presentations at 8 general practices in the West Midlands North Primary Care Research Network (WMN PCRN). Recruitment uses methods previously shown to be successful, in which an electronic tag is stamped on the medical records of eligible patients based on Read codes entered at the time of consultation, to identify patients for invitation. This ensures that recruitment is not dependent on GPs remembering about the study. Participants will complete baseline, 2 and 6 month questionnaires and are asked to give consent for medical record review. Attrition bias will be minimised by reminders and collection of a minimal data set. Poor outcome is lack of improvement on the SF-36v2 Physical Component Scale (PCS) between baseline and 6 month follow-up. Analyses will determine the discriminant and construct validity of the screening tool, establish risk strata cut-points and describe patients classified at low, medium and high risk of poor outcome. Predictive validity will be optimised using decision analysis, assessing the benefit of additional or alternative variables in the screening tool. Workpackage 2 focuses on specifying the intervention of stratified care. Study 2.1 will provide a detailed understanding of the perceived added value, and anticipated pitfalls and solutions to using a stratified primary care model that is based on prognosis with musculoskeletal pain patients. In 6 to 8 focus groups with GPs, other health professionals and patients, we will follow good qualitative research practice to analyse the data, including independent analysis of transcripts. Study 2.2 is an evidence synthesis of recent guidelines and systematic reviews of treatments that are suitable and available to NHS primary care. We will also examine whether information is available according to patient risk strata. In study 2.3, we will develop consensus about the appropriate matched treatment options for patients in each risk strata. We plan 3 consensus workshops with patients, clinicians, managers and commissioners using nominal group technique. In study 2.4, we will agree the content of the clinician support packages for stratified care delivery and the optimal and most effective ways of delivering the support packages. Workpackage 3 will test the feasibility of delivering stratified care in 2 general practices that participated in Workpackage 1, and is a before/after study. Stratified care is both use of the STarT-Musc tool and matched treatment options. We will train and support the practice teams to deliver stratified care to eligible patients consulting over a 3 month period. We will recruit 250-300 adults to complete a study questionnaire in order to test patient recruitment and data collection. Up to 30 audio-taped GP-patient consultations will be examined to explore the feasibility of our stratified care model in real-time. Two theoretical models will inform the programme as whole, but this study in particular, a model of behaviour change and a model of broader systems change. The quantitative and qualitative data will be analysed iteratively and fed back to the practice teams in workshops. Feasibility will be established if by the end of the 3 month period, the STarT-Musc tool is completed for more than two-thirds of patients coded with musculoskeletal problems and over 50% of patients receive their risk appropriate matched treatment options. Workpackage 4 is a pragmatic, cluster randomised trial with 20 GP practices (10 intervention, 10 usual care control) and 3100 patients, to test the clinical and cost-effectiveness of stratified primary care for musculoskeletal patients compared with usual non-stratified care. Patients will follow the care to which their practice is randomised. Individual patients cannot opt out of the intervention, but may opt out of data collection. Our plans follow recent recommendations for cluster trials to reduce selection bias where randomisation occurs prior to patient recruitment. In the intervention practices, patients will consult their GP and receive stratified care (the STarT-Musc screening tool and matched treatment options). We will collect outcomes at both the individual level (primary patient outcome is physical function using the SF36v2 PCS at 6 months) and cluster level (key process outcome is the proportion of patients who receive a risk strata matched treatment option), conduct a full economic evaluation and up to 45 one-to-one, semi-structured interviews with patients (n=30 in stratified care and n=15 in usual care). Our Research User Group will input into the interview topic guides for early interviews and provide their interpretations on emerging themes following early analysis in order to ensure the interviews investigate stratified care in ways that really reflect user perspectives.

Lay abstract: In primary care, 20% of adults will consult their general practitioner (GP) each year with a musculoskeletal problem, accounting for 1 in 6 GP consultations, 8.8 million physiotherapy consultations, and over 3.5 million calls per year to emergency services. Musculoskeletal problems represent the single largest group of chronic conditions for which patients consult their GPs. How to manage this enormous workload poses huge challenges for primary care services. Whilst many patients have mild complaints which could be self-managed with appropriate support, some have more serious or persistent problems that research has shown would benefit from treatments such as exercise programmes or pain management. The problem is that the traditional &ldquo;medical model&rdquo;, where treatment decisions are guided by the doctor making a specific diagnosis, has not helped identify who could be supported to self-manage and who needs more treatment. There is wide variation in care &ndash; some patients are offered unnecessary treatments whilst others are denied access to effective treatments. This makes primary care inefficient and does not get the right patient to the right treatment at the right time. We have shown, in a research environment and in everyday general practice, it is possible to use a simple set of questions to separate people who consult their GP about back pain into three groups: those likely to get better who can be given simple advice (low risk); those with more troublesome problems who can be referred for physiotherapy (medium risk); those with more complex problems (eg significant worries about the impact of pain) who can be referred to a specially trained physiotherapist (high risk). When people s back pain is treated according to the group they are in (stratified care), this leads to better pain relief and physical function, and is cheaper to deliver than usual care. If this approach can be extended to the larger group of patients with common musculoskeletal problems there is the real potential to improve patients experiences and outcomes, and increase the efficiency of primary care, in a major way. In a series of 4 linked workpackages we will use a variety of research methods to test a new set of questions to help group people with a range of common musculoskeletal problems; identify the treatment options which can be targeted to each strata (stratified care); test how this helps GPs and patients to agree treatment options; how it helps improve patients outcomes and experiences; and test whether it is cost-effective. We aim to develop a much more patient centred model for patients with musculoskeletal problems, where treatment is tailored to reduce the future risk of pain and disability. This represents a major step-up in terms of scale and ambition from our previous research.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL