PURPOSE We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs. METHODSThe IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. RESULTSThe 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed.CONCLUSIONS Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended. INTRODUCTIONI t has been stated that "most cases of back pain resolve regardless of the course of therapy, and some do not get better no matter what is done. Therein lies the problem for practitioners, patients, and policy makers."1 Health care systems universally face the challenge of providing effective primary care for low back pain within constrained resources, in the face of increased demands for treatment and investigations.2,3 Back pain is now the 6th highest contributor to the global burden of disease. 4 In the United Kingdom, 6% to 9% of adults consult a family physician for back pain each year, 5 accounting for 14% of consultations. 6 More than 60% still report pain and disability a year later, 7,8 and 2% to 7% will develop severe persistent symptoms 9 leading to high levels of reconsultation, work loss, and sickness certification. 10 evidence-based treatments, but the optimal approaches to tar...

Background. The IMPaCT Back study (IMplementation to improve Patient Care through Targeted treatment for Back pain) is a quality improvement study which aims to investigate the effects of introducing and supporting a subgrouping for targeted treatment system for patients with low back pain (LBP) in primary care. This paper details the subgrouping for targeted treatment system and the clinical training and mentoring programmes aimed at equipping clinicians to deliver it.The subgrouping and targeted treatment system. This system differs from ‘one-size fits all’ usual practice as it suggests that first contact health care practitioners should systematically allocate LBP patients to one of the three subgroups according to key modifiable prognostic indicators for chronicity. Patients in each subgroup (those at low, medium or high risk of chronicity) are then managed according to a targeted treatment system of increasing complexity.The subgrouping tools. Subgrouping tools help guide clinical decision-making about treatment and onward referral. Two subgrouping tools have been used in the IMPaCT Back study, a 9-item version used by participating physiotherapists and a 6-item version used by GPs.The targeted treatments. The targeted treatments include a minimal intervention delivered by GPs (for those patients at low risk of poor outcome) or referral to primary care physiotherapists who can apply physiotherapy approaches to addressing pain and disability (for those at medium risk) and additional cognitive-behavioural approaches to help address psychological and social obstacles to recovery (for those at high risk).The training packages. Building on previous interventions for other pilot studies and randomized trials, we have developed and delivered clinical training and support programmes for GPs and physiotherapists.Discussion. This paper describes in detail the IMPaCT Back study’s subgrouping for targeted treatment system and the training and mentoring packages aimed at equipping clinicians to deliver it, within the IMPaCT Back study.Study registration. ISRCTN55174281.

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.

Background Patients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost‐effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients. Methods Tool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF‐36 Physical Component Score [PCS]) and pain intensity were assessed at 2‐ and 6‐month cohort follow‐up; pain intensity was measured at 6‐month trial follow‐up. Results The tool was refined by replacing (3), adding (3) and removing (2) items, resulting in a 10‐item tool. Model fit (R2) was 0.422 and 0.430 and discrimination (c statistic) 0.839 and 0.822 for predicting 6‐month cohort PCS and pain (respectively). The tool classified 24.9% of cohort participants at low, 41.7% medium and 33.4% high risk, clearly discriminating between subgroups. The tool demonstrated model fit of 0.224 and discrimination 0.73 in trial participants. Multiple imputation confirmed robustness of findings. Conclusions The Keele STarT MSK Tool demonstrates good validity and acceptable predictive performance and clearly identifies groups of musculoskeletal pain patients with different characteristics and prognosis. Using prognostic information for stratification and treatment matching may be clinically/cost‐effective. Significance The paper presents the first musculoskeletal pain prognostic stratification tool specifically for use among all primary care patients with the five most common musculoskeletal pain presentations (back, neck, knee, shoulder or multisite pain). The Keele STarT MSK Tool identifies groups of musculoskeletal pain patients with clearly different characteristics and prognosis. Using this tool for stratification and treatment matching may be clinically and cost‐effective.