Objectives To determine the effectiveness and cost-effectiveness of a brief communication skills e-learning package on empathy and optimism for practitioners consulting with adult primary care patients presenting with musculoskeletal (MSK) pain.

Design A cluster randomised controlled trial from 31/10/22 to 28/6/24 using computer-generated block randomisation allocated general practices to intervention or usual care control (1:1) stratified by practice size and deprivation. Patients, trial statisticians, investigators, and researchers involved in collecting outcome data were blinded to allocation. Practitioners were not told which patients were participating in the trial.

Setting General practices in England and Wales (all NHS general practices eligible).

Participants Adults ≥18y consulting a participating practitioner face-to-face, by telephone, or videoconference were recruited into two groups prior to consultation: those consulting about new, recurrent, or ongoing MSK pain and scoring ≥ 4 on an 11-point scale at baseline; and those consulting for any other reason (All-comers). Participating primary care practitioners came from a range of disciplines (e.g., GPs, nurse practitioners, first-contact physiotherapists) and routinely saw patients with MSK pain.

Interventions Intervention arm practitioners received EMPathicO, an evidence-based theoretically-grounded, brief digital e-learning package using behaviour change techniques to enhance communication of clinical empathy and realistic optimism. Control arm practitioners did not receive EMPathicO and consulted patients as usual, access to EMPathicO was provided upon trial completion.

Main outcomes The MSK pain group patient-level dual primary outcomes were pain intensity and patient enablement. The All-comer group patient-level primary outcome was patient enablement. All outcomes were analysed over 6 months using a repeated-measures approach. Cost effectiveness was assessed from UK NHS and societal perspectives including personal expenses and productivity over 6 months.

Results 53 general practices were randomised (25 intervention, 28 control) from which 233 practitioners (115 intervention, 118 control) and 1682 patients were recruited (806 in the MSK pain group (439 intervention, 367 control) and 876 in the All-comers group (490 intervention, 386 control)). Intention to treat analysis found no statistically significant differences between intervention and usual care on primary outcomes. Among the MSK pain group, pain intensity adjusted mean difference was 0.06 (97.5% CI -0.19 to 0.31) and patient enablement adjusted mean difference was 0.17 (97.5% CI -0.05 to 0.40). Among the All-comers group, patient enablement adjusted mean difference was -0.12 (95% CI -0.32 to 0.07). We found no evidence of harm associated with the intervention. From a UK NHS perspective, the probability of cost-effectiveness at a willingness to pay threshold of £20,000 per quality-adjusted life year was 97% for the MSK pain group and 64% for the All-comers group. Compared to control, intervention practitioners had significantly higher self-efficacy for communicating empathy and optimism at 8 weeks (empathy adjusted mean difference was 0.78 (95% CI 0.45 to 1.10), optimism adjusted mean difference was 0.98 (95% CI 0.59 to 1.37)) and 34 weeks post-intervention (these mean differences were 0.63 (95% CI 0.32 to 0.93) and 0.75 (95% CI 0.39 to 1.10), respectively).

Conclusions Brief e-learning for primary care practitioners significantly increased practitioner self-efficacy for a sustained period, is probably cost-effective, and is safe for patients but did not improve pain intensity, patient enablement or other health outcomes. EMPathicO could be rapidly and widely disseminated to support practitioners delivering primary care consultations.

Registration ISRCTN18010240 registered 15 September 2022. Funding: NIHR School for Primary Care Research grant 563.

What is already known

Empathy education is provided in medical schools and health professional training, yet patients still report limited clinical empathy and related dissatisfaction with their clinical interactions.

Experimental research suggests realistic optimism has beneficial effects on patient outcomes including pain but how this translates in clinical settings is unknown.

Existing clinical empathy training is often too lengthy for busy primary care clinicians and cost effectiveness assessments are lacking.

What this study adds

This large, robust, trial undertaken in UK primary care suggests very brief e-learning for primary care practitioners in clinical empathy and realistic optimism is safe, is probably cost-effective, and significantly enhances practitioner self-efficacy over a sustained period but found no effect on patient outcomes.

The benefits for practitioners were found across the multidisciplinary primary care team of clinicians, including experienced GPs, GP registrars, physiotherapists and practice nurses from a broad range of GP practices.

The digital nature of the e-learning package would enable rapid widespread dissemination to clinicians at low cost.

The authors declare the following competing interests: FLB (research grant from NIHR School for Primary Care Research paid to institution; speakers honoraria from Stoneygate Centre for Empathic Healthcare and New Scientist), TB (research grant from NIHR School for Primary Care Research paid to institution), KG (research grant from NIHR School for Primary Care Research paid to institution; ModRUM license holder), NC (research grant from NIHR School for Primary Care Research paid to institution), RDH (none declared), ET (research grant from NIHR School for Primary Care Research paid to institution), AH (research grant from NIHR School for Primary Care Research paid to institution), MER (research grant from NIHR School for Primary Care Research paid to institution), MJR (research grant from NIHR School for Primary Care Research paid to institution; other research funding from NIHR SPCR, HTA, and PGfAR paid to institution; NIHR Research Professorship; on TSC/DMC for ERICA, BabyBathe and ASYMPTOMATIC trials), CM (research grant from NIHR School for Primary Care Research paid to institution; other funding from NIHR, MRC, NHS paid to institution; is the Director of the NIHR SPCR), LC (research grant from NIHR School for Primary Care Research paid to institution; paid role as Chief Medical Officer, NHS Shropshire, Telford and Wrekin; Salaried GP at Brook Medical Centre, Stoke-on-Trent; Senior Lecturer in General Practice Research, Keele University), JB (research grant from NIHR School for Primary Care Research), BS (research grant from NIHR School for Primary Care Research paid to institution; other research funding from NIHR paid to institution; member of NIHR HTA Commissioning Panel 15/09/2020 to present), LM (research grant from NIHR School for Primary Care Research paid to institution), SP (research grant from NIHR School for Primary Care Research paid to institution), JV (none declared), HA (research grant from NIHR School for Primary Care Research paid to institution; other research funding from NIHR, Research Council of Norway, University of Warwick/eConsult Ltd paid to institution; honoraria from Imperial College London, UCL, North West Cancer Research; received support for travel from NIHR, RCGP, University of Birmingham; advisory board member/chair for NIHR159467, NIHR160384, BRACE rapid evaluation centre, HED-LINE study, EPaCCS study; is Vice Chair of the Scientific Foundation Board, Royal College of General Practitioners), JH (research grant from NIHR School for Primary Care Research paid to institution), GML (none declared), JN (none declared), NI (none declared), PHL (none declared), PL (research grant from NIHR School for Primary Care Research paid to institution), HAE (research grant from NIHR School for Primary Care Research paid to institution; is Deputy Academic Capacity Development Lead for the NIHR SPCR and sits on the NIHR SPCR Board and Exec; works clinically as a GP at New Horizons Medical Partnership in Southampton as part of Professor of Primary Care Research post at the University of Southampton; Co-Authors the Oxford Handbook of General Practice published by Oxford University Press).

ISRCTN18010240

https://bmjopen.bmj.com/content/14/3/e081932

Funding: This project was funded by the National Institute for Health Research (NIHR) School for Primary Care Research grant (project reference 563). The Primary Care Research Centre, University of Southampton is a member of the NIHR School for Primary Care Research and supported by NIHR Research funds. Service support costs will be paid by the CRN. CDM is funded by the National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care West Midlands and the NIHR School for Primary Care Research. The EMPathicO e-learning package was developed using LifeGuide software, which was partly funded by the National Institute for Health Research Southampton Biomedical Research Centre (BRC). NIHR Local Clinical Research Networks (CRNs) supported practice recruitment. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The study sponsor (University of Southampton) and funders had no role in study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. The researchers are independent from the funders and all authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

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Ethic committee South Central - Hampshire B Research Ethics Committee gave ethical approval for this work (reference: 22/SC/0145).

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Data and code are available on request. Requests for deidentified participant data may be submitted to the University of Southampton data repository, quoting doi: [to be added on acceptance]. Requests would be subject to review by a subgroup of the trial team. Access to anonymised data may be granted following this review, subject to conditions including ethical approval, qualifications, and aims consistent with the original purpose of the study. All data-sharing activities would require a data-sharing agreement. Code will be shared via GitHub repository.