Clinical and cost-effectiveness of communication skills e-learning for primary care practitioners on patients' musculoskeletal pain and enablement: the Talking in Primary care (TIP) cluster-randomised controlled trial

ObjectivesTo 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. DesignA 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. SettingGeneral practices in England and Wales (all NHS general practices eligible). ParticipantsAdults [≥]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. InterventionsIntervention 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 outcomesThe 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. Results53 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 {pound}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). ConclusionsBrief 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. RegistrationISRCTN18010240 registered 15 September 2022. Funding: NIHR School for Primary Care Research grant 563. SummaryO_ST_ABSWhat is already knownC_ST_ABSO_LIEmpathy education is provided in medical schools and health professional training, yet patients still report limited clinical empathy and related dissatisfaction with their clinical interactions. C_LIO_LIExperimental research suggests realistic optimism has beneficial effects on patient outcomes including pain but how this translates in clinical settings is unknown. C_LIO_LIExisting clinical empathy training is often too lengthy for busy primary care clinicians and cost effectiveness assessments are lacking. C_LI What this study addsO_LIThis 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. C_LIO_LIThe 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. C_LIO_LIThe digital nature of the e-learning package would enable rapid widespread dissemination to clinicians at low cost. C_LI