Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients’ musculoskeletal pain and enablement
Christian Mallen,
Jennifer Bostock,
Taeko Becque,
Beth Stuart,
Jeremy Howick,
Jane Vennik,
Paul Little,
Matthew J Ridd,
Kirsty Garfield,
Paul H Lee,
Helen Atherton,
Felicity L Bishop,
Nazrul Islam,
Michelle E Robinson,
Geraldine M Leydon,
Emma Teasdale,
Jacqui Nuttall,
Leanne Morrison,
Lorna Clarson,
Hazel A Everitt,
Amy Herbert,
Nadia Cross,
Rachel Dewar-Haggart,
Sebastien Pollet
Affiliations
Christian Mallen
School of Medicine, Keele University, Staffordshire, UK
Jennifer Bostock
4 The Care Policy and Evaluation Centre (CPEC), London School of Economics, London, UK
Taeko Becque
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Beth Stuart
6 Wolfson Institute of Population Health, Queen Mary University of London, London, London, UK
Jeremy Howick
1 Stoneygate Centre for Empathic Healthcare, Leicester Medical School, Leicester, UK
Jane Vennik
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Paul Little
professor of primary care research
Matthew J Ridd
5 Population Health Sciences, University of Bristol Faculty of Health Sciences, Bristol, UK
Kirsty Garfield
7 Health Economics Bristol, Population Health Sciences, University of Bristol, Bristol, Bristol, UK
Paul H Lee
11 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
Helen Atherton
8 Unit of Academic Primary Care, University of Warwick, Coventry, UK
Felicity L Bishop
1 School of Psychology, University of Southampton, Southampton, UK
Nazrul Islam
4BSMMU, Rheumatology, Dhaka, Bangladesh
Michelle E Robinson
Keele University, Keele, UK
Geraldine M Leydon
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Emma Teasdale
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Jacqui Nuttall
11 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
Leanne Morrison
1 School of Psychology, University of Southampton, Southampton, UK
Lorna Clarson
4 Keele School of Medicine, Keele University, Newcastle-under-Lyme, UK
Hazel A Everitt
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Amy Herbert
3 Centre of Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK
Nadia Cross
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Rachel Dewar-Haggart
1 School of Psychology, University of Southampton, Southampton, UK
Sebastien Pollet
1 School of Psychology, University of Southampton, Southampton, UK
Introduction Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.Methods and analysis A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.Ethics approval and dissemination Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.Trial registration number ISRCTN18010240.
