School of Psychology, University of Southampton, Southampton, UK
Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK.
BMJ Open. 2024 Mar 19;14(3):e081932. doi: 10.1136/bmjopen-2023-081932.
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.
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.
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.
ISRCTN18010240.
有效的沟通可以帮助优化医疗保健互动和患者的治疗效果。然而，经过临床测试、成本效益分析或足够简短且描述详尽以用于初级保健的干预措施很少。本文介绍了一种经过严格开发的简短电子学习工具 EMPathicO 的有效性和成本效益的研究方案，该工具适用于患有和不患有肌肉骨骼疼痛的患者。
在英格兰和威尔士的全科医生（GP）诊所进行的一项集群随机对照试验，这些诊所服务于来自不同地理、社会经济和种族背景的患者。GP 诊所（1:1）随机分配接受 EMPathicO 电子学习的时间，或者在试验结束时。符合条件的从业者（例如全科医生、物理治疗师和护士从业者）参与管理患有肌肉骨骼疼痛的初级保健患者。患者招募由实践工作人员和研究人员管理。目标招募是 840 名患有肌肉骨骼疼痛的成年人和 840 名没有肌肉骨骼疼痛的成年人，通过面对面、电话或视频咨询。患者在预咨询基线、1 周和 1、3 和 6 个月后完成基于网络的问卷。有两个患者报告的主要结局：疼痛强度和患者赋权。从国民保健服务和社会角度考虑成本效益。次要和过程测量包括从业者使用 EMPathicO 的模式、从业者报告的自我效能感和意图、患者报告的症状严重程度、生活质量、满意度、对从业者同理心和乐观的看法、治疗预期、焦虑、抑郁和连续性护理。患者、从业者和实践工作人员的有意抽样参加了最多两次定性、半结构化访谈。
2022 年 7 月 1 日获得南英格兰汉普郡 B 研究伦理委员会的批准，2022 年 7 月 6 日获得健康研究管理局和威尔士健康与保健研究管理局的批准（REC 参考号 22/SC/0145；IRAS 项目 ID 312208）。结果将通过同行评议的学术出版物、会议演讲和患者及从业者渠道进行传播。如果成功，EMPathicO 可以以较低的成本快速提供给全国的初级保健实践。
ISRCTN82310332。
