Recruitment to Talking in Practice (TIP): Randomised controlled trial testing the effects of communication skills e-learning for primary care practitioners on patients’ musculoskeletal pain and enablement.
Problem
Previous research indicates that effective communication between patients and primary care practitioners (for example GPs, nurses and physiotherapists) can help to optimise healthcare interactions, improve self-management and patient outcomes such as pain. Previous development and feasibility work conducted in the NIHR SPCR Empathica study rigorously developed and feasibility tested a brief e-learning tool for practitioners to deliver positive empathic care ‘EMPathicO’.
Approach
The aim is to determine the effectiveness and cost-effectiveness of EMPathicO communication training for practitioners in improving patient outcomes in those with Musculoskeletal (MSK) pain and ‘All comers’.
TIP is a cluster randomised controlled trial in GP surgeries across England and Wales. Practitioners in approximately 42 GP surgeries serving patients from diverse geographic, socio-economic, and ethnic backgrounds are being randomised to receive the e-learning package immediately or at the end of the trial.
Agile flexible recruitment methods are being used to optimise recruitment and minimise clinician time needed to participate. This is particularly important currently when clinical workload pressures mean research time is limited. Practitioners consult as usual and do not need to identify or consent patient participants within the consultation.
The recruitment target is 840 adult patients with MSK pain and 840 with other conditions, consulting face to face, by telephone or video. Reception staff invite patients prior to the consultation to complete consent and a brief baseline questionnaire online. Post-consultation questionnaires are at 1 week, and 1, 3 and 6 months online. Interpreters are available if needed.
Findings
Patient-reported outcome measures are completed online or by paper questionnaire. Patient representatives were involved in determining which outcomes are most important for patients.
Two Co-Primary outcomes are being collected - Pain intensity using the 4-item pain intensity subscale from the Brief pain Inventory and Patient Enablement using the Patient Enablement Index. Secondary outcomes include: symptom severity, quality of life, patient satisfaction, health economic costs. Practitioner and patient-reported process measures assess empathy, expectancies, anxiety/depression and continuity of care.
Qualitative interviews are being undertaken with a purposive sample of patients and practitioners.
A mixed methods analysis aims to evaluate EMPathicO’s potential impact post-trial using the RE-AIM framework which involves addressing an intervention’s Reach, Effectiveness, Adoption, Implementation, and Maintenance
Practice and patient recruitment is ongoing.
Consequences
Flexible recruitment strategies are needed to enable recruitment to clinical trials in primary care the current environment. The challenges and range of strategies being employed will be discussed.
If found to be successful, this e-learning communication training could quickly be made available at low cost to primary care practices across the country.