Title: Testing the feasibility of a consultation-level intervention for frequent attenders with clinically inexplicable symptoms in primary care
Funder: Department of Health (England)

Abstract: BACKGROUND: Some patients attend primary care very often, despite having no identifiable medical problem to account for this. These patients use considerable NHS resources without necessarily gaining benefit and may even be harmed. AIM: To assess whether GP training in BATHE, a rapid intervention for the assessment of psychosocial factors that might be contributing to patients’ physical complaints, is an acceptable and potentially cost-effective model to improve health and well-being of frequent attenders (FAs) with persistent medically unexplained physical symptoms (MUPS). OBJECTIVES: 1. Refine the eligibility and exclusion criteria and operationally define the screening process; 2. Refine recruitment procedures in terms of how practices should best introduce the intervention to patients; 3. Estimate the prevalence of MUPS in general practice and the proportion of patients who will agree to take part in a study; 4. Optimise and manualise the content and delivery of GP training in BATHE and staff training to support the intervention; 5. Assess the extent of implementation fidelity and the acceptance by staff of the intervention; 6. Assess the acceptability to patients; 7. Determine the most important primary and secondary outcomes of interest and how best to collect them; 8. Determine how best to collect data on resource use and model how effective the intervention would need to be in order for it to be potentially cost-effective. RESEARCH QUESTION: 'Is it feasible to run a cluster RCT of this primary care intervention?' DESIGN: A feasibility study comprising of intervention testing plus process evaluation. SAMPLE: 6 GP practices and 108 patients. ELIGIBILITY: (i) registered patient at one of the study practices; (ii) ability to provide informed consent; (iii) aged ≥18 years; (iv) screened as within top 3% attenders in the year prior to records search. EXCLUSION: (i) patients consulting about a diagnosed physical or mental illness; (ii) patients consulting entirely for administrative or routine preventative reasons; and (iii) patients who would be unable to consult without an interpreter or complete self-report measures in English. INTERVENTION: GP training in the BATHE technique and assignment of patients to a 'usual' GP. OUTCOME MEASURES OF INTEREST: EQ-5D-5L health-related quality of life; Measure Yourself Medical Outcome Profile; Patient Enablement Index; Consultation and Relational Empathy Measure, Trust in Physician Scale; data on resource use and costs incurred. DATA COLLECTION: Following records searching and randomisation to 4 intervention practices and 2 treatment as usual controls, GP training will delivered by an expert over three 1.5 hour sessions. Patient recruitment to the study will follow randomisation. The process evaluation will consist of i) ethnographic observation of training, ii) observation and conversation analysis of 24 sample consultations (2 per GP, 3 GPs per practice), and iii) semi-structured interviews with BATHE trainers, 24 patients and 20 staff (3 GPs and 2 reception staff per practice). COST EVALUATION: (Objective 8) Data on resource use and costs incurred plus, in combination with EQ-5D data, initial modelling of the cost per QALY gained. ANALYSIS: All qualitative data will be analysed in order to address Objectives 2, 4, 5 and 6. Quantitative data will generate: estimates of eligibility, consent, recruitment and retention rates (Objectives 1-3); estimates of completion rates of outcome measures (Objective 7); estimates of implementation fidelity (Objective 5). Descriptive statistics will inform a sample size calculation for a future trial and decisions as to whether the inclusion of different measures would be informative (Objective 8). POTENTIAL BENEFITS: If successful, this intervention could improve health and well-being and quality of care for this patient group, and reduce the potential for iatrogenic harm and costs incurred from unnecessary medical interventions. The NHS benefit includes increased patient satisfaction and substantial cost-savings.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE