Recipient organisationNHS South Yorkshire Integrated Care Board
Funding£1.5M
PeriodFeb 2018 — Jul 2023
In plain English
AI plain-English summary
Around one million adults in the UK live with persistent physical symptoms that doctors cannot fully explain by disease, and a new trial will test whether a dedicated Symptoms Clinic can help them feel better and reduce unnecessary NHS visits. These “medically unexplained” symptoms—such as chronic pain, fatigue, or dizziness—cause real distress and account for more than a third of all specialist referrals. Many patients undergo repeated tests and consultations without getting a clear explanation or practical help. The Symptoms Clinic model, developed over several years, offers extended GP consultations that explain symptoms as understandable bodily processes and guide patients toward self-management. Early studies suggest it works and is acceptable to patients. If the trial succeeds, the NHS could adopt a low-cost, community-based clinic that improves quality of life for a large group of patients while cutting down on expensive referrals and diagnostic tests. The researchers will also analyse whether the clinic saves money overall. In the longer term, these clinics could become hubs for developing new treatments and spreading symptom-management skills across primary care.
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BACKGROUND Persistent physical symptoms, which are disproportionate to biomedical disease affect around 1 million people (2% of adults) in the UK. These “medically unexplained” symptoms (MUS) cause distress to patients and account for over one third of referrals to specialists. Although most persistent symptoms can be explained, many patients do not receive adequate explanations for their symptoms. We have rigorously developed the Symptoms Clinic treatment model, to focus on explaining symptoms and guide self-management. In preliminary studies it was acceptable to patients and showed promising results. AIMS AND RESEARCH QUESTIONS We aim to examine the effectiveness of a Symptoms Clinic by conducting a pragmatic RCT to test the primary hypothesis that compared to usual care alone, the Symptoms Clinic plus usual care leads to a clinically meaningful improvement in patients’ symptoms. The secondary hypothesis is that healthcare use will be reduced in a cost-effective way. Within the trial we will conduct a detailed process evaluation of the Symptoms Clinic. METHODS The trial will take place in three UK centres, delivered in newly configured Symptoms Clinics by specially trained GPs. Adults aged 18 or over will be recruited from GP practice lists using a three stage procedure: clinical record search, GP record screening and postal questionnaire. Inclusion criteria will be multiple persistent physical symptoms of moderate severity (PHQ-15 between 10 and 20) and repeated referral for diagnostic tests or specialist opinion. Patients will be excluded if their symptoms are primarily attributable to biomedical illness, or if they have severe disability. Patients will be randomised to receive either the Symptoms Clinic plus usual care or usual care alone. INTERVENTION The Symptoms Clinic Intervention (SCI) comprises extended psychologically -informed medical consultations. Patients receive an initial 50 minute consultation and 2-3 follow ups of 20 minutes. Clinic doctors explain symptoms as understandable bodily processes, and aim that patients feel understood and more able to self-manage. OUTCOMES The primary outcome will be symptoms (PHQ15) at 52 weeks after randomisation. Secondary outcomes will include healthcare use over 52 weeks (GP consults, referrals & tests), symptoms at 13 weeks and quality of life (conventional and capabilities based measures) at 13 and 52 weeks. ANALYSIS Outcomes will be analysed on an intention to treat basis using a general linear model correcting for baseline values. A sample size of 188 in each arm provides 90% power to detect a meaningful 2 point difference in PHQ15 allowing for 25% loss to follow up. PROCESS EVALUATIONS Pre-specified content analysis of consultations and interviews with selected patients and stakeholders will inform detailed process evaluations. HEALTH ECONOMIC EVALUATION Within-trial cost-effectiveness analysis will estimate cost per QALY. BENEFITS AND IMPACTS FOR NHS. The intervention is designed to improve patients' symptoms and reduce their healthcare use, particularly referral for specialist opinion and tests. We have seen improvement in symptoms in both our preliminary studies. In the longer run it is plausible that Symptom Clinics will act as a focus for the development and testing of further treatments, allow for the diffusion of skills into wider practice and contribute to the wider public discourse about persistent physical symptoms
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