Multiple Symptoms Study 3

18th December 2018

Study Overview

Multiple Symptoms Study 3 is a large randomised controlled trial to test the effectiveness of a Symptoms Clinic for people with persistent “medically unexplained” physical symptoms. Persistent physical symptoms affect around 1 million people (2% of adults) in the UK. They affect patients’ quality of life and account for at least one third of referrals from GPs to specialists.

We are looking for GP practices to help us to identify patients who would be eligible for the trial. This will involve completing a computer search, screening the patient list and completing a mail out. There will be a payment of £250.76 for all practices that take part.

Participants

Participants will be adults aged 18 – 69 years, recruited from GP practices using a combination of records search and postal questionnaire. They will have multiple physical symptoms which impair their quality of life to a moderate extent and will have had diagnostic tests or specialist opinion which did not show serious disease. Participants will be randomised to either attend the Symptoms Clinic or to continue with their usual care.

Intervention

The Symptoms Clinic is an extended-role GP intervention which has gone through several stages of development and piloting. The Symptoms Clinic is a locality based service delivered by specially trained GPs which uses a psychologically-informed medical consultation model developed for patients with persistent physical symptoms. The clinics are designed to allow patients to describe the nature and impact of their symptoms and help them find new ways of understanding and managing those symptoms drawing on current scientific knowledge. Each patient receives one 50 minute consultation and up to three structured 15 minute follow-ups.

Outcomes

The primary outcome will be physical symptoms (PHQ-15) at 52 weeks after randomisation. Secondary outcomes at 52 weeks include healthcare use (GP consultations, specialist referrals and investigations) and quality of life in order to estimate cost per QALY. Process evaluations will include analysis of consultations, and interviews with patients and key stakeholders.

For further information please contact Cara Mooney on:

Tel:       0114 222 4308

Email:   c.d.mooney@sheffield.ac.uk: See study contact above