Persistent physical symptoms Signs and Symptoms
Conditions
Interventions
Participant Identification:
Potential participants will be identified through a 3 stage process, this will include a computerised search, GP screening of patient list and invitation pack. The invitati
Sponsors
NHS Sheffield Clinical Commissioning Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 – 69 years (inclusive) at the time of the computer search 2. Current physical symptoms which meet the below criteria: 2.1. Clinical records suggest MUS (presence of at least one code for an MUS syndrome or at least two codes for negative investigations) 2.2. Records show at least 2 referrals for specialist opinion or diagnostic investigations in the last 3 years 2.3. Records show no evidence of any previous or current major illnesses likely to cause multiple symptoms 2.4. Doctors in the GP practice do not believe that the majority of the patient’s symptoms can be currently explained by other pathology 2.5. The score on the self-completed PHQ-15 symptoms scale is between 10 and 20 (inclusive) SUB-STUDY - Pen and brief PIS Any patient identified in the GP mail out as eligible to receive an MSS3 trial invitation pack will be entered into the pen and brief PIS sub-study
Exclusion criteria
Exclusion criteria: 1. A score of 3 on question 9 relating to thoughts of self-harm on the PHQ-9 completed at the baseline visit* 2. Difficulty conducting a healthcare consultation in English without either a professional or family interpreter or other assistance (either indicated in GP records, or becoming apparent during the enrolment and consent process) 3. The GP regards inviting them to participate as inappropriate (e.g. recent bereavement) 4. Severe symptom-related disability (e.g. requiring help with daily personal care or severely impaired mobility) 5. Undergoing active multidisciplinary rehabilitation, IAPT programme or specialist psychological treatment including specialist pain, fatigue or other symptom clinic at the time of screening. 6. Currently pregnant** or less than 6 months postnatal at the time of the screening telephone call *If a score of 3 is identified at any time point during the study the suicide protocol will be triggered **if a participant becomes pregnant after the screening telephone call they will remain in the study and continue to attend the Symptoms Clinic Intervention if allocated to the intervention group. SUB-STUDY - Pen and brief PIS There are no additional exclusion criteria for the pen and brief PIS sub-study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical symptoms measured by the PHQ-15; Timepoint(s): 52 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured by the EQ-5D-5L, SF-6D, and ICECAP; Timepoint(s): 13 weeks and 52 weeks after randomisation. The EQ-5D-5L will also be collected at 26 weeks after randomisation. 2. Healthcare resource use; Timepoint(s): Measured over a 52 week period after randomisation with an interval collection point at 26 weeks 3. Participants’ overall impression of change measured with the PGIC; Timepoint(s): 13 weeks and 52 weeks 4. Social functioning measured by the Ability to Participate in Social Roles and Activities (PROMIS); Timepoint(s): 13 weeks and 52 weeks 5. Physical symptoms measured by the PHQ-15 ; Timepoint(s): 13 weeks and 52 weeks 6. To understand factors associated with participants symptoms; depression, anxiety and health related concerns will be measured using the PHQ-9, SSD-12 and GAD-7 ; Timepoint(s): 13 weeks and 52 weeks 7. Health literacy measured using the HLS EU-6 ; Timepoint(s): 13 weeks and 52 weeks 8. The process of change within participants will be assessed through semi-structured interviews; Timepoint(s): assessed throughout the intervention and follow up period 9. Exploratory analysis of consultation content through transcription of consultations to understand the mechanisms by which the intervention affects outcomes; Timepoint(s): assessed throughout intervention delivery 10. Stakeholder acceptability of the Symptoms Clinic content and processes assessed through semi-structured interviews; Timepoint(s): assessed throughout the intervention and follow up period | — |
Countries
England, United Kingdom
Outcome results
None listed