Condition category
Signs and Symptoms
Date applied
24/09/2018
Date assigned
02/10/2018
Last edited
05/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Persistent (“medically unexplained”) 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. Current models of healthcare which focus on detecting disease do not help patients make sense of their persistent symptoms and there is little evidence to guide practice outside of specialised psychological settings. The Symptoms Clinic is a series of psychologically-informed medical consultations which have gone through several stages of development and piloting. They are delivered by an extended role GP (ER-GP) who has received specialist training. Consultations 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. Early studies suggest that the Symptoms Clinic is capable of producing clinically important short-term improvements in patients’ symptoms. The aim of this study is to test the longer term clinical and cost-effectiveness of the Symptoms Clinic and to understand how, if effective, it can be delivered in routine care.

Who can participate?
Patients aged 18 – 69 with medically unexplained symptoms

What does the study involve?
Participants are randomly allocated to either the control group or the intervention group. The control group does not receive any intervention and are reminded to continue to use their usual healthcare as needed. Participants in the intervention group attend an appointment for the first Symptoms Clinic. The first consultation lasts around 50 minutes, during which the ER-GP collects a detailed account from the patient of their current symptoms, and the ways in which those symptoms impact the patient. It includes medical history and targeted questions in relation to psychosocial matters. The latter part of the initial consultation involves the ER-GP proposing and negotiating explanations for the patient’s symptoms using the principles of “rational explanation" within one or more of the explanatory models developed from the early studies. There are up to three follow up appointments which last around 15 minutes each. The aim of these appointments is to develop ideas from the earlier consultation(s) and consolidate agreed explanations and action plans. Following the first and final consultation the ER-GP writes to the patient’s GP (copying in the patient) summarising findings, explanation and plan. All consultations are audio-recorded for quality control purposes, supervision and analysis. These recordings are securely stored by the University of Sheffield. Participants are contacted after 13, 26 and 52 weeks and asked to complete questionnaires. After 52 weeks healthcare use data is also collected from primary care records by a delegated member of the research team. During the enrolment appointment the participants may also be asked if they would be happy to be contacted about taking part in an interview. A sample of those who consent to this are contacted to discuss the option and if appropriate an interview is scheduled. Following the final data collection participants are sent a debrief letter and a £10 voucher as a thank you for their participation. The debrief letter includes details of when the study results are expected to be available and how they can access these.

What are the possible benefits and risks of participating?
Some people who took part in the previous studies found that the Symptoms Clinic helped them to make sense of their symptoms and reduced the impact of symptoms on their daily life. Taking part will help to give us more information about whether the Symptoms Clinics do benefit people with persistent physical symptoms. After completing the final study questionnaire participants will be sent a £10 high street voucher as a thank you for their time. Possible risks of taking part are that participants will need to attend at least one visit to the study centre which will last around 1 hour and 40 minutes. Those allocated to the Symptoms Clinic will have a number of consultations with a doctor who will not be their usual GP. There is a small risk that participants might find consultations about their symptoms difficult or distressing. In total the four consultations will take around two hours. The researchers will reimburse appropriate travel costs for participants to attend study appointments; this may include taxi fares to and from the study centre if required.

Where is the study run from?
1. NHS Sheffield Clinical Commissioning Group (UK)
2. NHS Gateshead Clinical Commissioning Group (UK)
3. NHS Oldham Clinical Commissioning Group (UK)
4. NHS Stockport Clinical Commissioning Group (UK)

When is the study starting and how long is it expected to run for?
February 2018 to July 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Miss Cara Mooney
c.d.mooney@sheffield.ac.uk

Trial website

https://www.sheffield.ac.uk/scharr/sections/dts/ctru/mss3

Contact information

Type

Scientific

Primary contact

Miss Cara Mooney

ORCID ID

http://orcid.org/0000-0002-3086-7348

Contact details

Clinical Trials Research Unit
ScHARR
The University of Sheffield
30 Regent Court
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 4308
c.d.mooney@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38720

Study information

Scientific title

Multiple Symptoms Study 3: pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms

Acronym

Study hypothesis

Preliminary studies suggest that the Symptoms Clinic is capable of producing clinically important short-term improvements in patients’ symptoms. This study is a randomised controlled trial designed to test the longer term clinical and cost-effectiveness of the intervention and to understand how, if effective, it can be delivered in routine care.

Ethics approval

North West – Greater Manchester Central Research Ethics Committee, 25/06/2018, ref: 18/NW/0422

Study design

Randomised; Both; Design type: Treatment, Process of Care, Education or Self-Management, Complex Intervention, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Health Services Research; Health Category: Generic health relevance

Intervention

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 invitation pack will contain a participant information sheet, screening questionnaire and reply form with a return envelope. The invitation pack will be sent to participants from their usual care GP practice.

Receipt of participant reply form:
When a potential participant returns a reply form and screening questionnaire to the research team they will check the screening questionnaire for eligibility. If the score is between 10 and 20 on the PHQ-15 then the Sheffield CTRU research team will refer to potential participant to a local research nurse.

Research nurse contact:
A local research nurse will contact the patient using the details provided to discuss the study further and answer any questions from the patient. If a potential participant wishes to proceed, the research nurse will complete screening checks by inquiring directly about the exclusion criteria relating to personal care, active multidisciplinary rehabilitation, and current specialist psychological treatment. When discussions are complete the researcher will make an appointment with the patient for study enrolment. If the patient wishes to have more time to consider participation then a second phone call can be arranged.

Enrolment and randomisation:
The enrolment appointment will be completed by a local research nurse and will last around 1 hour and 40 minutes. The research nurse will discuss the study with the patient, complete the informed consent process and collect baseline data. The baseline measures are participant completed questionnaires.
Near the end of this visit the research nurse will enter the participant demographic details, PHQ-15 score and confirmation of consent directly into the randomisation system and an allocation will be generated. The participant will be informed of their allocation. The control group will not receive any intervention and will be reminded to continue to use their usual healthcare as needed. If randomised to the intervention group an appointment for the first Symptoms Clinic will be made.

Symptoms clinic first appointment:
The first consultation will last around 50 minutes, during which the ER-GP will collect a detailed account from the patient of their current symptoms, and the ways in which those symptoms impact the patient. It includes medical history and targeted questions in relation to psychosocial matters. The latter part of the initial consultation involves the ER-GP proposing and negotiating explanations for the patient’s symptoms using the principles of “rational explanation" within one or more of the explanatory models developed from our preliminary studies.

Symptoms clinic follow up appointments:
There will be up to three follow up appointments which will last around 15 minutes each. The aim of these appointments will be to develop ideas from the earlier consultation(s) and consolidate agreed explanations and action plans.

Following the first and final consultation the ER-GP will write to the patient’s GP (copying in the patient) summarising findings, explanation and plan.

Audio-recording of the Symptoms Clinic:
All consultations will be audio-recorded for quality control purposes, supervision and analysis. These recordings will be securely stored by the University of Sheffield.

Participant follow up:
Participants will be contacted at 13, 26* and 52 weeks after randomisation and asked to complete the questionnaire pack. This will include:
Physical Symptoms (PHQ-15)
Health profile SF12
Self-reported healthcare use
PHQ-9 & SSD-12
GAD-7
EQ-5D-5L & ICECAP
Patient Global Impression of Change
HL-6
PAM-13
PROMIS Short Form - Ability to Participate in Social Roles and Activities
*At the 26 week timepoint only the PHQ-15, self-reported healthcare use and EQ-5D-5L will be completed.
After 52 weeks healthcare use data will also be collected from primary care records by a delegated member of the research team.

Participant interviews:
During the enrolment appointment the participants may also be asked if they would be happy to be contacted about taking part in an interview. A sample of those who consent to this will be contacted by the qualitative researcher to discuss the option and if appropriate an interview will be scheduled.

Participant debrief:
Following the final outcome data collection participants will be sent a debrief letter and a £10 voucher as a thank you for their participation. The debrief letter will include details of when the study results are expected to be available and how they can access these.

SUB-STUDY - Pen and Brief PIS:
We will undertake an embedded trial to investigate the effectiveness of including a pen incentive and /or brief PIS with the trial invitation pack on recruitment of participants to the MSS3 trial. Participants will be recruited via mail out from general practices. Participants will be randomly allocated to receive a pen with the trial logo, or no pen; with or without the addition of a brief PIS. This sub-study should not represent any further burden to participants.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Physical symptoms measured by the PHQ-15; Timepoint(s): 52 weeks after randomisation

Secondary outcome measures

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

Overall trial start date

01/02/2018

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 376; UK Sample Size: 376

Participant 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

Recruitment start date

15/10/2018

Recruitment end date

31/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Sheffield Clinical Commissioning Group
S9 4EU
United Kingdom

Trial participating centre

NHS Gateshead Clinical Commissioning Group
NE15 8NY
United Kingdom

Trial participating centre

NHS Oldham Clinical Commissioning Group
OL9 6EE
United Kingdom

Trial participating centre

NHS Stockport Clinical Commissioning Group
SK1 3XE
United Kingdom

Sponsor information

Organisation

NHS Sheffield Clinical Commissioning Group

Sponsor details

c/o Michelle Horspool
Sheffield
S9 4EU
United Kingdom
+44 (0)781 486 7370
Michelle.Horspool@shsc.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/136/07

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2018: The recruitment start date was changed from 01/10/2018 to 15/10/2018. 02/10/2018: Uploaded protocol Version 2.0, 20 August 2018 (not peer reviewed).