Condition category
Signs and Symptoms
Date applied
24/06/2015
Date assigned
24/06/2015
Last edited
24/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
For some patients who attend primary care more significantly than the norm, although they experience persistent symptoms, a cause cannot readily be identified. Often, GPs may feel a pressure to do something and may prescribe medications or refer them for investigations and specialist appointments that they do not need. This may do patients more harm than good and incur unnecessary costs. One general practice has recently taken the initiative to change the way they look after this group of patients. The GPs have received expert training in a technique called BATHE that enhances the therapeutic relationship with their patients. When a patient seeks medical advice, either in a telephone or face-to-face consultation, after obtaining information about their complaint, the doctor applies the technique. The patients report high satisfaction with their care and consulting rates have dropped. We would like to take this model and observe whether it works in a wider range of patients in different types of practices. We also want to find out whether the intervention could be tested in a larger trial.

Who can participate?
Adult patients attending one of the GP practices taking place in the study,

What does the study involve?
Participating GP practices are randomly allocated into either the intervention group or control group. Eligible patients attending a control group GP practice receive normal care. Eligible patients attending a intervention group GP practice receive care via the BATHE technique. Data is collected from practice records and, using a questionnaire, from the patients themselves, about the service they receive over a period of 12 months, related personal costs, and any change in their health. We also record a sample of consultations to see how well the GPs are applying their training and we interview a group of patients and practice staff about their experiences. The results will be used to inform the design of a large study which will provide evidence about the effectiveness and cost-effectiveness of this method of caring for this patient group.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
NHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Groups (UK)

When is the study starting and how long is it expected to run for?
July 2015 to August 2015

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

Who is the main contact?
Dr Rebecca Barnes

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca K. Barnes

ORCID ID

Contact details

University of Bristol
Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18657

Study information

Scientific title

Testing the feasibility of a consultation-level intervention for patients in primary care who attend more significantly than the norm with clinically inexplicable symptoms

Acronym

Study hypothesis

Some patients attend primary care significantly more often than the norm, 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 by over-treatment. This feasibility study will 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 reduce consulting rates.

Ethics approval

NRES Committee South West - Central Bristol, 30/05/2015, ref: 15/SW/0085

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases

Intervention

1. Intervention: GP training in the BATHE technique and assignment of eligible patients to a 'usual' GP
2. Control: Treatment as usual

BATHE is an acronym (Background, Affect, Trouble, Handling and Empathy) for an established consultation technique designed to facilitate a more 'whole person' approach. This includes taking into account all aspects of patients' lives that might be having an impact on their health, and supporting self-management

Follow Up Length: 12 month(s); Practices are randomised and eligible patients invited to participate

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary outcome measure will be difference in number of consultations (including consultation type), hospital admissions, tests/investigations, referrals and prescriptions extracted from the patient record between baseline and 12 months. items not available from this source will be obtained using a specially designed patient questions to be completed at 6 and 12 months.

Secondary outcome measures

Secondary outcomes to be measured at baseline and 12 months include patient health-related quality of life measured using the EQ-5D-5L; the SF-12 Health Survey; the Patient Health Questionnaire (PHQ-9); the Generalised Anxiety Disorder (GAD-7) scale; the PHQ-15 for monitoring somatic symptom severity; the PAM-13 Patient Activation Measure to measure knowledge, skills and confidence integral to managing one’s own health and healthcare; and a patient satisfaction measure based on the GP Patient Survey.

At months 3 and 6 the questionnaire will include the EQ-5D-5L, PHQ-15 and PAM-13 only

At 6 and 12 months, questionnaires will also be used to obtain: information about the use of social services; personal out-of-pocket expenditure by patients and their carers due to their health such as over-the-counter medicine and remedies, travel costs, and expenditure on prescriptions; and wider costs to society such as the use of voluntary services and time off work.

Overall trial start date

01/07/2015

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Registered patient at one of the study practices
2. Patients aged ≥18 years
3. Within top 3% attenders in the 12 months prior to commencement of records search

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90; Description: 60 intervention, 30 control

Participant exclusion criteria

1. Patients whose attendance can be accounted for by a diagnosed physical or mental illness
2. Patients with life-threatening illness such as cancer
3. Patients over 80 years with 4+medical problems
4. Patients at high risk of hospital admission
5. Patients undergoing distressing one-off events such as bereavement
6. Vulnerable adults and patients without capacity to provide informed consent

Recruitment start date

01/07/2015

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group
South Plaza, Marlborough Street
Bristol
BS1 3NX
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes