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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
GP practice
Study 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
Primary outcome measure
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 study start date
01/07/2015
Overall study end date
31/08/2015
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned Sample Size: 90; UK Sample Size: 90; Description: 60 intervention, 30 control
Total final enrolment
96
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/01/2019 | 21/02/2020 | Yes | No |
| Results article | qualitative study results | 03/09/2019 | 09/04/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |