Defining an evidence base for the use of advice and guidance referrals

ISRCTN ISRCTN12647415
DOI https://doi.org/10.1186/ISRCTN12647415
IRAS number 333799
Secondary identifying numbers CPMS 58336, NIHR158681, IRAS 333799
Submission date
10/06/2024
Registration date
29/07/2024
Last edited
02/08/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
When a GP needs a specialist’s input with the care of a patient, one option is to use Advice and Guidance (A&G). A&G is an electronic way for a GP to ask a consultant a clinical question and a specialist responds, usually within a few days. The response may be to send an appointment for the patient to see a specialist, try a treatment, or do a test. A&G was introduced to speed up access to a specialist opinion and cut waiting times for outpatient care. A&G became more important during the COVID-19 pandemic as it meant patients did not automatically need to travel to hospital. The use of A&G is now encouraged to help the NHS recover from the pandemic. There are very few studies telling us whether A&G has a better or worse effect on patient care than the usual referral system.

We will study the impact of Advice and Guidance on patients, healthcare workers and the healthcare system, in terms of:
• how often, why and when A&G is used
• views about its impact on the quality of care and patient satisfaction
• impact on how NHS services are used.

This will help us to work out whether A&G reduces waiting times and access to specialist care as planned, without making the quality of patient care worse. This will be done in comparison to the more traditional way of referring patients to be seen by a specialist in outpatients.

Who can participate?
We will interview patients who have had experience of the A&G process. We will also interview clinicians and commissioners who are involved in using A&G.

What will the study involve?
Interviews are likely to last between 30 and 90 minutes and will be one off events. There will be no follow-up interviews. Participants will be free to pause or stop their interview at any point without any expectation to continue. Interviewers are not able to provide clinical advice and will advise participants to seek support from their own clinical teams if needed.  

What are the possible benefits and risks of participating?
By participating, patients will provide insight into and ideas about how A&G can be used effectively and safely in the care journey. Risks of being interviewed might include raising worries or concerns about healthcare.

Where is the study run from?
The research team is based at Keele University (UK)

When is the study starting and how long is it expected to run for?
June 2024 to May 2026

Who is funding the study?
This study is funded by the NIHR HSDR (NIHR158681). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Who is the main contact?
research.badger@keele.ac.uk

Contact information

Dr Claire Burton
Scientific

School of Medicine, Keele University
Keele
ST5 5BG
United Kingdom

ORCiD logoORCID ID 0000-0003-4688-3075
Phone +44 1782 738213
Email c.burton@keele.ac.uk
Mrs Alice Faux-Nightingale
Public

School of Medicine, Keele University
Keele
ST5 5BG
United Kingdom

ORCiD logoORCID ID 0000-0002-4865-181X
Phone +44 1782 731750
Email a.faux-nightingale@keele.ac.uk

Study information

Study designObservational qualitative
Primary study designObservational
Secondary study designQualitative study
Study setting(s)Other
Study typeTreatment
Participant information sheet Not yet available in web format, please use the contact details to request a patient information sheet.
Scientific titleBuilding an evidence base for the use of ADvice and GuidancE Referrals at the primary-secondary care interface – a multistage mixed-methods study
Study acronymBADGER
Study hypothesisThe overarching aim of the study is to measure the impact of Advice & Guidance (A&G) on patients, primary care clinicians, secondary care specialists, and the healthcare system in terms of quality of care, satisfaction with the process and service utilisation to understand how it works for whom, where, and why. The aim of the study was developed in partnership with our study lay co-applicant and Public and Patient Involvement and Engagement (PPIE) group who have experiences of A&G.
Ethics approval(s)

Approved 13/06/2024, North East - Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle-upon-Tyne, NE2 4NQ, United Kingdom; +44 207 104 8286; tyneandwearsouth.rec@hra.nhs.uk), ref: 24/NE/0110

ConditionDefining an evidence base for the use of advice and guidance referrals
InterventionThe BADGER study will interview up to 75 patient people. This will include 30 patients who have had Advice and Guidance used in their care, 40 clinical staff who use Advice and Guidance in their work in GP surgeries and hospitals (including doctors, nurses, pharmacists), and 5 healthcare commissioners. The interviews will ask participants about their experiences of Advice and Guidance, what works well and what doesn’t, and how they see the future for Advice and Guidance.

Participants will be required to complete the consent form prior to the interview, either by returning a signed consent form to the team prior to interview, or immediately prior to the interview during the interview appointment. An opportunity for questions will be provided prior to the interview. Interviews will take place at a mutually agreed location, for example, in the homes or local public space for public participants, or remotely using a platform such as MS Teams.

Participants will be thanked for their time in line with current guidance.
Intervention typeOther
Primary outcome measureSemi-structured interviews will be conducted using topic guides co-developed by and in agreement with our PPIE group and collaborating stakeholders. Topic guides will explore patient interviewees’ experiences and perceptions of the use of A&G during and after the consultation process, and aspects of an ‘ideal’ interaction between patients and health care professionals in relation to the use of A&G. Clinician participants will be interviewed around their own experiences and perceptions of the A&G process. Topic guides will be used flexibly to allow interviewers to explore any unexpected findings and enable comparison between accounts during analysis.

Interviews will be digitally recorded with consent. Audio-recordings of interviews will be transcribed and anonymised before analysis. A reflexive thematic analysis approach will be taken to obtain a rich and contextualised understanding of the strengths and weaknesses of the use of A&G in patient care at the primary secondary care interface.

Interviews are likely to last between 30 and 90 minutes and will be single events. There will be no follow-up/longitudinal interviews. Participants will be free to pause or stop their interview at any point without any expectation to continue. It will be made clear that interviewers are not able to provide clinical advice and will advise participants to seek support from their own clinical teams if necessary.  

An inductive, reflexive thematic analysis will be carried out on the data following the principles outlined by Braun & Clarke.The data will be analysed within the participant groups, and as a complete dataset to holistically explore the experiences and interactions of the participants, and to identify any patterns and consistencies across the accounts.  
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/06/2024
Overall study end date31/05/2026

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 75; UK Sample Size: 75
Participant inclusion criteria1. Patients: Adult patients (18 years or over) registered at a participating practice with an episode of A&G recorded in their electronic health record in the last 3 months, and have capacity to consent to an interview.
2. PCCs: participants will be eligible if they currently work in the NHS and are users of A&G.
3. SCSs: participants will be eligible if they currently work in the NHS and are users of A&G.
4. Commissioners: participants will be eligible if they currently work in the NHS and are familiar with its use at Trust / local System level.
Participant exclusion criteria1. Patients: participants will be excluded if they do not have capacity to consent for themselves, or are unable to meaningfully communicate about their experiences in an interview. If English is not their first language, translation services will be used so as not to exclude due to language barriers.
2. PCCs, SCSs, Commissioners: participants will be excluded if they have no experience or knowledge of using A&G.
Recruitment start date01/07/2024
Recruitment end date31/03/2026

Locations

Countries of recruitment

  • United Kingdom

Study participating centres

NIHR CRN: North West Coast
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Prescot Street
Liverpool
L7 8XP
United Kingdom
NIHR CRN: West Midlands
James House
Newport Road
Albrighton
Wolverhampton
WV7 3FA
United Kingdom

Sponsor information

Keele University
University/education

Keele
Newcastle under Lyme
ST5 5BG
United Kingdom

Phone +44 1782732980
Email research.governance@keele.ac.uk
Website http://www.keele.ac.uk/
ROR logo "ROR" https://ror.org/00340yn33

Funders

Funder type

Government

National Institute for Health and Care Research / HSDR

No information available

Results and Publications

Intention to publish date31/05/2027
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSharing our understanding how A&G works for who, where, and why, and our resulting resources will be delivered throughout the project. Essential components of our outputs include highlighting ‘quick wins’ to enable rapid uptake to ease compound pressures, focus on health inequalities, fostering sustainable healthcare and adoption of future IT innovations. Outputs will enable optimization of the established A&G system, delivering practical, real-world solutions to primary care, specialist services and overarching Integrate Care Boards, patients and policy makers in how to make use of the system in a safe, effective, and efficient manner to reduce compound pressures on the NHS.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Alice Faux-Nightingale (a.faux-nightingale@keele.ac.uk). Any subsequent requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University SOP data sharing procedure.

Editorial Notes

02/08/2024: Internal review.
10/06/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).