Defining an evidence base for the use of advice and guidance referrals
| ISRCTN | ISRCTN12647415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12647415 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 333799 |
| Protocol serial number | CPMS 58336, NIHR158681, IRAS 333799 |
| Sponsor | Keele University |
| Funder | National Institute for Health and Care Research / HSDR |
- Submission date
- 10/06/2024
- Registration date
- 29/07/2024
- Last edited
- 18/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
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
Scientific
School of Medicine, Keele University
Keele
ST5 5BG
United Kingdom
 ORCID ID |
0000-0003-4688-3075 |
|---|---|
| Phone | +44 1782 738213 |
| c.burton@keele.ac.uk |
Public
School of Medicine, Keele University
Keele
ST5 5BG
United Kingdom
| ORCID ID |
0000-0002-4865-181X |
|---|---|
| Phone | +44 1782 731750 |
| a.faux-nightingale@keele.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational qualitative |
| Secondary study design | Qualitative study |
| Study type | Participant information sheet |
| Scientific title | Building an evidence base for the use of ADvice and GuidancE Referrals at the primary-secondary care interface – a multistage mixed-methods study |
| Study acronym | BADGER |
| Study objectives | The 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 |
| Health condition(s) or problem(s) studied | Defining an evidence base for the use of advice and guidance referrals |
| Intervention | The 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 type | Other |
| Primary outcome measure(s) |
Semi-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. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 114 Years |
| Sex | All |
| Target sample size at registration | 75 |
| Total final enrolment | 75 |
| Key inclusion criteria | 1. 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. |
| Key exclusion criteria | 1. 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. |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Prescot Street
Liverpool
L7 8XP
England
Newport Road
Albrighton
Wolverhampton
WV7 3FA
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2.0 | 18/06/2024 | 10/06/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN12647415 Protocol v2.0 18Jun2024.pdf
- Protocol file
Editorial Notes
18/11/2025: The following changes were made to the trial record:
1. The date of final enrolment was changed from 31/03/2026 to 31/10/2025.
2. The total final enrolment was added.
10/06/2025: Uploaded protocol (not peer-reviewed) as an additional file.
02/08/2024: Internal review.
10/06/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
