Accessible Results: using co-production methods to enable patients with diverse needs to access and understand their blood test results online

ISRCTN ISRCTN12339902
DOI https://doi.org/10.1186/ISRCTN12339902
IRAS number 349062
Secondary identifying numbers NIHR159467, CPMS 66092
Submission date
31/10/2024
Registration date
04/11/2024
Last edited
29/01/2025
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 of protocol

Background and study aims
NHS England has rolled out online access to test results for patients via the NHS App. Blood tests are the most common type of test requested in primary care. Viewing blood test results online may improve patient engagement and satisfaction. It could also lead to patient anxiety and could mean more patients contact their GP practices to discuss results. Making sure patients can understand their blood results online could therefore have an important impact on primary care workload. Patients need to know what to do next when they receive a blood test result; if this is not communicated well then patients could come to harm. Test result communication is therefore important for patient safety. It is important to make sure that all patients can understand their test results, and that groups such as older people with low digital literacy, minority ethnic groups, and people with disabilities, are not disadvantaged by the move to online blood test result communication. NHS England has acknowledged that the NHS App is not currently fully accessible.
The aim of this study is to develop tools and guidance to help patients with a wide range of needs to access and understand their online blood test results.

Who can participate?
WP1: Patients aged 18 years and over who have had a blood test in the previous month; carers aged 18 years and over of patients who have had a blood test in the previous month; a member of primary care staff involved in systems of blood test communication (to include both clinical and non-clinical staff)
WP2: Patients and carers aged 18 years and over; people aged 18 years and over employed in a role that involves communicating test results to patients, such as GPs, nurses, receptionists, practice managers, healthcare assistants, laboratory staff, clinical biochemists or haematologists.
WP3: Patients (or carers of patients) aged 18 years and over who have had a blood test in the past 1 month; patients (or carers of patients) aged 18 years and over who have been involved in the WP2 workshops

What does the study involve?
This study will use the 'person-based approach', which is an established method for engaging diverse users in developing health interventions. An advisory panel of patients and carers will be involved throughout the three stages of the research (called 'work packages' or WPs). For WP1 the researchers will interview around 40 patients who are having blood tests done in primary care, and 20 primary care staff. They will include patients who have difficulties accessing their results due to disabilities, low digital literacy, or cultural barriers. They will ask them to talk through their test results with us ('think-aloud'). If the patients are not able to view their own results online, the researchers will show them what online blood test results look like, and find out how this could be made more accessible for them. The researchers will ask staff about their attitudes and experiences of the move to online test communication. WP2 will use a series of co-production workshops with patients, carers and healthcare professionals to develop template tools for online blood test results communication. WP3 will test these template tools with a wide range of people, using online surveys. The researchers will use this feedback to develop a final version of the tools. They will share their tools and guidance with stakeholders including the NHS App team, using engagement activities throughout and a dissemination event. This is important to make sure they are used as widely as possible.

What are the possible benefits and risks of participating?
The tools and guidance we develop will be freely available. This work is important to help patients to take ownership of their data and health. Sharing blood test results in a way that is meaningful for patients could also help reduce patient anxiety, improve patient safety and reduce the number of phone calls to GP practices to discuss these results.

Where is the study run from?
University of Bristol (UK)

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

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

Who is the main contact?
Dr Jessica Watson, accessible-results-study@bristol.ac.uk

Study website

Contact information

Dr Jessica Watson
Public, Scientific, Principal Investigator

Centre for Academic Primary Care (CAPC)
Population Health Sciences
Bristol Medical School
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

ORCiD logoORCID ID 0000-0002-8177-6438
Phone +44 (0)7837002664
Email jessica.watson@bristol.ac.uk

Study information

Study designWP1: qualitative interviews with patients and staff; WP2: co-production workshops to develop draft tools and guidance; WP3: web-based user-testing and refinement of the tools and guidance
Primary study designObservational
Secondary study designPerson-based approach
Study setting(s)Community, GP practice, Internet/virtual
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleAccessible Results: enabling patients with diverse needs to access and understand their blood test results online
Study objectivesImproving patient access and understanding of online blood test results is important for patient centred care, patient safety and GP workload.
Ethics approval(s)

Approved 17/01/2025, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8290, +44 (0)207 104 8061, +44 (0)207 104 8077; gmeast.rec@hra.nhs.uk), ref: 24/NW/0385

Health condition(s) or problem(s) studiedPromoting the accessibility of online blood test results
InterventionThe person-based approach will be utilised, working with patients, carers, clinicians and other stakeholders. The project will comprise three work packages (WP), building on an ongoing systematic review.

WP1: qualitative interviews with patients and staff to identify user needs.
Six GP practices serving diverse communities in Bristol and Manchester will be recruited, and interviews conducted with around 40 patients and 20 primary care staff. Sampling will include a range of participants, including patients with accessibility needs.

WP2: co-production workshops to develop draft tools and guidance.
8-10 co-production workshops will be conducted involving diverse patient groups, primary care staff and a PPIE advisory panel to develop draft tools and guidance to facilitate the accessibility of online blood test results. These will be user-tested and iteratively refined in subsequent workshops and later WP1 interviews.

WP3: web-based user-testing and refinement of the tools and guidance.
A questionnaire will be disseminated to patients via GP practices and community groups for further user testing and refinement of the tools and guidance.

The final output will be an implementation intervention which may include:
1. Prototype tools for presenting test results in a more accessible way in the NHS App
2. Template wording for clinicians to use when adding comments to test results
3. Posters and/or leaflets for patients to improve their understanding of online test results
4. Resources for patients with diverse needs to help them navigate results online
Intervention typeOther
Primary outcome measureWork package 1: A detailed understanding of patient and staff experiences of online access to test results, collected using qualitative interviews conducted between March - August 2025.
Work package 2: Draft tools and guidance to improve online test communication, developed using co-production workshops involving diverse patient groups, primary care staff and a PPIE advisory panel between May - October 2025
Work package 3: Web-based user-testing and refinement of the tools and guidance using a questionnaire disseminated to patients via GP practices and community groups between Jan - May 2026
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date02/09/2024
Completion date31/08/2026

Eligibility

Participant type(s)Patient, Health professional, Carer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1360
Key inclusion criteriaWP1:
Patient and carer interview participants:
Patient aged ≥18 years who has had a blood test in the previous month
Or:
Carer aged ≥18 of a patient who has had a blood test in the previous month

Primary care staff interview participants:
Member of primary care staff involved in systems of blood test communication (to include both clinical and non-clinical staff)

WP2:
Patient workshops:
Participant aged ≥18 years
Or:
Carer aged ≥18 years of a patient

Clinician workshops:
Person aged ≥18 years employed in a role that involves communicating test results to patients For example, GPs, nurses, receptionists, practice managers, healthcare assistants, laboratory staff, clinical biochemists or haematologists.

WP3:
Patient (or carer of a patient) aged ≥18 years who has had a blood test in the past 1 month
OR
Patient (or carer of a patient) aged ≥18 years who has been involved in the WP2 workshops
Key exclusion criteriaWP1:
Patient and carer interview participants:
1. Clinician feels it would be clinically inappropriate to invite a participant (e.g. patient on palliative care register)
2. Person is unable to give informed consent

Primary care staff interview participants:
Locum staff or staff members working less than 1 day per week in a practice

WP2:
Patient workshops:
1. Person is unable to give informed consent
2. Clinician feels it would be clinically inappropriate to invite a participant (e.g. patient on palliative care register)

WP3:
Clinician feels it would be clinically inappropriate to invite a participant (e.g. patient on palliative care register)
Date of first enrolment10/02/2025
Date of final enrolment31/05/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

NHS Bristol, North Somerset and South Gloucestershire ICB
Floor 2
North Wing
100 Temple Street
Bristol
BS1 6AG
United Kingdom

Sponsor information

University of Bristol
University/education

Augustine's Courtyard
Orchard Lane
Bristol
BS1 5DS
England
United Kingdom

Phone +44 (0)117 455 3545
Email Anna.Brooke@bristol.ac.uk
Website http://bristol.ac.uk/
ROR logo "ROR" https://ror.org/0524sp257

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
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
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination planResults will be presented at national and international conferences. Academic papers from all three WP will be submitted to high impact factor journals for open access publication. The researchers will work with their PPIE co-production panel to produce patient-relevant and accessible research summaries.

Two public contributors have helped to design the project and will be involved in every stage of the research. The researchers will also involve a wider group of public contributors in a PPI advisory panel. They will be involved in every phase of the research including co-production of the tools for test communication and will help us to understand the results from a patient's perspective.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository at the University of Bristol Medical School. The raw data will not be shared beyond the core research team. Access to the full anonymised study data set will be limited to members of the immediate research team, the study steering group and authorised representatives from the Sponsor or host institution for monitoring and/or audit of the study to ensure compliance with regulations. Personal data will not be shared with any third parties.

Editorial Notes

29/01/2025: The ethics approval was added and the recruitment start date was updated from 03/01/2025 to 10/02/2025.
16/01/2025: Internal review.
31/10/2024: Study's existence confirmed by the NIHR.