The patient path to a diagnosis of atrial fibrillation (irregular and often abnormally fast heart rate)

ISRCTN ISRCTN15264658
DOI https://doi.org/10.1186/ISRCTN15264658
IRAS number 317170
Secondary identifying numbers IRAS 317170, CPMS 53867
Submission date
03/11/2022
Registration date
15/11/2022
Last edited
03/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Atrial fibrillation (AF) is a heart condition that causes an irregular heartbeat. It affects up to 10 in 100 people over the age of 65. AF greatly increases the risk of stroke and people with AF are five times more likely to have a stroke compared to people without AF. AF-related strokes are more severe, disabling and fatal than strokes not related to AF. Many people with AF are prescribed medicines known as anticoagulants, which help to reduce blood clots forming and causing an AF-related stroke.

AF can be difficult to detect because the irregular heartbeat is not present at all times and not all patients have symptoms. New research has shown more patients have symptoms than previously thought, and that patients with symptoms experience delay in getting a diagnosis. This is because patients think some of the symptoms are trivial and doctors do not always associate them with AF. Currently, about 500,000 people with AF in England have not been diagnosed. As a result, half of all AF-related strokes occur in people unaware they have AF. Early diagnosis and treatment is vital because patients are at highest risk of stroke in the first four months of having AF.

This study aims to explore patient journeys to AF diagnosis in order to better understand how AF presents. The knowledge from the study will help people to recognise symptoms earlier and seek medical help, and help healthcare professionals to better recognise AF in their day-to-day practice.

Who can participate?
Patients with a recent diagnosis of atrial fibrillation and primary healthcare professionals can participate.

What does the study involve?
The study will be conducted in 20 GP practices in the West Midlands. We will carry out interviews with patients who have received a recent diagnosis of AF to understand the range of symptoms they experienced prior to diagnosis and how AF was detected. We will also carry out interviews with GPs and practice nurses to understand the challenges of identifying AF in practice. We will then hold a meeting with a small group including patients, AF experts, GPs, practice nurses and individuals from relevant charities to understand the learning from the findings.

Following that, we plan to create educational materials from this learning for the public and healthcare professionals. The findings will be shared with the public, healthcare professionals and the NHS in a number of ways including publications, presentations at conferences for GPs, social media, and posters for display in GP practices. The educational materials will be made widely available on the internet and to all relevant charities and organisations.

The founder of the AF Association who is a member of the research team will lead on sharing findings with the public. Improved public awareness and clinician understanding of AF will result in earlier detection of AF and treatment to reduce AF-related stroke.

What are the possible benefits and risks of participating?
There are no risks in taking part in the study. The knowledge gained from the study may benefit others by helping people to recognise symptoms earlier and seek medical help. The study may also help healthcare professionals to better recognise AF in their day-to-day practice.

Where is the study run from?
Institute of Applied Health Research, University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
April 2020 to September 2023

Who is funding the study?
NIHR Research for Patient Benefit Programme (UK)

Who is the main contact?
Dr Patricia Apenteng, p.n.k.apenteng@bham.ac.uk

Contact information

Dr Patricia Apenteng
Principal Investigator

Institute of Applied Health Research
Murray Learning Centre
Birmingham
B15 2TT
United Kingdom

ORCiD logoORCID ID 0000-0003-0835-3495
Phone +44 1214148666
Email p.n.k.apenteng@bham.ac.uk

Study information

Study designQualitative study
Primary study designObservational
Secondary study designQualitative study
Study setting(s)GP practice
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe Patient Path to a diagnosis of Atrial Fibrillation: a qualitative study in primary care
Study acronymP-PAF
Study hypothesisThis research seeks to address the patient identification gap in atrial fibrillation through generation of knowledge to improve awareness of the presentations of atrial fibrillation among public and health professionals.
Ethics approval(s)Approved 22/09/2022, East of Scotland Research Ethics Service (Tayside Medical Science Centre, Dundee DD1 9SY, UK; +44(0)1382383878; tay.eosres@nhs.scot), ref: 22/ES/0040
ConditionAtrial fibrillation
InterventionParticipants will take part in one interview with the study researcher. The interview will last up to one hour.
Intervention typeOther
Primary outcome measure1. Patient experiences of the journey to diagnosis of atrial fibrillation will be measured using qualitative interviews.
2. The perspectives of primary health care professionals on the detection of atrial fibrillation in primary care will be measured using qualitative interviews.
The qualitative data will be analysed using framework analysis, and Andersen’s model of Total Patient Delay will be applied as a guide to understand the trajectory to a diagnosis of AF.
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/04/2022
Overall study end date30/09/2023

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit50 Years
SexBoth
Target number of participants50
Participant inclusion criteriaPatients
1. Men and women aged 50 years and above
2. With a diagnosis of AF within the last 6 months
3. Ability to understand the information provided in the participant information sheet and consent form
4. Ability to provide informed consent

Primary healthcare professionals
1. General practitioners
2. Practice nurses
3. Ability to provide informed consent
Participant exclusion criteriaPatients
1. Patients that the GP determines are not suitable to be approached to participate e.g. patients receiving end of life care
2. People aged below 50 years
3. People who lack capacity to consent

Primary healthcare professionals
1. Participants under 18 years old
Recruitment start date01/12/2022
Recruitment end date30/06/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Birmingham
Institute of Applied Health Research
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham
University/education

Head of Research Governance and Integrity
Finance Office
Aston Webb
Birmingham
B15 2TT
England
United Kingdom

Phone +44 1214147618
Email researchgovernance@contacts.bham.ac.uk
Website http://www.birmingham.ac.uk/index.aspx
ROR logo "ROR" https://ror.org/03angcq70

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 date31/03/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publications in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to participant confidentiality.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

03/11/2022: Trial's existence confirmed by East of Scotland Research Ethics Service.