Do patient information animations enhance patient understanding compared to patient information leaflets alone for a clinical trial investigating CT coronary angiography to guide treatment of heart attack (myocardial infarction)?

ISRCTN ISRCTN41904454
DOI https://doi.org/10.1186/ISRCTN41904454
Integrated Research Application System (IRAS) 355138
Sponsor Accord (United Kingdom)
Funder NHS Lothian
Submission date
26/03/2026
Registration date
27/03/2026
Last edited
27/03/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This short research study is using a questionnaire to help design a larger research study to improve the care pathway for patients admitted to the hospital for investigation of a heart attack (non-ST elevation myocardial infarction). Patient involvement in developing research studies is a key step in designing clinical trials to ensure that researchers look at questions that are important to patients.
This study aims to:
1. To understand whether patients admitted to the hospital with a heart attack would be interested in taking part in a study using CT scanning of the coronary artery blood vessels supplying the heart to improve their care.
2. To understand whether the use of a cartoon video explaining the trial helps patient understanding of what the study is trying to do.

Who can participate?
Patients aged 16 years and over admitted to hospital with a diagnosis of non-ST elevation myocardial infarction and scheduled for invasive coronary angiography.

What does the study involve?
The study involves reading information about a proposed clinical trial using CT coronary angiography to guide the treatment of patients with non-ST elevation myocardial infarction. Participants will be split into two groups. Half will read a standard patient information leaflet describing the proposed clinical trial. Half will read the leaflet and view a video animation describing the trial in detail. After reading the leaflet and viewing the animation, participants will respond to a short questionnaire. The questionnaire is designed to understand participants' understanding of the trial and treatment pathways for myocardial infarction and whether participants would be prepared to take part in the trial.

What are the possible benefits and risks of participating?
This is a simple questionnaire-based study examining participant understanding of treatment pathways and views about taking part in a future clinical trial. By taking part, participants may help guide the design of a future clinical trial and help improve patient care. It is not thought that there are any risks.

Where is the study run from?
Edinburgh Heart Centre, The Royal Infirmary of Edinburgh, UK.

When is the study starting and how long is it expected to run for?
April 2026 to January 2027.

Who is funding the study?
NHS Lothian, UK.

Who is the main contact?
Dr Peter Henriksen, phenrik1@ed.ac.uk

Contact information

Dr Peter Henriksen
Principal investigator, Scientific, Public

Edinburgh Heart Centre
The Royal Infirmary of Edinburgh
51 Little France Crescent
EH164SA
United Kingdom

ORCiD logoORCID ID 0000-0003-4974-0344
Phone +44 01312421046
Email peter.henriksen@nhs.scot

Study information

Primary study designInterventional
AllocationNon-randomized controlled trial
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentSequential
PurposeHealth services research, This study is part of patient engagement and involvement in the planning of a multicentre UK trial comparing CT coronary angiography guided management of patients with NSTEMI with standard care.
Scientific titleDo patient information animations enhance patient understanding compared to patient information leaflets alone for a clinical trial investigating CT coronary angiography to guide treatment of heart attack (myocardial infarction)?
Study acronymDECIDE MI- video animation Trial
Study objectives 1. To understand whether use of a video animation explaining a complicated clinical trial improves patient understanding of what the study is trying to do and increases preparedness to take part.
2. To understand whether patients admitted to hospital with a heart attack would be willing to take part in a study using CTCA to facilitate early discharge and guide treatment decisions and care.
Ethics approval(s)

Approved 05/03/2026, HRA and Health and Care Research Wales (Health and Care Research Wales, Floor Four, North, Welsh Government Offices, Cathays Park, King Edward VII Avenue, Cardiff, CF10 3NQ, Cardiff, CF10 3NQ, United Kingdom; +44 02920 230457; approvals@hra.nhs.uk), ref: 26/NW/0018

Health condition(s) or problem(s) studiedPatients with non-ST elevation myocardial infarction
InterventionFollowing enrolment, participants will be allocated sequentially on each site to group 1: Reading the patient information leaflet only and group 2: Reading the patient information leaflet and viewing the video animation. The animation will be available as a link or QR code that can be accessed on the patient’s phone through hospital wifi or mobile network. It may also be viewed on a handheld mobile device supplied by the investigator.
After the participant has read the leaflet and reviewed the patient animation (group 2 only), they will answer a short questionnaire with simple ’True’, ‘False’, and ‘don’t know’ responses. The process of reading the leaflet, viewing the video animation and answering the questions will take up to 30 minutes. The study ends with the completion of the questionnaire.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Participant understanding and knowledge score between groups measured using a questionnaire at immediately following enrolment
Key secondary outcome measure(s)
  1. Patient preparedness to take part in the proposed research study measured using a questionnaire at immediately following enrolment
Completion date04/01/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit16 Years
Upper age limit100 Years
SexAll
Target sample size at registration88
Key inclusion criteriaPatients admitted to hospital with a diagnosis of non-ST elevation myocardial infarction and scheduled for invasive coronary angiography
Key exclusion criteria1. Patients with unstable symptoms, ongoing chest pain or ECG changes
2. Patients with non ST elevation myocardial infarction who are considered unsuitable or too frail for invasive coronary angiography
3. Unable to give consent owing to capacity or cognitive impairment
Date of first enrolment01/04/2026
Date of final enrolment02/10/2026

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Scotland

Study participating centre

Edinburgh Heart Centre, The Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.0 17/11/2025 27/03/2026 No No

Additional files

49277_Protocol_V1.0_17Nov2025.pdf
Protocol file

Editorial Notes

27/03/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).