CONNECT: COroNary aNgioplasty dECision Tool
Research type
Research Study
Full title
The development, acceptability and usability of an interactive digital patient decision tool for elective coronary angioplasty.
IRAS ID
264825
Contact name
Felicity Astin
Contact email
Sponsor organisation
University of Huddersfield
Clinicaltrials.gov Identifier
42182, NIHR CRN Portfolio ID; 123623, EDGE ID
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Background:
Deciding whether or not to have a treatment that has side-effects can be difficult for people. In a ‘good’ decision-making (DM) process, doctors, nurses and patients ‘work’ together to think about the risks and benefits of each treatment, with the patient choosing their preferred option (informed consent).
Research with doctors and people with heart disease has shown that the ‘quality’ of the DM process could be much better. People with stable heart disease need to decide between treatment with tablets, or coronary angioplasty (CA); a treatment in which blood vessels are widened. Many people often overrate the benefits, underrate the risks, and feel ‘fixed’ by CA. Some people say ‘yes’ to CA treatment without understanding its effects.
Decision aids (DAs) are ‘tools’ that offer a solution to this problem as they help doctors and patients to work together. A digital DA would help but there is nothing currently available for CA.
Study aim:
To develop a CA DA for elective angioplasty procedures and find out its acceptability and usability with patients, doctors and nurses.
Methods:
The DA content will be confirmed in two co-production design workshops with patients and doctors/nurses. The acceptability and usability of the DA will be measured using cognitive interviews and questionnaires at two NHS Trusts in the North of England. Cognitive interviews will involve asking questions to 10 patients and 10 doctors and nurses whilst they are using the prototype digital DA. A bespoke questionnaire will also be completed. Questionnaire and interview questions will ask about the presentation, comprehension, content and acceptability of the DA. Health literacy levels of patient participants will be measured using a validated 3-item questionnaire.
Outcome:
Results from this 6-month study will be used to produce a finalised prototype digital CA DA that will be evaluated in a future study.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1008
Date of REC Opinion
27 Jun 2019
REC opinion
Favourable Opinion