Informed Consent for PCI: Questionnaire Study
Research type
Research Study
Full title
Mixed methods study to optimise informed consent for Percutaneous Coronary Intervention (PCI) in clinical practice: Questionnaire Study
IRAS ID
160732
Contact name
Felicity Astin
Contact email
Sponsor organisation
Mid Yorkshire NHS Trust
Research summary
Percutaneous Coronary Intervention (PCI) is a common treatment given to people to relieve narrowing or blockages in blood vessels that supply heart muscle. Serious complications are uncommon but death is one of them. Obtaining valid consent for any invasive treatment is a legal and ethical principle that reflects the right of patients to determine what happens to their own bodies and is a central tenet of best practice. The amount and quality of the information provided to patients as part of the PCI consent process has been described as variable. Patients tend to overestimate the benefits of PCI, forget the risks and are not always made aware of alternative treatments. This suggests that patients are not always fully informed in the way that they should be. To explore the informed consent process for PCI we will develop a questionnaire to survey 400 cardiologists and 400 patients in England. This data, qualitative data from Phase 1 of the study and published evidence will be used to identify obstacles and enablers to best practice informed consent. Stakeholders will work with researchers to develop an integrated knowledge mobilisation strategy to support the adoption and diffusion of new practices to optimise PCI informed consent process in NHS practice. Service user led initiatives (film and service user led guidance) will be central to service improvement. Patients will be better supported to make PCI treatment choices. We will use the example of PCI to learn about, and thus improve, the consent process more widely across the NHS. Informed consent is an ethical and legal requirement, and relevant to all invasive medical treatment given to patients across multiple NHS settings in the UK.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
14/LO/1498
Date of REC Opinion
14 Aug 2014
REC opinion
Favourable Opinion