Mixed Methods Study to Optimise Informed Consent for Percutaneous Coronary Intervention (PCI) in Clinical Practice


This study is funded by NIHR Research for Patient Benefit and is led by Professor Felicity Astin at the University of Huddersfield, with collaborators from the University of Salford (Dr Joy Probyn), University of Leeds (Dr Joanne Greenhalgh and Dr Janet Holt), Mid Yorks NHS Hospitals Trust (Dr Dwayne Conway and Judith Wright), Sheffield Teaching Hospitals NHS Trust (Dr Allison Morton) and service users (Keith Wakefield). The aim of this study is to describe and observe the informed consent process for PCI from the perspectives of patients and cardiologists and identify options for service improvement. Percutaneous Coronary Intervention (PCI) is a treatment, conducted under local anaesthetic, to widen narrowed coronary arteries that supply the heart with blood. Obtaining valid consent for invasive treatment is a legal and ethical principle that reflects the right of patients to determine what happens to their bodies and is fundamental to good practice. However,the practice of obtaining consent is variable as is the amount and quality of information provided to patients and families. This suggests that patients are not always fully informed in the way that they should be.

We will interview patients and cardiologists, tape consent conversations in real life practice and survey cardiologists and patients in England. Findings 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.

Project team: Felicity Astin (PI) (University of Hudderfield), Joy Probyn (University of Salford), Dr Dwayne Conway, Judith Wright (Mid Yorks NHS Trust), Dr Joanne Greenhalgh, Dr Janet Holt (School of Healthcare, University of Leeds, Mr Keith Marshall, Dr Allison Morton (Sheffield Teaching Hospitals NHS Trust)