Title: Informed consent for Percutaneous Coronary Intervention: a mixed methods study to optimise clinical practice
Funder: Department of Health (England)

Abstract: Background : PCI is a treatment, conducted under local anesthetic, to widen narrowed coronary arteries that supply the heart with blood. PCI improves blood flow without the need for open heart surgery and can be used in 2 ways; as a planned treatment for people with 'stable' arterial disease, or as an urgent treatment for people with 'unstable' narrowing that can cause heart muscle damage. The associated risks and benefits of PCI vary according to these 2 types of clinical presentation (stable/unstable). PCI is one of the most widely used interventions in modern medicine making it a priority for investigation. In 2010 over 87,000 people received PCI in the UK (1) and 1 million in the US (2). Serious complications are uncommon but death is one (3) underlying the importance informed consent. 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 (4). The practice of obtaining consent is variable as is the amount and quality of information provided to patients and families (5). Patients overestimate the benefits, forget the risks and are not always aware of alternative treatments to PCI (6). Current approaches to obtaining informed consent for PCI appear to be suboptimal (6,7). Aim: The overarching aim is to describe and observe the informed consent process for PCI from the perspectives of patients, carers and cardiologists and identify options for service improvement. Research questions: How is the PCI consent process understood, interpreted and experienced by patients and carers? How is the PCI consent process understood, interpreted, experienced and practised by cardiologists? How does the ‘reality’ of PCI informed consent in practice compare with General Medical Council (GMC) guidance? What factors act as barriers and facilitators to the implementation of GMC guidance? What resources to support PCI informed consent are acceptable to patients, carers and cardiologists? How can knowledge be translated into action to optimise PCI informed consent? Study Objectives: Explore patients' and carers' experiences of the PCI consent process; Explore cardiologists' attitudes to, and practices of, PCI consent; Compare PCI consent processes in practice with principles outlined in GMC guidance; Identify social, organizational and professional factors that mediate PCI informed consent experiences and practices; Identify barriers and facilitators to the implementation of GMC guidance; Convene and establish a community of practice to develop a ‘knowledge mobilization’ strategy to optimize PCI informed consent; Host ‘Policy and Practice’ and 'Service User & Carer' events, with national representation, to present evidence (1-5) and raise awareness about PCI informed consent; Convene a working group (membership from 6-7) to consider evidence (1-5) to inform the development of resources to support PCI informed consent; Develop resources and test for user acceptability; Plan of investigation: Mixed methods study in 3 phases; Phase 1 : Qualitative study A series of in-depth, face-to-face interviews with (60) patients treated with PCI and (20) carers and (30-35) practicing interventional cardiologists; Audiorecording of 60 PCI consent episodes in NHS settings. Phase 2 : An anonymous, national survey to assess Cardiologists (400) attitudes to, and practices of, PCI informed consent; Patients (400) attitudes to, and preferences for, PCI informed consent practices; Phase 3 : Development of knowledge mobilisation strategy and resources (User tested film/guidance) to disseminate evidence to optimise PCI consent. Benefits : Legal and ethical guidance emphasise that patients have the right to information to help them make choices about PCI treatment. By using current practice in PCI consent as an exemplar, we can learn about, and thus improve, the way in which informed consent is practised.


Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: CARDIOVASCULAR