Title: Patient and family involvement in serious incident investigations: Developing and testing national and local guiding processes
Funder: Department of Health and Social Care

Abstract: Despite a decade of improvement in NHS safety, there is still a significant level of harm to patients, with long-term UK costs estimated to be £65 million. Thus, improving how we learn from past care failures is important to reduce future harm to patients, as well as the litigation costs associated with harm. UK policy emphasises the need for openness following serious incidents, and that patients and families can improve learning. Examples of serious incidents are unexpected deaths, serious physical or psychological harm, or concerns of abuse or misconduct. Currently there is little evidence about how serious incidents, complaints and litigation are linked. With NHS Resolution data suggesting only 30% of legal claims start with a complaint, focusing only on complaints is unlikely to reduce litigation and improve learning from harm. Instead, their current focus is on earlier involvement of patients and families in serious incident investigations, believing that this will improve the experience of stakeholders, potentially divert complaints and reduce litigation costs. The proposed research therefore aims to develop and test processes to guide the involvement of patients and families in serious incident investigations. Our ultimate aim is to improve the experience of patients and families in serious incident investigations, and improve the learning from investigations._x000D_ _x000D_ Despite the policy focus, the involvement of patients and families in serious incident investigations is low, with little evidence about its potential to reduce complaints, improve investigations, or reduce litigation costs. Some US research suggests that patients and families can provide information about harm events, but these findings have not been tested in practice. Our previous UK-based research suggests that patients and families could, and should, be involved in learning from harm events. However, there is no current research that supports health services in involving patients and families in serious incident investigations, and no understanding of the impact of this on experience, or likelihood of pursuing litigation. This research aims to meet this need._x000D_ _x000D_ First, we will explore experiences of patients and families, doctors and nurses, and those investigating incidents, of serious incidents, investigation processes, and why litigation was, or wasn’t, pursued. We will then identify ‘common principles’ to help us design (with patients, staff and investigators) new serious incident investigation processes that involve and learn from patients and their families. We will design the new investigation processes across three healthcare settings - with a national investigation body, the Healthcare Safety Investigation Branch, and with two mental health Trusts, and two acute care Trusts. We chose these settings as they have important differences in the challenges of, and opportunities for involving patients and families. Next we will test the co-designed processes over 12 months. We will observe 25 serious incident investigations to understand how patient and family involvement changes investigations, decisions to litigate, and acceptability of the process to all stakeholders. In the final stage we will refine the investigation processes and resources, and share our findings with policy makers and healthcare organisations. In particular, we will work with our patient and family forums to creatively share findings with the public and patient advocacy organisations.

Lay abstract: Aim_x000D_ Co-design processes to guide involvement of patients and families in serious incident investigations at a national, and local level, and to test these processes to understand their impact upon experience, learning and decisions to litigate._x000D_ Background_x000D_ Reported serious incidents (severe harm, death) are estimated to be 10,000 annually,[1] with enormous, ever increasing costs of litigation.[2] Thus, there is a need to improve learning from serious incidents to reduce incidence, and the fiscal burden of litigation. Reasons why claims are pursued are complex and unclear.[3] NHS Resolution posit that involving patients and families earlier in investigations will reduce costs of administering claims, as well as divert claims pursued for explanation. Other policy and regulatory organisations have proposed greater involvement of patients and families in serious incident investigations, to support better learning. However, there is currently no UK-based evidence to guide organisations to involve patients and families meaningfully in serious incident investigations, to support learning, or reduce the likelihood of litigation._x000D_ Objectives_x000D_ 1) Explore current involvement of patients and families in serious incident investigations._x000D_ 2) Explore experiences of patients, families, staff and investigators, who have been involved in a serious incident, or serious incident investigation, what might have influenced decisions to litigate, and views on the potential involvement of patients and families._x000D_ 3) Identify common principles to involve patients and families in investigations, and use these to co-design local and national processes for involvement._x000D_ 4) Explore if processes to involve patients and families are feasible and acceptable to all stakeholders and their influence on learning, recommendations, action plans, and decisions to litigate._x000D_ Methods_x000D_ In Stage 1 (0-6months), a documentary analysis of policies within England will explore how NHS Trusts involve patients and families in serious incident investigations. A scoping review will explore involvement of patients and families in serious incident investigations and decisions to litigate. In Stage 2 (7-15months) we will interview patients, families, investigators and staff (n=60), to support development of the programme theory underpinning the co-designed processes. Data from these stages will be integrated in Stage 2B, to guide co-design. In Stage 3 (16-21months), we will co-design three parallel processes to involve patients and families in investigations, within national (Healthcare Safety Investigation Branch: HSIB), mental health and acute care. In Stage 4 (22-34months), we will implement the prototype guidance and resources in 25 investigations across 5 organisations, conducting an ethnography to assess feasibility, and explore stakeholder experiences, impact on learning, recommendations, actions, and decisions to litigate. In Stage 5 (35-39months), the final guidance and digital platform will be produced._x000D_ Impact and dissemination_x000D_ Commissioners, regulators and policy makers have all been consulted in preparing this proposal, and have a keen interest in the final research outputs. The HSIB are committed to using the co-designed process, and will role model this usage for the wider NHS. We plan to disseminate widely, to a variety of audiences, through eight academic publications, two policy-facing reports, and the key research output – the co-designed guidance on a digital platform.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE