Background

Reported serious incidents (severe harm or death) are estimated to be 10,000 annually, with enormous, ever-increasing costs associated with litigation. There is a need to improve the process of learning from serious incidents to reduce incidence and the financial burden of litigation. The reasons why claims are pursued are complex and, as yet, unclear. NHS Resolution posits 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.

Research aim

To co-design processes and resources to guide the role 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 likelihood of seeking legal recourse.

Research Questions

1. What is the current involvement of patients and families in serious incident investigations?

2. What is the experience of patients and families who have been involved in a serious incident, or serious incident investigation, and what might have influenced decisions to litigate?

3. What is the experience of frontline healthcare staff and investigators who have been involved in a serious incident investigation, and what might have influenced decisions to litigate?

4. What are the views of frontline healthcare staff and investigators on the potential involvement of patients and families in serious incident investigations?

5. What are the common principles necessary for involving patients and families in serious incident investigations?

6. How might these common principles be reflected in local and national processes for involving patients and families in serious incident investigations?

7. Are co-designed processes for involving patients and families in serious incident investigations feasible and acceptable to patients, families, healthcare staff and investigators?

8. How do co-designed processes influence serious incident investigations in terms of depth of learning, recommendations, action plans, and decisions to litigate?

Methods

In Stage 1 (0-6months [Oct 2019 – Mar 2020]), a documentary analysis of published policies within England will explore how NHS Trusts involve of patients and families in serious incident investigations. A scoping review will explore the involvement of patients and families in serious incident investigations and decisions to litigate. In Stage 2 (7-15months [Apr 2020 – Jan 2021]) we will interview patients, families, investigators and healthcare staff (n=60), to support the development of the programme theory underpinning the codesigned processes. Data from these stages will be integrated in Stage 2B, to guide co-design. In Stage 3 (16- 21months [Feb 2021 – Jul 2021]), we will co-design three parallel processes to involve patients and families in serious incident investigations, within national (Healthcare Safety Investigation Branch: HSIB), mental health and acute care. In Stage 4 (22-34months [Aug 2021 – Aug 2022]), we will implement the prototype guidance and resources in 25 investigations across 5 organisations, conducting a focused ethnography to assess feasibility, and explore stakeholder experiences, impact on learning, recommendations, actions, and decisions to litigate. In Stage 5 (35-39months [Sep 2022 – Jan 2023]), the final guidance and digital platform will be produced.

Impact and Dissemination

Commissioners, regulators and policymakers 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 codesigned guidance on a digital platform.

Research Team

Principal Investigator: Professor Jane O’Hara
Principal Researcher: Dr Ruth Simms-Ellis
Research Fellows: Dr Lauren Ramsey, Dr Siobhan McHugh
Co-applicants: Professor Rebecca Lawton, Dr Gemma Louch, Professor John Baker, Dr Laura Sheard, Scott Morrish, Professor Carl Macrae, Dr Joseph Langley and Professor Justin Waring.

Contact for more information

Jane.O’Hara@bthft.nhs.uk
R.Simms-Ellis@Leeds.ac.uk
L.Ramsey@Leeds.ac.uk
Siobhan.McHugh@bthft.nhs.uk
@PfiSii