The Learn Together programme (Part B): Evaluating co-designed guidance to support patient and family involvement in patient safety incident investigations

Lauren Ramsey ^1* Justin Waring ² Laura Sheard ³ Daisy Halligan ¹ Siobhan McHugh ⁴ Ruth Simms-Ellis ^1,5 Joe Langley ⁶ Jenni Murray ¹ Olivia Rogerson ⁵ Jane K O'Hara ^1,7

• ¹ Yorkshire and Humber Patient Safety Research Collaboration, Bradford, United Kingdom
• ² Loughborough University, Loughborough, United Kingdom
• ³ University of York, York, United Kingdom
• ⁴ Leeds Beckett University, Leeds, England, United Kingdom
• ⁵ University of Leeds, Leeds, England, United Kingdom
• ⁶ Sheffield Hallam University, Sheffield, England, United Kingdom
• ⁷ THIS Institute, University of Cambridge, Cambridge, England, United Kingdom

Background: Expectations of patient and family involvement in investigations of harm are becoming conventional. Nonetheless, how people should be involved, is less clear. Therefore, the 'Learn Together' guidance was co-designed, aiming to provide support to investigators, patients and families.Aim: To longitudinally evaluate use of the Learn Together guidance in practice.Methods: A fifteen-month process evaluation took place across five sites, following 29 investigations in which the Learn Together guidance was used. Sites comprised two mental health and two physical health hospital Trusts, and an independent maternity investigatory body in England. 127 interviews were conducted with investigators, patients, families, staff, and management. Interview and observational data were analyzed using thematic analysis.Findings: The guidance supported the systematic involvement of patients and families in investigations and informed them how, why, and when to be involved. However, within hospitals, investigators often had to conduct 'pre-investigations' to source appropriate details of people to contact, juggle ethical dilemmas of involving vs. re-traumatizing, and work within contexts of unclear processes and responsibilities. These issues were largely circumvented when investigations were conducted by an independent body, due to better established processes, infrastructure and resources, however independence did introduce challenge to the rebuilding of relationships between families and hospitals. Involvement fluctuated over time and sharing a draft investigation report marked an important part of the process. This was made particularly difficult within hospitals, as investigators often had to navigate systemic barriers alone. Organizational learning was also a challenge.Conclusions: Investigations of harm are complex, relational processes that have the potential to repair, or compound harm. The Learn Together guidance helped to support patient and family involvement and the evaluation led to further revisions, to better inform and support patients, families and investigators in ways that meet their needs (learn-together.org.uk). The five-stage process is designed to center the needs of patients and families, before moving to address organizational needs for learning and improvement. However, we call for formal recognition, support and training for the complex challenges investigators face and appropriate and flexible infrastructure to enable a receptive organizational culture and context for meaningful involvement.