What changes following the launch of the Patient Safety Incident Response Framework in the English NHS? A formative and summative evaluation of the implementation of a national patient safety policy.

Overall Research Aim To explore the implementation of a new national patient safety policy, the Patient Safety Incident Response Framework (PSIRF), within the English NHS across the multiple layers of the regulatory and health service context, to understand how to support future patient safety policy development and implementation. Background Large numbers of patients continue to be harmed as a result of safety incidents, and current approaches to responding to and learning from safety incidents are increasingly questioned for their effectiveness in reducing harm. Many types of incident are frequently repeated across the NHS and organisations struggle to implement policies to improve safety and share learning. As a result, NHS England is launching a new national policy framework (PSIRF) that has far-reaching implications at all levels of healthcare by seeking to create incident response and learning processes that are more proactive, proportionate, flexible, learning-focused, equitable and fair. The launch of PSIRF offers a unique opportunity to explore and learn from the real-time implementation of a new national patient safety policy, including the logics and objectives underlying the policy, how the policy is interpreted and enacted across a range of stakeholder groups, what the policy changes and improves, and what lessons might be learned for future policy design and implementation. Methods This multilevel, mixed-methods evaluation will explore PSIRF implementation nationally with a longitudinal survey and documentary analysis, and organisationally through in-depth ethnography at six case study organisations from three NHS regions. The programme is divided into three empirical phases. After a set-up period, Phase 1 (pre-implementation, months 4-12) will examine the policy context before the PSIRF is introduced. The logic underpinning the policy will be analysed through interviews (n=30) with policymakers. A mixed-methods evaluation of pre-implementation context will involve a rapid scoping review of how incidents are currently investigated and learned from, and rapid qualitative data collection at six case study organisations to understand pre-PSIRF context (n=10-12 per site). Phase 2 (post-implementation, months 13-30) will examine policy roll-out. A national longitudinal survey of all English NHS Trusts (n= 223) will explore key indicators and aspects of PSIRF implementation; documentary analysis of selected Trust implementation plans (n=20) will examine how PSIRF is interpreted and enacted; and 3 stakeholder workshops with patient safety leads (n=25) will explore safety metrics and local experiences. Organisational ethnography will be conducted across the six case study sites to explore PSIRF implementation (three 8 week cycles of fieldwork per case). Phase 3 (empirical synthesis, months 31-36) will integrate all findings to understand what worked in the implementation of the PSIRF and why. Impact and Dissemination Key policymakers and stakeholders have been extensively consulted in preparing this proposal. NHS England is strongly supportive, and formative findings will be regularly shared to support ongoing implementation. We plan to disseminate widely through 7 journal articles, 3 practice-facing reports and other mechanisms including blogs and podcasts. A key output will be a ‘Patient Safety Policy Implementation Handbook’ detailing actionable strategies and recommendations for future policy implementation.