What changes following the launch of the Patient Safety Incident Response Framework in the English National Health Service? Protocol for a formative and summative evaluation of the implementation of a national patient safety policy (March 2026)

Summary

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 incidents are frequently repeated across the NHS and organisations struggle to implement policies to improve safety and share learning. As a result, NHS England launched a new national policy framework, the Patient Safety Incident Response 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.

Content

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.

This multilevel, mixed-methods evaluation will explore PSIRF implementation nationally and organisationally. The evaluation is divided into three phases.

Phase 1 will examine the policy context before the PSIRF is introduced. The logic underpinning the policy will be analysed through interviews with policymakers. An evaluation of pre-implementation context will involve a rapid review and rapid qualitative data collection at six case study organisations from three NHS regions.

Phase 2 will examine policy implementation. A national longitudinal survey of all English NHS Trusts and Integrated Care Boards (ICBs) will explore key indicators and aspects of PSIRF implementation. A documentary analysis of selected NHS Trust implementation plans will examine how PSIRF is interpreted and enacted and workshops with patient safety leads will explore safety metrics and local experiences. Qualitative analyses relating to national events and supporting resources will explore ongoing PSIRF implementation, and a national survey of patients and families involved in Patient Safety Incident Investigations under PSIRF will be conducted to understand the perspectives of patients. Organisational ethnography will be conducted across the six case study organisations to explore PSIRF implementation over time.

Phase 3 will integrate all findings to understand what worked in the implementation of the PSIRF and why. Outputs and dissemination We will disseminate widely through publications in academic journals, public talks, practice and policy facing reports and other mechanisms including blogs and podcasts. The main output will be a document to guide the development and implementation of future patient safety policy.