Title: 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.
Funder: Department of Health and Social Care

Abstract: Despite two decades of effort to improve the safety of patients, 1 in 10 patients are still harmed during hospital stays in the NHS, with some problems, such as mistakes in giving people the right medication, occurring repeatedly. The main way that NHS hospitals measure and manage safety is by monitoring the number, type and severity of harmful events. Hospitals are supposed to learn from these safety events to help prevent them from happening in the future. However, hospitals often struggle to learn and respond effectively when thing go wrong, which suggests that current patient safety policy has not been effective. _x000D_ _x000D_ The problem of how to develop and roll out patient safety policy to bring about national improvements in safety is important, but currently there is a lack of knowledge about the best ways to do this. In April 2022, NHS England will launch a new way of responding to safety events, called the Patient Safety Incident Response Framework (PSIRF). The PSIRF aims to support hospitals to be more flexible in how they respond when things go wrong. One of the key changes is that hospitals will no longer be asked to investigate every event that results in harm. This new policy is likely to have important effects: it may create new opportunities for learning by allowing hospitals to focus on the most serious safety problems, but it might also have implications for fairness and equity in responses to harmful events. _x000D_ _x000D_ The aim of this research is to understand in real time how the roll out of this new policy happens across the English NHS, and what impact it has. This will inform the way future patient safety policy are developed and launched. This study will combine a range of different types of research, examining how the policy works broadly across the NHS and in depth at a range of hospitals. We will start by exploring what NHS hospitals normally do when something goes wrong with care. We will do this in six NHS Trusts across three regions in England, and in both physical health and mental health hospitals. Alongside this, we will speak to people who were involved in developing the PSIRF to understand what they wanted to change, and how they think the new policy will improve safety. This will provide an important foundation for evaluating how the new policy works. _x000D_ _x000D_ One part of the evaluation will involve surveying all NHS hospitals across England, first just after the roll out of the PSIRF, and again after 18-months. We will also review formal policy documents from 20 hospitals. In the other part of our evaluation, we will observe in real-time how things change in our six participating NHS hospitals following the PSIRF launch. We will speak to patients and the public, staff, managers, as well as regulatory bodies like the Care Quality Commission, to understand how the new approach is working, and what the challenges are. Together this will provide information about if and how the approach to safety management in English hospitals is changing in response to the PSIRF. _x000D_ _x000D_ Finally, we will bring all of this new evidence together to create a series of recommendations about how to develop and roll out patient safety policies in the future. The learning from this research has the potential to significantly improve the effectiveness of the PSIRF, as well as the development and roll out of future patient safety policies. Ultimately, this should help to improve the safety of care and reduce patient harm across the NHS.

Lay abstract: Overall Research Aim _x000D_ 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._x000D_ _x000D_ Background _x000D_ 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. _x000D_ _x000D_ Methods _x000D_ 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. _x000D_ _x000D_ Impact and Dissemination_x000D_ 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.

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