Title: The Patient Safety Collaborative Evaluation Study (The PiSCES Study)
Funder: Department of Health and Social Care

Abstract: Background The Francis Report published in February 2013 called for fundamental culture change across the health and social care system[1]. The government responded to these recommendations in the report Hard Truths and made a number of recommendations including developing a network of Patient Safety Collaboratives (PSC). The aim of PSCs is to create a comprehensive, effective and sustainable improvement system that will deliver the cultural change called for in the Francis Report[2]. Aims in relation to the issue to be addressed This research proposal will evaluate the impact the PSCs are having on patient care. We will take a realist approach; that is, we will seek answers to the questions; what parts of the PSC work, for whom and in what respects, to what extent and how? This approach is increasingly used for evaluations of complex multifactorial interventions in favour to the blunter but less nuanced traditional research question did it work? Specifically, our proposed research will address these questions:- How have the PSCs have been implemented in each of the 15 Academic Health Science Network (AHSN) regions? What organizational changes have providers made? How have they done this and what have they learned from the PSCs? What are the costs of participation and implementation? Have the PSCs made a detectable difference on rates of harm and adverse events involving patients as measured using routine data? Has change in practice taken place on the frontline of services? How has implementation varied across PSCs and what generalizable knowledge can be shared about this? Research plan and methods of investigation This will be a mixed methods evaluation using three different methods of investigation:- Implementation process: qualitative, interview based methods will be used at every level within two PSCs (one urban and one larger rural) to understand how each is run, what barriers there were to implementation and what lessons can be learnt to inform the ongoing running of the PSC. Measures of patient safety culture: specialised surveys of NHS staff using the SCORE questionnaire will be administered to a large representative sample to the whole healthcare system within one AHSN. 15,000 questionnaire responses will be gathered at the beginning of the research period and again at 2 years. Measures of concurrent changes in service and patient outcomes: Quantitative re-analysis of routinely collected administrative data. Standardised in-hospital mortality index (SHMI) will be accessed from the Healthcare Evaluation Data (HED) database and used to compare mortality data. Patient and staff survey data will also be analysed to assess impact of the PSCs and compare across them. The National Reporting and Learning System (NRLS) will be used to access and analyse data on reported harm incidents. Research team Rod Sheaff (health policy and implementation, organisation theory) Rob Bethune (surgery, patient safety, safety culture) Natasha Doran (qualitative health service research) Iain Lang (health services research, public health) Amelia Brooks (patient safety and quality improvement) Richard Blackwell (data analysis) Allan Frankel, Michael Leonard and Brian Sexton (safety culture) Potential impact/influence on the relevant policy field, users and wider stakeholders. The expected outcome of this research is a thorough evaluation of the impact of the PSCs. The realist approach will demonstrate what parts of this complex social intervention work and who it works for. Potential impacts are expected to include:- Enabling NHS England to demonstrate the return on investment of PSC funding Informing the ongoing running of the collaboratives, showing what has worked and what has not worked so well Guiding future central policy in terms of patient safety.

Lay abstract: Safe health care is a basic expectation for patients and the public and a core responsibility for healthcare organisations. However, existing healthcare systems often fail to reliably provide safe care to all patients. The findings of the Francis Report demonstrated that the major changes required to reliably deliver safe health care in the NHS have not yet taken place. The Government's response to the Francis Report includes a policy to implement 15 Patient Safety Collaboratives (PSC) covering the entire geography of England. The PSCs will last for a minimum of five years. This proposed research project aims to evaluate the progress of the PSCs in the first two years to determine what difference they are making and how their impact can be maximised in the remainder of the programme. The research project will achieve these aims using three different research methods:- Independent interviewers will speak to staff and patients involved with PSCs to find out how PSCs have been run, what impact they have had on organisations (such as hospitals) and whether people believe that care has improved. These interviews will also help us understand which parts of the collaboratives worked and which did not. We will use existing data to compare levels of harm before the programme, at the start, and after two years. We can use the same data to compare across the PSCs. We will analyse patient and staff surveys to see what difference the PSCs made and again to compare them. Staff will complete a questionnaire at the start and end of the evaluation. The questionnaire is specially designed to assess how teams and organisations think about patient safety. Previous research has shown that this accurately reflects the standard of care being given and the chances of patients being unintentionally harmed. To give us the best understanding of how PSCs have done and the extent to which they have worked we will bring together the results of each of these approaches and combine them into a final report that we will ensure is widely heard about, read, and acted upon.

Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE