Award Title: Strengthening the Implementation and Operationalisation of ‘Open Disclosure’ with Women and Families after Unexpected Harm in NHS Maternity Care
Funder: Department of Health and Social Care

Abstract: BACKGROUND:  Open Disclosure is the discussion between health providers and the patient, their family, carers and other support people about incidents that result in harm to a patient while receiving health care. This includes expressing regret for what has happened, keeping the patient and family informed, providing feedback on investigations, and the steps taken to prevent a recurrence of the adverse event. _x000D_
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It can reduce distress for those harmed and help clinicians and services to learn to prevent this harm happening again. However, there is a lot of variation in how open disclosure is practiced across the NHS and we need to know more about what patients, families and NHS staff find the most helpful.  This is particularly notable in NHS maternity care where harm can devastate families and fears of litigation are widespread.  There is urgent need to understand how and when some maternity teams are managing to improve the open disclosure process and to what effect. _x000D_
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AIMS: We want to find the key factors to support improvements in Open Disclosure within maternity care. We also want to find out the effects that Open Disclosure has for women and families, clinical teams, and service managers.  To work with these interest groups to produce guidance on Open Disclosure practices and processes for women, families and NHS staff._x000D_
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STUDY PLAN:  First, we will develop a framework of the key factors that support Open Disclosure improvements from international literature and in discussions with experts.  Second, we will refine this framework by an in-depth study in maternity care.  This will involve interviews with senior service, professional and user-group representatives who will also help to identify 3 units or networks where Open Disclosure is practiced for detailed case study.  Each case study will include staff interviews, observations of Open Disclosure work routines and effects, and analysis of paperwork.  Finally, we will discuss and develop our findings with service-user and senior service and professional representatives to agree the framework for co-designed study outputs. _x000D_
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STUDY OUTPUTS: We will include recommendations for managers and policy-makers and filmed and written guidance for staff teams and for women and families on Open Disclosure processes and practices.

Lay Abstract: Open disclosure [OD], the discussion of harm in healthcare with affected patients or families, is a patient or family entitlement.  It may also enhance learning for safety improvement, reduce the distress of those harmed and increase public trust in healthcare.  There is often a significant gap between what patients and families want from OD and what clinicians or organisations provide. There are complex barriers to OD: fear of litigation and loss of reputation; lack of skills and effective systems. Despite the legal duty of candour on NHS organisations, disparities in OD between trusts are notable. NHS maternity services are central to policy reform and under public pressure to improve OD. There is limited understanding of how maternity providers can achieve this. This study will examine what improvements are being made, how and their felt effects._x000D_
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1.to generate actionable evidence to inform maternity providers and NHS trusts on how to strengthen Open Disclosure in NHS maternity services; _x000D_
2. to collaborate in the production of outputs to support improvements in OD for the benefit of women and families, staff teams and quality and safety of maternity care. _x000D_
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RESEARCH QUESTION: ‘what are the critical factors that can improve the incidence and quality of Open Disclosure in NHS maternity care?’ _x000D_
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METHODOLOGY: a realist evaluation to identify the critical factors that contribute to improvements in OD. Approaching OD improvement as a complex social intervention, the evaluation will explore what assumptions underlie these approaches and examine ‘what works, for whom, in what circumstances, in why respects and why’.  This approach will establish a transferable theory of critical factors for improving OD. _x000D_
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STUDY PLAN: The 36-month, three-phased research plan is:  _x000D_
Phase 1 [Months 1-21] to establish working hypotheses of OD improvement and to refine these hypotheses by realist review of the international literature and telephone interviews with national and regional stakeholders [n=60]; _x000D_
Phase 2 [Months 22-30] construct three ethnographic case studies using the methods of observation; return staff interview (with managers, clinicians, administrators, and women/family representatives [n=48]); and documentary analysis of records of OD improvements in  the three purposively selected services, trusts or networks to further refine or revise our hypotheses;_x000D_
Phase 3 [Months 29-36], to include 6 interpretive forums for study participants to make sense of findings and advise on the design of some study outputs, and 1 summative forum for dissemination of initial findings, mutual learning and network building among study participants and policy makers. _x000D_
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OUTPUTS: briefing documents and tailored recommendations for service, trust and organisation managers; actionable guidance on OD for staff and women and families (written and video); ongoing lay summaries of study progress and findings; in-depth understanding of process of OD improvement (mechanisms and contexts by which they are effective for different participants and service concerns); academic papers and HS&DR report.  Tailored dissemination, supported by stakeholder analysis, will ensure that the study has academic and societal impact. _x000D_
The multi-professional/disciplinary research team have extensive experience of research and quality improvement work in OD and in maternity care. The views and interests of women and families have been, and will be, represented at all study stages.

Research Activity Codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health Categories: REPRODUCTIVE HEALTH AND CHILDBIRTH