Investigation of the critical factors required to improve the disclosure and discussion of harm with affected women and families: a study protocol for a qualitative, realist study in NHS maternity services (the DISCERN study)

Patients and families are entitled to an open disclosure and discussion of healthcare incidents affecting them. This reduces distress and contributes to learning for safety improvement. Complex barriers prevent effective disclosure and continue in the English NHS, despite a legal duty of candour. NHS maternity services are the focus of significant efforts to improve this. There is limited understanding of how, and to what effect, they are achieving this. Methods and analysis A 27-month, three-phased realist evaluation identifying the critical factors contributing to improvements in the disclosure and discussion of incidents with affected families. The evaluation asks 'what works, for whom, in what circumstances, in why respects and why?'. Phase 1: establish working hypotheses of key factors and outcomes of interventions improving disclosure and discussion, by realist literature review and in-depth realist interviews with key stakeholders (n=approximately 20] Phase 2: refine or overturn hypotheses, by ethnographic case-study analysis using triangulated qualitative methods (non-participant observation, interviews (n=12) and documentary analysis) in up to 4 purposively sampled NHS trusts. Phase 3: consider hypotheses and design outputs during seven interpretive forums. Ethics and dissemination Phase 1 study approval by King's College London's Ethics Panel (BDMRESC 22033) and National Research Ethical Approval for Phases 2-3 (IRASID:262197) (CAG:20/CAG/0121) (REC:20/LO/1152). Study sponsorship by King's College London (HS&DR 17/99/85). Findings to be disseminated through tailored management briefings; clinician and family guidance (written and video); lay summaries, academic papers, and report with outputs tailored to maximise academic and societal impact. Views of women/family groups are represented throughout.