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Patient and family involvement in serious incident investigations

Patient and family involvement in serious incident investigations: Developing and testing national and local guiding processes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14463242
Enrollment
75
Registered
2021-04-20
Start date
2021-12-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guiding organisations to involve patients and families meaningfully in serious incident investigations, to support learning or reduce the likelihood of litigation. Other

Interventions

The overall research project contains 5 stages, this registration will focus on stage 4. Details on all stages are included for background and context. In Stage 1 (0-6 months) a documentary analysis o
HSIB), mental health and acute care. In Stage 4 (22-34 months) we will implement the prototype guidance and resources in 25 investigations across 5 organisations, conducting an ethnography to assess t

Sponsors

Bradford Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient and family: 1. Experienced a ‘serious’ incident as defined by the Trust 2. The serious incident is new (occurring in the last few days) 3. There is no police involvement 4. They are >16 years of age 5. They have capacity to consent to the interview Investigators: 1. Experience of conducting serious incident investigations Staff: 1. Directly involved in the serious incident

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Understanding how the new intervention is enacted and experienced in different socio-cultural and organisational contexts -using ‘in situ’ interviews, electronic summary records and documents related to the investigation, actions and outcomes 2. Understanding how patients and families are engaged and involved in investigations, including how procedures are explained, the opportunities for communication and shared decision-making, the influence of status and power differences, and the unwritten rules that seem to shape social order - using non-participant observations of investigation processes 3. Interpretive thematic analysis will preliminarily include open and thematic coding to develop descriptive accounts of the common and distinct processes of investigation, the expectations and experiences of participants of these processes, and the types of learning and recommendations developed. Over a 3-6 month period, analysis will be discussed by the core qualitative team through weekly and monthly meetings (face-to-face and remote), before being presented to the wider research team for further development and then the final stakeholder event

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026