Patient and family involvement in serious incident investigations
| ISRCTN | ISRCTN14463242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14463242 |
| IRAS number | 279096 |
| Secondary identifying numbers | IRAS 279096 |
- Submission date
- 19/01/2021
- Registration date
- 20/04/2021
- Last edited
- 28/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Serious incidents in health care are events where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant that they warrant our particular attention to ensure these incidents are identified correctly, investigated thoroughly and, most importantly, trigger actions that will prevent them from happening again.
UK policy emphasises the need for openness following serious incidents, and that patients and families can improve learning. Examples of a serious incident are unexpected deaths, serious physical or psychological harm, or concerns of abuse or misconduct. Certainly, there is little evidence about how serious incidents, complaints and litigation are linked. The proposed research therefore aims to develop and test processes to guide the involvement of patients and families in serious incident investigations. Our ultimate aim is to improve the experience of patients and families in serious incident investigations and improve the learning from investigations.
Who can participate?
Patients and family who have experienced a ‘serious’ incident as defined by the Trust, along with experienced investigators and staff involved.
What does the study involve?
First, we will explore the experiences of patients and families, doctors and nurses, and those investigating incidents, of serious incidents, investigation processes and why litigation was or was not pursued. We will then identify 'common principles' to help us identify (with patient, staff and investigators) new serious incident investigation processes that involve and learn from patients and their families. We will design the new investigation processes across three healthcare settings - with a national investigation body, the Healthcare Safety Investigation Branch, and with two mental health Trusts and two acute care trusts. We chose these settings as they have important differences in the challenges of and opportunities for involving patients and families. Next we will test the co-designed processes over 12 months. We will observe 25 serious incident investigations, to understand how patient and family involvement changes investigations, decision to litigate and acceptability of the process to all stakeholders. In the final stage we will refine the investigation processes and resources and share out findings with policy makers and healthcare organisations. In particular, we will work with our patient and family forums to creatively share findings with the public and patients advocacy organisations.
What are the possible benefits and risks of participating?
Possible benefits: We anticipate that, as a result of their investigator piloting the new processes and guidance, patients and family members will feel listened to, important, supported and guided through the serious investigation process. It is possible that being involved in testing these may also minimise the experience of compounded harm that patients commonly feel after traditional serious incident investigations. The information participants provide about their experiences of these new processes and guidance will help improve them for future patients, which we anticipate will ultimately contribute to national policy in this area. Therefore participants may benefit from knowing that they are likely to influence national policy.
Possible risks: Patient and family participants may find it upsetting to talk about their difficult healthcare harm experiences. Our researchers are highly skilled in sensitive research and will take great care to not exacerbate an already difficult time in people’s lives. However, if the research is causing distress, participants have the right to withdraw. We will also ensure that participants are provided with relevant sources of support. Staff participants may find implementing the new guidance challenging or stressful. For example, compared to ‘regular’ investigations, the new approach may increase their workload, or the degree of interpersonal contact with upset patients and families. They may also feel overwhelmed by following an unfamiliar process. The researchers will be on hand to support staff with any additional emotional burden and any difficulties with following the guidance. Staff may also feel they have insufficient time to be interviewed, causing them stress. In this regard, the researchers will be very flexible in how these take place. Our partner sites are aware of the commitment involved and the research team will work with leaders to facilitate/support staff involvement in the research.
Where is the study run from?
Bradford Teaching Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2019 to June 2024
Who is funding the study?
NIHR Health Services and Delivery Research (HS&DR) Programme (UK)
Who is the main contact?
Prof. Jane O'Hara, Jane.O'Hara@thisinstitute.cam.ac.uk
Contact information
Scientific
School of Healthcare
University of Leeds
Leeds
LS2 9JT
United Kingdom
 ORCID ID |
0000-0001-5551-9975 |
|---|---|
| Phone | +44 (0)113 343 1201 |
| Jane.O'Hara@thisinstitute.cam.ac.uk |
Study information
| Study design | Multi-centre interventional non-randomized study with qualitative data collection |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet. |
| Scientific title | Patient and family involvement in serious incident investigations: Developing and testing national and local guiding processes |
| Study acronym | PFI-SII |
| Study objectives | Research Aim: To co-design processes and resources to guide the role of patients and families in serious incident investigations at a national, and local level, and to test these processes to understand their impact upon experience, learning and likelihood of seeking legal recourse. |
| Ethics approval(s) | Approved 18/09/2020, East of England Cambridgeshire and Hertfordshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)20 7104 8096; lauragreenfield@nhs.net), ref: 20/EE/0133 |
| Health condition(s) or problem(s) studied | Guiding organisations to involve patients and families meaningfully in serious incident investigations, to support learning or reduce the likelihood of litigation. |
| Intervention | 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 of policies within England will explore how NHS Trusts involve patients and families in serious incident investigations. A scoping review will explore the involvement of patients and families in serious incident investigations and decisions to litigate. In Stage 2 (7-15 months) we will interview patients, families, investigators and staff (n=60) to support the development of the programme theory underpinning the co-designed processes. Data from these stages will be integrated into Stage 2B (months 13-15) to guide the co-design. In Stage 3 (16-21 months) we will co-design three parallel processes to involve patients and families in investigations, within national (Healthcare Safety Investigation Branch; 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 the feasibility and explore. During this time, a digital platform will be developed to house the guidance and resources. In Stage 5 (35-39 months) the final guidance and digital platform will be produced. Stage 4 methodology: Methodology The three co-designed processes (mental healthcare, acute healthcare, national level) will be assessed for feasibility and acceptability with patients, families, investigators and NHS healthcare staff within 25 real-life serious incident investigations over the course of 12 months, within 25 investigations: 5 at HSIB, and 5 at each of the four participating NHS Trusts. These 25 investigation cases will be sensitively and strategically chosen in collaboration with management at the respective organisations. We will identify and select investigation types that will serve as i) extreme / deviant cases; ii) maximum variation cases, and iii) critical cases. We will adopt a focused, pragmatic ethnographic approach to investigate how the new intervention is enacted and experienced in different socio-cultural and organisational contexts. We will use non-participant observations of investigation processes and ‘in situ’ ethnographic interviews with participating professionals, patients and family members. The ethnographic data will take the form of field notes, electronic summary records, interview transcripts and documents relating the investigation, report and actions. Intervention The intervention will be implemented by Investigators conducting the selected investigations. It will take the form of a guidance document including: (a) the relevant co-designed process, (b) a decision tree to establish with the patient and family their preferred level of involvement and (c) support materials/resources to support the investigators in implementing the new approaches. Duration Investigators will implement the intervention throughout the full ‘life-cycle’ of the sample investigations, anticipated to take around 60 days, in accordance with reporting requirements. Interviews take place before the investigation starts and on its conclusion. There is no follow-up. Participant involvement Upon a selected investigation being started the research team will be contacted by the relevant lead investigator from the participating NHS Trusts. An initial ‘briefing interview’ with the investigator will be arranged, and the schedule of meetings confirmed with the researchers. From this point, a field researcher will ‘shadow’ the investigator to describe the processes of evidence gathering and preliminary analysis, for example collecting witness statements. Preliminary interview will be arranged with the patient and/or family members to understand their expectations of the process and views about the incident - after they have been contacted by the lead investigator (n=25; one per investigation). Patients and family members will also be observed where they are provided with the co-produced guidance developed through Stage 3. All investigation meetings involving patients and family members will be observed, estimated between 3 and 5. The content and recommendations of each Investigation Report will be reviewed to determine the extent of influence of patient and family involvement. After the life-cycle has elapsed (i.e. within 60 days), a further series of interviews will be carried out with professionals and patient/family members (n=3- 5 per investigation: 75-125 in total) to understand their experiences of the investigation processes. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2019 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | N=3-5 participants per investigation; n=75-125 in total across the 25 investigations. |
| Total final enrolment | 61 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/12/2021 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Victoria Rd
Saltaire
Shipley
Bradford
BD18 3LD
United Kingdom
Thorpe Park Gardens
Leeds
LS15 8ZB
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Old Ively Road
Farnborough
Guildford
GU14 0LX
United Kingdom
Sponsor information
Hospital/treatment centre
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
England
United Kingdom
| Phone | +44 (0)1274 382575 |
|---|---|
| jane.dennison@bthft.nhs.uk | |
| Website | https://www.bradfordhospitals.nhs.uk/ |
"ROR" |
https://ror.org/05gekvn04 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We have a series of planned publications in high impact peer-reviewed journals: From stage 1 - 2 papers presenting the mapping of national policies, and the scoping review of the literature on patient and family experience of serious incident investigations and factors influencing decisions to litigate. From Stage 2 - one paper presenting the findings from the qualitative exploration of the experience of patients, families and healthcare professionals of serious incident investigations and decisions to litigate. We will also produce a suite of visual representations of the integrated findings, the common principles and the programme theory. In Stage 3A - one paper presenting the meta-level synthesis of Stage 1 & 2 findings, and how these were used within the stakeholder event to agree a common set of principles for involving patients and families in serious incident investigations. We will also complete a public facing report for policy makers summarising the common principles for involving patients and families in serious incident investigations, as agreed with stakeholders. In Stage 3B -one paper presenting the co-design process and the processes developed to support the involvement of patients and families in serious incident investigations, and the commonalities and differences between the three healthcare settings. We will also work iteratively with a website developer to build a prototype digital platform that can support the content guidance developed within the three healthcare settings. In Stage 4 - 2 papers presenting the feasibility and acceptability of the prototype guidance and the findings from the in-depth ethnography respectively. A key output here will be the final digital platform containing guidance and materials. One academic paper presenting a summary of the final stakeholder work to complete the platform. Public facing report for policy makers summarising the final stakeholder event and final version of the guidance produced. A project research summary is available at https://yhpstrc.org/wp-content/uploads/2019/10/PFI-SII-Summary-Research-Plan-1st-October-2019.pdf |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V2.0 | 08/03/2021 | 20/04/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/05/2025 | 28/05/2025 | Yes | No |
Additional files
- ISRCTN14463242_Protocol_V2.0_08Mar2021.docx
- Uploaded 20/04/2021
Editorial Notes
28/05/2025: Publication reference added.
10/05/2024: The intention to publish date was changed from 30/04/2024 to 30/06/2025.
01/05/2024: The following changes were made to the trial record:
1. The contact email was changed.
2. A contact was removed.
23/06/2023: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2023 to 30/06/2024 and the plain English summary updated accordingly.
2. The total final enrolment was added.
13/03/2023: The intention to publish date was changed from 30/09/2023 to 30/04/2024.
01/11/2022: The recruitment end date was changed from 31/12/2022 to 31/03/2023.
11/10/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/07/2022 to 31/12/2022.
2. The public contact has been changed.
15/07/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2022 to 30/06/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 31/03/2023 to 30/09/2023.
10/11/2021: The recruitment start date was changed from 01/10/2021 to 01/12/2021.
20/04/2021: Uploaded protocol Version 2.0, 08 March 2021 (not peer reviewed).
03/03/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
