Background evidence

Stage 1: Literature review and documentary analysis

Months 1 – 15 (October 2019 – December 2020)

What we did:

1A) Literature Review

First, we wanted to better understand how patients and families are being involved in serious incident investigations and their experience of the process. To do this we undertook a literature review, of both academic publications and non-academic online sources (‘grey literature’). We screened over 5,000 potentially relevant academic papers to identify 24 relevant studies which we studied in depth. These studies explored patient, family and staff perspectives on involvement in investigations across acute, mental health, and maternity settings. We also identified and reviewed 39 online sources, including independent reports, NHS resources, publications by charities, research commentaries and videos.

1B) Documentary Analysis

Second, we wanted to understand what might be regarded as best practice for involving patients and families in serious incident investigations and to map out the ‘landscape’ in terms of Trust-level policies on this. We undertook a documentary analysis of a random sample of 45 serious incident investigation policies from acute and mental health NHS Trusts across England. From 103 Trusts contacted, we received 22 policy documents, which we increased to 45 through an additional online search. Our sample represented around 21% of acute Trusts and 25% of mental health Trusts in England. ​

What we found:

From identifying these sources of information, we synthesised the common themes across the literature. Our literature review found that most patients and families valued being involved; however, it was important that investigations were flexible and sensitive to both clinical and emotional aspects of care to avoid compounding harm. This included the following: early active listening with empathy for trauma, sincere and timely apology, fostering trust and transparency, making realistic timelines clear, and establishing effective non-adversarial communication. Most staff perceived that patient and family involvement could improve investigation quality, promote an open culture, and help ensure future safety. However, it was made difficult when multidisciplinary input was absent, workload and staff turnover were high, training and support needs were unmet, and fears surrounded litigation. Potential solutions included enhancing the clarity of roles and responsibilities, adequately training staff, and providing long and short-term support to stakeholders. Our review provides insights to ensure patient and family involvement in serious incident investigations considers both clinical and emotional aspects of care, is meaningful for all key stakeholders, and avoids compounding harm. However, significant gaps in the literature remain. You can access the review here.

Stage 2: Interviews and Synthesis of Findings

Months 1-15 (October 2019 – December 2020)

Here we wanted to:

1. To understand the context within which processes for supporting great involvement in serious incident investigations would operate.
2. To develop the programme theory that would underpin the co-designed investigation resources.

What we did:

2A) Interviews

We conducted an in-depth interview study with 50 participants (21 patients and families; 10 healthcare staff; 17 investigators; 2 legal staff) to understand experiences of being involved in serious incident investigations. We also explored staff views about involving patients and families in investigations. We recruited participants through our partner NHS Trust organisations and social media. Interviews were semi-structured so participants had flexibility to explore what was important to them, and took place by phone and online (e.g. through Zoom or Microsoft Teams). We used thematic analysis to generate overall findings reflecting common experience between, and divergence across, the different participant groups. A secondary analysis of the data is also specifically exploring the types of harm people experience as a result of investigation processes.

2B) Synthesis

To develop the programme theory, we held internal workshops after the interview study closed, to organise and synthesise all our findings from stage 1 and 2A. As an organising framework, we divided the investigation resources into four broad phases: (1) identification of incident/issue (2) disclosure (3) investigation (4) response/outcome. We reviewed all our findings through the lens of these temporal phases. Taking each stakeholder group in turn (patients and families; healthcare staff; investigators), we extracted data about their experiences and needs at each temporal phase, creating a large matrix.

What we found:

Two papers are currently being written up for publication in relation to the interview study.

Our main finding about people’s experiences was that serious incident investigations compound harm if involvement is poor or mishandled. This informed our programme theory that investigations need to support healing and restoration as well as learning – we termed this ‘Restorative Learning’. Our Restorative Learning theory went on to underpin the co-designed investigation resources. We also refined the common, human needs we identified into ’10 common principles for meaningful involvement’. These were iterated with a 50-strong co-design community and informed the co-design process (see stage 3).

Stage 3: Co-design

Months 19 – 24 (April – September  2021)

Our two goals for this stage were:

1. To iterate and agree the common principles for involvement.
2. To co-design three parallel processes for guiding patient and family involvement in mental healthcare, acute care and national level serious incident investigations, reflecting the common principles.

What we did:

This 6-month co-design phase started with an initial Stakeholder Event to share and iterate the ‘common principles for meaningful involvement’ and the programme theory. This was followed by two rounds of participatory workshops, organised across three parallel streams (acute, mental health, and national investigations). Each stream focused on refining/tailoring the common needs within their particular setting, and identified the best ways of addressing these to create great investigation resources. The workshops were followed by development sessions to iterate these processes and the accompanying support resources (‘outputs’). The co-design phase closed with a Stakeholder Sharing Event to finalise the agreed processes and outputs.

Due to COVID-19 social distancing, the full co-design process was implemented virtually by post, online Zoom sessions and a shared Miroboard.

We recruited 51 stakeholders to our virtual co-design community, including patients, family members, healthcare staff, investigators, family liaison officers, policy representatives from NHS England and Improvement and NHS Resolution, legal staff, academics, researchers and designers. All community members initially received a postal pack including a Welcome Booklet and a Rebuilding Investigations Kit, developed by designers at Lab4Living at Sheffield Hallam and the research team. The Rebuilding Investigations Kit was a board game for completion before the first virtual community meeting to reflect individually on the complexities of a serious incident investigation, including different perspectives and needs.

What we found:

As a result of the in-depth co-design phase, we designed the new Learn Together approach to involvement in incident investigations. Supporting this approach is our investigation resources. This includes information booklets for patients, family members and healthcare staff. We also co-designed a guidance booklet to support investigators to involve patients, families and staff at each stage of the investigation. This is based on three key communication touchpoints which include: initial contact, continued contact and closing contact. A separate booklet has been created to support family involvement in maternity investigations conducted by the Healthcare Safety Investigation Branch (HSIB).

Copies of these can be downloaded here.

The Learn Together investigation resources has been incorporated into NHS England and Improvement’s national policy for involvement within the new Patient Safety Incident Response Framework.

Stage 4: Implementation and evaluation of co-designed guidance in live investigations

Months 25 – 39 (October 2021 – December 2022)

What we did:

This stage is currently underway, and involves testing out the new co-designed guidance over 12 months in 25 live investigations: 5 at each of our four participating Trusts (two mental health; two acute care) and 5 at the Healthcare Safety Investigation Branch (HSIB). Our aims are to:

1. Determine if they are feasible and acceptable to patients, families, healthcare staff and investigators.
2. Understand if, and how, they influence learning, recommendations, action plans and decisions to litigate.

Investigation cases are being sensitively chosen with our partner organisations and will only be conducted by investigators trained in the new Learn Together process. To date, over 45 investigators across our five partner organisations have been trained in incorporating the Learn Together approach.
We are adopting a focused, pragmatic ethnographic approach to investigate how the guidance is enacted and experienced in different socio-cultural and organisational contexts. This involves observations to understand, for example, how patients and families are involved, how procedures are explained, the influence of status and power and any unwritten rules that seem to shape social order. It also involves ‘in situ’ interviews with participating professionals (e.g. healthcare staff, investigators, lawyers) and patients and family members. Our data involves field notes, summary records, interview transcripts and documents related to the investigation, report and actions.

What we found:

We will use open and thematic coding to develop accounts of common and distinct processes of investigation, participants’ expectations and experiences of these processes and the types of learning and recommendations developed.

Stage 5: Refine and share guidance

Months 40 – 45 (January – June 2023)

What we did:

Based on learning from Stage 4, we revised the guidance to ensure that it met our aims, and the needs of key stakeholders including patients, families, healthcare staff and investigators.

What we found:

We shared the final versions of the Learn Together guides, website and supporting resources with our research community in May 2023. Over the next year, we will be working with the NHS England Patient Safety Policy Team to revisit the national guidance document that sits alongside the new Patient Safety Incident Response Framework (PSIRF), to integrate the learning from this programme.