Co-designing and testing the learn together guidance to support patient and family involvement in patient safety investigations: a mixed-methods study.

Background

There are multiple reasons for involving patients and families in incident investigations. Fiscally, costs due to clinical negligence claims approximate £4 billion annually. Logically, patients and families provide important information about patient safety incidents. Morally, involving harmed patients and families helps address their concerns. However, little United Kingdom-based evidence was available to support systematic involvement.

Objective

To co-design processes and resources to guide the involvement of patients and families in incident investigations at a national and local level, and to test these processes to understand their impact upon experience, learning and likelihood of litigation.

Design and methods

A mixed-methods programme of research was undertaken. Stage 1 comprised a scoping review of evidence for the experience of patients/families in incident investigations, and a documentary analysis of 43 National Health Service Trust incident investigation policies. Stage 2A extended this with 41 qualitative interviews with patients/families, healthcare staff and investigators. Stage 2B synthesised previous data to develop common principles and programme theory. Stage 3 involved a 6-month co-design phase with a 'co-design community' of > 50 stakeholders. In stages 4 and 5, co-designed guidance was evaluated in a 15-month ethnography, within four National Health Service Trusts and the national independent investigatory body. Twenty-nine investigations were followed in real time, including 127 interviews and 45 hours of observation. Four final co-design workshops supported iterations to the final guidance and website. A substudy explored meaningful involvement in, and learning from, investigations following suicide via interviews and a qualitative survey involving 32 people (healthcare staff, policy-makers and managers; people bereaved by suicide).

Findings

Stage 1 found stakeholders valued involvement, but it was not well supported by local policy, even though it likely reduces litigation. Stage 2A found a need for navigational support, and support for other needs. In stage 2B, 10 common principles and a programme theory were developed, emphasising the aim of reducing compounded harm, alongside promoting organisational learning. In stage 3, four draft guidance booklets and a training session were developed. Stage 4 found these to be feasible, with stakeholders positive about involvement, and generally agreed that it aided organisational learning. The guidance supported systematisation of involvement and encouraged relational working, but wider organisational challenges were highlighted. The substudy found that suicide was regarded as somewhat different to other safety events. Meaningful involvement was complicated by a range of factors and should be decoupled from postvention support.

Limitations

Undertaking research during the pandemic may have impacted sample representativeness in stage 2A. Ethnically minoritised and lower socioeconomic groups were under-represented across the programme.

Future research

Research should explore how people from minoritised groups experience investigations and any required adaptations to the approach. Research should also explore the possibilities for 'harm-centred' rather than 'incident-centred' responses to safety.

Conclusions

Investigations are complex, relational processes. Our guidance was found to be feasible, with stakeholders being positive about involvement and the impact on organisational learning. It may help to reduce the significant and long-lasting experience of compounded harm for patients and families. However, involvement may always be challenging due to the divergent needs of patients/families and organisations.

Study registration

This study is registered as Current Controlled Trials ISRCTN14463242.

Funding

This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 18/10/02) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 18. See the NIHR Funding and Awards website for further award information.

Around 10,000 patient safety incidents resulting in severe harm or death happen every year within the English National Health Service. As well as the burden of harm for patients and families, the cost of legal claims is large. Involving patients and families in investigating incidents may help to clarify why something went wrong. It can also help make sure that investigations answer their questions. However, there was a lack of evidence to help people investigating incidents do this well. This research aimed to develop and test processes to guide the involvement of patients and families in incident investigations, to improve learning for organisations, and the experience of patients and families. We spoke to patients and families, healthcare staff, and people who investigate incidents about their experience of investigations. We also looked at policies from National Health Service Trusts. We identified 10 ‘common principles’ that could help people investigating incidents to involve patients and families meaningfully. Then, with over 50 people (patients/families, staff, investigators, managers) we developed new involvement guidance (https://learn-together.org.uk/). We tested this guidance over 15 months in 29 investigations. One further small study also looked at investigation effectiveness after a death by suicide, and who should be involved. Everyone valued involvement and agreed it helped learning, but current guidance did not support it. Being part of an investigation was emotional and complicated, so information to help people understand and be involved was important. The testing of our guidance found that it supported investigators to involve patients and families, but the organisational systems they work in can make involvement difficult. Investigations after suicide are thought to be different to other incident investigations, and that support for bereaved families should be made available. The Learn Together guides may support involvement of patients and families, but investigators need to be trained and supported properly to make it work.