ABSTRACT Background Patient safety incidents cause substantial harm globally, with affected patients and families often experiencing additional ‘compounded harm’ from inadequate organisational responses. Despite policy imperatives emphasising engagement as essential for safety improvement, significant gaps persist in the National Health Service (NHS), where involvement in Serious Incident (SI) investigations is often overlooked or treated as a p2assive process. While previous qualitative research has primarily used thematic analysis, discourse analytic approaches can offer deeper insights into nuanced patterns of meaning. Design/Objective We conducted discourse analysis on 49 semi‐structured interviews with healthcare professionals across six NHS Trusts to examine how staff construct agency in their accounts of engaging patients and families in SI investigations and how these discourses are linked to the broader organisational context. Results Findings illustrate two prevailing but contested discourses: one depicting staff engagement with patients and families as inconsistent and limited, and the other emphasising their integral role in the investigation process. Interviewees framed themselves as either powerless or powerful, aligning with these respective discourses, while organisational factors, such as professional roles and work relationships, also influenced those constructions. Discussion A focus on the linguistic construction of agency, control and responsibility provides a powerful lens for understanding persistent gaps in patient and family engagement and highlights the value of incorporating discourse analytic approaches into health policy development and implementation. Patient or Public Contribution A Citizens' Panel ( n = 16) was involved throughout the broader research programme, ensuring public accountability; supporting wider discussions about the emergent findings of the research and their implications for fairness, equality, diversity and inclusion; and supporting the dissemination of findings in creative and accessible ways.

Parks are important spaces to engage with physical activity (PA) for adolescents, but challenges remain in transforming them into inclusive spaces for adolescent girls. Guided by intersectionality as a critical inquiry and praxis, with gendered understanding of Lefebvre’s notion of ‘the right to the city’, this paper presents a whole-of-community approach to co-produce local park-based PA interventions for ethnically diverse adolescent girls in socio-economically deprived urban areas in Bradford, United Kingdom (UK). We facilitated eight workshops, each was comprised of photo-elicitation discussion and feeding back research findings activities, with 37 adolescent girls, boys, and parents across two local parks – one was in a predominantly White British neighbourhood, and the other British Pakistani which was also co-developed with local adolescent girls. Three themes from the workshops are: 1) the limitations of focusing on park quality; 2) social support to improve adolescent girls’ confidence as active citizens, and; 3) multi-sited educational interventions to transform restrictive gender norms. Building on these themes, intervention ideas related to walking, youth workers, and Park Ambassadors are assembled into complex interventions called Girls and Their Parks (S-PARKS). We also call for greater use of a whole-of-community approach to intersectionality for co-producing PA interventions for adolescent girls.

Prison health is intricately connected to public health given the significant burden of poor health which the majority of people in prison experience. Prison healthcare suffers from chronic understaffing, mostly due to macroeconomic austerity. The COVID-19 pandemic inflicted extensive damage on this already fragile milieu. We employ decentred theory as a sensitising concept to articulate competing narratives about prison healthcare decision-making during the pandemic. We predominantly draw upon 44 interviews conducted in 2021. We found that non-urgent healthcare provision almost collapsed with exhausted healthcare staff trying to deliver a reduced service to patients who felt abandoned. Consequently, our analysis portrayed narratives of suffering, trauma and injustice that were experienced in markedly different ways. Many participants compared a muddled and un(der)funded prison healthcare COVID-19 strategy against that of well financed community healthcare. Decision makers implicitly competed with each other over lines of accountability and responsibility. The research process itself was distorted and resisted by various actors in both overt and covert ways. We argue that prison healthcare is emblematic of a devalued and underfunded public healthcare agenda where actors have been physically and emotionally harmed by habiting space within a struggling institution during the largest public health crisis of the past century.

Introduction Effective communication is central to safe, ethical maternity care. Women with cross-cultural communication needs are more likely to experience intersecting disadvantage, with poor maternal and infant outcomes. A professionally trained interpreter (PTI) can raise the quality of clinical care for patients to approach or equal that for patients without cross-cultural communication needs. The need to improve interpreter services has been recognised at the strategic level of the NHS to improve safety and personalised care. However, evidence for how to achieve this is limited from the UK context.Methods We explored the experiences of PTIs working in maternity services in England using qualitative interviews. We analysed the data thematically, informed by Critical Race Theory, which argues that inequality is deeply embedded in policy, law and institutional structures and practices. We discussed interim findings with our lived experience group.Results We interviewed 28 interpreters with a range of qualifications who worked for language agencies or in-house NHS interpreting services. Our analysis constructed three themes: The ‘shady’ agency; ‘You can get anyone and you don’t know how experienced they are’; ‘you are never part of a team’. We found that institutional practices and outsourcing marginalise interpreters, compromising worker well-being and patient safety.Conclusion To ensure patient safety, it is essential for the NHS to recognise the professional status of medical interpreters and integrate PTIs into the core clinical team. This will require investment in standardised interpreter training, access to supervision and career development. Embedding interpreters in NHS safety culture is essential for equitable and effective care.

Background The Peripheral Arterial Disease Quality Improvement Programme (PAD QIP) was a quality improvement (QI) collaborative between 11 English vascular surgery centres from May 2020 to May 2022, aiming to expedite treatment for PAD. This qualitative study explored beliefs about the PAD QIP and barriers and facilitators to implementation of changes in vascular surgery.Methods Sixteen semi-structured interviews were conducted with clinicians from the vascular centres that participated in the PAD QIP and were analysed using framework analysis, based on the five broad domains within the Consolidated Framework for Implementation Research.Results Five themes captured the main factors that affected the implementation of changes in the pathway of patients with chronic limb-threatening ischaemia: the programme, the benefit for patients, the role of the team, the resources and organisational processes, and the polarising effect of COVID-19. Regarding the programme, participants stated that the concrete timeframes, external performance monitoring, peer comparison and the programme’s national reach helped them obtain resources to implement changes. Learning from and sharing experiences with others was also useful. Accurate performance data were considered essential for leveraging resources, but data entry was onerous and required dedicated staff. The view that the programme was beneficial for patients, the support of a team of healthcare professionals and organisational support in the form of resources were important requirements for implementation, while the COVID-19 pandemic also played a crucial role as a contextual factor beyond the control of the participants. The main factors that differed between high-implementation and low-implementation centres were team beliefs, team structure, team compatibility, networks/communication, resources, implementation climate, relative priority and evidence strength.Conclusions This QI collaborative facilitated the implementation of changes according to participants, while team and organisational support was crucial.

INTRODUCTION:Food insecurity reduces people's chances to live healthy and active lives and places a significant burden on healthcare systems. Levels have significantly increased in the UK since 2010, due to the impact of austerity and, more recently, the COVID-19 pandemic and the cost of living crisis. This increase is projected to continue. Households with children are amongst those at highest risk for food insecurity. A variety of community food organisations (CFOs), such as community gardens, community kitchens, food banks and social markets, have been essential in responding to rising food insecurity, including providing emergency food and other types of support such as welfare advice. However, beyond food banks, little is known about differing approaches to food aid in the UK, including how these organisations provide additional services to address the underlying issue that has led someone to seek emergency food support. AIM:To understand what approaches used by community food organisations are most likely to help prevent the need for emergency food in two multicultural communities in the North (Bradford) and South (Tower Hamlets, London) of England, with high levels of ill-health and food insecurity. RESEARCH DESIGN, SETTING AND PARTICIPANTS:This is a mixed methods study informed by complex systems theory. Methods include participatory systems mapping and qualitative longitudinal research. We will map the availability and type of help with food, and produce a typology of CFO approaches, using a survey, multiple local and national participatory system mapping workshops and interviews with local and national stakeholders (WP1). Then, we will conduct a longitudinal qualitative research using a 'researcher in residence' approach in up to 10 CFOs purposively sampled to reflect the diversity of prevention strategies adopted by CFOs. Research will include: a) a 12 month ethnographic study; b) three waves of 'go along' interviews with up to 35 families; and c) a visual study where the same families are invited to share photos and videos about their food thoughts via Indeemo research app. OUTPUTS AND DISSEMINATION:Outputs will include: a) a toolkit on CFOs to support local and national policy and implementation decisions, b) a travelling exhibition with visual representations of people's lived experiences c) publications in academic journals, d) blog posts, e) public talks, and f) policy briefs. Findings will help decision makers to invest in the most accessible, beneficial and culturally appropriate resources for communities.

BackgroundWhilst patients and families can and do support patient safety in several ways, empirical evidence for the specific impact of involvement in patient safety incident investigations and their outcomes, has been limited, with little information about how to undertake involvement meaningfully.AimWe aimed to (i) develop a set of common principles to guide involvement of patients and families in patient safety incident investigations; (ii) develop a working programme theory for how these might be enacted; (iii) co-design guidance to support the meaningful involvement of patients and families in patient safety incident investigations.MethodsWe synthesised three existing data sets (a literature review, a documentary analysis of incident investigation policies and 42 interviews with patients, families, lawyers, incident investigators, and healthcare staff) relating to patient and family involvement in incident investigations. Ten common principles and a working programme theory were drafted. Within a convened co-design community, we then developed guidance for patients, families, staff, and investigators in local NHS Trust and national investigations, via a series of workshops.FindingsWe developed ten ‘common principles” and a working programme theory for an approach that might support meaningful patient and family involvement in incidents investigations. Based on these principles and the programme theory, we co-designed guidance to be used within NHS Trust and national investigations of harm that follow patient safety incidents. The guidance includes information, resources and tools to enable better understanding and practice, from the perspective of patients, families, investigators and staff, on how to be meaningfully involved.ConclusionsOur ten common principles and co-designed guidance emphasise two key things. First, that organizational learning is not the only desired outcome for incident investigations, with patients, families and staff reporting the need for restoration and repair. Second, that investigations can be part of reparation, but when it fails to address the needs of stakeholders arising from investigations, it can compound the harm of the original incident. As a result, we juxtapose existing theories, and illuminate new insights, proposing a theory of “restorative learning”. We see design as an ongoing phenomenon—the guidance is our current iteration, and we learnt several valuable lessons about doing co-design.

BACKGROUND:In England online services in general practice encompass a range of provision from ordering repeat medication to having a consultation. Some groups of individuals may find accessing and/or using such services difficult and may require 'digital facilitation', that is the range of processes, procedures, and personnel which seeks to support NHS patients in their uptake and use of online services. AIM:To gain insight, from the perspective of general practice staff and patients/carers, into how and why digital facilitation might lead to benefits, and the key processes involved in supporting patients to use online services. DESIGN AND SETTING:Eight general practices across England with varied geographical and sociodemographic characteristics were included in the study. METHOD:This was a focused ethnographic case study of observations and interviews (N = 69). RESULTS:Typically, digital facilitation was delivered in an ad hoc fashion to individual patients. Online services were delivered via multiple systems each working differently and creating a need for support so that patients could access them. Younger practice staff were expected to deliver support on account of their age, despite there being no evidence of age-related training and experience. It was understood by practice staff that patients with challenging personal circumstances may require specific support to access online services. CONCLUSION:At present patient use of online services is supported by digital facilitation that is primarily delivered by reception staff. Supporting patients to use online services requires review of how many services are provided and what for, and consideration for the time and effort needed to support patients to use them.

Background Transitions from hospital to home are a risky time for older people (aged 75 years and older). Unplanned and often avoidable hospital re-admissions are therefore high in this group. This research aimed to understand if increased involvement of older people in their care in hospital would improve the safety and experience of care transitions. Objectives In six work packages we set out to: understand patient and carer involvement in and experience of care transitions explore staff experiences of delivering good transitional care develop and validate a new measure (the Partners at Care Transitions Measure) to assess patient experience and safety during care transitions create a theory and logic model to inform the co-designed transitions intervention followed by a formative evaluation test the feasibility of delivering a trial to evaluate the intervention evaluate the clinical- and cost-effectiveness of the transitions intervention with a parallel process evaluation. Design Qualitative methods (1 and 2), literature reviewing, Delphi techniques and validation testing (3), co-design (4), cluster feasibility trial (5) and cluster randomised controlled trial (6). Settings National Health Service acute hospital trusts, general practices, patients and carer homes across the north of England, United Kingdom. Participants Patients aged 75 years and older and their caregivers. National Health Service staff working in acute National Health Service trusts on wards delivering the intervention. Intervention ‘Your Care Needs You’ intervention to support patient and carer involvement in hospital care in preparation for returning home. This comprised fixed components: a booklet, an advice sheet for managing at home and a film; and flexible components: ongoing staff involvement of patients through multiple approaches. Implementation included a nominated lead, staff training and posters. Main outcome measures Primary outcome was unplanned 30-day hospital re-admissions. Secondary outcomes included: unplanned 60- and 90-day hospital re-admissions; quality of transition; health-related quality of life (EuroQol-5 Dimensions, five-level version); and self-reported healthcare resource use. Data sources National Health Service Secondary Use Services data and Hospital Episodes data for work package 2 and routinely recorded National Health Service acute trust hospital data on re-admissions for work packages 5 and 6. Review methods Systematic narrative review for preparatory work on patient involvement; narrative meta review of transitions interventions; scoping review of transitions measures. Results Work package 1: Six themes relating to patient experience of care transitions. Patient involvement in hospital care found to be challenging ‘work’ that was often invisible to staff. Work package 2: National Health Service staff reported that high-quality care transitions were facilitated primarily through trust and strong relationships. Work package 3: A measure of quality and safety of care transitions (Partners at Care Transitions Measure) developed and validated with good internal reliability and internal consistency. Work package 4: An intervention called ‘Your Care Needs You’ that required revisions to support implementation. Work package 5: Primary outcome data were collected for 90% of participants. Follow-up questionnaire response rates were lower than anticipated (75% vs. 85%). Information on the acceptability, usability and implementation of the intervention informed iterations to the intervention and implementation package. Work package 6: 4947 participants from 39 hospital wards took part in the main trial. Six hundred and thirteen participants from 35 wards took part in the nested cohort. No differences were observed in the primary outcome of unplanned re-admission (Y/N) at 30 days post discharge [17% experienced re-admission within 30 days in the ‘Your Care Needs You’ group, 18% in care-as-usual, odds ratio: (0.93; 95% confidence interval, 0.78 to 1.10; p = 0.372)], and also at 60 and 90 days post discharge but all results were in favour of the intervention with a reduction in total re-admissions of 13% over 90 days [incidence rate ratio: 0.87 (0.76 to 0.99), p = 0.039]. There was a statistically significant reduction in Partners at Care Transitions Measure safety concerns at 30 days post discharge. The intervention is likely to be cost-effective. Limitations The main trial was conducted during the COVID-19 pandemic which exacerbated staffing challenges and limited opportunities to enhance and support implementation of the intervention. Participant recruitment to the nested study was challenging, resulting in fewer patients than planned and a less diverse sample than that included in the primary cohort. Therefore, while our primary cohort is representative of the patients in the hospital during the trial period, the nested cohort may suffer from some bias. Conclusions The ‘Your Care Needs You’ intervention offers a way to support staff and patients/families to facilitate greater involvement in care. This research demonstrates that increased involvement in hospital care has the potential to improve safety at transitions. Finding ways to support staff to encourage better patient involvement could lead to even more benefits being realised. Future work Hospitals could consider involving volunteers in supporting greater patient and family involvement. There was some indication that the component of the intervention most favoured was the patient advice for discharge. Trial registration This trial is registered as Current Controlled Trials ISRCTN51154948 (WP5) and ISRCTN17062524 (WP6). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20017) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 4. See the NIHR Funding and Awards website for further award information. Plain language summary Moving from hospital to home (the ‘transition’) is a risky time for older patients (75+ years). Around 18% of patients end up back in hospital as an emergency. Most of the time, these re-admissions cannot be avoided, but oftentimes they can. In this research, we wanted to understand and improve the experience and safety of care for older people as they move from hospital to home to reduce unnecessary hospital re-admissions. To do this, we conducted six pieces of research (called work packages). First, we tried to understand from patients, families and staff how they experienced care transitions. Next, we developed a tool to measure these experiences. We then worked with staff and patients and members of the public to develop an approach (called ‘Your Care Needs You’), to help involve and prepare older people for going home after a hospital stay. ‘Your Care Needs You’ included a booklet, an advice sheet for managing at home, and a film, for patients. We then ran a trial to find out if people who received ‘Your Care Needs You’ were less likely to go back into hospital. For this, we put ‘Your Care Needs You’ into 18 wards and compared hospital re-admissions there with 21 wards which delivered care as usual. We found that the rate at which patients were re-admitted to hospital was better in the ‘Your Care Needs You’ wards but this was not significantly better. Three months after discharge, the number of people being re-admitted to the hospital was 13% less in the ‘Your Care Needs You’ wards. The approach also reduced the problems that people experienced (such as falls) around 1 month after discharge. We found that many of the wards did not deliver the approach as planned, so not all patients got ‘Your Care Needs You’. This was mainly because of staffing pressures after the COVID-19 pandemic. While some patients found the approach useful, others thought it was not for them. The approach is cheap to deliver and, on balance, is worth the cost. Scientific summary Background For older people and those with complex needs, the transition from hospital to home is risky. Approximately one in five patients experience an adverse event; two-thirds of which could be prevented or ameliorated. Rates of unplanned hospital re-admissions have increased over the last 10 years, particularly for older people. Systematic reviews of transition interventions reveal that most include multiple elements, with strategies prior to and following discharge and variable success. Knowing which of these elements represent the active ingredients is important for the management of scarce resources. There is some suggestion that interventions that seek to involve patients are most effective, but no definitive evidence. Here we address this gap in understanding. Aim To investigate whether greater involvement of patients and their families can improve patient experience and safety at transitions. Objectives Work package 1 To capture the experiences of older patients (75 years +) and their families during the transition from hospital to home. To identify opportunities for greater patient involvement in care. Work package 2 To explore how high-performing teams successfully deliver safe care to older people during transitions. Work package 3 To develop a measure of the quality-of-care transitions. Work package 4 To develop and test the acceptability of the transition intervention. Work package 5 To assess the feasibility of the ‘Your Care Needs You’ (YCNY) intervention and trial processes. Work package 6 To determine the clinical effectiveness of YCNY in a full cluster randomised controlled trial (cRCT). To determine the cost-effectiveness of YCNY compared to care as usual. Methods Work package 1: Qualitative study of patient and family experience of care transitions A longitudinal ethnographic study in two NHS Trusts exploring the involvement and experience of 32 community-dwelling older patients (75 years +) and 18 family members during their transitions from hospital to home. Semistructured interviews at up to five points from hospital admission to 3 months post discharge, supplemented with non-participant observations and go-along interviews. Data were analysed using thematic analysis. Work package 2: Qualitative study exploring how high-performing teams support care transitions A positive deviance approach to identify four wards and six general practices showing exceptionally low or reducing rates of hospital re-admissions compared to similar services. Semistructured interviews and focus groups with 157 multidisciplinary staff and observation of 9 discharge meetings. Interviews and focus groups were recorded and transcribed verbatim and data analysed using a pen-portrait approach. Work package 3: Development and testing of a care transitions measure Measure development and pilot testing A conceptual model of the transitional period developed based on findings from literature reviews and WP1 findings. A pool of items tapping into the constructs of this model was refined and simplified resulting in a two-part measure: Partners at Care Transitions Measure 1 (PACT-M1) and Partners at Care Transitions Measure 2 (PACT-M2). PACT-M1 underwent pilot testing with 15 older patients. Descriptive statistics and frequencies were calculated for each questionnaire item. Measure validation A validation study measuring internal reliability and internal consistency in the PACT-M1 and PACT-M2 within one NHS hospital trust. Eligible patients were administered the questionnaire by telephone and post. Reliability was assessed using Cronbach’s alpha and exploratory factor analysis used to evaluate dimensionality. Response rates and missing data were scrutinised and subscales refined. Work package 4: Development and refinement of a care transitions intervention Intervention development Functional resonance analysis method was used to model the transition process. This revealed the informal handover of four functional care activities to patients and families at discharge: management of medications; daily activities; health conditions; and escalation processes. The programme theory proposed that for patients to manage these activities they would need to practise them in hospital. A scoping review and stakeholder workshops supported the development of the Partners at Care Transitions (PACT) intervention. Formative evaluation and intervention refinement A formative evaluation to explore the acceptability and usability of the prototype intervention and identified implementation strategies. On 3 wards in 1 NHS trust, we recruited 25 older patients and interviewed 15 staff and 6 informal carers. Data collection using semistructured interviews and observations of intervention use. Analysis was iterative, using template analysis and group discussions leading to intervention refinement and the YCNY intervention. Work package 5: Trial feasibility study of Your Care Needs You A cRCT was conducted to test the feasibility of the YCNY intervention and trial methodology. Wards caring for older people were recruited and randomised on a 3 : 2 basis. The feasibility of accessing hospital re-admission data for our primary outcome together with other trial critical data capture was assessed. We also tested the process of data collection for our secondary outcomes, patient experience (measured by PACT-M) at 5, 30 and 90 days post discharge. We aimed to recruit 20 older patients per ward, over a 4- to 5-month period. The feasibility of conducting a full cost-effectiveness analysis was evaluated. Acceptability, usefulness and feasibility of the intervention and implementation package were assessed by observations and interviews. Work package 6: Cluster randomised controlled trial assessing the clinical effectiveness, cost-effectiveness and fidelity of Your Care Needs You with parallel process evaluation Clinical effectiveness trial data collection A cRCT of YCNY. Forty wards, covering a range of specialties and routinely caring for older people, from 11 NHS Trusts were randomly allocated equally to 1 of 2 arms: intervention or care-as-usual (control). Wards were stratified by specialty, the percentage of patients over 75 years, and NHS trust. Our primary outcome measure of 30-day unplanned hospital re-admission rates (routine data) required a sample size of 5440 based on a 10% attrition rate to detect a 4.5% difference in re-admissions with 80% power. We used a nested cohort to assess the quality of transitions (PACT-M and the validated Care Transition Measure-3) as secondary outcomes. Allowing for clustering and attrition, this required a sample size of 1000 for 80% power. Clinical effectiveness analysis Analysis for the primary outcome (30-day unplanned hospital re-admissions) included treatment allocation, ward type, baseline ward re-admission rate, percentage of patients 75 + and gender as fixed effects and trust and ward as random effects to account for clustering. Two sensitivity analyses were conducted as well as a secondary complier-average causal effect analysis to assess the impact of fidelity on outcomes. The same model specifications were used for the 60- and 90-day re-admission data. A mixed-effects linear regression approach was used to analyse patient experience measures [PACT-M and Coleman’s Transition Measure-3 (CTM-3)] data and similar sensitivity analysis to those for the primary outcome were applied. All other data were summarised descriptively. Fidelity data collection and analysis We used the modified Conceptual Framework for Implementation to underpin frame fidelity assessment. Data were gathered from all intervention wards using a 26-item measure covering intervention delivery, receipt, engagement with and usefulness. An overall score from 0 to 3 was calculated, with three representing high fidelity. Health economics analysis Short-term cost-effectiveness (during the first 90 days post discharge) was calculated from the mean costs of intervention delivery (intervention group) and service utilisation (both groups) and quality-adjusted life-years (QALYs) for each group generated within the trial. Long-term (over a lifetime) cost-effectiveness was calculated using a de novo hybrid model comprising a decision-tree model and a partitioned survival model. Process evaluation data collection and analysis A process evaluation on eight intervention wards (across four trusts) to understand how the intervention was delivered, received and used by staff and patients and how this was shaped by context. We interviewed 23 staff and 19 patients (pre and post discharge) and conducted 94 hours of ward observations. Interview data in the form of recordings and detailed notes were analysed using constant comparison to identify themes/subthemes. Results Work package 1: Qualitative study of patient and family involvement and experience of care transitions We identified six themes relating to: a disappointing discharge; delivery and receipt of community care; involvement (in care), choice and decision-making; information provision; physical and social environment; and medicines. While people mostly felt safe and cared for in hospital, many ‘handed over’ their care and so were unprepared for picking this back up when they returned home. Work package 2: Qualitative study exploring how teams support care transitions Three themes were identified that demonstrate how high-performing teams support safe care transitions: building relationships with patients based on a holistic understanding of their needs; having relationships with other staff (within and across teams) based on valuing and trusting one another; and bridging gaps in care by enhanced communication, adjusting patient expectations and adapting to competing priorities. Despite being identified as high-performing, staff in these teams described that delivering exceptionally safe care was very challenging and only possible for the most complex patients. Work package 3: Development and testing of a measure of care transitions Development and pilot testing Through modelling of transitions and item generation and refinement a measure comprising two parts: PACT-M1 administered to patients shortly after discharge with eight items measuring experiences of preparedness for managing at home and seven safety items measuring post-discharge adverse events; and the PACT-M2, administered 1 month post discharge with eight items measuring the patient experience of managing care at home and the same adverse event items. Participants reported that items were easy to understand and complete. Measure validation One hundred and eighty-five patients were recruited. Response rates were 75% (n = 138) at time point 1, 59% (n = 110) at time point 2 and 50% (n = 92) at time point 3. Reliability analyses of the PACT-M1 and PACT-M2 were good (α = 0.84 and 0.92, respectively). The factor analysis revealed a single-factor solution explaining 44% of the variance for PACT-M1 and 60% for PACT-M2. All items were retained. Work package 4: Development and refinement of a transitions intervention Intervention development Guided by stakeholder workshops with patients and staff we co-designed a prototype intervention to support management of the four key functions (see above): knowing more, moving more, managing medicines and escalation. A scoping review and activities to consolidate all available evidence-supported intervention development. Formative evaluation and intervention refinement Staff and patients saw the value in, and need for, the intervention, but several challenges with the acceptability and usability of the prototype were identified. Examples include the messages within the booklet not being strong enough and the lack of time to complete the discharge template (by staff). We identified implementation strategies and key changes to the intervention. Work package 5: Trial feasibility study of the Partners at Care Transitions intervention We randomised 10 wards (6 to intervention and 4 to control) across 3 NHS Trusts. Subsequently, due to extreme staff shortages, five wards could not participate but were retained and treated according to their randomised allocation. Of 721 patients screened, 161 were recruited (95 intervention, 66 control). Routine primary outcome data were gathered for 90% of participants. Item completion within questionnaires was high. The COVID-19 pandemic meant follow-up data collection ceased early. Patient attrition rate (17.4%; n = 28) was higher than expected (10%). Data on usability, acceptability and implementation were gathered from 10 patients and 17 staff alongside 91 ward-level observations. Staff reported the need for, and value of, the intervention and patients varied in their views about its value and manner in how they engaged with it. Full implementation of the intervention was challenging because of staff shortages, lack of information technology embedding/integration (film and discharge summary), lack of buy-in from the wider ward team and organisational impediments. We responded to these challenges by modifying the intervention and enhancing the implementation strategy. Work package 6: Cluster randomised controlled trial of the Partners at Care Transitions intervention A total of 4947 patients from 39 wards were included in the primary analysis cohort. For the nested cohort, 613 participants from 35 wards were recruited. Clinical effectiveness There was no significant difference in the primary outcome of unplanned 30-day re-admissions or 60 or 90 days (as odds ratios) between intervention and control. However, at all time points, the rate was lower in the intervention group. Total number of re-admissions was also lower in the intervention group at all time points and this reached statistical significance across 90 days post discharge with 13% fewer re-admissions. At 30 days post discharge, significant differences were observed in PACT-M adverse event items and in the CTM-3 in favour of the intervention but not at other times. Fidelity Twenty-three per cent of patients reported receiving booklets and 77% found them useful or very useful. Further, 29% of patients reported receiving the advice sheet for managing at home and 86% found them useful or very useful. Overall fidelity to the intervention was moderate for majority of wards (n = 11, 68.75%) and low for the remaining five (31.25%). Fidelity to the intervention had no impact on re-admissions at 30 days. Cost-effectiveness In the short term, differences in costs and QALYs were in favour of the intervention, suggesting that the intervention could be cost-effective. Similarly in the longer term (over a lifetime), the intervention is likely to be cost-effective. Process evaluation While the core values of the intervention appeared to be understood and valued by the staff, translating this into practice was oftentimes challenging and the patients interviewed felt they already had the knowledge in the booklet. Conclusion We developed a novel intervention called YCNY to support safety and experience for older people leaving hospital and going home. We also developed and validated (PACT-M) to measure patient experience and safety during care transitions. A randomised controlled trial of YCNY found some evidence of clinical benefit with the majority of results in favour of YCNY, although only secondary outcomes were statistically significant (total number of unplanned re-admissions after 3 months and the number of patient-reported adverse events after 30 days). YCNY is likely to be cost-effective in both the short term and long term. Staff valued YCNY intervention, but they struggled to fully implement it in the challenging post-COVID era. Implications for health care There is some promise for promoting safety at transitions from hospital to home through greater involvement of patients and their relatives in their care. To optimise the potential gains, staff need to engage differently with patients, and this was not always possible in the current depleted healthcare system. The intervention is freely available to all NHS hospitals. Recommendations for research Further research is needed to explore opportunities for developing and delivering an intervention to support patient involvement in care before hospital admission. Patients found the advice sheet for managing at home (a component of the YCNY intervention) to be the most useful. Further research is needed to develop a systems-integrated patient-friendly discharge summary. The methodology of fidelity assessments for complex healthcare interventions requires further development. Trial registration This trial is registered as Current Controlled Trials ISRCTN51154948 (WP5) and ISRCTN17062524 (WP6). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20017) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 4. See the NIHR Funding and Awards website for further award information.

BackgroundExpectations of patient and family involvement in investigations of healthcare harm are becoming conventional. Nonetheless, how people should be involved, is less clear. Therefore, the “Learn Together” guidance was co-designed, aiming to provide practical and emotional support to investigators, patients and families.AimTo longitudinally evaluate use of the Learn Together guidance in practice—designed to support patient and family involvement in investigations of healthcare harm.MethodsA 15-month process evaluation took place across five sites, following 29 investigations in which the Learn Together guidance was used. Sites comprised two mental health and two physical health hospital Trusts, and an independent maternity investigatory body in England. Longitudinally, 127 interviews were conducted with investigators, patients, families, staff, and management. Interview and observational data were synthesized using Pen Portraits and analyzed using multi-case thematic analysis.FindingsThe guidance supported the systematic involvement of patients and families in investigations of healthcare harm and informed them how, why, and when to be involved across settings. However, within hospital Trusts, investigators often had to conduct “pre-investigations” to source appropriate details of people to contact, juggle ethical dilemmas of involving vs. re-traumatizing, and work within contexts of unclear organizational processes and responsibilities. These issues were largely circumvented when investigations were conducted by an independent body, due to better established processes, infrastructure and resources, however independence did introduce challenge to the rebuilding of relationships between families and the hospital Trust. Across settings, the involvement of patients and families fluctuated over time and sharing a draft investigation report marked an important part of the process—perhaps symbolic of organizational ethos surrounding involvement. This was made particularly difficult within hospital Trusts, as investigators often had to navigate systemic barriers alone. Organizational learning was also a challenge across settings.ConclusionsInvestigations of healthcare harm are complex, relational processes that have the potential to either repair, or compound harm. The Learn Together guidance helped to support patient and family involvement and the evaluation led to further revisions, to better inform and support patients, families and investigators in ways that meet their needs (https://learn-together.org.uk). In particular, the five-stage process is designed to center the needs of patients and families to be heard, and their experiences dignified, before moving to address organizational needs for learning and improvement. However, as a healthcare system, we call for more formal recognition, support and training for the complex challenges investigators face—beyond clinical skills, as well as the appropriate and flexible infrastructure to enable a receptive organizational culture and context for meaningful patient and family involvement.

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.

Background Transitions from hospital to home are risky for older people. The role of patient involvement in supporting safe transitions is unclear. Objective To assess the clinical effectiveness of an intervention to improve the safety and experience of care transitions for older people. Trial design Cluster randomised controlled trial. Participants Eleven National Health Service acute hospital trusts and 42 wards (clusters) routinely providing care for older people (aged 75 years and older) planning to transition back home. Intervention Patient involvement ward-level intervention—Your Care Needs You (YCNY). Outcomes Unplanned hospital readmission rates within 30 days of discharge (primary outcome). Secondary outcomes included readmissions at 60 and 90 days post-discharge, experience of transitions and safety events. Randomisation Ward as the unit of randomisation from varying medical specialities randomised to YCNY or care-as-usual on a 1:1 basis. Blinding Ward staff, research nurses and researchers were unblinded. Patients were unaware of treatment allocation. Statisticians were blinded to the primary outcome data until statistical analysis plan sign-off. Results Using a mixed effects logistic regression we saw no significant difference in unplanned 30-day readmission rates (OR 0.93; 95% CI, 0.78 to 1.10; P = .372) between intervention (17%) and control (19%). At all timepoints, rates were lower in the intervention group. The total number of readmissions was lower in the intervention group (all timepoints) reaching statistical significance across 90-days with 13% fewer readmissions (IRR: 0.87; 95% CI 0.76 to 0.99) than the control. At 30-days only, intervention group patients reported better experiences of transitions and significantly fewer safety events. Serious adverse events were similarly observed in both groups [YCNY: 26 (52.0%), Care-as-usual: 24 (48.0%)]. None related to treatment. Conclusions YCNY did not significantly impact on unplanned hospital readmissions at 30 days but in some secondary outcomes we did find evidence of clinical benefit.

OBJECTIVE:School food and catering constitutes the largest area of public sector food spend in the UK, with the potential to influence health on a population scale. This review sought to understand and map the existing evidence linking school meals contracts for food procurement with the quality of food provided and health and academic outcomes for school children. DESIGN:A scoping review of the peer reviewed and grey literature published between 1988 and 2023 was conducted. The strategy searched in Medline, Web of Science, Scopus, ERIC and Google, using key words related to population, exposure and outcomes. SETTING:UK and International. PARTICIPANTS:School meal services. RESULTS:Thirty documents were included representing 16 papers, 3 books and 11 reports. Documents revealed a complex and fragmented school meal provision system and inconsistent evidence relating to the outcomes of interest. Most studies focused on sustainability or nutrition/ guideline compliance and the main types of food providers discussed were commercial contractors, local authorities and in house catering. However, there was a lack of clarity in contract specifications and definitions of quality and concerns over compliance monitoring and financial viability impacting quality. We found no substantial body of peer reviewed research linking school food procurement contract type with food quality or outcomes of interest. CONCLUSIONS:The lack of research in this area (and conflicting findings) meant that it was impossible to draw robust conclusions on the benefits of using any particular contract provision type over another. Given the magnitude of public sector spending and the need for urgent improvements to the dietary health of the nation, this presents a significant gap in our knowledge.

This study aimed to understand the role of a national patient safety policy, the Serious Incident Framework, on local organisational practices of responding to, investigating, and learning from patient safety incidents in the National Health Service (NHS) in England. Qualitative interviews were conducted with healthcare professionals in six NHS organisations and analysed using inductive thematic analysis and taking a constant comparison approach. Systemic challenges linked to the policy's prescriptive requirements were identified, including its emphasis on metrics such as incident closure and harm levels, which often obscured meaningful learning and systemic improvement. The findings highlight the misalignment between the policy's key aims and principles and its practical implementation, revealing an 'industry of investigations' that risked turning the investigative process into a compliance-oriented 'tick box exercise'. Furthermore, the overspecification of performance requirements coupled with the underspecification of substantive guidance led to variability in investigative processes, organisational capacity and resources, and investigator training and expertise. The involvement of patients and families affected by safety incidents was found to be inconsistent and often limited, with perceptions of senior managers and frontline staff underlining some tensions in operationalising large patient safety policies. The analysis considers how the development and implementation of national safety incident policies needs to carefully and intelligently balance the need for adaptive flexibility, clarity of guidance, and specification of organisational resourcing and infrastructure to ensure future national policy can effectively support local practices of learning from safety incidents.

BackgroundThere is a growing international policy focus on involving those affected by healthcare safety incidents, in subsequent investigations. Nonetheless, there remains little UK-based evidence exploring how this relates to the experiences of those affected over time, including the factors influencing decisions to litigate.AimsWe aimed to explore the experiences of patients, families, staff and legal representatives affected by safety incidents over time, and the factors influencing decisions to litigate.MethodsParticipants were purposively recruited via (i) communication from four NHS hospital Trusts or an independent national investigator in England, (ii) relevant charitable organizations, (iii) social media, and (iv) word of mouth to take part in a qualitative semi-structured interview study. Data were analyzed using an inductive reflexive thematic approach.Findings42 people with personal or professional experience of safety incident investigations participated, comprising patients and families (n = 18), healthcare staff (n = 7), legal staff (n = 1), and investigators (n = 16). Patients and families started investigation processes with cautious hope, but over time, came to realize that they lacked power, knowledge, and support to navigate the system, made clear in awaited investigation reports. Systemic fear of litigation not only failed to meet the needs of those affected, but also inadvertently led to some pursuing litigation. Staff had parallel experiences of exclusion, lacking support and feeling left with an incomplete narrative. Importantly, investigating was often perceived as a lonely, invisible and undervalued role involving skilled “work” with limited training, resources, and infrastructure. Ultimately, elusive “organizational agendas” were prioritized above the needs of all affected.ConclusionsIncident investigations fail to acknowledge and address emotional distress experienced by all affected, resulting in compounded harm. To address this, we propose five key recommendations, to: (1) prioritize the needs of those affected by incidents, (2) overcome culturally engrained fears of litigation to re-humanize processes and reduce rates of unnecessary litigation, (3) recognize and value the emotionally laborious and skilled work of investigators (4) inform and support those affected, (5) proceed in ways that recognize and seek to reduce social inequities.

Abstract Background Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and β-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing). Methods BioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC). The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking. The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed. Discussion The BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship. Trial registration ISRCTN11633399. Registered 24/06/2022.

The considered shift from individual blame and sanctions towards a commitment to system-wide learning from incidents in healthcare has led to increased understanding of both the moral and epistemic importance of involving those affected. It is important to understand whether and how local policy describes and prompts involvement with a view to understanding the policy landscape for serious incident investigations in healthcare. This study aimed to explore the way in which involvement of those affected by serious incidents is represented in incident investigation policy documents across acute and mental health services in the English NHS, and to identify guidance for more effective construction of policy for meaningful involvement. We conducted a documentary analysis of 43 local serious incident investigation policies to explore the way in which involvement in serious incident investigations is represented in policy documents across acute and mental health services in the NHS in England. Three headline findings were generated. First, we identified involvement as a concept was conspicuous by its absence in policy documents. Direct reference to support or involvement of those affected by serious incidents was lacking. Even where involvement and support were recognised as important, this was described as a passive process rather than there being moral or epistemic justification for more active contribution to learning. Second, learning from serious incidents was typically described as a high priority but the language used was unclear and ‘learning’ was more often positioned as construction of an arbitrary set of recommendations rather than a participatory process of deconstruction and reconstruction of specific systems and processes. Third, there was an emphasis placed on a just and open culture but paradoxically this was reinforced by expected compliance, positioning investigations as a tool through which action is governed rather than an opportunity to learn from and with the experiences and expertise of those affected. More effective representation in policy of the moral and epistemic reasons for stakeholder involvement in serious incident investigations may lead to better understanding of its importance, thus increasing potential for organisational learning and reducing the potential for compounded harm. Moreover, understanding how structural elements of policy documents were central to the way in which the document is framed and received is significant for both local and national policy makers to enable more effective construction of healthcare policy documents to prompt meaningful action.