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Background: There 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. Aims: We 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. Methods: Participants 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. Findings: 42 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. Conclusions: Incident 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 FROM AUTHOR]

Background: Healthcare organisations risk harming patients and their families twofold. First, through the physical, emotional and/or financial harm caused by safety incidents themselves, and second, through the organisational response to incidents. The former is well-researched and targeted by interventions. However, the latter, termed 'compounded harm' is rarely acknowledged. Aims: We aimed to explore the ways compounded harm is experienced by patients and their families as a result of organisational responses to safety incidents and propose how this may be reduced in practice. Methods: We used framework analysis to qualitatively explore data derived from interviews with 42 people with lived or professional experience of safety incident responses. This comprised 18 patients/relatives, 16 investigators, seven healthcare staff and one legal staff. People with lived and professional experience also helped to shape the design, conduct and findings of this study. Findings: We identified six ways that patients and their families experienced compounded harm because of incident responses. These were feeling: (1) powerless, (2) inconsequential, (3) manipulated, (4) abandoned, (5) de-humanised and (6) disoriented. Discussion: It is imperative to reduce compounded harm experienced by patients and families. We propose three recommendations for policy and practice: (1) the healthcare system to recognise and address epistemic injustice and equitably support people to be equal partners throughout investigations and subsequent learning to reduce the likelihood of patients and families feeling powerless and inconsequential; (2) honest and transparent regulatory and organisational cultures to be fostered and enacted to reduce the likelihood of patients and families feeling manipulated; and (3) the healthcare system to reorient towards providing restorative responses to harm which are human centred, relational and underpinned by dignity, safety and voluntariness to reduce the likelihood of patients and families feeling abandoned, de-humanised and disoriented. [ABSTRACT FROM AUTHOR]

Background: 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. Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

This opinion paper investigates how healthcare organizations identify and act upon different types of risk signals. These signals may generally be acknowledged, but we also often see with hindsight that they might not be because they have become a part of normal practice. Here, we detail how risk signals from patients and families should be acknowledged as system-level safety critical information and as a way of understanding and changing safety culture in healthcare. We discuss how healthcare organizations could work more proactively with patient experience data in identifying risks and improving system safety. [ABSTRACT FROM AUTHOR]

Background: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home. Methods: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. Discussion: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. Trial registration: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020. [ABSTRACT FROM AUTHOR]

Introduction: Complex intervention development has been described as the 'Cinderella' black box in health services research. Greater transparency in the intervention development process is urgently needed to help reduce research waste. Methods: We applied a new consensus‐based framework for complex intervention development to our programme of research, in which we developed an intervention to improve the safety and experience of care transitions for older people. Through this process, we aimed to reflect on the framework's utility for intervention development and identify any important gaps within it to support its continued development. Findings: The framework was a useful tool for transparent reporting of the process of complex intervention development. We identified potential 'action' gaps in the framework including 'consolidation of evidence' and 'development of principles' that could bracket and steer decision‐making in the process. Conclusions: We consider that the level of transparency demonstrated in this report, aided through use of the framework, is essential in the quest for reducing research waste. Patient or Public Contribution: We have involved our dedicated patient and public involvement group in all work packages of this programme of research. Specifically, they attended and contributed to co‐design workshops and contributed to finalizing the intervention for the pilot evaluation. Staff also participated by attending co‐design workshops, helping us to prioritize content ideas for the intervention and supporting the development of intervention components outside of the workshops. [ABSTRACT FROM AUTHOR]

Introduction: Healthcare system resilience is a conceptual approach that seeks to explore how health services adapt and respond to variability in demand and resources. As has been witnessed since the beginning of the COVID‐19 pandemic, healthcare services have undergone many reconfigurations. One understudied aspect of how the 'system' is able to adapt and respond is the contribution of key stakeholders—patients and families, and in the context of the pandemic, the general public as a whole. This study aimed to understand what people were doing during the first wave of the pandemic to protect the safety of their health, and the health of others from COVID‐19, and the resilience of the healthcare system. Methods: Social media (Twitter) was used as a method of recruitment due to its ability for social reach. Twenty‐one participants took part in 57 semistructured interviews over three time points from June to September 2020. The included an initial interview and invitation to two follow‐up interviews after 3 and 6 weeks. Interviews were conducted virtually using Zoom—an encrypted secure video conferencing software. A reflexive thematic analysis approach to analysis was used. Results: Three themes, each with its own subthemes were identified in the analysis: (1) A 'new safety normal'; (2) Existing vulnerabilities and heightened safety and (3) Are we all in this together? Conclusion: This study found that the public had a role in supporting the resilience of healthcare services and systems during the first wave of the pandemic by adapting their behaviour to protect themselves and others, and to avoid overwhelming the National Health Service. People who had existing vulnerabilities were more likely to experience safety gaps in their care, and be required to step in to support their safety, despite it being more difficult for them to do so. It may be that the most vulnerable were previously required to do this extra work to support the safety of their care and that the pandemic has just illuminated this issue. Future research should explore existing vulnerabilities and inequalities, and the heightened safety consequences created by the pandemic. Patient and Public Contribution: The National Institute for Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC), Patient and Public Involvement and Engagement Research Fellow and NIHR Yorkshire and Humber PSTRC Patient Involvement in Patient Safety theme lay leader are involved in the preparation of a lay version of the findings within this manuscript. [ABSTRACT FROM AUTHOR]

Introduction: Care Opinion is an online feedback platform supporting patients to author stories about their care. It is not known whether authors would be willing to be involved in improving care through research. The aims of this study were to explore the views and preferences of Care Opinion authors about joining an online research community and to pilot new research community functionality. Methods: Five hundred and nine Care Opinion authors were invited to take part in an online survey in June 2019. Survey items included questions about participants' willingness to take part in research and their preferences for supporting processes. Data were analysed descriptively. Authors were invited to consent to join a research community and were asked to participate in three pilot studies. Results: One hundred and sixty‐three people consented to take part in the survey (32%). Participants indicated they would like to know the time commitment to the project (146, 90%), details about the organization carrying out the research (124, 76%) and safeguarding information (124, 76%). Over half indicated that they did not know how to get involved in healthcare research (87, 53%). Subsequently, 667 authors were invited to join the research community, 183 (27%) accepted, and three studies were matched to their expressed preferences for project attributes or organization type. Conclusion: Many people who leave online feedback about their experiences of healthcare are also willing to join a research community via that platform. They have strong preferences for supporting University and NHS research. Eligibility and acceptance rates to join pilot research studies varied. Further work is needed to grow the research community, increase its diversity, and create relevant and varied opportunities to support research. Patient or Public Contribution: Four members of the Safety In Numbers patient and public involvement and engagement (PPIE) group advised about survey development. [ABSTRACT FROM AUTHOR]

Healthcare staff are encouraged to use feedback from their patients to inform service and quality improvement. Receiving patient feedback via online channels is a relatively new phenomenon that has rarely been conceptualised. Further, the implications of a wide, varied and unknown(able) audience being able to view and interact with online patient feedback are yet to be understood. We applied a theoretical lens of dramaturgy to a large ethnographic dataset, collected across three NHS Trusts during 2019/2020. We found that organisations demonstrated varying levels of 'preparedness to perform' online, from invisibility through to engaging in public conversation with patients within a wider mission for transparency. Restrictive 'cast lists' of staff able to respond to patients was the hallmark of one organisation, whereas another devolved responding responsibility amongst a wide array of multidisciplinary staff. The visibility of patient‐staff interactions had the potential to be culturally disruptive, dichotomously invoking either apprehensions of reputational threat or providing windows of opportunity. We surmise that a transparent and conversational feedback response frontstage aligns with the ability to better prioritise backstage improvement. Legitimising the autonomous frontstage activity of diverse staff groups may help shift organisational culture, and gradually ripple outwards a shared responsibility for transparent improvement. [ABSTRACT FROM AUTHOR]

Background: The Partners at Care Transitions (PACTs) intervention was developed to support older people's involvement in hospital to improve outcomes at home. A booklet, question card, record sheet, induction leaflet, and patient‐friendly discharge letter support patients to be more involved in their health and wellbeing, medications, activities of daily living and post‐discharge care. We aimed to assess intervention acceptability, identify implementation tools, and further develop the intervention. Methods: This was a qualitative formative evaluation involving three wards from one hospital. We recruited 25 patients aged 75 years and older. Ward staff supported intervention delivery. Data were collected in wards and patients' homes, through semi‐structured interviews, observation, and documentary analysis. Data were analysed inductively and iteratively with findings sorted according to the research aims. Results: Patients and staff felt there was a need for, and understood the purpose of, the PACT intervention. Most patients read the booklet but other components were variably used. Implementation challenges included time, awareness, and balancing intervention benefits against risks. Changes to the intervention and implementation included clarifying the booklet's messages, simplifying the discharge letter to reduce staff burden, and using prompts and handouts to promote awareness. Conclusion: The PACT intervention offers a promising new way to improve care transitions for older people by supporting patient involvement in their care. After further development of the intervention and implementation package, it will undergo further testing. Patient or Public Contribution: This study regularly consulted a panel representing the local patient community, who supported the development of this intervention and its implementation. [ABSTRACT FROM AUTHOR]

Background: Video-reflexive ethnography (VRE) has been argued to be an alternative approach to collaborative learning in healthcare teams, more able to capture the complexities of the healthcare environment than simulation. This study aims to explore the feasibility and acceptability of employing VRE as an improvement tool in acute maternity services.Method: Focused ethnography and semi-structured interviews (n = 17) explored the feasibility of employing VRE from the perspective of the researcher-facilitator, and that of the healthcare staff participants. Reflexive thematic analysis was used to generate key themes.Results: We identified four themes related to feasibility of employing VRE as an improvement approach: laying the groundwork; challenges of capturing in-situ video footage; effective facilitation of reflexive feedback; and, power to change. Of note was the central role of the facilitator in building and maintaining staff trust in the process, particularly in being able to guide collaborative, non-punitive discussion during reflexive feedback sessions. Interestingly, when considering implementation of change, structural hierarchies were evident with more senior staff better able to develop and effect ideas. Two themes related to acceptability of VRE among healthcare staff were identified: staff response to the role of VRE in improvement; and the power of a different perspective. Staff were overwhelmingly positive about their experience of VRE, particularly appreciating the time, space and autonomy it afforded them to navigate and articulate ideas for change and improvement.Conclusion: VRE is both feasible and acceptable as an improvement tool with acute, multi-disciplinary maternity staff teams. It is an important healthcare improvement tool that could prompt the development and maintenance of team resilience factors in the face of increasing stress and burn-out of healthcare staff in maternity services. [ABSTRACT FROM AUTHOR]

Background: The 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. Methods: A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. Results: Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences. Conclusions: If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. Trial registration: ISRCTN: 51154948. [ABSTRACT FROM AUTHOR]

Background: Healthcare is not without risk. Despite two decades of policy focus and improvement efforts, the global incidence of harm remains stubbornly persistent, with estimates suggesting that 10% of hospital patients are affected by adverse events. Methods: We explore how current investigative responses can compound the harm for all those affected—patients, families, health professionals and organizations—by neglecting to appreciate and respond to the human impacts. We suggest that the risk of compounded harm may be reduced when investigations respond to the need for healing alongside system learning, with the former having been consistently neglected. Discussion: We argue that incident responses must be conceived within a relational as well as a regulatory framework, and that this—a restorative approach—has the potential to radically shift the focus, conduct and outcomes of investigative processes. Conclusion: The identification of the preconditions and mechanisms that enable the success of restorative approaches in global health systems and legal contexts is required if their demonstrated potential is to be realized on a larger scale. The policy must be co‐created by all those who will be affected by reforms and be guided by restorative principles. Patient or Public Contribution: This viewpoint represents an international collaboration between a clinician academic, safety scientist and harmed patient and family members. The paper incorporates key findings and definitions from New Zealand's restorative response to surgical mesh harm, which was co‐designed with patient advocates, academics and clinicians. [ABSTRACT FROM AUTHOR]

Background: A worldwide pandemic of a new and unknown virus is characterised by scientific uncertainty. However, despite this uncertainty, health authorities must still communicate complex health risk information to the public. The mental models approach to risk communication describes how people perceive and make decisions about complex risks, with the aim of identifying decision-relevant information that can be incorporated into risk communication interventions. This study explored how people use mental models to make sense of scientific information and apply it to their lives and behaviour in the context of COVID-19. Methods: This qualitative study enrolled 15 male and female participants of different ages, with different levels of education and occupational backgrounds and from different geographical regions of Norway. The participants were interviewed individually, and the interview data were subjected to thematic analysis. The interview data were compared to a expert model of COVID-19 health risk communication based on online information from the Norwegian Institute of Public Health. Materials in the interview data not represented by expert model codes were coded inductively. The participants' perceptions of and behaviours related to health risk information were analysed across three themes: virus transmission, risk mitigation and consequences of COVID-19. Results: The results indicate that people placed different meanings on the medical and scientific words used by experts to explain the pandemic (e.g., virus transmission and the reproduction number). While some people wanted to understand why certain behaviour and activities were considered high risk, others preferred simple, clear messages explaining what to do and how to protect themselves. Similarly, information about health consequences produced panic in some interviewees and awareness in others. Conclusion: There is no one-size-fits-all approach to public health risk communication. Empowering people with decision-relevant information necessitates targeted and balanced risk communication. [ABSTRACT FROM AUTHOR]

Background: A worldwide pandemic of a new and unknown virus is characterised by scientific uncertainty. However, despite this uncertainty, health authorities must still communicate complex health risk information to the public. The mental models approach to risk communication describes how people perceive and make decisions about complex risks, with the aim of identifying decision-relevant information that can be incorporated into risk communication interventions. This study explored how people use mental models to make sense of scientific information and apply it to their lives and behaviour in the context of COVID-19.Methods: This qualitative study enrolled 15 male and female participants of different ages, with different levels of education and occupational backgrounds and from different geographical regions of Norway. The participants were interviewed individually, and the interview data were subjected to thematic analysis. The interview data were compared to a expert model of COVID-19 health risk communication based on online information from the Norwegian Institute of Public Health. Materials in the interview data not represented by expert model codes were coded inductively. The participants' perceptions of and behaviours related to health risk information were analysed across three themes: virus transmission, risk mitigation and consequences of COVID-19.Results: The results indicate that people placed different meanings on the medical and scientific words used by experts to explain the pandemic (e.g., virus transmission and the reproduction number). While some people wanted to understand why certain behaviour and activities were considered high risk, others preferred simple, clear messages explaining what to do and how to protect themselves. Similarly, information about health consequences produced panic in some interviewees and awareness in others.Conclusion: There is no one-size-fits-all approach to public health risk communication. Empowering people with decision-relevant information necessitates targeted and balanced risk communication. [ABSTRACT FROM AUTHOR]

Background: Transitions of care are often risky, particularly for older people, and shorter hospital stays mean that patients can go home with ongoing care needs. Most previous research has focused on fundamental system flaws, however, care generally goes right far more often than it goes wrong. We explored staff perceptions of how high performing general practice and hospital specialty teams deliver safe transitional care to older people as they transition from hospital to home.Methods: We conducted a qualitative study in six general practices and four hospital specialties that demonstrated exceptionally low or reducing readmission rates over time. Data were also collected across four community teams that worked into or with these high-performing teams. In total, 157 multidisciplinary staff participated in semi-structured focus groups or interviews and 9 meetings relating to discharge were observed. A pen portrait approach was used to explore how teams across a variety of different contexts support successful transitions and overcome challenges faced in their daily roles.Results: Across healthcare contexts, staff perceived three key themes to facilitate safe transitions of care: knowing the patient, knowing each other, and bridging gaps in the system. Transitions appeared to be safest when all three themes were in place. However, staff faced various challenges in doing these three things particularly when crossing boundaries between settings. Due to pressures and constraints, staff generally felt they were only able to attempt to overcome these challenges when delivering care to patients with particularly complex transitional care needs.Conclusions: It is hypothesised that exceptionally safe transitions of care may be delivered to patients who have particularly complex health and/or social care needs. In these situations, staff attempt to know the patient, they exploit existing relationships across care settings, and act to bridge gaps in the system. Systematically reinforcing such enablers may improve the delivery of safe transitional care to a wider range of patients.Trial Registration: The study was registered on the UK Clinical Research Network Study Portfolio (references 35272 and 36174 ). [ABSTRACT FROM AUTHOR]

Background: The nonlinear nature of contagious diseases and the potential for exponential growth can be difficult to grasp for the general public. This has strong implications for public health communication, which needs to be both easily accessible and efficient. A pandemic is an extreme situation, and the accompanying strict societal measures are generally easier to accept if one understands the underlying reasoning behind them. Bringing about informed attitude change and achieving compliance to strict restrictions requires explanations of scientific concepts and terminologies that laypersons can understand. Objective: The aim of the project is to develop effective, evidence-based modes of video communication for translating complex, but important, health messages about pandemics to both the general population and decision makers. The study uses COVID-19 as a case to learn and prepare society for handling the ongoing and future pandemics, as well as to provide evidence-based tools for the science communication toolbox. Methods: The project applies a mixed methods design, combining qualitative methods (eg, interviews, observational studies, literature reviews) and quantitative methods (eg, randomized controlled trials [RCTs]). The project brings together researchers from a wide range of academic fields, as well as communication industry professionals. Results: This study has received funding from the Trond Mohn Foundation through the Research Council of Norway’s “COVID-19 Emergency Call for Proposals” March 2020. Recruitment and data collection for the exploratory first phase of the project ran from February 2021 to March 2021. Creative communication work started in May 2021, and the production of videos for use in the RCTs in the final phase of the project started in September 2021. Conclusions: The COVCOM project will take on several grand challenges within the field of communicating science and provide evidence-based tools to the science communication toolbox. A long-term goal of the project is to contribute to the creation of a more resilient health care system by developing communication responses tailormade for different audiences, preparing society for any future pandemic. [ABSTRACT FROM AUTHOR]

Medical education has an important role in developing attitudes, behaviors and cultures that support safe care. Increasingly, however, research has argued for a more interprofessional approach to be taken. This scoping review examines the design and impact of interprofessional education interventions involving medical students that focus on patient safety. We systematically searched PubMed, EMBASE, PsycINFO and CINAHL between January 2000 and November 2019. Studies were eligible if they included medical students and at least one other profession, interactive learning, a strong emphasis on patient safety in the learning objectives, and an empirical method of evaluation. Forty-three studies met these criteria and the diverse range of approaches to intervention design and method of evaluation are detailed in this review. We found that interprofessional patient safety education interventions are generally well received by students with knowledge and skill gain documented; several also reported changes in student behaviour. However, the lack of empirically driven study designs, combined with the lack of rigour when reporting, makes it difficult to draw clear comparisons. Future research should address this, and in particular, report how and why the intervention has been designed to be delivered interprofessionally. [ABSTRACT FROM AUTHOR]

Background: Failures in care for people with learning disabilities have been repeatedly highlighted and remain an international issue, exemplified by a disparity in premature death due to poor quality and unsafe care. This needs urgent attention. Therefore, the aim of the study was to understand the care experiences of people with learning disabilities, and explore the potential patient safety issues they, their carers and families raised. Methods: Two data sources exploring the lived experience of care for people with learning disabilities were synthesised using an integrative approach, and explored using reflexive thematic analysis. This comprised two focus groups with a total of 13 people with learning disabilities and supportive staff, and 377 narratives posted publicly via the feedback platform Care Opinion. Results: The qualitative exploration highlighted three key themes. Firstly, health and social care systems operated with varying levels of rigidity. This contributed to an inability to effectively cater to; complex and individualised care needs, written and verbal communication needs and needs for adequate time and space. Secondly, there were various gaps and traps within systems for this population. This highlighted the importance of care continuity, interoperability and attending to the variation in support provision from professionals. Finally, essential 'dependency work' was reliant upon social capital and fulfilled by paid and unpaid caring roles to divergent extents, however, advocacy provided an additional supportive safety net. Conclusions: A series of safety inequities have been identified for people with learning disabilities, alongside potential protective buffers. These include; access to social support and advocacy, a malleable system able to accommodate for individualised care and communication needs, adequate staffing levels, sufficient learning disabilities expertise within and between care settings, and the interoperability of safety initiatives. In order to attend to the safety inequities for this population, these factors need to be considered at a policy and organisational level, spanning across health and social care systems. Findings have wide ranging implications for those with learning disabilities, their carers and families and health and social care providers, with the potential for international learning more widely. [ABSTRACT FROM AUTHOR]

Logic models feature prominently in intervention research yet there is increasing debate about their ability to express how interventions work in the real-world. 'Real-world' logic models are a new proposition which express complex interventions in context. They are designed to help researchers strike a balance between context-sensitivity and scalability. This article explores the utility of real-world logic models in a trial involving a complex intervention called 'Your Care Needs You', designed to improve hospital-home transitions for UK older patients. The approach is found to usefully capture, refine and express important learning about intervention-implementation-context dynamics. The findings imply the need for intervention researchers to think creatively about how to implement interventions in diverse and sometimes challenging environments and to develop understanding of how complex interventions adapt on implementation to produce outcomes. The possibility of assessing the wider social and policy context within intervention research is also posed. [ABSTRACT FROM AUTHOR]

Background: Resilient and responsive healthcare systems is on the agenda as ever before. COVID-19, specialization of services, resource demands, and technology development are all examples of aspects leading to adaptations among stakeholders at different system levels whilst also attempting to maintain high service quality and safety. This commentary sets the scene for a journal collection on Resilient and responsive health systems in a changing world. The commentary aims to outline main challenges and opportunities in resilient healthcare theory and practice globally, as a backdrop for contributions to the collection.Main Text: Some of the main challenges in this field relate to a myriad of definitions and approaches to resilience in healthcare, and a lack of studies having multilevel perspectives. Also, the role of patients, families, and the public in resilient and responsive healthcare systems is under researched. By flipping the coin, this illustrates opportunities for research and practice and raise key issues that future resilience research should pay attention to. The potential of combining theoretical lenses from different resilience traditions, involvement of multiple stakeholders in co-creating research and practice improvement, and modelling and visualizing resilient performance are all opportunities to learn more about how healthcare succeeds under stress and normal operations.Conclusion: A wide understanding of resilience and responsiveness is needed to support planning and preparation for future disasters and for handling the routine small-scale adaptation. This collection welcomes systematic reviews, quantitative, qualitative, and mixed-methods research on the topic of resilience and responsiveness in all areas of the health system. [ABSTRACT FROM AUTHOR]

Purpose: The purpose is to share strategies, rationales and lessons learnt from user involvement in a quality and safety improvement research project from the practice field in nursing homes and homecare services. Design/methodology/approach: This is a viewpoint paper summarizing how researchers and co-researchers from the practice field of nursing homes and homecare services (nurse counsellors from different municipalities, patient ombudsman and next-of-kin representatives/and elderly care organization representant) experienced user involvement through all phases of the research project. The project included implementation of a leadership intervention. Findings: Multiple strategies of user involvement were applied during the project including partnership in the consortium, employment of user representatives (co-researchers) and user-led research activities. The rationale was to ensure sound context adaptation of the intervention and development of tailor-made activities and tools based on equality and mutual trust in the collaboration. Both university-based researchers and Co-researchers experienced it as useful and necessary to involve or being involved in all phases of the research project, including the designing, planning, intervention implementation, evaluation and dissemination of results. Originality/value: User involvement in research is a growing field. There is limited focus on this aspect in quality and safety interventions in nursing homes and homecare settings and in projects focussing on the leadership' role in improving quality and safety. [ABSTRACT FROM AUTHOR]

Background: Responses from the H1N1 swine flu pandemic and the recent COVID-19 coronavirus pandemic provide an opportunity for insight into the role of health authorities' ways of communicating health risk information to the public. We aimed to synthesise the existing evidence regarding different modes of communication used by health authorities in health risk communication with the public during a pandemic.Methods: We conducted a rapid scoping review. MEDLINE and EMBASE were searched for publications in English from January 2009 through October 2020, covering both the full H1N1 pandemic and the response phase during the COVID-19 pandemic. The search resulted in 1440 records, of which 48 studies met our eligibility criteria.Results: The present review identified studies across a broad interdisciplinary field of health risk communication. The majority focused on the H1N1 pandemic and the COVID-19 pandemic. A content analysis of the studies identified three categories for modes of communication: i) communication channels, ii) source credibility and iii) how the message is communicated. The identified studies on social media focused mainly on content and engagement, while studies on the effect of the use of social media and self-protective behaviour were lacking. Studies on the modes of communication that take the diversity of receivers in the field into account are lacking. A limited number of studies of health authorities' use of graphic and audio-visual means were identified, yet these did not consider/evaluate creative communication choices.Conclusion: Experimental studies that investigate the effect of health authorities' videos and messages on social media platforms and self-protective behaviour are needed. More studies are needed across the fields of health risk communication and media studies, including visual communication, web design, video and digital marketing, at a time when online digital communication is central to reaching the public. [ABSTRACT FROM AUTHOR]

Background Teamwork and communication are recognised as key contributors to safe and high-quality patient care. Interventions targeting process and relational aspects of care may therefore provide patient safety solutions that reflect the complex nature of healthcare. Team reflexivity is one such approach with the potential to support improvements in communication and teamwork, where reflexivity is defined as the ability to pay critical attention to individual and team practices with reference to social and contextual information. Objective To systematically review articles that describe the use of team reflexivity in interprofessional hospital-based healthcare teams. Methods Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, six electronic databases were searched to identify literature investigating the use of team reflexivity in interprofessional hospital-based healthcare teams. The review includes articles investigating the use of team reflexivity to improve teamwork and communication in any naturally occurring hospital-based healthcare teams. Articles' eligibility was validated by two second reviewers (5%). Results Fifteen empirical articles were included in the review. Simulation training and video-reflexive ethnography (VRE) were the most commonly used forms of team reflexivity. Included articles focused on the use of reflexive interventions to improve teamwork and communication within interprofessional healthcare teams. Communication during interprofessional teamworking was the most prominent focus of improvement methods. The nature of this review only allows assessment of team reflexivity as an activity embedded within specific methods. Poorly defined methodological information relating to reflexivity in the reviewed studies made it difficult to draw conclusive evidence about the impact of reflexivity alone. Conclusion The reviewed literature suggests that VRE is well placed to provide more locally appropriate solutions to contributory patient safety factors, ranging from individual and social learning to improvements in practices and systems. Trial registration number CRD42017055602. [ABSTRACT FROM AUTHOR]

Background: The number of physician associates (PAs) training and working in the UK has increased over the last few years following the proliferation of postgraduate courses. Understanding early experiences and what impacts on engagement is important if we are to appropriately support this relatively new professional group. Methods: This paper reports on a cross-sectional analysis of the first year of data from a prospective 10-year longitudinal cohort study. First year PA students (n = 89) were enrolled from five universities in one UK region where the training programmes were less than 2 years old. Data collected were: demographic information, wellbeing, burnout and engagement, expectations, placement experience, performance and caring responsibilities. Pearson's correlations were used to examine relationships between variables and to select variables for a hierarchical regression analysis to understand which factors were associated with engagement. Descriptive statistics were calculated for questions relating to experience. Results: The experiences of PA students during their first 3–6 months were mixed. For example, 78.7% of students felt that there were staff on placement they could go to for support, however, 44.8% reported that staff did not know about the role and 61.3% reported that staff did not know what clinical work they should undertake. Regression analysis found that their level of engagement was associated with their perceived career satisfaction, overall well-being, and caring responsibilities. Conclusions: The support systems required for PAs may need to be examined as results showed that the PA student demographic is different to that of medical students and caring responsibilities are highly associated with engagement. A lack of understanding around the PA role in clinical settings may also need to be addressed in order to better support and develop this workforce. [ABSTRACT FROM AUTHOR]

Background: Understanding the resilience of healthcare is critically important. A resilient healthcare system might be expected to consistently deliver high quality care, withstand disruptive events and continually adapt, learn and improve. However, there are many different theories, models and definitions of resilience and most are contested and debated in the literature. Clear and unambiguous conceptual definitions are important for both theoretical and practical considerations of any phenomenon, and resilience is no exception. A large international research programme on Resilience in Healthcare (RiH) is seeking to address these issues in a 5-year study across Norway, England, the Netherlands, Australia, Japan, and Switzerland (2018-2023). The aims of this debate paper are: 1) to identify and select core operational concepts of resilience from the literature in order to consider their contributions, implications, and boundaries for researching resilience in healthcare; and 2) to propose a working definition of healthcare resilience that underpins the international RiH research programme.Main Text: To fulfil these aims, first an overview of three core perspectives or metaphors that underpin theories of resilience are introduced from ecology, engineering and psychology. Second, we present a brief overview of key definitions and approaches to resilience applicable in healthcare. We position our research program with collaborative learning and user involvement as vital prerequisite pillars in our conceptualisation and operationalisation of resilience for maintaining quality of healthcare services. Third, our analysis addresses four core questions that studies of resilience in healthcare need to consider when defining and operationalising resilience. These are: resilience 'for what', 'to what', 'of what', and 'through what'? Finally, we present our operational definition of resilience.Conclusion: The RiH research program is exploring resilience as a multi-level phenomenon and considers adaptive capacity to change as a foundation for high quality care. We, therefore, define healthcare resilience as: the capacity to adapt to challenges and changes at different system levels, to maintain high quality care. This working definition of resilience is intended to be comprehensible and applicable regardless of the level of analysis or type of system component under investigation. [ABSTRACT FROM AUTHOR]

Background: Measures exist to improve early recognition of, and response to deteriorating patients in hospital. Despite these, 7% of the deaths reported to the National Reporting and Learning System from acute hospitals in 2015 related to a failure to recognise or respond to deterioration. Interventions have been developed that allow patients and relatives to escalate patient deterioration to a critical care outreach team. However, there is not a strong evidence base for the clinical effectiveness of these interventions, or patients' ability to recognise deterioration. Aims: The aims of this study were as follows. (a) To identify methods of involving patients in recognising deterioration in hospital, generated by health professionals. (b) To develop and evaluate an identified method of patient involvement in practice, and explore its feasibility and acceptability from the perspectives of patients. Methods: The study used a mixed-methods design. A measure to capture patient-reported wellness during observation was developed (Patient Wellness Questionnaire) through focus group discussion with health professionals and patients, and piloted on inpatient wards. Results: There was limited uptake where patients were asked to record ratings of their wellness using the Patient Wellness Questionnaire themselves. However, where the researcher asked patients about their wellness using the Patient Wellness Questionnaire and recorded their responses during observation, this was acceptable to most patients. Conclusions: This study has developed a measure that can be used to routinely collect patient-reported wellness during observation in hospital and may potentially improve early detection of deterioration. [ABSTRACT FROM AUTHOR]

Background: Current models of patient‐enacted involvement do not capture the nuanced dynamic and interactional nature of involvement in care. This is important for the development of flexible interventions that can support patients to 'reach‐in' to complex health‐care systems. Objective: To develop a dynamic and interactional model of patient‐enacted involvement in care. Search strategy: Electronic search strategy run in five databases and adapted to run in an Internet search engine supplemented with searching of reference lists and forward citations. Inclusion criteria: Qualitative empirical published reports of older people's experiences of care transitions from hospital to home. Data extraction and synthesis: Reported findings meeting our definition of involvement in care initially coded into an existing framework. Progression from deductive to inductive coding leads to the development of a new framework and thereafter a model representing changing states of involvement. Main results: Patients and caregivers occupy and move through multiple states of involvement in response to perceived interactions with health‐care professionals as they attempt to resolve health‐ and well‐being‐related goals. 'Non‐involvement', 'information‐acting', 'challenging and chasing' and 'autonomous‐acting' were the main states of involvement. Feeling uninvolved as a consequence of perceived exclusion leads patients to act autonomously, creating the potential to cause harm. Discussion and conclusion: The model suggests that involvement is highly challenging for older people during care transitions. Going forward, interventions which seek to support patient involvement should attempt to address the dynamic states of involvement and their mediating factors. [ABSTRACT FROM AUTHOR]

Background: The PRASE (Patient Reporting and Action for a Safe Environment) intervention provides a way to systematically collect patient feedback to support service improvement. To provide a sustainable mechanism for the PRASE intervention, a 2‐year improvement project explored the potential for hospital volunteers to facilitate the collection of PRASE feedback. Objective: To explore the implementation of the PRASE intervention delivered in collaboration with hospital volunteers from the perspectives of key stakeholders. Design: A qualitative case study design was utilized across three acute NHS trusts in the United Kingdom between March 2016 and October 2016. Ward level data (staff interviews; action planning meeting recordings; implementation fidelity information) were analysed taking a pen portrait approach. We also carried out focus groups with hospital volunteers and interviews with voluntary services/patient experience staff, which were analysed thematically. Results: Whilst most ward staff reported feeling engaged with the intervention, there were discordant views on its use and usefulness. The hospital volunteers were positive about their involvement, and on some wards, worked with staff to produce actions to improve services. The voluntary services/patient experience staff participants emphasised the need for PRASE to sit within an organisations' wider governance structure. Conclusion: From the perspective of key stakeholders, hospital volunteers facilitating the collection of PRASE feedback is a feasible means of implementing the PRASE intervention. However, the variability around ward staff being able to use the feedback to make changes to services demonstrates that it is this latter part of the PRASE intervention cycle that is more problematic. [ABSTRACT FROM AUTHOR]

Introduction Hospital admissions are shorter than they were 10 years ago. Notwithstanding the benefits of this, patients often leave hospital requiring ongoing care. The transition period can therefore be risky, particularly for older people with complex health and social care needs. Previous research has predominantly focused on the errors and harms that occur during transitions of care. In contrast, this study adopts an asset-based approach to learn from factors that facilitate safe outcomes. It seeks to explore how staff within high-performing ('positively deviant') teams successfully support transitions from hospital to home for older people. Methods and analysis Six high-performing general practices and six hospital specialties that demonstrate exceptionally low or reducing 30-day emergency hospital readmission rates will be invited to participate in the study. Healthcare staff from these clinical teams will be recruited to take part in focus groups, individual interviews and/or observations of staff meetings. Data collection will explore the ways in which teams successfully deliver exceptionally safe transitional care and how they overcome the challenges faced in their everyday clinical work. Data will be thematically analysed using a pen portrait approach to identify the manifest (explicit) and latent (abstract) factors that facilitate success. Ethics and dissemination Ethical approval was obtained from the University of Leeds. The study will help develop our understanding of how multidisciplinary staff within different healthcare settings successfully support care transitions for older people. Findings will be disseminated to academic and clinical audiences through peer-reviewed articles, conferences and workshops. Findings will also inform the development of an intervention to improve the safety and experience of older people during transitions from hospital to home. [ABSTRACT FROM AUTHOR]

Background Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. Methods Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014. Patient volunteers, supported by researchers, developed a classification framework of patient-reported safety concerns from a random sample of 231 reports. All reports were then classified using the patient-developed categories. Following this, all patient-reported safety concerns underwent a two-stage clinical review process for identification of patient safety incidents. Results Of the 2471 inpatients recruited, 579 provided 1155 patient-reported incident reports. 14 categories were developed for classification of reports, with communication the most frequently occurring (22%), followed by staffing issues (13%) and problems with the care environment (12%). 406 of the total 1155 patient incident reports (35%) were classified by clinicians as a patient safety incident according to the standard definition. 1 in 10 patients (264 patients) identified a patient safety incident, with medication errors the most frequently reported incident. Conclusions Our findings suggest that patients can provide insight about safety that complements existing patient safety measurement, with a frequency of reported patient safety incidents that is similar to those obtained via case note review. However, patients provide a unique perspective about hospital safety which differs from and adds to current definitions of patient safety incidents. Trial registration number ISRCTN07689702; preresults. [ABSTRACT FROM AUTHOR]

Objective Solutions to quality and safety problems exist within healthcare organisations, but to maximise the learning from these positive deviants, we first need to identify them. This study explores using routinely collected, publicly available data in England to identify positively deviant services in one region of the country. Design A mixed methods study undertaken July 2014 to February 2015, employing expert discussion, consensus and statistical modelling to identify indicators of quality and safety, establish a set of criteria to inform decisions about which indicators were robust and useful measures, and whether these could be used to identify positive deviants. Setting Yorkshire and Humber, England. Participants None - analysis based on routinely collected, administrative English hospital data. Main outcome measures We identified 49 indicators of quality and safety from acute care settings across eight data sources. Twenty-six indicators did not allow comparison of quality at the sub-hospital level. Of the 23 remaining indicators, 12 met all criteria and were possible candidates for identifying positive deviants. Results Four indicators (readmission and patient reported outcomes for hip and knee surgery) offered indicators of the same service. These were selected by an expert group as the basis for statistical modelling, which supported identification of one service in Yorkshire and Humber showing a 50% positive deviation from the national average. Conclusion Relatively few indicators of quality and safety relate to a service level, making meaningful comparisons and local improvement based on the measures difficult. It was possible, however, to identify a set of indicators that provided robust measurement of the quality and safety of services providing hip and knee surgery. [ABSTRACT FROM AUTHOR]

Healthcare professionals work in emotionally charged settings; yet, little is known about the role of emotion in ensuring safe patient care. This article presents current knowledge in this field, drawing upon psychological approaches and evidence from clinical settings. We explore the emotions that health professionals experience in relation to making a medical error and describe the impact on healthcare professionals and on their professional and patient relationships. We also explore how positive and negative emotions can contribute to clinical decision making and affect responses to clinical situations. Evidence to date suggests that emotion plays an integral role in patient safety. Implications for training, practice and research are discussed in addition to strategies to facilitate health services to understand and respond to the influence of emotion in clinical practice. [ABSTRACT FROM AUTHOR]

Objectives: To compare a new co-designed, patient incident reporting tool with three established methods of detecting patient safety incidents and identify if the same incidents are recorded across methods. Method: Trained research staff collected data from inpatients in nine wards in one university teaching hospital during their stay. Those classified as patient safety incidents were retained. We then searched for patient safety incidents in the corresponding patient case notes, staff incident reports and reports to the Patient Advice and Liaison Service specific to the study wards. Results: In the nine wards, 329 patients were recruited to the study, of which 77 provided 155 patient reports. From these, 68 patient safety incidents were identified. Eight of these were also identified from case note review, five were also identified in incident reports, and two were also found in the records of a local Patient Advice and Liaison Service. Reports of patients covered a range of events from their immediate environment, involving different health professionals and spanning the entire spectrum of care. Conclusion: Patient safety incidents reported by patients are unlikely to be found through other established methods of incident detection. When hospitalized patients are asked about their care, they can provide a unique perspective on patient safety. Co-designed, real-time reporting could be a helpful addition to existing methods of gathering patient safety intelligence. [ABSTRACT FROM AUTHOR]

Purpose: Stress is a significant concern for individuals and organisations. Few studies have explored stress, burnout and patient safety in hospital nursing on a daily basis at the individual level. This study aimed to examine the effects of chronic stress and daily hassles on safety perceptions, the effect of chronic stress on daily hassles experienced and chronic stress as a potential moderator. Method: Utilising a daily diary design, 83 UK hospital nurses completed three end-of-shift diaries, yielding 324 person days. Hassles, safety perceptions and workplace cognitive failure were measured daily, and a baseline questionnaire included a measure of chronic stress. Hierarchical multivariate linear modelling was used to analyse the data. Results: Higher chronic stress was associated with more daily hassles, poorer perceptions of safety and being less able to practise safely, but not more workplace cognitive failure. Reporting more daily hassles was associated with poorer perceptions of safety, being less able to practise safely and more workplace cognitive failure. Chronic stress did not moderate daily associations. The hassles reported illustrate the wide-ranging hassles nurses experienced. Conclusion: The findings demonstrate, in addition to chronic stress, the importance of daily hassles for nurses' perceptions of safety and the hassles experienced by hospital nurses on a daily basis. Nurses perceive chronic stress and daily hassles to contribute to their perceptions of safety. Measuring the number of daily hassles experienced could proactively highlight when patient safety threats may arise, and as a result, interventions could usefully focus on the management of daily hassles. [ABSTRACT FROM AUTHOR]

Background Measures exist to improve early recognition of, and response to, deteriorating patients in hospital. However, deteriorating patients continue to go unrecognized. To address this, interventions have been developed that invite patients and relatives to escalate patient deterioration to a rapid response team ( RRT). Objective To systematically review articles that describe these interventions and investigate their effectiveness at reducing preventable deterioration. Search strategy Following PRISMA guidelines, four electronic databases and two web search engines were searched to identify literature investigating patient and relative led escalation. Inclusion criteria Articles investigating the implementation or use of systems involving patients and relatives in the detection of clinical patient deterioration and escalation of patient care to address any clinical or non-clinical outcomes were included. Articles' eligibility was validated by a second reviewer (20%). Data extraction Data were extracted according to pre-defined criteria. Data synthesis Narrative synthesis was applied to included studies. Main results Nine empirical studies and 36 grey literature articles were included in the review. Limited studies were conducted to establish the clinical effectiveness of patient and relative led escalation. Instead, studies investigated the impact of this intervention on health-care staff and available resources. Although appropriate, this reflects the infancy of research in this area. Patients and relatives did not overwhelm resources by activating the RRT. However, they did activate it to address concerns unrelated to patient deterioration. Conclusions Activating a RRT may not be the most appropriate or cost-effective method of resolving non-life-threatening concerns. [ABSTRACT FROM AUTHOR]

Background Evidence suggests that patients can meaningfully feed back to healthcare providers about the safety of their care. The PRASE (Patient Reporting and Action for a Safe Environment) intervention provides a way to systematically collect feedback from patients to support service improvement. The intervention is being implemented in acute care settings with patient feedback collected by hospital volunteers for the first time. Objective To undertake a formative evaluation which explores the feasibility and acceptability of the PRASE intervention delivered in collaboration with hospital volunteers from the perspectives of key stakeholders. Design A qualitative evaluation design was adopted across two acute NHS trusts in the UK between July 2014 and November 2015. We conducted five focus groups with hospital volunteers (n=15), voluntary services and patient experience staff (n=3) and semi-structured interviews with ward staff (n=5). Data were interpreted using framework analysis. Results All stakeholders were positive about the PRASE intervention as a way to support service improvement, and the benefits of involving volunteers. Volunteers felt adequate training and support would be essential for retention. Staff concentrated on the infrastructure needed for implementation and raised concerns around sustainability. Findings were fed back to the implementation team to support revisions to the intervention moving into the subsequent summative evaluation phase. Conclusion Although there are concerns regarding sustainability in practice, the PRASE intervention delivered in collaboration with hospital volunteers is a promising approach to collect patient feedback for service improvement. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention. Design A multicentre cluster randomised controlled trial. Setting Clusters were 33 hospital wards within five hospitals in the UK. Participants All patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition. Intervention The ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings. Measurements Primary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS). Results Intervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention. Limitations Adherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure. Conclusions Patients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components. [ABSTRACT FROM AUTHOR]

Objectives A patient safety intervention was tested in a 33-ward randomised controlled trial. No statistically significant difference between intervention and control wards was found. We conducted a process evaluation of the trial and our aim in this paper is to understand staff engagement across the 17 intervention wards. Design Large qualitative process evaluation of the implementation of a patient safety intervention. Setting and participants National Health Service staff based on 17 acute hospital wards located at five hospital sites in the North of England. Data We concentrate on three sources here: (1) analysis of taped discussion between ward staff during action planning meetings; (2) facilitators' field notes and (3) follow-up telephone interviews with staff focusing on whether action plans had been achieved. The analysis involved the use of pen portraits and adaptive theory. Findings First, there were palpable differences in the ways that the 17 ward teams engaged with the key components of the intervention. Five main engagement typologies were evident across the life course of the study: consistent, partial, increasing, decreasing and disengaged. Second, the intensity of support for the intervention at the level of the organisation does not predict the strength of engagement at the level of the individual ward team. Third, the standardisation of facilitative processes provided by the research team does not ensure that implementation standardisation of the intervention occurs by ward staff. Conclusions A dilution of the intervention occurred during the trial because wards engaged with Patient Reporting and Action for a Safe Environment (PRASE) in divergent ways, despite the standardisation of key components. Facilitative processes were not sufficiently adequate to enable intervention wards to successfully engage with PRASE components. [ABSTRACT FROM AUTHOR]