Strengthening open disclosure after incidents in maternity care: a realist synthesis of international research evidence.

BACKGROUND: Open Disclosure (OD) is open and timely communication about harmful events arising from health care with those affected. It is an entitlement of service-users and an aspect of their recovery, as well as an important dimension of service safety improvement. Recently, OD in maternity care in the English National Health Service has become a pressing public issue, with policymakers promoting multiple interventions to manage the financial and reputational costs of communication failures. There is limited research to understand how OD works and its effects in different contexts. METHODS: Realist literature screening, data extraction, and retroductive theorisation involving two advisory stakeholder groups. Data relevant to families, clinicians, and services were mapped to theorise the relationships between contexts, mechanisms, and outcomes. From these maps, key aspects for successful OD were identified. RESULTS: After realist quality appraisal, 38 documents were included in the synthesis (22 academic, 2 training guidance, and 14 policy report). 135 explanatory accounts were identified from the included documents (with n = 41 relevant to families; n = 37 relevant to staff; and n = 37 relevant to services). These were theorised as five key mechanism sets: (a) meaningful acknowledgement of harm, (b) opportunity for family involvement in reviews and investigations, (c) possibilities for families and staff to make sense of what happened, (d) specialist skills and psychological safety of clinicians, and (e) families and staff knowing that improvements are happening. Three key contextual factors were identified: (a) the configuration of the incident (how and when identified and classified as more or less severe); (b) national or state drivers, such as polices, regulations, and schemes, designed to promote OD; and (c) the organisational context within which these these drivers are recieived and negotiated. CONCLUSIONS: This is the first review to theorise how OD works, for whom, in what circumstances, and why. We identify and examine from the secondary data the five key mechanisms for successful OD and the three contextual factors that influence this. The next study stage will use interview and ethnographic data to test, deepen, or overturn our five hypothesised programme theories to explain what is required to strengthen OD in maternity services.

The historiography of a profession: The societal and political drivers of the health information management profession in Australia.

Health information permeates healthcare delivery from point-of-care, across the continuum of care and throughout the healthcare system's policy, population health, research, planning and funding arenas. Health information managers (HIMs) expertly manage that information. This commentary theorises the health information management profession for the first time. Its purpose is to identify and contextualise, via a historiographical account, the societal and political drivers that have shaped contemporary Australian health information management and HIMs' scientific work. It seeks to build our knowledge of the socio-political influences on the profession's emergence and development, and the projected drivers of its future. Eight critical, socio-political drivers were identified and are addressed in temporaneous order. Scientific medicine has reflected the influences on medicine in the past century and a half of the medical record and other technologies, laboratory-based sciences, evidence-based medicine and evidence-based health. Standardisation has underpinned and guided the profession's practice. The hegemony of non-medical healthcare managers and resource- and performance-related accountabilities emerged in the 1960s, as did the efficiencies of bureaucratisation in healthcare and post-bureaucratic shifts to textualisation and technogovernance. Technologisation has driven constant change in health information management, as have the forces of the fast-paced risk society. Since the 1980s, the health consumer movement has propelled regulatory mechanisms that accord patients' access rights to their medical records and mandate information privacy protections. Finally, a nascent commodification of health information has emerged. These forces exert ongoing impacts on the profession. They will, we conclude, singularly and collectively continue to shape its discourses and direction.

Relational aspects of building capacity in economic evaluation in an Australian Primary Health Network using an embedded researcher approach.

BACKGROUND: Health organisations are increasingly implementing 'embedded researcher' models to translate research into practice. This paper examines the impact of an embedded researcher model known as the embedded Economist (eE) Program that was implemented in an Australian Primary Health Network (PHN) located in regional New South Wales, Australia. The site, participants, program aims and design are described. Insights into the facilitators, challenges and barriers to the integration of economic evaluation perspectives into the work of the PHN are provided. METHODS: The eE Program consisted of embedding a lead health economist on site, supported by offsite economists, part-time, for fifteen weeks to collaborate with PHN staff. Evaluation of the eE at the PHN included qualitative data collection via semi-structured interviews (N= 34), observations (N=8) and a field diary kept by the embedded economists. A thematic analysis was undertaken through the triangulation of this data. RESULTS: The eE Program successfully met its aims of increasing PHN staff awareness of the value of economic evaluation principles in decision-making and their capacity to access and apply these principles. There was also evidence that the program resulted in PHN staff applying economic evaluations when commissioning service providers. Evaluation of the eE identified two key facilitators for achieving these results. First, a highly receptive organisational context characterised by a work ethic, and site processes and procedures that were dedicated to improvement. Second was the development of trusted relationships between the embedded economist and PHN staff that was enabled through: the commitment of the economist to bi-directional learning; facilitating access to economic tools and techniques; personality traits (likeable and enthusiastic); and because the eE provided ongoing support for PHN projects beyond the fifteen-week embedding period. CONCLUSIONS: This study provides the first detailed case description of an embedded health economics program. The results demonstrate how the process, context and relational factors of engaging and embedding the support of a health economist works and why. The findings reinforce international evidence in this area and are of practical utility to the future deployment of such programs.

Using video reflexive ethnography to explore the use of variable rate intravenous insulin infusions.

BACKGROUND: The use of variable rate intravenous insulin infusion (VRIII) is a complex process that has consistently been implicated in reports of error and consequent harm. Investment in patient safety has focused mainly on learning from errors, though this has yet to be proved to reduce error rates. The Resilient Health Care approach advocates learning from everyday practices. Video reflexive ethnography (VRE) is an innovative methodology used to capture everyday practices, reflect on and thereby improve these. This study set out to explore the use of VRIIIs by utilising the VRE methodology. METHODS: This study was conducted in a Vascular Surgery Unit. VRE methodology was used to collect qualitative data that involved videoing healthcare practitioners caring for patients treated with VRIII and discussing the resulting clips with participants in reflexive meetings. Transcripts of these were subjected to thematic analysis. Quantitative data (e.g. blood glucose measurements) were collected from electronic patient records in order to contextualise the outcomes of the video-observed tasks. RESULTS: The use of VRE in conjunction with quantitative data revealed that context-dependent adaptations (seeking verbal orders to treat hypoglycaemia) and standardised practices (using VRIII guidelines) were strategies used in everyday work. Reflexive meetings highlighted the challenges faced while using VRIII, which were mainly related to lack of clinical knowledge, e.g. prescribing/continuing long-acting insulin analogues alongside the VRIII, and problems with organisational infrastructure, i.e. the wireless blood glucose meter results sometimes not updating on the electronic system. Reflexive meetings also enabled participants to share the meanings of the reality surrounding them and encouraged them to suggest solutions tailored to their work, for example face-to-face, VRIII-focused training. CONCLUSIONS: VRE deepened understanding of VRIII by shedding light on its essential tasks and the challenges and adaptations entailed by its use. Future research might focus on collecting data across various units and hospitals to develop a full picture of the use of VRIIIs.

Integrating the complexity of healthcare improvement with implementation science: a longitudinal qualitative case study.

BACKGROUND: Implementation science seeks to enable change, underpinned by theories and frameworks such as the Consolidated Framework for Implementation Research (CFIR). Yet academia and frontline healthcare improvement remain largely siloed, with limited integration of implementation science methods into frontline improvement where the drivers include pragmatic, rapid change. Using the CIFR lens, we aimed to explore how pragmatic and complex healthcare improvement and implementation science can be integrated. METHODS: Our research involved the investigation of a case study that was undertaking the implementation of an improvement intervention at a large public health service. Our research involved qualitative data collection methods of semi-structured interviews and non-participant observations of the implementation team delivering the intervention. Thematic analysis identified key themes from the qualitative data. We examined our themes through the lens of CFIR to gain in-depth understanding of how the CFIR components operated in a 'real-world' context. RESULTS: The key themes emerging from our research outlined that leadership, context and process are the key components that dominate and affect the implementation process. Leadership which cultivates connections with front line clinicians, fosters engagement and trust. Navigating context was facilitated by 'bottom-up' governance. Multi-disciplinary and cross-sector capability were key processes that supported pragmatic and agile responses in a changing complex environment. Process reflected the theoretically-informed, and iterative implementation approach. Mapping CFIR domains and constructs, with these themes demonstrated close alignment with the CFIR. The findings bring further depth to CFIR. Our research demonstrates that leadership which has a focus on patient need as a key motivator to engage clinicians, which applies and ensures iterative processes which leverage contextual factors can achieve successful, sustained implementation and healthcare improvement outcomes. CONCLUSIONS: Our longitudinal study highlights insights that strengthen alignment between implementation science and pragmatic frontline healthcare improvement. We identify opportunities to enhance the relevance of CFIR in the 'real-world' setting through the interconnected nature of our themes. Our study demonstrates actionable knowledge to enhance the integration of implementation science in healthcare improvement.

Investigation of the critical factors required to improve the disclosure and discussion of harm with affected women and families: a study protocol for a qualitative, realist study in NHS maternity services (the DISCERN study).

Patients and families are entitled to an open disclosure and discussion of healthcare incidents affecting them. This reduces distress and contributes to learning for safety improvement. Complex barriers prevent effective disclosure and continue in the English NHS, despite a legal duty of candour. NHS maternity services are the focus of significant efforts to improve this. There is limited understanding of how, and to what effect, they are achieving this. METHODS AND ANALYSIS: A 27-month, three-phased realist evaluation identifying the critical factors contributing to improvements in the disclosure and discussion of incidents with affected families. The evaluation asks 'what works, for whom, in what circumstances, in why respects and why?'.Phase 1: establish working hypotheses of key factors and outcomes of interventions improving disclosure and discussion, by realist literature review and in-depth realist interviews with key stakeholders (n=approximately 20]Phase 2: refine or overturn hypotheses, by ethnographic case-study analysis using triangulated qualitative methods (non-participant observation, interviews (n=12) and documentary analysis) in up to 4 purposively sampled NHS trusts.Phase 3: consider hypotheses and design outputs during seven interpretive forums. ETHICS AND DISSEMINATION: Phase 1 study approval by King's College London's Ethics Panel (BDMRESC 22033) and National Research Ethical Approval for Phases 2-3 (IRASID:262197) (CAG:20/CAG/0121) (REC:20/LO/1152). Study sponsorship by King's College London (HS&DR 17/99/85).Findings to be disseminated through tailored management briefings; clinician and family guidance (written and video); lay summaries, academic papers, and report with outputs tailored to maximise academic and societal impact. Views of women/family groups are represented throughout.

Modelling the use of variable rate intravenous insulin infusions in hospitals by comparing Work as Done with Work as Imagined.

BACKGROUND: Variable rate intravenous insulin infusions (VRIIIs) are widely used to treat elevated blood glucose (BG) in adult inpatients who are severely ill and/or will miss more than one meal. VRIIIs can cause serious harm to the patient if used incorrectly. Recent safety initiatives have embraced the Resilient Health Care (RHC) approach to safety by understanding how VRIIIs are expected to be used (Work as Imagined, 'WAI') and how it is actually used in everyday clinical care (Work as Done, 'WAD'). OBJECTIVES: To systematically compare WAI and WAD and analyse adaptations used in situ to develop a model explaining VRIII use. METHODS: A qualitative observational study video-recording healthcare practitioners using VRIII. The video data were transcribed and inductively coded to develop a hierarchical task analysis (HTA) to represent WAD. This HTA was compared with a HTA previously developed to represent WAI. The comparison output was used to develop a model of VRIII use. RESULTS: While many of the tasks in the WAD HTA were aligned with the tasks presented in the WAI HTA, some important ones did not. When misalignment was observed, permanent adaptations (e.g. signing as a witness for a changed VRIII's rate without independently verifying whether the new rate was appropriate) and temporary workarounds (e.g. not administering intermediate-acting insulin analogues although the intermediate-acting insulin prescription was not suspended) were the most frequently observed adaptations. The comparison between WAI and WAD assisted in developing a model of VRIII use. The model shed light on strategies used to imagine everyday work (e.g. incident reports, VRIII guidelines), how everyday work was accomplished (e.g. context-dependent adaptations) and how these contributed to both successful and unsuccessful outcomes. CONCLUSIONS: This study provided in-depth understanding of the tasks required while using VRIIIs, and responses and adaptations needed to achieve safer care in a complex environment.

Using institutional entrepreneurship to understand the role of innovation teams in healthcare: a longitudinal qualitative study.

OBJECTIVES: We draw on institutional theory to explore the roles and actions of innovation teams and how this influences their behaviour and capabilities as 'institutional entrepreneurs (IEs)', in particular the extent to which they are both 'willing' and 'able' to facilitate transformational change in healthcare through service redesign. DESIGN: A longitudinal qualitative study that applied a 'researcher in residence' as an ethnographic approach. SETTING: The development and implementation of two innovation projects within a single public hospital setting in an Australian state jurisdiction. PARTICIPANTS: Two innovation teams, with members including senior research fellows, PhD scholars and front-line clinicians (19 participants and 47 interviews). RESULTS: Despite being from the same hospital, the two innovation teams occupied contrasting subject positions with one facilitating transformational improvements in service delivery, while the other sought more conservative improvements. Cast as 'IEs' we show how one team took steps to build legitimacy for their interventions enabling spread and scale in improvements and how, in the other case, failure to build legitimacy resulted in unintended consequences which undermined the sustainability of the improvements achieved. CONCLUSIONS: Adopting an institutional approach provided insight into the 'willingness' and 'ability' to facilitate transformational change in healthcare through service redesign. The manner in which innovation teams operate from different subject positions influences the structural and normative legitimacy afforded to their activities. Specifically, we observed that those with the most power (organisational or professional) to bring about transformational change can be the least willing to do so in ways which challenge current practice. Those most willing to challenge the status quo (more peripheral organisation members or professionals) can be least able to deliver transformation. Better understanding of these insights can inform healthcare leaders in supporting innovation team efforts, considering their subject position.

"Slow science" for 21st century healthcare: reinventing health service research that serves fast-paced, high-complexity care organisations.

PURPOSE: The purpose of this paper is to argue for an improved conceptualisation of health service research, using Stengers' (2018) metaphor of "slow science" as a critical yardstick. DESIGN/METHODOLOGY/APPROACH: The paper is structured in three parts. It first reviews the field of health services research and the approaches that dominate it. It then considers the healthcare research approaches whose principles and methodologies are more aligned with "slow science" before presenting a description of a "slow science" project in which the authors are currently engaged. FINDINGS: Current approaches to health service research struggle to offer adequate resources for resolving frontline complexity, principally because they set more store by knowledge generalisation, disciplinary continuity and integrity and the consolidation of expertise, than by engaging with frontline complexity on its terms, negotiating issues with frontline staff and patients on their terms and framing findings and solutions in ways that key in to the in situ dynamics and complexities that define health service delivery. ORIGINALITY/VALUE: There is a need to engage in a paradigm shift that engages health services as co-researchers, prioritising practical change and local involvement over knowledge production. Economics is a research field where the products are of natural appeal to powerful health service managers. A "slow science" approach adopted by the embedded Economist Program with its emphasis on pre-implementation, knowledge mobilisation and parallel site capacity development sets out how research can be flexibly produced to improve health services.

Embedding an economist in regional and rural health services to add value and reduce waste by improving local-level decision-making: protocol for the 'embedded Economist' program and evaluation.

BACKGROUND: Systematic approaches to the inclusion of economic evaluation in national healthcare decision-making are usual. It is less common for economic evaluation to be routinely undertaken at the 'local-level' (e.g. in a health service or hospital) despite the largest proportion of health care expenditure being determined at this service level and recognition by local health service decision makers of the need for capacity building in economic evaluation skills. This paper describes a novel program - the embedded Economist (eE) Program. The eE Program aims to increase local health service staff awareness of, and develop their capacity to access and apply, economic evaluation principles in decision making. The eE program evaluation is also described. The aim of the evaluation is to capture the contextual, procedural and relational aspects that assist and detract from the eE program aims; as well as the outcomes and impact from the specific eE projects. METHODS: The eE Program consists of a embedding a health economist in six health services and the provision of supported education in applied economic evaluation, provided via a community of practice and a university course. The embedded approach is grounded in co-production, embedded researchers and 'slow science'. The sites, participants, and program design are described. The program evaluation includes qualitative data collection via surveys, semi-structured interviews, observations and field diaries. In order to share interim findings, data are collected and analysed prior, during and after implementation of the eE program, at each of the six health service sites. The surveys will be analysed by calculating frequencies and descriptive statistics. A thematic analysis will be conducted on interview, observation and filed diary data. The Framework to Assess the Impact from Translational health research (FAIT) is utilised to assess the overall impact of the eE Program. DISCUSSION: This program and evaluation will contribute to knowledge about how best to build capacity and skills in economic evaluation amongst decision-makers working in local-level health services. It will examine the extent to which participants are able to improve their ability to utilise evidence to inform decisions, avoid waste and improve the value of care delivery.

What Drives Patients' Complaints About Adverse Events in Their Hospital Care? A Data Linkage Study of Australian Adults 45 Years and Older.

OBJECTIVE: The aim of the study was to determine from patient-reported data the relationships between patients' experiences of adverse events (AEs), the disclosure of the events, and patients propensity for complaints or legal action. METHODS: A cross-sectional survey was administered to 20,000 participants randomly chosen from the 45 and Up Study. The surveyed participants were older than 45 years and hospitalized in New South Wales, Australia, between January and June 2014. They were identified using data linkage to capture experiences of AEs. RESULTS: Of the 7661 respondents, 474 participants (7%) reported experiencing an AE. Those who did not receive an apology or expression of regret in the incident disclosure process were significantly more likely to make a complaint (P < 0.05). Those who found out about the event from hospital staff but did not receive a formal open disclosure process were found to be significantly more likely to seek legal advice (P < 0.05). Patients who made a complaint generally perceived that they experienced more problems in their hospital care, with significant differences identified between those who did and did not make a complaint on 13 of the 15-item Picker Patient Experience Questionnaire. CONCLUSIONS: Although incident disclosure was not associated with whether a complaint was made or legal action pursued, significant associations between key aspects of the disclosure process and these outcomes were noted. Significant differences between those who did and did not make a complaint were noted in relation to the timing and apology components of open disclosure. The critical role of overall patient experience in the context of optimal AE management was evident from these data.

An overview of healthcare improvement: unpacking the complexity for clinicians and managers in a learning health system.

Given the pace of technological advancement and government mandates for healthcare and system transformation, there is an imperative for change. Health systems are highly complex in their design, networks and interacting components, and experience demonstrates that change is very challenging to enact, sustain and scale. Policy-makers, academics and clinicians all need better insight into the nature of this complexity and an understanding of the evidence-base that can support healthcare improvement (HCI), or quality improvement, interventions and make them more effective in driving change. The evidence base demonstrates the vital role of clinical engagement and leadership in HCI, and it is imperative that clinicians engage to improve front-line healthcare. The literature on HCI is vast, applies different and inconsistent terminology and encompasses often loosely defined and overlapping concepts. An increasingly broad range of disciplines has contributed to the available evidence base, but often discipline-specific perspectives frame these contributions. Available literature can also be overly driven by the generation of theoretical concepts and the advancement of academic understanding. It does not necessarily primarily provide focussed and pragmatic insights to guide and inform frontline practice. We aim to address these issues by summarising theories, frameworks, models and success factors for improvement in complex health systems to assist clinicians and others to engage and lead change. We integrate the field of HCI into the learning health system highlighting the key role of the clinician. We seek to inform stakeholders; clinicians and managers to guide the planning, enacting, sustaining and scaling of HCI.

Trajectories of hospital infection control: Using non-representational theory to understand and improve infection prevention and control.

In this paper we undertake an innovative analysis of infection prevention and control (IPC) activities in hospitals, using non-representational theory of space (2005). We deployed video-reflexive ethnography in three wards in two metropolitan teaching hospitals involving 252 healthcare workers as participants. We analysed our data iteratively using non-representational theory, which showed hospital space being constantly produced from varied, intersecting, and sometimes competing trajectories of hospital work, objects and people. The approach enabled multiple material factors impinging on routine IPC (including objects such as rolls of surgical tape), and habitual or prioritised actions (such as safeguarding patient privacy) to be included in analysis. The analysis also included the role of time which has been absent from other discussions of IPC, highlighting the transience of spaces produced through IPC practices and the need to continually re-make them. We found many situations in which the complexity of practice, rather than failures of compliance, contributed to potential microbial transmission. We show how inconsistency and confusion about IPC practice often can only be resolved through action. Our findings suggest that further reduction in preventable hospital infection rates will require better integration of IPC with other work trajectories; a shift in emphasis from compliance monitoring to collaborative practice; and greater use of in situ risk assessment and judgment.

Sustained fall in inpatient MRSA prevalence after a video-reflexive ethnography project; an observational study.

BACKGROUND: Maintaining optimal infection prevention and control (IPC) in a busy, clinical environment is challenging. Video-reflexive ethnography (VRE) is a collaborative, interventionist approach to practice improvement. We hypothesised that giving clinicians opportunities to view and reflect on video footage of everyday ward activities would raise awareness of, and suggest strategies to reduce, pathogen transmission risks. We undertook a VRE project, between March and September 2013, in two tertiary hospital surgical wards, with persistently high methicillin resistant Staphylococcus aureus (MRSA) endemicity, despite previous IPC interventions. METHODS: This study was a retrospective/prospective observational study, using interrupted time-series analyses, to assess the effects of the VRE project on hand hygiene compliance, inpatient MRSA infections (newly infected patients, per 1000 occupied bed days) and inpatient MRSA colonisation prevalence, measured by serial point prevalence surveys. Follow-up continued until June 2016. RESULTS: The VRE project was associated with changes in IPC behaviour and outcomes. Hand hygiene compliance increased (from 62% to 75%; p < 0.0001) and MRSA colonisation prevalence decreased significantly, in both wards (baseline 42%; average post-VRE 12%; p=<0.0001), MRSA infection rate decreased in one ward. Interpretation of results was complicated by a potential confounding effect of unplanned environmental hydrogen peroxide decontamination (HPD). Improved hand hygiene compliance was a predicted outcome of VRE, but also a potential contributor to reduced MRSA transmission. CONCLUSION: Separate contributions of VRE (the intervention), HPD and hand hygiene compliance were uncertain, but their combined effect was significantly reduced MRSA endemicity, which previously had been resistant to attempted IPC interventions.

Fostering nursing innovation to prevent and control antimicrobial resistance using approaches from the arts and humanities.

BACKGROUND: Efforts to address the complex global problem of antimicrobial resistance (AMR) highlight the need for imagination and innovation. However, nursing has not yet leveraged its potential to innovate to prevent AMR advancing. AIMS: This paper focuses on the initial phase of an ongoing research and development study that seeks to foster nursing imagination and innovation by enhancing the meaningfulness of AMR for practising nurses and by facilitating their creative ideas. METHODS: This aim is addressed through application of arts and humanities approaches, in particular the use of visualisation, co-design and historical methods, underpinned by the Design Council Double Diamond process model. The first phase with 20 UK participants explored how hospital and community-based nurses understand and respond to the priorities and consequences of AMR within their everyday working lives. RESULTS: Nurses varied in their conceptualisations of AMR and in their depictions and explanations of its meaning and priority within everyday practices. Some saw infection prevention and control as bound up with AMR, whereas others differentiated in the context of specific work activities. Insights into related reasoning and practice tactics were also generated. CONCLUSIONS: The initial project phase provides a basis for fostering nursing innovation in this important field.

To follow a rule? On frontline clinicians' understandings and embodiments of hospital-acquired infection prevention and control rules.

This article reports on a study of clinicians' responses to footage of their enactments of infection prevention and control. The study's approach was to elicit clinicians' reflections on and clarifications about the connections among infection control activities and infection control rules, taking into account their awareness, interpretation and in situ application of those rules. The findings of the study are that clinicians responded to footage of their own infection prevention and control practices by articulating previously unheeded tensions and constraints including infection control rules that were incomplete, undergoing change, and conflicting; material obstructions limiting infection control efforts; and habituated and divergent rule enactments and rule interpretations that were problematic but disregarded. The reflexive process is shown to elicit clinicians' learning about these complexities as they affect the accomplishment of effective infection control. The process is further shown to strengthen clinicians' appreciation of infection control as necessitating deliberation to decide what are locally appropriate standards, interpretations, assumptions, habituations and enactments of infection control. The article concludes that clinicians' 'practical wisdom' is unlikely to reach its full potential without video-assisted scrutiny of and deliberation about in situ clinical work. This enables clinicians to anchor their in situ enactments, reasonings and interpretations to local agreements about the intent, applicability, limits and practical enactment of rules.