What can Safety Cases offer for patient safety? A multisite case study.

BACKGROUND: The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways. METHODS: Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams. RESULTS: The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm. CONCLUSIONS: The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors.

Why is safety in intrapartum electronic fetal monitoring so hard? A qualitative study combining human factors/ergonomics and social science analysis.

BACKGROUND: Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk. METHODS: Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method. RESULTS: CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely. CONCLUSIONS: CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces.

Seven features of safety in maternity units: a framework based on multisite ethnography and stakeholder consultation.

BACKGROUND: Reducing avoidable harm in maternity services is a priority globally. As well as learning from mistakes, it is important to produce rigorous descriptions of 'what good looks like'. OBJECTIVE: We aimed to characterise features of safety in maternity units and to generate a plain language framework that could be used to guide learning and improvement. METHODS: We conducted a multisite ethnography involving 401 hours of non-participant observations 33 semistructured interviews with staff across six maternity units, and a stakeholder consultation involving 65 semistructured telephone interviews and one focus group. RESULTS: We identified seven features of safety in maternity units and summarised them into a framework, named For Us (For Unit Safety). The features include: (1) commitment to safety and improvement at all levels, with everyone involved; (2) technical competence, supported by formal training and informal learning; (3) teamwork, cooperation and positive working relationships; (4) constant reinforcing of safe, ethical and respectful behaviours; (5) multiple problem-sensing systems, used as basis of action; (6) systems and processes designed for safety, and regularly reviewed and optimised; (7) effective coordination and ability to mobilise quickly. These features appear to have a synergistic character, such that each feature is necessary but not sufficient on its own: the features operate in concert through multiple forms of feedback and amplification. CONCLUSIONS: This large qualitative study has enabled the generation of a new plain language framework-For Us-that identifies the behaviours and practices that appear to be features of safe care in hospital-based maternity units.

Separating, replacing, intersecting: The influence of context on the construction of the medical-nursing boundary.

The distribution of work, knowledge, and responsibilities between doctors and nurses is a longstanding object of interest for medical sociologists. Whereas the strategies through which nurses and doctors construct their professional boundary have been thoroughly examined, little is known about why the regulation of the medical-nursing boundary varies across care settings. In the article, I argue that this gap in knowledge can be attributed to insufficient examination of the 'negotiation context', namely the features of the social and organisational environment that directly affect doctor-nurse boundary negotiations. Adopting a negotiated order perspective, and drawing data from a hospital ethnography, the article describes the different ways of constructing the medical-nursing boundary (separating, replacing, and intersecting) which were observed in three different care settings (a neurology ward, a neurosurgical ward, and an intensive care unit). Constant comparison of the observed interactional patterns led to the identification of three factors that significantly affected the construction of the medical-nursing boundary, specifically: patients' state of awareness, the type of clinical approach adopted by nurses and doctors, and the level of acuity on the ward. The article advances our knowledge of the medical-nursing boundary by shedding light on its flexible and contextual nature and by adding further nuance to the boundary-blurring/boundary-reinforcing dichotomy. New features of the 'negotiation context' are identified that enable more convincing explanations of why the medical-nursing boundary varies across care settings. Finally, the study advances the negotiated order theory by offering a framework for considering the structural differences that shape local negotiations.

Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial.

BACKGROUND: Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. METHODS/DESIGN: The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle. DISCUSSION: The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02645357.

[Computerized decision support systems: EBM at the bedside]. / Sistemi computerizzati di supporto alle decisioni cliniche: l'EBM al letto del malato.

INTRODUCTION: One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making. OBJECTIVES: The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. METHODS: The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. RESULTS: The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. DISCUSSION: CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.

Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial.

BACKGROUND: Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge. METHODS/DESIGN: We designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period. DISCUSSION: The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES). TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02577198?term=NCT02577198&rank=1.

Invisible walls within multidisciplinary teams: Disciplinary boundaries and their effects on integrated care.

Delivery of interdisciplinary integrated care is central to contemporary health policy. Hospitals worldwide are therefore attempting to move away from a functional organisation of care, built around discipline-based specialisation, towards an approach of delivering care through multidisciplinary teams. However, the mere existence of such teams may not guarantee integrated and collaborative work across medical disciplines, which can be hindered by boundaries between and within professions. This paper analyses the boundaries that affect collaboration and care integration in newly created multidisciplinary teams. Empirical data are drawn from an ethnographic research conducted in the sub-intensive stroke unit of an Italian public hospital. Data collection involved 180 h of observations and conversations with 42 healthcare providers. Findings show that disciplinary boundaries hinder both intra-professional and inter-professional collaboration. Doctors from different disciplines adopt different, and sometimes conflicting, clinical approaches, doctors and nurses construct discipline-specific professional identities, and conflicts emerge between doctors and nurses from different disciplines over the regulation of the medical-nursing boundary. Achieving collaboration and integration between professionals from different disciplines may be particularly challenging when the group with less institutional power (nurses, in this case) has developed a high level of expertise on the needs of the patients targeted by the team. Effective interdisciplinary work thus requires not only bridging boundaries within the medical professional group, but also addressing the dynamics of resistance in merging doctors and nurses with different disciplinary backgrounds. In the paper, we summarise these results in a framework that contributes knowledge to the field of professional boundaries in healthcare while offering practical insights to forge new interdisciplinary relationships, which are more embedded in the daily experience of care providers.

Reorganising hospitals to implement a patient-centered model of care: Effects on clinical practice and professional relationships in the Italian NHS.

PURPOSE: The purpose of this paper is to understand how the introduction of a patient-centered model (PCM) in Italian hospitals affects the pre-existent configuration of clinical work and interacts with established intra/inter-professional relationships. DESIGN/METHODOLOGY/APPROACH: Qualitative multi-phase study based on three main sources: health policy analysis, an exploratory interview study with senior managers of eight Italian hospitals implementing the PCM, and an in-depth case study that involved managerial and clinical staff of one Italian hospital implementing the PCM. FINDINGS: The introduction of the PCM challenges clinical work and professional relationships, but such challenges are interpreted differently by the organisational actors involved, thus giving rise to two different "narratives of change". The "political narrative" (the views conveyed by formal policies and senior managers) focuses on the power shifts and conflict between nurses and doctors, while the "workplace narrative" (the experiences of frontline clinicians) emphasises the problems linked to the disruption of previous discipline-based inter-professional groups. PRACTICAL IMPLICATIONS: Medical disciplines, rather than professional groupings, are the main source of identification of doctors and nurses, and represent a crucial aspect of clinicians' professional identity. Although the need for collaboration among medical disciplines is acknowledged, creating multi-disciplinary groups in practice requires the sustaining of new aggregators and binding forces. ORIGINALITY/VALUE: This study suggests further acknowledgment of the inherent complexity of the political and workplace narratives of change rather than interpreting them as the signal of irreconcilable perspectives between managers and clinicians. By addressing the specific issues regarding which the political and workplace narratives clash, relationship of trust may be developed through which problems can be identified, mutually acknowledged, articulated, and solved.

[Barriers and facilitators to the implementation of computerized decision support systems in Italian hospitals: a grounded theory study]. / Barriere e facilitatori all'implementazione dei sistemi di supporto decisionale computerizzati in ospedale: uno studio "grounded theory".

INTRODUCTION: Computerized Decision Support Systems (CDSSs) connect health care professionals with high-quality, evidence-based information at the point-of-care to guide clinical decision-making. Current research shows the potential of CDSSs to improve the efficiency and quality of patient care. The mere provision of the technology, however, does not guarantee its uptake. This qualitative study aims to explore the barriers and facilitators to the use of CDSSs as identified by health providers. METHODS: The study was performed in three Italian hospitals, each characterized by a different level of familiarity with the CDSS technology. We interviewed frontline physicians, nurses, information technology staff, and members of the hospital board of directors (n=24). A grounded theory approach informed our sampling criteria as well as the data collection and analysis. RESULTS: The adoption of CDSSs by health care professionals can be represented as a process that consists of six "positionings," each corresponding to an individual's use and perceived mastery of the technology. In conditions of low mastery, the CDSS is perceived as an object of threat, an unfamiliar tool that is difficult to control. On the other hand, individuals in conditions of high mastery view the CDSS as a helpful tool that can be locally adapted and integrated with clinicians' competences to fulfil their needs. In the first positionings, the uptake of CDSSs is hindered by representational obstacles. The last positionings, alternatively, featured technical obstacles to CDSS uptake. DISCUSSION: Our model of CDSS adoption can guide hospital administrators interested in the future integration of CDSSs to evaluate their organizational contexts, identify potential challenges to the implementation of the technology, and develop an effective strategy to address them. Our findings also allow reflections concerning the misalignment between most Italian hospitals and the current innovation trends toward the uptake of computerized decision support technologies.

Exploring the practice of patient centered care: The role of ethnography and reflexivity.

Patient centered care (PCC) is an essential dimension of healthcare systems' mission worldwide and is recognized as an important condition for ensuring the quality of care. Nonetheless, it is also acknowledged that various care providers perceive patient centeredness differently and that there remain several unanswered questions about the aspects of healthcare delivery that are linked to an actual achievement of PCC. In the paper, we categorize the current research on PCC into two streams ("dyadic" and "organizational") and we discuss the strengths and weaknesses of each. Despite their important contributions to healthcare services research, these approaches to PCC do not fully capture the network of practices and relationships constituting patients and providers' experiences within healthcare contexts. Therefore, we propose an alternative interpretation of PCC that integrates insights from "practice theories" and emphasizes the negotiated and local nature of patient centeredness, which is accomplished through the engagement of providers and patients in everyday care practices. To develop such interpretation, we propose a research approach combining ethnographic and reflexive methods. Ethnography can help achieve more nuanced descriptions of what PCC truly encapsulates in the care process by drawing attention to the social and material reality of healthcare contexts. Reflexivity can help disentangle and bring to surface the tacit knowledge spread in everyday care practices and transform it into actionable knowledge, a type of knowledge that may support services improvement toward PCC. We anticipate that such improvement is far from straightforward: an actual achievement of PCC may challenge the interests of different stakeholders and unsettle consolidated habits, hierarchies and power dynamics. This unsettlement, however, can also serve as a necessary condition for engaging in a participative process of internal development. We discuss the outcomes, limitations and benefits of our approach through a hospital case study.

Barriers and facilitators to the uptake of computerized clinical decision support systems in specialty hospitals: protocol for a qualitative cross-sectional study.

BACKGROUND: Computerized clinical decision support systems (CDSSs) have been shown to improve the efficiency and quality of patient care by connecting healthcare professionals with high quality, evidence-based information at the point-of-care. The mere provision of CDSSs, however, does not guarantee their uptake. Rather, individual and institutional perceptions can foster or inhibit the integration of CDSSs into routine clinical workflow. Current studies exploring health professionals' perceptions of CDSSs focus primarily on technical and usability issues, overlooking the social or cultural variables as well as broader administrative or organizational roles that may influence CDSS adoption. Moreover, there is a lack of data on the evolution of perceived barriers or facilitators to CDSS uptake across different stages of implementation. METHODS: We will conduct a qualitative, cross-sectional study in three Italian specialty hospitals involving frontline physicians, nurses, information technology staff, and members of the hospital board of directors. We will use semi-structured interviews following the Grounded Theory framework, progressively recruiting participants until no new information is gained from the interviews. DISCUSSION: CDSSs are likely to become an integral and diffuse part of clinical practice. Various factors must be considered when planning their introduction in healthcare settings. The findings of this study will guide the development of strategies to facilitate the successful integration of CDSSs into the regular clinical workflow. The evaluation of diverse health professionals across multiple hospital settings in different stages of CDSS uptake will better capture the complexity of roles and contextual factors affecting CDSS uptake.