What Might Be Required for Inspections to Be Considered Fair? Comment on "What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya's Health Facility Inspection Reforms".

Tama et al offer us an interesting analysis of a piloted regulatory reform that introduced a Joint Health Inspections (JHIs) system in three Kenyan counties. The study highlights key factors facilitating or hindering the implementation of the reform. In this commentary we reflect on the concept of fairness, which is one of the topics that is discussed in the study. We describe four important dimensions of fairness in the context of inspections: expectation clarity, consistency of assessment, consistency of enforcement, and fairness to patients. We argue that all four dimensions are important in the regulatory design, in order for the inspection to be perceived as fair.

Learning team-based quality improvement in a virtual setting: a qualitative study.

OBJECTIVE: The objective was to explore students' perceptions of learning quality improvement (QI) in a virtual setting and identify factors that promote or inhibit virtual learning. DESIGN: We used an exploratory case study design with focus group interviews. The data were analysed using a thematic analysis approach, with an analytical framework derived from activity theory and Bloom's revised taxonomy of six categories of cognitive processes of learning. SETTING: Postgraduate students participating in a virtual 1-day simulation module to learn QI at two universities in Norway. PARTICIPANTS: Four focus groups with a total of 12 participants. RESULTS: The students' descriptions of learning outcomes indicate that the learning activity involved a variety of cognitive activities, including higher-order cognitive processes. We identified three themes pertaining to the students' experiences of the virtual learning activity: learning through active participation, constructing a virtual learning opportunity and creating a virtual learning environment. The students described that participation and active engagement led to a greater understanding and an integration of theory and practical improvement skills. They reported that to engage in the virtual learning opportunity, it was necessary to create a learning environment where they felt psychologically safe. CONCLUSION: Our findings indicate that it is possible to facilitate collaborative learning integrating theoretical knowledge and practical skills in a virtual setting. Students experienced that engaging in the virtual learning activity contributed to the integration of theoretical knowledge and practical skills. Psychological safety seems to be important for students' engagement in the virtual learning activity. A virtual learning environment alters prior common norms for interaction based on physical presence, which in turn affect students feeling of psychological safety. Educators need to be aware of this and facilitate a virtual learning environment where students feel comfortable to engage.

Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial.

BACKGROUND: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support. METHODS: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis. RESULTS: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028). CONCLUSIONS: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017).

Contextual factors of external inspections and mechanisms for improvement in healthcare organizations: A realist evaluation.

External inspections constitute a key element of healthcare regulation. Improved quality of care is one of the important goals of inspections but the mechanisms of how inspections might contribute to quality improvement are poorly understood. Drawing on interviews with healthcare professionals and managers and health record data from inspected organizations, we used a realist evaluation approach to explore how twelve inspections of healthcare providers in x= Norway influenced quality improvement. We found that for inspections to contribute to quality improvement, there must be contextual structures present supporting accountability and engaging staff in improvement work. When such structures are present, inspections can contribute to improvement by creating awareness of gaps between desired and current practices, which leads to readiness for change and stimulates intra-organizational reasoning around quality improvement. We discuss our findings using the theory of de- and recoupling, noting how regulators can identify decoupling between intended goals, management systems, practices, and patient outcomes. We further argue that regulators can contribute to a recoupling between these levels by having the capacity to track the providers' clinical performance over time. This will hold the organization accountable for implementing improvement measures and evaluate the effects of the measures on quality of care.

Correction: Early diagnosis of sepsis in emergency departments, time to treatment, and association with mortality: An observational study.

[This corrects the article DOI: 10.1371/journal.pone.0227652.].

Promoting leadership and quality improvement through external inspections of management of sepsis in Norwegian hospitals: a focus group study.

OBJECTIVE: Inspections and other forms of external assessment may contribute to positive changes in the health services, but the mechanisms of such change remain unclear. We did a study to explore how external inspections may foster clinical improvement in hospitals. DESIGN: Focus group study. SETTING: Statutory inspections of sepsis treatment in hospital emergency departments in Norway. PARTICIPANTS: Clinicians, managers and inspection teams involved with the inspections of sepsis treatment in emergency departments at four different hospitals. Twelve focus group interviews were carried out, with a total of 47 participants. RESULTS: Three themes emerged as central for understanding how the inspections could contribute to clinical improvement in the emergency departments: (1) increasing awareness about the need to improve the quality of care by providing data on clinical performance, (2) building acceptance for improvement through professional credibility and focus on clinical practice, and (3) fostering leadership commitment. CONCLUSION: Our findings suggest that the inspections have the potential to enhance hospital management and staff's understanding of complicated care processes and help strengthen the organisational commitment to bring about systemic quality improvements.

Effects of external inspections on sepsis detection and treatment: a stepped-wedge study with cluster-level randomisation.

OBJECTIVE: To evaluate the effects of external inspections on (1) hospital emergency departments' clinical processes for detecting and treating sepsis and (2) length of hospital stay and 30-day mortality. DESIGN: Incomplete cluster-randomised stepped-wedge design using data from patient records and patient registries. We compared care processes and patient outcomes before and after the intervention using regression analysis. SETTING: Nationwide inspections of sepsis care in emergency departments in Norwegian hospitals. PARTICIPANTS: 7407 patients presenting to hospital emergency departments with sepsis. INTERVENTION: External inspections of sepsis detection and treatment led by a public supervisory institution. MAIN OUTCOME MEASURES: Process measures for sepsis diagnostics and treatment, length of hospital stay and 30-day all-cause mortality. RESULTS: After the inspections, there were significant improvements in the proportions of patients examined by a physician within the time frame set in triage (OR 1.28, 95% CI 1.07 to 1.53), undergoing a complete set of vital measurements within 1 hour (OR 1.78, 95% CI 1.10 to 2.87), having lactate measured within 1 hour (OR 2.75, 95% CI 1.83 to 4.15), having an adequate observation regimen (OR 2.20, 95% CI 1.51 to 3.20) and receiving antibiotics within 1 hour (OR 2.16, 95% CI 1.83 to 2.55). There was also significant reduction in mortality and length of stay, but these findings were no longer significant when controlling for time. CONCLUSIONS: External inspections were associated with improvement of sepsis detection and treatment. These findings suggest that policy-makers and regulatory agencies should prioritise assessing the effects of their inspections and pay attention to the mechanisms by which the inspections might contribute to improve care for patients. TRIAL REGISTRATION: NCT02747121.

Mediators of change in healthcare organisations subject to external assessment: a systematic review with narrative synthesis.

OBJECTIVES: External inspections are widely used to improve the quality of care. The effects of inspections remain unclear and little is known about how they may work. We conducted a narrative synthesis of research literature to identify mediators of change in healthcare organisations subject to external inspections. METHODS: We performed a literature search (1980-January 2020) to identify empirical studies addressing change in healthcare organisations subject to external inspection. Guided by the Consolidated Framework for Implementation Research, we performed a narrative synthesis to identify mediators of change. RESULTS: We included 95 studies. Accreditation was the most frequent type of inspection (n=68), followed by statutory inspections (n=19), and external peer review (n=9). Our findings suggest that the regulatory context in which the inspections take place affect how they are acted on by those being inspected. The way inspections are conducted seem to be critical for how the inspection findings are perceived and followed up. Inspections can engage and involve staff, facilitate leader engagement, improve communication and enable the creation of new networks for reflection on clinical practice. Inspections can contribute to creating an awareness of the inspected organisation's current practice and performance gaps, and a commitment to change. Moreover, they can contribute to facilitating the planning and implementation of change, as well as self-evaluation and the use of data to evaluate performance. CONCLUSIONS: External inspections can affect different mediators of organisational change. The way and to what extent they do depend on a range of factors related to the outer setting, the way inspections are conducted and how they are perceived and acted on by the inspected organisation. To improve the quality of care, the organisational change processes need to involve and impact the way care is delivered to the patients.

Inspecting teams' and organisations' expectations regarding external inspections in health care: a qualitative study.

BACKGROUND: There is a gap in the literature regarding what takes place between the announcement of a regulatory intervention, such as an external inspection of a health care organisation, and the inspecting body's site visit. This study aimed to explore inspecting bodies' expectations of how inspected organisations should prepare before an external inspection and to elucidate how inspected health care organisations prepare before site visits. METHODS: This qualitative study was based on data from 17 group interviews with a total of 75 participants representing inspection teams, organisation leaders and clinicians in inspected health care organisations. The data were analysed using a qualitative content analysis method. RESULTS: We identified two approaches to how the inspection teams expected that the inspected organisations should prepare before site visits. In the first approach the inspection teams did not expect any improvement activities to be initiated during this period and focused on identifying inadequacies that the inspected organisations should subsequently improve. In the second approach the inspection teams expected organisations to review their own practices and begin improvement activities if necessary. The inspected organisations responded in different ways to an upcoming site visit, and the organisations' leaders were important in determining which activities would be initiated. Organisations in which leaders involved clinicians in assessing care delivery tended to initiate action to improve and expected inspection teams to assess their ongoing improvement work and provide guidance on further improvements. Leaders who did not involve clinicians in assessing the quality of care tended to perceive the current quality of care as adequate on the basis of reviewing written guidelines. They did not initiate action to improve care delivery apart from updating written guidelines describing how care should be delivered, and they expected the inspection team to confirm that their current practices were in line with the guidelines and external standards. CONCLUSIONS: To promote anticipatory effects in inspected organisations, inspecting bodies should stress the importance of assessing clinical practice and involving frontline clinical staff and leaders in the assessment and in improvement work before the site visit.

Early diagnosis of sepsis in emergency departments, time to treatment, and association with mortality: An observational study.

BACKGROUND: Early recognition of sepsis is critical for timely initiation of treatment. The first objective of this study was to assess the timeliness of diagnostic procedures for recognizing sepsis in emergency departments. We define diagnostic procedures as tests used to help diagnose the condition of patients. The second objective was to estimate associations between diagnostic procedures and time to antibiotic treatment, and to estimate associations between time to antibiotic treatment and mortality. METHODS: This observational study from 24 emergency departments in Norway included 1559 patients with infection and at least two systemic inflammatory response syndrome criteria. We estimated associations using linear and logistic regression analyses. RESULTS: Of the study patients, 72.9% (CI 70.7-75.1) had documented triage within 15 minutes of presentation to the emergency departments, 44.9% (42.4-47.4) were examined by a physician in accordance with the triage priority, 44.4% (41.4-46.9) were adequately observed through continual monitoring of signs while in the emergency department, and 25.4% (23.2-27.7) received antibiotics within 1 hour. Delay or non-completion of these key diagnostic procedures predicted a delay of more than 2.5 hours to antibiotic treatment. Patients who received antibiotics within 1 hour had an observed 30-day all-cause mortality of 13.6% (10.1-17.1), in the timespan 2 to 3 hours after admission 5.9% (2.8-9.1), and 4 hours or later after admission 10.5% (5.7-15.3). CONCLUSIONS: Key procedures for recognizing sepsis were delayed or not completed in a substantial proportion of patients admitted to the emergency department with sepsis. Delay or non-completion of key diagnostic procedures was associated with prolonged time to treatment with antibiotics. This suggests a need for systematic improvement in the initial management of patients admitted to emergency departments with sepsis.

Effects of external inspection on sepsis detection and treatment: a study protocol for a quasiexperimental study with a stepped-wedge design.

INTRODUCTION: Inspections are widely used in health care as a means to improve the health services delivered to patients. Despite their widespread use, there is little evidence of their effect. The mechanisms for how inspections can promote change are poorly understood. In this study, we use a national inspection campaign of sepsis detection and initial treatment in hospitals as case to: (1) Explore how inspections affect the involved organizations. (2) Evaluate what effect external inspections have on the process of delivering care to patients, measured by change in indicators reflecting how sepsis detection and treatment is carried out. (3) Evaluate whether external inspections affect patient outcomes, measured as change in the 30-day mortality rate and length of hospital stay. METHODS AND ANALYSIS: The intervention that we study is inspections of sepsis detection and treatment in hospitals. The intervention will be rolled out sequentially during 12 months to 24 hospitals. Our effect measures are change on indicators related to the detection and treatment of sepsis, the 30-day mortality rate and length of hospital stay. We collect data from patient records at baseline, before the inspections, and at 8 and 14 months after the inspections. We use logistic regression models and linear regression models to compare the various effect measurements between the intervention and control periods. All the models will include time as a covariate to adjust for potential secular changes in the effect measurements during the study period. We collect qualitative data before and after the inspections, and we will conduct a thematic content analysis to explore how inspections affect the involved organisations. ETHICS AND DISSEMINATION: The study has obtained ethical approval by the Regional Ethics Committee of Norway Nord and the Norwegian Data Protection Authority. It is registered at www.clinicaltrials.gov (Identifier: NCT02747121). Results will be reported in international peer-reviewed journals. TRIAL REGISTRATION: NCT02747121; Pre-results.

A retrospective review of how nonconformities are expressed and finalized in external inspections of health-care facilities.

BACKGROUND: External inspections are widely used in health care as a means of improving the quality of care. However, the way external inspections affect the involved organization is poorly understood. A better understanding of these processes is important to improve our understanding of the varying effects of external inspections in different organizations. In turn, this can contribute to the development of more effective ways of conducting inspections. The way the inspecting organization states their grounds for noncompliant behavior and subsequently follows up to enforce the necessary changes can have implications for the inspected organization's change process. We explore how inspecting organizations express and state their grounds for noncompliant behavior and how they follow up to enforce improvements. METHODS: We conducted a retrospective review, in which we performed a content analysis of the documents from 36 external inspections in Norway. Our analysis was guided by Donabedian's structure, process, and outcome model. RESULTS: Deficiencies in the management system in combination with clinical work processes was considered as nonconformity by the inspecting organizations. Two characteristic patterns were identified in the way observations led to a statement of nonconformity: one in which it was clearly demonstrated how deficiencies in the management system could affect clinical processes, and one in which this connection was not demonstrated. Two characteristic patterns were also identified in the way the inspecting organization followed up and finalized their inspection: one in which the inspection was finalized solely based on the documented changes in structural deficiencies addressed in the nonconformity statement, and one based on the documented changes in structural and process deficiencies addressed in the nonconformity statement. CONCLUSION: External inspections are performed to improve the quality of care. To accomplish this aim, we suggest that nonconformities should be grounded by observations that clearly demonstrate how deficiencies in the management system might affect the clinical processes, and that the inspection should be finalized based on documented changes in both structural and process deficiencies addressed in the nonconformity statement.

A qualitative study of contextual factors' impact on measures to reduce surgery cancellations.

BACKGROUND: Contextual factors influence quality improvement outcomes. Understanding this influence is important when adapting and implementing interventions and translating improvements into new settings. To date, there is limited knowledge about how contextual factors influence quality improvement processes. In this study, we explore how contextual factors affected measures to reduce surgery cancellations, which are a persistent problem in healthcare. We discuss the usefulness of the theoretical framework provided by the model for understanding success in quality (MUSIQ) for this kind of research. METHOD: We performed a qualitative case study at Førde Hospital, Norway, where we had previously demonstrated a reduction in surgery cancellations. We interviewed 20 clinicians and performed content analysis to explore how contextual factors affected measures to reduce cancellations of planned surgeries. RESULTS: We identified three common themes concerning how contextual factors influenced the change process: 1) identifying a need to change, 2) facilitating system-wide improvement, and 3) leader involvement and support. Input from patients helped identify a need to change and contributed to the consensus that change was necessary. Reducing cancellations required improving the clinical system. This improvement process was based on a strategy that emphasized the involvement of frontline clinicians in detecting and improving system problems. Clinicians shared information about their work by participating in improvement teams to develop a more complete understanding of the clinical system and its interdependencies. This new understanding allowed clinicians to detect system problems and design adequate interventions. Middle managers' participation in the improvement teams and in regular work processes was important for successfully implementing and adapting interventions. CONCLUSION: Contextual factors interacted with one another and with the interventions to facilitate changes in the clinical system, reducing surgery cancellations. The MUSIQ framework is useful for exploring how contextual factors influence the improvement process and how they influence one another. Discussing data in relation to a theoretical framework can promote greater uniformity in reporting findings, facilitating knowledge-building across studies.

Patient experiences with interventions to reduce surgery cancellations: a qualitative study.

BACKGROUND: The cancellation of planned surgery harms patients, increases waiting times and wastes scarce health resources. Previous studies have evaluated interventions to reduce cancellations from medical and management perspectives; these have focused on cost, length of stay, improved efficiency, and reduced post-operative complications. In our case a hospital had experienced high cancellation rates and therefore redesigned their pathway for elective surgery to reduce cancelations. We studied how patients experienced interventions to reduce cancellations. METHODS: We conducted a comparative, qualitative case study by interviewing 8 patients who had experienced the redesigned pathway, and 8 patients who had experienced the original pathway. We performed a content analysis of the interviews using a theory-based coding scheme. Through a process of coding and condensing, we identified themes of patient experience. RESULTS: We identified three common themes summarizing patients' positive experiences with the effects of the interventions: the importance of being involved in scheduling time for surgery, individualized preparation before the hospital admission, and relationships with few clinicians during their hospital stay. CONCLUSIONS: Patients appreciated the effects of interventions to reduce cancellations, because they increased their autonomy. Unanticipated consequences were that the telephone reminder created a personalized dialogue and centralization of surgical preparation and discharge processes improved continuity of care. Thus apart from improving surgical logistics, the pathway became more patient-centered.

Sustainability of healthcare improvement: what can we learn from learning theory?

BACKGROUND: Changes that improve the quality of health care should be sustained. Falling back to old, unsatisfactory ways of working is a waste of resources and can in the worst case increase resistance to later initiatives to improve care. Quality improvement relies on changing the clinical system yet factors that influence the sustainability of quality improvements are poorly understood. Theoretical frameworks can guide further research on the sustainability of quality improvements. Theories of organizational learning have contributed to a better understanding of organizational change in other contexts. To identify factors contributing to sustainability of improvements, we use learning theory to explore a case that had displayed sustained improvement. METHODS: Førde Hospital redesigned the pathway for elective surgery and achieved sustained reduction of cancellation rates. We used a qualitative case study design informed by theory to explore factors that contributed to sustain the improvements at Førde Hospital. The model Evidence in the Learning Organization describes how organizational learning contributes to change in healthcare institutions. This model constituted the framework for data collection and analysis. We interviewed a strategic sample of 20 employees. The in-depth interviews covered themes identified through our theoretical framework. Through a process of coding and condensing, we identified common themes that were interpreted in relation to our theoretical framework. RESULTS: Clinicians and leaders shared information about their everyday work and related this knowledge to how the entire clinical pathway could be improved. In this way they developed a revised and deeper understanding of their clinical system and its interdependencies. They became increasingly aware of how different elements needed to interact to enhance the performance and how their own efforts could contribute. CONCLUSIONS: The improved understanding of the clinical system represented a change in mental models of employees that influenced how the organization changed its performance. By applying the framework of organizational learning, we learned that changes originating from a new mental model represent double-loop learning. In double-loop learning, deeper system properties are changed, and consequently changes are more likely to be sustained.

A new pathway for elective surgery to reduce cancellation rates.

BACKGROUND: The cancellation of planned surgeries causes prolonged wait times, harm to patients, and is a waste of scarce resources. To reduce high cancellation rates in a Norwegian general hospital, the pathway for elective surgery was redesigned. The changes included earlier clinical assessment of patients, better planning and documentation systems, and increased involvement of patients in the scheduling of surgeries. This study evaluated the outcomes of this new pathway for elective surgery and explored which factors affected the outcomes. METHODS: We collected the number of planned operations, performed operations, and cancellations per month from the hospital's patient administrative system. We then used Student's t-test to analyze differences in cancellation rates (CRs) before and after interventions and a u-chart to analyze whether the improvements were sustained. We also conducted semi-structured interviews with employees of the hospital to explore the changes in the surgical pathway and the factors that facilitated these changes. RESULTS: The mean CR was reduced from 8.5% to 4.9% (95% CI for mean reduction 2.6-4.5, p < 0.001). The reduction in the CR was sustained over a period of 26 months after the interventions. The median number of operations performed per month increased by 17% (p = 0.04). A clear improvement strategy, involvement of frontline clinicians, introduction of an electronic scheduling system, and engagement of middle managers were important factors for the success of the interventions. CONCLUSION: The redesign of the old clinical pathway contributed to a sustained reduction in cancellations and an increased number of performed operations.

[Networks for improving quality in general medicine]. / Laeringsnettverk for bedre kvalitet i allmennpraksis.

BACKGROUND: Quality networks are more common in hospitals than in general practice. This study investigates the feasibility of quality networks in general practice, with attention to key factors that may enhance results from continuous quality improvement, such as team leadership, multidisciplinary involvement and optimalising resources. MATERIAL AND METHODS: Multidisciplinary teams from six general practices in a Norwegian county met five times during one year for instructions and mutual learning. A doctor, a nurse and laboratory and administrative personnel represented each office. After an introduction to the improvement method, the teams set out to identify and improve a significant problem area in their practices. Between the five meetings the groups were given individual counselling on their improvement projects. The teams were encouraged to evaluate how they organised and managed their improvement efforts. RESULTS AND INTERPRETATION: All teams achieved substantial improvements of their problem areas, except for one case, where the leader left in the middle of the project. The meetings led to enthusiasm and stimulated multidisciplinary reflection on own practice. The teams also reported several positive generic effects, e.g. improved communication between professions. The continuous self-evaluation of how the improvement projects were organised generated helpful ideas when progress slowed down. The study demonstrates that networks for quality improvement are useful in general practice, and that awareness of management issues can improve the chances of success.