What stage are low-income and middle-income countries (LMICs) at with patient safety curriculum implementation and what are the barriers to implementation? A two-stage cross-sectional study.

OBJECTIVES: The improvement of safety in healthcare worldwide depends in part on the knowledge, skills and attitudes of staff providing care. Greater patient safety content in health professional education and training programmes has been advocated internationally. While WHO Patient Safety Curriculum Guides (for Medical Schools and Multi-Professional Curricula) have been widely disseminated in low-income and middle-income countries (LMICs) over the last several years, little is known about patient safety curriculum implementation beyond high-income countries. The present study examines patient safety curriculum implementation in LMICs. METHODS: Two cross-sectional surveys were carried out. First, 88 technical officers in Ministries of Health and WHO country offices were surveyed to identify the pattern of patient safety curricula at country level. A second survey followed that gathered information from 71 people in a position to provide institution-level perspectives on patient safety curriculum implementation. RESULTS: The majority, 69% (30/44), of the countries were either considering whether to implement a patient safety curriculum or actively planning, rather than actually implementing, or embedding one. Most organisations recognised the need for patient safety education and training and felt a safety curriculum was compatible with the values of their organisation; however, important faculty-level barriers to patient safety curriculum implementation were identified. Key structural markers, such as dedicated financial resources and relevant assessment tools to evaluate trainees' patient safety knowledge and skills, were in place in fewer than half of organisations studied. CONCLUSIONS: Greater attention to patient safety curriculum implementation is needed. The barriers to patient safety curriculum implementation we identified in LMICs are not unique to these regions. We propose a framework to act as a global standard for patient safety curriculum implementation. Educating leaders through the system in order to embed patient safety culture in education and clinical settings is a critical first step

Revisiting interaction in knowledge translation

Abstract Background Although the study of research utilization is not new, there has been increased emphasis on the topic over the recent past. Science push models that are researcher driven and controlled and demand pull models emphasizing users/decision-maker interests have largely been abandoned in favour of more interactive models that emphasize linkages between researchers and decisionmakers. However, despite these and other theoretical and empirical advances in the area of research utilization, there remains a fundamental gap between the generation of research findings and the application of those findings in practice. Methods Using a case approach, the current study looks at the impact of one particular interaction approach to research translation used by a Canadian funding agency. Results Results suggest there may be certain conditions under which different levels of decisionmaker involvement in research will be more or less effective. Four attributes are illuminated by the current case study: stakeholder diversity, addressability/actionability of results, finality of study design and methodology, and politicization of results. Future research could test whether these or other variables can be used to specify some of the conditions under which different approaches to interaction in knowledge translation are likely to facilitate research utilization. Conclusion This work suggests that the efficacy of interaction approaches to research translation may be more limited than current theory proposes and underscores the need for more completely specified models of research utilization that can help address the slow pace of change in this area.</p

Improving Nursing Home Care through Feedback On PerfoRMance Data (INFORM): Protocol for a cluster-randomized trial

Background Audit and feedback is effective in improving the quality of care. However, methods and results of international studies are heterogeneous, and studies have been criticized for a lack of systematic use of theory. In TREC (Translating Research in Elder Care), a longitudinal health services research program, we collect comprehensive data from care providers and residents in Canadian nursing homes to improve quality of care and life of residents, and quality of worklife of caregivers. The study aims are to a) systematically feed back TREC research data to nursing home care units, and b) compare the effectiveness of three different theory-based feedback strategies in improving performance within care units. Methods INFORM (Improving Nursing Home Care through Feedback On PerfoRMance Data) is a 3.5-year pragmatic, three-arm, parallel, cluster-randomized trial. We will randomize 67 Western Canadian nursing homes with 203 care units to the three study arms, a standard feedback strategy and two assisted and goal-directed feedback strategies. Interventions will target care unit managerial teams. They are based on theory and evidence related to audit and feedback, goal setting, complex adaptive systems, and empirical work on feeding back research results. The primary outcome is the increased number of formal interactions (e.g., resident rounds or family conferences) involving care aides – non-registered caregivers providing up to 80% of direct care. Secondary outcomes are a) other modifiable features of care unit context (improved feedback, social capital, slack time) b) care aides’ quality of worklife (improved psychological empowerment, job satisfaction), c) more use of best practices, and d) resident outcomes based on the Resident Assessment Instrument – Minimum Data Set 2.0. Outcomes will be assessed at baseline, immediately after the 12-month intervention period, and 18 months post intervention. Discussion INFORM is the first study to systematically assess the effectiveness of different strategies to feed back research data to nursing home care units in order to improve their performance. Results of this study will enable development of a practical, sustainable, effective, and cost-effective feedback strategy for routine use by managers, policy makers and researchers. The results may also be generalizable to care settings other than nursing homes. Trial registration ClinicalTrials.gov Identifier: NCT02695836 . Date of registration: 24 February 201

Understanding nurses’ and physicians’ fear of repercussions for reporting errors: clinician characteristics, organization demographics, or leadership factors?

Abstract Background Identifying and understanding factors influencing fear of repercussions for reporting and discussing medical errors in nurses and physicians remains an important area of inquiry. Work is needed to disentangle the role of clinician characteristics from those of the organization-level and unit-level safety environments in which these clinicians work and learn, as well as probing the differing reporting behaviours of nurses and physicians. This study examines the influence of clinician demographics (age, gender, and tenure), organization demographics (teaching status, location of care, and province) and leadership factors (organization and unit leadership support for safety) on fear of repercussions, and does so for nurses and physicians separately. Methods A cross-sectional analysis of 2319 nurse and 386 physician responders from three Canadian provinces to the Modified Stanford patient safety climate survey (MSI-06). Data were analyzed using exploratory factor analysis, multiple linear regression, and hierarchical linear regression. Results Age, gender, tenure, teaching status, and province were not significantly associated with fear of repercussions for nurses or physicians. Mental health nurses had poorer fear responses than their peers outside of these areas, as did community physicians. Strong organization and unit leadership support for safety explained the most variance in fear for both nurses and physicians. Conclusions The absence of associations between several plausible factors including age, tenure and teaching status suggests that fear is a complex construct requiring more study. Substantially differing fear responses across locations of care indicate areas where interventions may be needed. In addition, since factors affecting fear of repercussions appear to be different for nurses and physicians, tailoring patient safety initiatives to each group may, in some instances, be fruitful. Although further investigation is needed to examine these and other factors in detail, supportive safety leadership appears to be central to reducing fear of reporting errors for both nurses and physicians

Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions

Abstract Background Fidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg’s popular Treatment Fidelity model, this paper aims to increase understanding of how to practically and comprehensively assess fidelity in complex, group-level, interventions. Approach and lessons learned Drawing on our experience using a mixed methods approach to assess fidelity in the INFORM study (Improving Nursing home care through Feedback On perfoRMance data—INFORM), we report on challenges and adaptations experienced with our fidelity assessment approach and lessons learned. Six fidelity assessment challenges were identified: (1) the need to develop succinct tools to measure fidelity given tools tend to be intervention specific, (2) determining which components of fidelity (delivery, receipt, enactment) to emphasize, (3) unit of analysis considerations in group-level interventions, (4) missing data problems, (5) how to respond to and treat fidelity ‘failures’ and ‘deviations’ and lack of an overall fidelity assessment scheme, and (6) ensuring fidelity assessment doesn’t threaten internal validity. Recommendations and conclusions Six guidelines, primarily applicable to group-level studies of complex interventions, are described to help address conceptual, methodological, and practical challenges with fidelity assessment in pragmatic trials. The current study offers guidance to researchers regarding key practical, methodological, and conceptual challenges associated with assessing fidelity in pragmatic trials. Greater attention to fidelity assessment and publication of fidelity results through detailed studies such as this one is critical for improving the quality of fidelity studies and, ultimately, the utility of published trials. Trial registration ClinicalTrials.gov NCT02695836. Registered on February 24, 201

Sustained effects of the INFORM cluster randomized trial: an observational post-intervention study

Abstract Background Numerous studies have examined the efficacy and effectiveness of health services interventions. However, much less research is available on the sustainability of study outcomes. The purpose of this study was to assess the lasting benefits of INFORM (Improving Nursing Home Care Through Feedback On perfoRMance data) and associated factors 2.5 years after removal of study supports. INFORM was a complex, theory-based, three-arm, parallel cluster-randomized trial. In 2015–2016, we successfully implemented two theory-based feedback strategies (compared to a simple feedback approach) to increase nursing home (NH) care aides’ involvement in formal communications about resident care. Methods Sustainability analyses included 51 Western Canadian NHs that had been randomly allocated to a simple and two assisted feedback interventions in INFORM. We measured care aide involvement in formal interactions (e.g., resident rounds, family conferences) and other study outcomes at baseline (T1, 09/2014-05/2015), post-intervention (T2, 01/2017-12/2017), and long-term follow-up (T3, 06/2019–03/2020). Using repeated measures, hierarchical mixed models, adjusted for care aide, care unit, and facility variables, we assess sustainability and associated factors: organizational context (leadership, culture, evaluation) and fidelity of the original INFORM intervention. Results We analyzed data from 18 NHs (46 units, 529 care aides) in simple feedback, 19 NHs (60 units, 731 care aides) in basic assisted feedback, and 14 homes (41 units, 537 care aides) in enhanced assisted feedback. T2 (post-intervention) scores remained stable at T3 in the two enhanced feedback arms, indicating sustainability. In the simple feedback group, where scores were had remained lower than in the enhanced groups during the intervention, T3 scores rose to the level of the two enhanced feedback groups. Better culture (β = 0.099, 95% confidence interval [CI] 0.005; 0.192), evaluation (β = 0.273, 95% CI 0.196; 0.351), and fidelity enactment (β = 0.290, 95% CI 0.196; 0.384) increased care aide involvement in formal interactions at T3. Conclusions Theory-informed feedback provides long-lasting improvement in care aides’ involvement in formal communications about resident care. Greater intervention intensity neither implies greater effectiveness nor sustainability. Modifiable context elements and fidelity enactment during the intervention period may facilitate sustained improvement, warranting further study—as does possible post-intervention spread of our intervention to simple feedback homes

Examining fidelity in the INFORM trial: a complex team-based behavioral intervention

Abstract Background Fidelity in complex behavioral interventions is underexplored. This study examines the fidelity of the INFORM trial and explores the relationship between fidelity, study arm, and the trial’s primary outcome—care aide involvement in formal team communications about resident care. Methods A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial. Results Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042). Conclusions Overall fidelity enactment was associated with improvements in formal team communications, but the study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials