Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial.

BACKGROUND: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources. OBJECTIVE: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety. METHODS: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients' self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits. RESULTS: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024. CONCLUSIONS: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57878.

Building Cultures of High Reliability: Lessons from the High Reliability Organization Paradigm.

Safety models from disciplines outside of health care have begun to diffuse into the health care safety arena. This article explores high reliability organizing (HRO) theory, which privileges culture as means to adaptively learn and reliably perform. A brief history of the HRO paradigm and factors that contribute to cultures of high reliability is provided, followed by review of existing research to discern which HRO ideas have diffused into research on anesthesiology and perioperative care. High reliability research is growing and concepts seem useful; but there is a long way to go before the benefits of HRO are fully realized.

Primary care teams' reported actions to improve medication safety: a qualitative study with insights in high reliability organising.

BACKGROUND: Our aim was to understand actions by primary care teams to improve medication safety. METHODS: This was a qualitative study using one-on-one, semistructured interviews with the questions guided by concepts from collaborative care and systems engineering models, and with references to the care of older adults. We interviewed 21 primary care physicians and their team members at four primary care sites serving patients with mostly low socioeconomic status in Southwest US during 2019-2020. We used thematic analysis with a combination of inductive and deductive coding. First, codes capturing safety actions were incrementally developed and revised iteratively by a team of multidisciplinary analysts using the inductive approach. Themes that emerged from the coded safety actions taken by primary care professionals to improve medication safety were then mapped to key principles from the high reliability organisation framework using a deductive approach. RESULTS: Primary care teams described their actions in medication safety mainly in making standard-of-care medical decisions, patient-shared decision-making, educating patients and their caregivers, providing asynchronous care separate from office visits and providing clinical infrastructure. Most of the actions required customisation at the individual level, such as limiting the supply of certain medications prescribed and simplifying medication regimens in certain patients. Primary care teams enacted high reliability organisation principles by anticipating and mitigating risks and taking actions to build resilience in patient work systems. The primary care teams' actions reflected their safety organising efforts as responses to many other agents in multiple settings that they could not control nor easily coordinate. CONCLUSIONS: Primary care teams take many actions to shape medication safety outcomes in community settings, and these actions demonstrated that primary care teams are a reservoir of resilience for medication safety in the overall healthcare system. To improve medication safety, primary care work systems require different strategies than those often used in more self-contained systems such as hospital inpatient or surgical services.

Crossing Academic Boundaries for Diagnostic Safety: 10 Complex Challenges and Potential Solutions From Clinical Perspectives and High-Reliability Organizing Principles.

OBJECTIVE: We apply the high-reliability organization (HRO) paradigm to the diagnostic process, outlining challenges to enacting HRO principles in diagnosis and offering solutions for how diagnostic process stakeholders can overcome these barriers. BACKGROUND: Evidence shows that healthcare is starting to organize for higher reliability by employing various principles and practices of HRO. These hold promise for enhancing safer care, but there has been little consideration of the challenges that clinicians and healthcare systems face while enacting HRO principles in the diagnostic process. To effectively deploy the HRO perspective, these barriers must be seriously considered. METHOD: We review key principles of the HRO paradigm, the diagnostic errors and harms that potentially can be prevented by its enactment, the challenges that clinicians and healthcare systems face in executing various principles and practices, and possible solutions that clinicians and organizational leaders can take to overcome these challenges and barriers. RESULTS: Our analyses reveal multiple challenges including the inherent diagnostic uncertainty; the lack of diagnosis-focused performance feedback; the fact that diagnosis is often a solo, rather than team, activity; the tendency to simplify the diagnostic process; and professional and institutional status hierarchies. But these challenges are not insurmountable-there are strategies and solutions available to overcome them. CONCLUSION: The HRO lens offers some important ideas for how the safety of the diagnostic process can be improved. APPLICATION: The ideas proposed here can be enacted by both individual clinicians and healthcare leaders; both are necessary for making systematic progress in enhancing diagnostic performance.

Gender Bias in Collaborative Medical Decision Making: Emergent Evidence.

This initial, exploratory study on gender bias in collaborative medical decision making examined the degree to which physicians' reliance on a team member's patient care advice differs as a function of the gender of the advice giver. In 2018, 283 anesthesiologists read a brief, online clinical vignette and were randomly assigned to receive treatment advice from 1 of 8 possible sources (physician or nurse, man or woman, experienced or inexperienced). They then indicated their treatment decision, as well as the degree to which they relied upon the advice given.The results revealed 2 patterns consistent with gender bias in participants' advice taking. First, when treatment advice was delivered by an inexperienced physician, participants reported replying significantly more on the advice of a man versus a woman, F(1,61) = 4.24, P = .04. Second, participants' reliance on the advice of the woman physician was a function of her experience, F(1,62) = 6.96, P = .01, whereas reliance on the advice of the man physician was not, F(1,60) = 0.21, P = .65.These findings suggest women physicians, relative to men, may encounter additional hurdles to performing their jobs, especially at early stages in their careers. These hurdles are rooted in psychological biases of others, rather than objective features of cases or treatment settings. Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do with social category membership. The authors recommend institutions adopt policies and practices encouraging equal attention to advice, regardless of the source, to help ensure advice taking is a function of information quality rather than the attributes of the advice giver. Such policies and practices may help surface and implement diverse expert perspectives in collaborative medical decision making, promoting better and more effective patient care.

Treating the "Not-Invented-Here Syndrome" in Medical Leadership: Learning From the Insights of Outside Disciplines.

Physicians are being increasingly called upon to engage in leadership at all levels of modern health organizations, leading many to call for greater research and training interventions regarding physician leadership development. Yet, within these calls to action, the authors note a troubling trend toward siloed, medicine-specific approaches to leadership development and a broad failure to learn from the evidence and insight of other relevant disciplines, such as the organizational sciences. The authors describe how this trend reflects what has been called the "not-invented-here syndrome" (NIHS)-a commonly observed reluctance to adopt and integrate insights from outside disciplines-and highlight the pitfalls of NIHS for effective physician leadership development. Failing to learn from research and interventions in the organizational sciences inhibits physician leadership development efforts, leading to redundant rediscoveries of known insights and reinventions of existing best practices. The authors call for physician leaders to embrace ideas that are "proudly developed elsewhere" and work with colleagues in outside disciplines to conduct collaborative research and develop integrated training interventions to best develop physician leaders who are prepared for the complex, dynamic challenges of modern health care.

A framework for operationalizing risk: A practical approach to patient safety.

The importance of patient safety has grown tremendously; however, there are insufficient resources dedicated to its practical application. We provide an overview of the framework for addressing patient safety within the Johns Hopkins Health System, which approaches patient safety in the context of risk at the patient, provider, unit, and system levels. We present practical examples of how this approach is applied and highlight the resources needed as well as describe how it fits within the broader quality management infrastructure in the health system on its journey toward high reliability.

Latent risk assessment tool for health care leaders.

Efforts to improve quality of care and patient safety have concentrated on provider practice and frontline care processes. Little attention has focused on understanding the role that leadership decisions play in creating risk within a health care system. The framework and tool described in this article builds on Reason's construct of latent organizational failure, by assessing the latent risks of leadership decisions, and identifying appropriate mitigation strategies before the implementation of a change. Stakeholders who will be involved in or impacted by the change are engaged in the assessment to more thoroughly explore both technical and cultural risks.

Huddling for high reliability and situation awareness.

BACKGROUND: Studies show that implementing huddles in healthcare can improve a variety of outcomes. Yet little is known about the mechanisms through which huddles exert their effects. To help remedy this gap, our study objectives were to explore hospital administrator and frontline staff perspectives on the benefits and challenges of implementing a tiered huddle system; and propose a model based on our findings depicting the mediating pathways through which implementing a huddle system may reduce patient harm. METHODS: Using qualitative methods, we conducted semi-structured interviews and focus groups to obtain a deeper understanding of the huddle system and its outcomes as implemented in an academic tertiary care children's hospital with 539 inpatient beds. We recruited healthcare providers representing all levels using a snowball sampling technique (10 interviews), and emails, flyers, and paper invitations (six focus groups). We transcribed recordings and analysed the data using established techniques. RESULTS: Five themes emerged and provided the foundational constructs of our model. Specifically we propose that huddle implementation leads to improved efficiencies and quality of information sharing, increased levels of accountability, empowerment, and sense of community, which together create a culture of collaboration and collegiality that increases the staff's quality of collective awareness and enhanced capacity for eliminating patient harm. CONCLUSIONS: While each construct in the proposed model is itself a beneficial outcome of implementing huddles, conceptualising the pathways by which they may work allows us to design ways to evaluate other huddle implementation efforts designed to help reduce failures and eliminate patient harm.

The high-reliability pediatric intensive care unit.

In health care, reliability is the measurable capability of a process, procedure, or health service to perform its intended function in the required time under actual or existing conditions (as opposed to the ideal circumstances under which they are often studied). This article outlines the current state of reliability in a clinical context, discusses general principles of reliability, and explores the characteristics of high-reliability organizations as a desirable future state for pediatric critical care.

A method to evaluate cardiac surgery mortality: phase of care mortality analysis.

BACKGROUND: This is a study of a method of mortality review, adopted by the Michigan Society of Thoracic and Cardiovascular Surgeons, to enhance understanding of mortality and potentially avoidable deaths after cardiac surgery, utilizing a voluntary statewide database. METHODS: A system to categorize mortality was developed utilizing a phase of care mortality analysis approach as well as providing criteria to classify mortality as potentially "avoidable." For each mortality, the operating surgeon categorized a cardiac surgery mortality trigger into 1 of 5 time frames: preoperative, intraoperative, intensive care unit (ICU), postoperative floor, and discharge. RESULTS: A total of 53,674 adult cardiac operations were performed from January 1, 2006 to June 30, 2010 with a crude mortality of 3.5% (1,905 of 53,674). Of the mortalities analyzed, 35% (618 of 1,780) were preoperative, 25% (451 of 1,780) were ICU, 19% (333 of 1,780) were intraoperative, 11% (198 of 1,780) were floor, and 10% (180 of 1,780) were discharge phase. "Avoidable" mortality triggers occurred in 53% (174 of 333) of the intraoperative, 41% (253 of 618) and (184 of 451) of the preoperative and ICU phases, 42% (83 of 198) of the floor, and 19% (35 of 180) of the discharge phase. Overall potentially avoidable mortality was 41% (729 of 1780). Thirty-six percent (644 of 1,780) of the mortalities were coronary artery bypass grafting patients and 29% (188 of 644) of these were in the preoperative phase, with a mean predicted risk of 16%. CONCLUSIONS: This analysis identifies the occurrence of potentially avoidable mortalities in the 4 hospital phases of care, with the largest absolute number of avoidable mortalities occurring in the preoperative phase. A focus on these phases of care provides significant opportunity for quality improvement initiatives. Utilizing phase of care mortality analysis stimulates surgeons and hospitals to develop and refine mortality reviews and provides a structured statewide platform for discussion, education, quality improvement, and enhanced outcomes.

Becoming a high reliability organization.

Aircraft carriers, electrical power grids, and wildland firefighting, though seemingly different, are exemplars of high reliability organizations (HROs)--organizations that have the potential for catastrophic failure yet engage in nearly error-free performance. HROs commit to safety at the highest level and adopt a special approach to its pursuit. High reliability organizing has been studied and discussed for some time in other industries and is receiving increasing attention in health care, particularly in high-risk settings like the intensive care unit (ICU). The essence of high reliability organizing is a set of principles that enable organizations to focus attention on emergent problems and to deploy the right set of resources to address those problems. HROs behave in ways that sometimes seem counterintuitive--they do not try to hide failures but rather celebrate them as windows into the health of the system, they seek out problems, they avoid focusing on just one aspect of work and are able to see how all the parts of work fit together, they expect unexpected events and develop the capability to manage them, and they defer decision making to local frontline experts who are empowered to solve problems. Given the complexity of patient care in the ICU, the potential for medical error, and the particular sensitivity of critically ill patients to harm, high reliability organizing principles hold promise for improving ICU patient care.

The impact of safety organizing, trusted leadership, and care pathways on reported medication errors in hospital nursing units.

CONTEXT: Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on the joint benefits of safety organizing and other contextual factors that help foster safety. OBJECTIVES: Although we know that organizational practices often have more powerful effects when combined with other mutually reinforcing practices, little research exists on the joint benefits of safety organizing and other contextual factors believed to foster safety. Specifically, we examined the benefits of bundling safety organizing with leadership (trust in manager) and design (use of care pathways) factors on reported medication errors. SUBJECTS: A total of 1033 RNs and 78 nurse managers in 78 emergency, internal medicine, intensive care, and surgery nursing units in 10 acute-care hospitals in Indiana, Iowa, Maryland, Michigan, and Ohio who completed questionnaires between December 2003 and June 2004. RESEARCH DESIGN: Cross-sectional analysis of medication errors reported to the hospital incident reporting system for the 6 months after the administration of the survey linked to survey data on safety organizing, trust in manager, use of care pathways, and RN characteristics and staffing. RESULTS: Multilevel Poisson regression analyses indicated that the benefits of safety organizing on reported medication errors were amplified when paired with high levels of trust in manager or the use of care pathways. CONCLUSIONS: Safety organizing plays a key role in improving patient safety on hospital nursing units especially when bundled with other organizational components of a safety supportive system.