Structural Equation Modeling Analysis on Associations of Moral Distress and Dimensions of Organizational Culture in Healthcare: A Cross-Sectional Study of Healthcare Professionals.

OBJECTIVE: Moral distress is a complex phenomenon experienced by healthcare professionals. This study examined the relationships between key dimensions of Organizational Culture in Healthcare (OCHC)-perceived psychological safety, ethical climate, patient safety-and healthcare professionals' perception of moral distress. DESIGN: Cross-sectional survey. SETTING: Pediatric and adult critical care medicine, and adult hospital medicine healthcare professionals in the United States. PARTICIPANTS: Physicians (n = 260), nurses (n = 256), and advanced practice providers (n = 110) participated in the study. MAIN OUTCOME MEASURES: Three dimensions of OCHC were measured using validated questionnaires: Olson's Hospital Ethical Climate Survey, Agency for Healthcare Research and Quality's Patient Safety Culture Survey, and Edmondson's Team Psychological Safety Survey. The perception of moral distress was measured using the Moral Distress Amidst a Pandemic Survey. The hypothesized relationships between various dimensions were tested with structural equation modeling (SEM). RESULTS: Adequate model fit was achieved in the SEM: a root-mean-square error of approximation =0.072 (90% CI 0.069 to 0.075), standardized root mean square residual = 0.056, and comparative fit index =0.926. Perceived psychological safety (ß= -0.357, p <.001) and patient safety culture (ß = -0.428, p<.001) were negatively related to moral distress experience. There was no significant association between ethical climate and moral distress (ß = 0.106, p = 0.319). Ethical Climate, however, was highly correlated with Patient Safety Culture (factor correlation= 0.82). CONCLUSIONS: We used structural equation model to test a theoretical model of multi-dimensional organizational culture and healthcare climate (OCHC) and moral distress.Significant associations were found, supporting mitigating strategies to optimize psychological safety and patient safety culture to address moral distress among healthcare professionals. Future initiatives and studies should account for key dimensions of OCHC with multi-pronged targets to preserve the moral well-being of individuals, teams, and organizations.

Understanding the Patient Experience of Receiving Clinically Actionable Genetic Results from the MyCode Community Health Initiative, a Population-Based Genomic Screening Initiative.

Understanding unselected individuals' experiences receiving genetic results through population genomic screening is critical to advancing clinical utility and improving population health. We conducted qualitative interviews with individuals who received clinically actionable genetic results via the MyCode© Genomic Screening and Counseling program. We purposively sampled cohorts to seek diversity in result-related disease risk (e.g., cancer or cardiovascular) and in personal or family history of related diseases. Transcripts were analyzed using a two-step inductive coding process of broad thematic analysis followed by in-depth coding of each theme. Four thematic domains identified across all cohorts were examined: process assessment, psychosocial response, behavioral change due to the genetic result, and family communication. Coding of 63 interviews among 60 participants revealed that participants were satisfied with the results disclosure process, initially experienced a range of positive, neutral, and negative psychological reactions to results, adjusted positively to results over time, undertook clinically indicated actions in response to results, and communicated results with relatives to whom they felt emotionally close. Our findings of generally favorable responses to receiving clinically actionable genetic results via a genomic screening program may assuage fear of patient distress in such programs and guide additional biobanks, genomic screening programs, and research studies.

COVID-19 and Moral Distress: A Pediatric Critical Care Survey.

BACKGROUND: Moral distress adversely affects the delivery of high-quality patient care and places health care professionals at risk for burnout, moral injury, and the loss of professional integrity. OBJECTIVES: To investigate whether pediatric critical care professionals are experiencing moral distress during the COVID-19 pandemic and, if so, for what reasons. METHODS: An exploratory survey of pediatric critical care professionals was conducted via the Pediatric Acute Lung Injury and Sepsis Investigators Network from April to May 2020. The survey was derived from a framework integrating contemporary literature on moral distress, moral resilience, and expert consensus. Integration of descriptive statistics for quantitative data and thematic analysis for qualitative data yielded mixed insights. RESULTS: Overall, 85.8% of survey respondents reported moral distress. Nurses reported higher degrees of moral distress than other professional groups. Inducers of moral distress were related to challenges to professional integrity and lack of organizational support. Five themes were identified: (1) psychological safety, (2) expectations of leadership, (3) connectedness through a moral community, (4) professional identity challenges, and (5) professional versus social responsibility. Most respondents were confident in their ability to reason through ethical dilemmas (76.0%) and think clearly when confronting an ethical challenge even when pressured (78.9%). CONCLUSIONS: During the COVID-19 pandemic, pediatric critical care professionals are experiencing moral distress due to various factors that challenge their professional integrity. Despite these challenges, they also exhibit attributes of moral resilience. Organizations have opportunities to cultivate a psychologically safe and healthy work environment to mitigate anticipatory, present, and lingering moral distress.

Geisinger's effort to realize its potential as a learning health system: A progress report.

OBJECTIVES: In the last two decades, several organizational initiatives have moved Geisinger into closer alignment with the key characteristics of the learning health system (LHS) model. The intent of this experience report is to provide a firsthand view of the potential of the model and of the complex, multifaceted nature of any endeavor designed and implemented to realize that potential. METHODS: After describing Geisinger, we offer a critical self-assessment of our progress toward the goal of becoming an LHS, followed by an account of the challenges. RESULTS: Geisinger has made incremental but measurable progress in implementing the LHS model, especially in two key domains: in patient-clinician engagement and science and informatics. Other challenges, however, present significant opportunities for additional forward movement, especially with respect to incentives, culture, and leadership. CONCLUSION: Becoming a fully realized LHS is and will be a long-term challenge for any organization that embraces this aspiration.

Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force.

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.

Pediatric reporting of genomic results study (PROGRESS): a mixed-methods, longitudinal, observational cohort study protocol to explore disclosure of actionable adult- and pediatric-onset genomic variants to minors and their parents.

BACKGROUND: Exome and genome sequencing are routinely used in clinical care and research. These technologies allow for the detection of pathogenic/likely pathogenic variants in clinically actionable genes. However, fueled in part by a lack of empirical evidence, controversy surrounds the provision of genetic results for adult-onset conditions to minors and their parents. We have designed a mixed-methods, longitudinal cohort study to collect empirical evidence to advance this debate. METHODS: Pediatric participants in the Geisinger MyCode® Community Health Initiative with available exome sequence data will have their variant files assessed for pathogenic/likely pathogenic variants in 60 genes designated as actionable by MyCode. Eight of these genes are associated with adult-onset conditions (Hereditary Breast and Ovarian Cancer Syndrome (HBOC), Lynch syndrome, MUTYH-associated polyposis, HFE-Associated Hereditary Hemochromatosis), while the remaining genes have pediatric onset. Prior to clinical confirmation of results, pediatric MyCode participants and their parents/legal guardians will be categorized into three study groups: 1) those with an apparent pathogenic/likely pathogenic variant in a gene associated with adult-onset disease, 2) those with an apparent pathogenic/likely pathogenic variant in a gene associated with pediatric-onset disease or with risk reduction interventions that begin in childhood, and 3) those with no apparent genomic result who are sex- and age-matched to Groups 1 and 2. Validated and published quantitative measures, semi-structured interviews, and a review of electronic health record data conducted over a 12-month period following disclosure of results will allow for comparison of psychosocial and behavioral outcomes among parents of minors (ages 0-17) and adolescents (ages 11-17) in each group. DISCUSSION: These data will provide guidance about the risks and benefits of informing minors and their family members about clinically actionable, adult-onset genetic conditions and, in turn, help to ensure these patients receive care that promotes physical and psychosocial health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03832985. Registered 6 February 2019.

A Model for Genome-First Care: Returning Secondary Genomic Findings to Participants and Their Healthcare Providers in a Large Research Cohort.

There is growing interest in communicating clinically relevant DNA sequence findings to research participants who join projects with a primary research goal other than the clinical return of such results. Since Geisinger's MyCode Community Health Initiative (MyCode) was launched in 2007, more than 200,000 participants have been broadly consented for discovery research. In 2013 the MyCode consent was amended to include a secondary analysis of research genomic sequences that allows for delivery of clinical results. Since May 2015, pathogenic and likely pathogenic variants from a set list of genes associated with monogenic conditions have prompted "genome-first" clinical encounters. The encounters are described as genome-first because they are identified independent of any clinical parameters. This article (1) details our process for generating clinical results from research data, delivering results to participants and providers, facilitating condition-specific clinical evaluations, and promoting cascade testing of relatives, and (2) summarizes early results and participant uptake. We report on 542 participants who had results uploaded to the electronic health record as of February 1, 2018 and 291 unique clinical providers notified with one or more participant results. Of these 542 participants, 515 (95.0%) were reached to disclose their results and 27 (5.0%) were lost to follow-up. We describe an exportable model for delivery of clinical care through secondary use of research data. In addition, subject and provider participation data from the initial phase of these efforts can inform other institutions planning similar programs.

Patient-Centered Precision Health In A Learning Health Care System: Geisinger's Genomic Medicine Experience.

Health care delivery is increasingly influenced by the emerging concepts of precision health and the learning health care system. Although not synonymous with precision health, genomics is a key enabler of individualized care. Delivering patient-centered, genomics-informed care based on individual-level data in the current national landscape of health care delivery is a daunting challenge. Problems to overcome include data generation, analysis, storage, and transfer; knowledge management and representation for patients and providers at the point of care; process management; and outcomes definition, collection, and analysis. Development, testing, and implementation of a genomics-informed program requires multidisciplinary collaboration and building the concepts of precision health into a multilevel implementation framework. Using the principles of a learning health care system provides a promising solution. This article describes the implementation of population-based genomic medicine in an integrated learning health care system-a working example of a precision health program.

Parental attitudes and expectations towards receiving genomic test results in healthy children.

Little evidence is available to guide returning genomic results in children without medical indication for sequencing. Professional guidelines for returning information on adult-onset conditions are conflicting. The goal of this study was to provide preliminary information on parental attitudes and expectations about returning medically actionable genomic results in children who have been sequenced as part of a population biobank.Four focus groups of parents with a child enrolled in a population biobank were conducted. A deliberative engagement format included education about professional guidelines and ethical issues around returning results to children. Parents were presented two scenarios where their healthy child has a pathogenic variant for: (a) a medically actionable childhood condition; (b) a hereditary cancer syndrome with no medical management until adulthood. Thematic analysis was conducted on verbatim transcripts. Regardless of the scenario, parents stated that the genomic information was important, was like other unexpected medical information, and disclosure should be tailored to the child's age and result. Parents wanted the results in their child's medical record. Reasons for learning adult-onset results in their healthy children included to prepare their child for necessary medical action in adulthood. Parents also provided suggestions for program design. This preliminary evidence suggests that parents desire genomic results and expect to use this information to protect their child's health. More empirical research on psychosocial adjustment to such information with continued engagement of parents and children is needed to further inform how to best support families in the communication and use of genomic information.

Early cancer diagnoses through BRCA1/2 screening of unselected adult biobank participants.

PurposeThe clinical utility of screening unselected individuals for pathogenic BRCA1/2 variants has not been established. Data on cancer risk management behaviors and diagnoses of BRCA1/2-associated cancers can help inform assessments of clinical utility.MethodsWhole-exome sequences of participants in the MyCode Community Health Initiative were reviewed for pathogenic/likely pathogenic BRCA1/2 variants. Clinically confirmed variants were disclosed to patient-participants and their clinicians. We queried patient-participants' electronic health records for BRCA1/2-associated cancer diagnoses and risk management that occurred within 12 months after results disclosure, and calculated the percentage of patient-participants of eligible age who had begun risk management.ResultsThirty-seven MyCode patient-participants were unaware of their pathogenic/likely pathogenic BRCA1/2 variant, had not had a BRCA1/2-associated cancer, and had 12 months of follow-up. Of the 33 who were of an age to begin BRCA1/2-associated risk management, 26 (79%) had performed at least one such procedure. Three were diagnosed with an early-stage, BRCA1/2-associated cancer-including a stage 1C fallopian tube cancer-via these procedures.ConclusionScreening for pathogenic BRCA1/2 variants among unselected individuals can lead to occult cancer detection shortly after disclosure. Comprehensive outcomes data generated within our learning healthcare system will aid in determining whether population-wide BRCA1/2 genomic screening programs offer clinical utility.

Distribution and clinical impact of functional variants in 50,726 whole-exome sequences from the DiscovEHR study.

The DiscovEHR collaboration between the Regeneron Genetics Center and Geisinger Health System couples high-throughput sequencing to an integrated health care system using longitudinal electronic health records (EHRs). We sequenced the exomes of 50,726 adult participants in the DiscovEHR study to identify ~4.2 million rare single-nucleotide variants and insertion/deletion events, of which ~176,000 are predicted to result in a loss of gene function. Linking these data to EHR-derived clinical phenotypes, we find clinical associations supporting therapeutic targets, including genes encoding drug targets for lipid lowering, and identify previously unidentified rare alleles associated with lipid levels and other blood level traits. About 3.5% of individuals harbor deleterious variants in 76 clinically actionable genes. The DiscovEHR data set provides a blueprint for large-scale precision medicine initiatives and genomics-guided therapeutic discovery.

Leadership Perspectives on Operationalizing the Learning Health Care System in an Integrated Delivery System.

INTRODUCTION: Healthcare leaders need operational strategies that support organizational learning for continued improvement and value generation. The learning health system (LHS) model may provide leaders with such strategies; however, little is known about leaders' perspectives on the value and application of system-wide operationalization of the LHS model. The objective of this project was to solicit and analyze senior health system leaders' perspectives on the LHS and learning activities in an integrated delivery system. METHODS: A series of interviews were conducted with 41 system leaders from a broad range of clinical and administrative areas across an integrated delivery system. Leaders' responses were categorized into themes. FINDINGS: Ten major themes emerged from our conversations with leaders. While leaders generally expressed support for the concept of the LHS and enhanced system-wide learning, their concerns and suggestions for operationalization where strongly aligned with their functional area and strategic goals. DISCUSSION: Our findings suggests that leaders tend to adopt a very pragmatic approach to learning. Leaders expressed a dichotomy between the operational imperative to execute operational objectives efficiently and the need for rigorous evaluation. Alignment of learning activities with system-wide strategic and operational priorities is important to gain leadership support and resources. Practical approaches to addressing opportunities and challenges identified in the themes are discussed. CONCLUSION: Continuous learning is an ongoing, multi-disciplinary function of a health care delivery system. Findings from this and other research may be used to inform and prioritize system-wide learning objectives and strategies which support reliable, high value care delivery.

The Geisinger MyCode community health initiative: an electronic health record-linked biobank for precision medicine research.

PURPOSE: Geisinger Health System (GHS) provides an ideal platform for Precision Medicine. Key elements are the integrated health system, stable patient population, and electronic health record (EHR) infrastructure. In 2007, Geisinger launched MyCode, a system-wide biobanking program to link samples and EHR data for broad research use. METHODS: Patient-centered input into MyCode was obtained using participant focus groups. Participation in MyCode is based on opt-in informed consent and allows recontact, which facilitates collection of data not in the EHR and, since 2013, the return of clinically actionable results to participants. MyCode leverages Geisinger's technology and clinical infrastructure for participant tracking and sample collection. RESULTS: MyCode has a consent rate of >85%, with more than 90,000 participants currently and with ongoing enrollment of ~4,000 per month. MyCode samples have been used to generate molecular data, including high-density genotype and exome sequence data. Genotype and EHR-derived phenotype data replicate previously reported genetic associations. CONCLUSION: The MyCode project has created resources that enable a new model for translational research that is faster, more flexible, and more cost-effective than traditional clinical research approaches. The new model is scalable and will increase in value as these resources grow and are adopted across multiple research platforms.Genet Med 18 9, 906-913.

Organ markets and the ends of medicine.

As the gap between the need for and supply of human organs continues to widen, the aim of securing additional sources of these "gifts of the body" has become a seemingly overriding moral imperative, one that could-and some argue, should-override the widespread ban on organ markets. As a medical practice, organ transplantation entails the inherent risk that one human being, a donor, will become little more than a means to the end of healing for another human being and that he or she will come to have a purely instrumental value. With the establishment of organ markets, not only will the harms of instrumentalization be a reality-the ends of medicine will be further compromised and confused.