Melissa M. Bottrell

Special Report: The Ethics of Using QI Methods to Improve Health Care Quality and Safety

PREFACE Powerful forces of change are at work within the American health care system. The public debate concerning health care financing and access to insurance coverage is intensifying. But below the surface of the media and policy debate about cost and access, a quieter but perhaps more significant process of change is under way: the transformation of health care management and delivery--indeed, health professional work itself-through health care quality improvement. The innovative, interdisciplinary quality improvement (QI) movement has begun to significantly upgrade delivery of health care in the United States. Taking its cue from reform approaches in other industries, and driven especially by studies indicating a shockingly widespread incidence of medical errors and a striking lack of consistency in the standard of care patients receive in different facilities and from different practitioners, the QI movement has arrived in health care. Using knowledge gained from the disciplines of medicine, nursing, health care management, and medical and health services research, it attempts to mobilize people within the health care system to work together in a systematic way to improve the care they provide. In this work, discipline-specific knowledge is combined with experiential learning and discovery to make improvements. Ethical issues arise in QI because attempts to improve the quality of care for some patients may sometimes inadvertently cause harm, or may benefit some at the expense of others, or may waste scarce health care resources. Ethical issues also arise because some activities aimed at improvement have been interpreted as a form of medical research in which patients are used as subjects. If this interpretation is correct, QI would come under the same complex review and regulatory requirements that have been set up to govern biomedical and other types of research. But is this type of regulation necessary, given what QI involves? Is it the most effective and reasonable way to regulate QI to ensure that it is carried out in an ethical fashion? These are important questions, both conceptually and practically. Thus far, however, relatively few attempts have been made to address QI from an ethical perspective, and the interface between research and quality improvement has not been adequately explored or defined. Federal agencies with responsibilities in this area have disagreed on where the interface between medical research and QI lies and how it should be handled. (See Box 1 for a particularly dramatic example of such a conflict.) The strict ethical rules of oversight, regulation, and patient consent for human subjects research, including the requirement for institutional review board (IRB) approval, have significant implications for the feasibility and cost of pursuing QI activities. More specifically, the mechanism developed to govern ethical conduct in one important area--human subjects research--could have the perverse, if unintended, consequence of interfering directly with an equally important ethical imperative in another area-that is, unceasing efforts by health care professionals to make clinical care safer and more effective. The current state of uncertainty about what is ethically and legally required to safeguard participants in QI activities has already become a disincentive to engage in QI, making it more difficult to bring about the system transformation urgently needed if health care is to be made better and safer for patients. 1. The Pittsburgh ESRD Case In October 2000, a nephrologist coauthored an article about a project to improve the dialysis care delivered to patients in Medicares End Stage Renal Disease (ESRD) program. (1) Some time after the article appeared, the university at which he held a faculty appointment notified him that an audit of faculty publications had identified this project as a quality improvement effort that met the definition of human subjects research but had not undergone IRB review. …

Ethical challenges within Veterans Administration healthcare facilities: perspectives of managers, clinicians, patients, and ethics committee chairpersons.

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondents role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions.

Preventive Ethics: Addressing Ethics Quality Gaps on a Systems Level

BACKGROUND Preventive ethics (PE) is a key component of IntegratedEthics (IE), an innovative model developed by the Veterans Health Administration (VA)s National Center for Ethics in Health Care which establishes a comprehensive, systematic, integrated approach to ethics in health care organizations. Since early 2008, IE has been implemented throughout all 153 medical centers and 21 regional networks within the US Department of Veterans Affairs (VA) health care system. ISSUES A STEP-BY-STEP APPROACH TO ETHICS QUALITY IMPROVEMENT: PE employs a systematic, step-by-step process improvement approach called ISSUES Identify an issue, Study the issue, Select a strategy, Undertake a plan, Evaluate and adjust, and Sustain and spread. After the ethics quality gap is described, a measureable and achievable improvement goal based on the gap is developed. One of the most challenging aspects of describing an ethics quality gap is to establish an appropriate ethical standard on which to base the operational definition of best ethics practice. PRACTICAL STEPS TO DEVELOPING A PREVENTIVE ETHICS FUNCTION: Within the VAs IE model, PE is situated as a subcommittee of the IE council, which is chaired by the facility director (equivalent to a hospital chief executive officer) and oversees all aspects of the organizations ethics program, including ethical leadership, ethics consultation, and PE. Each VA medical center is required to have a PE team led and managed by a PE coordinator and may need to address ethics issues across the full range of health care ethics domains. CONCLUSIONS The VAs IE model establishes a robust conceptual framework, along with concrete tools and resources, to integrate PE concepts into the day-to-day operations of a health care organization and is directly transferrable to other health care organizations and systems.

The IntegratedEthicsTM Staff Survey: A Tool to Evaluate and Improve Ethical Practices in Health Care

Background: To improve ethics quality in health care, health care organizations need a way to characterize whether ethical practices throughout the organization are consistent with accepted ethics standards, norms, and expectations for the organization and its staff. We developed the IntegratedEthics™ Staff Survey (IESS) to fill this need. Methods: The IESS was developed and validated through a rigorous multiyear process. This process included reviews of the bioethics and health care literature to develop conceptual maps of common ethical issues in health care; focus groups and interviews with institutional stakeholders to identify key ethical concerns; cognitive testing, pilot testing, and field testing to ensure that questions were understandable and useful; and item reduction and modification to reduce respondent burden. Results: The IESS addresses staff perceptions of ethical practices in nine domains: everyday workplace, business and management, government service, patient privacy and confidentiality, resource allocation, shared decision making with patients, professionalism in patient care, end-of-life care, and research. The 2010 version of the survey consisted of 76 questions (excluding 8 demographic questions), including questions about the degree to which facility staff demonstrate behavior consistent with specific ethical practices, systems-level or organizational factors that support or interfere with ethical practices, and the ethical environment and culture. The IESS has served as a catalyst for multiple quality improvement and educational activities. Conclusions: The IESS represents an across-the-board approach to measuring ethics quality in multiple areas encompassing clinical, organizational, and research ethics. In addition to its use in quality improvement efforts, the IESS may be used to assess whether there are systematic differences across different disciplines, services, and supervisory levels; to evaluate the effectiveness of ethics programs; and to identify trends in ethical practices over time.

Perceptions of Ethical Leadership and the Ethical Environment and Culture: IntegratedEthicsTM Staff Survey Data from the VA Health Care System

Background: To enhance understanding of ethical leadership and the ethical environment and culture (EL/EEC) in the Department of Veterans Affairs (VA) health care system, we mapped selected questions from the VA IntegratedEthics™ Staff Survey (IESS), a national survey of employees’ perceptions of ethical practices, to the Ethical Leadership Compass Points (ELC), a tool to help leaders cultivate an environment and culture that makes it easy for employees to “do the right thing.” The ELC distills insights and principles from organizational and business ethics and provides leaders with specific behaviors that can be incorporated into daily administrative routines. Methods: We analyzed the responses of 88,605 VA employees to the 2010 IESS questions that previously were mapped to the ELC. Descriptive statistics were used to characterize overall distribution of responses to the survey questions, and Pearsons chi-squared tests were performed to assess differences in responses by employee characteristics. Multiple regression analyses examined the association between perceptions of EL/EEC and perceptions of the organizations’ overall ethics quality. Results: Physicians and employees with a higher level of supervisory responsibility were more likely to have the most positive perceptions of EL/EEC and the organizations overall ethics quality. More than three-quarters of the variation in perceptions of overall ethics quality was explained by employee perceptions of EL/EEC. The IESS questions that showed the largest associations with perceptions of overall ethics quality addressed fair allocation of resources across programs and services, avoidance of mixed messages that create ethical uncertainty or conflict, fair treatment of employees, and following up on ethical concerns reported by employees. Conclusions: These results support the important relationships between ethical leadership, an organizations environment and culture, and overall ethics quality. Certain ethical leadership practices may have a larger impact on employees’ perceptions of overall ethics quality than others.

Perceptions of Clinical Ethics Practices

Background: Clinical ethics is fundamental to the quality of health care and is a concern facing all health care systems. This study examined clinicians’ perceptions of ethical practices in shared decision making with patients, end-of-life care, professionalism in patient care, and patient privacy and confidentiality in order to identify strengths in ethical practices and opportunities for improvement. Methods: We analyzed data from the 48,857 clinician respondents to the 2010 IntegratedEthics™ Staff Survey (IESS). The IESS was developed to provide a broad snapshot of a health care organizations ethical practices for quality improvement purposes. We used descriptive statistics to evaluate clinicians’ perceptions of clinical ethics practices and multivariate logistic regression analyses to evaluate associations between clinician- and organization-level characteristics and positive ethical practices. Results: Survey results suggest opportunities for improvement in ethical practices, including giving patients sufficient time to discuss treatment recommendations, giving better guidance to clinicians on how to maintain professional boundaries, disclosing medical errors to patients and surrogates, and providing clinicians with better education about ethical issues in end-of-life care. The majority of respondents were familiar with the ethics consultation service (ECS). Familiarity with the ECS was significantly associated with length of time working at VA, physician status, and manager/supervisory level of responsibility. If confronted with an ethical concern, approximately three-quarters of respondents reported that they would be very or moderately likely to use the ECS. Conclusions: The results from this study support quality improvement activities by allowing health care organizations to compare clinical ethics practices across staff groups, settings, and time. After a facility obtains its results, the next steps should include seeking greater understanding through qualitative interviews, and then selecting topics for quality improvement initiatives. These activities will reinforce the importance of ethics as a component of health care quality and promote a positive ethics environment.