Introduction (continued)

An Agenda for Research in Ambulatory Patient Safety

Synthesis of a multidisciplinary conference to develop an agenda for research in ambulatory patient safety.

Executive Summary (continued)

It appears that the period of sweeping away old taboos about discussing limitations in current reporting systems and barriers to collecting data is ending. We are now entering a period where large sums have been allocated to move forward a range of mandatory and voluntary reporting projects linked to future improvements in patient safety across the spectrum of health care delivery, including ambulatory care.

The key tasks in the next few years will include:

  • Standardizing nomenclature, reducing reporting burdens as systems proliferate and compete, and learning how to handle large volumes of data without creating "electronic graveyards" and alienating those who report by failing to provide meaningful feedback and failure to achieve systems improvements.
  • Advances in confidentiality and protection for peer review to provide a firm foundation that replaces the patchwork quilt of State and Federal protections and exceptions that have hampering sharing of information and learning.
  • A new regulatory model that helps create a positive cycle in which accountability and learning can both increase, with organizations demonstrating how well they have learned from analysis of reported data, and how they have improved patient safety.

Infrastructure for Ambulatory Care

It may well be that the greatest potential gains in patient safety—and more generally, in quality and efficiency—will prove to be from improving the infrastructure supporting management of information, communication, and coordination of care. Improving the more clinical elements of care such as choosing the most appropriate antibiotic or ensuring a high level of skill in the performance of an ambulatory surgery procedure remains important, but many improvements in clinical processes and clinical decisions can be more easily achieved with a stronger infrastructure.

Conference participants recognized the importance of improved information management and decision support systems, and most suggested that these and other tools should be viewed within a larger context. Improving support systems for physicians and patients may require improved information systems and devices, but regardless of the type of infrastructure support, it is important to first consider the tasks and functions needed, and how best to accomplish them.

Physicians are the principal managers of most patients' care and of the clinical processes of care, and physicians make or guide many of the most important decisions about care. The processes and systems of ambulatory care must support physicians by providing the information when and where it is needed, decision support where that adds value, and mechanisms for tracking and managing steps in the patient's diagnostic and therapeutic process. Therefore, a physician practice or other ambulatory care entity must manage a number of clinical processes (e.g., evaluation and treatment of acute asthma episode), clinical support processes (e.g., ordering, performing, reporting, and interpreting clinical laboratory tests), administrative processes (e.g., patient scheduling) and business functions (e.g., billing)

Dr. Brent James and colleagues at Intermountain Health Care have identified the patient conditions that account for most inpatient care, and the key processes through which care is provided, including the support functions and systems upon which clinicians rely. James and colleagues have also begun to identify the key patient groups and the clinical and support processes for ambulatory care. The results of these studies, along with excellent conceptual models from Nelson, Batalden, and colleagues and from the Idealized Design of Clinical Office Practice project of the Institute for Healthcare Improvement, should provide a substantial amount of the content of an ambulatory care model that is needed to guide improvements in infrastructure.

The use of information technology such as the Internet, electronic mail, electronic medical records, provider order entry, and decision support has the potential to transform the provision of care to patients. Considerable attention has recently been devoted to the potential of information systems and other devices to improve patient safety, driven in significant part by growing evidence that supports the effectiveness of computerized systems as a means to improve quality and safety. Decision support systems can provide computerized reminders about preventive services to prevent errors of omission, as well as highlight drug-drug interactions to prevent errors of commission. The evidence is most extensive for the effectiveness of computerized physician order entry (CPOE) systems in hospitals, and evidence of the effectiveness of CPOE to reduce medication errors and adverse drug events is beginning to emerge for outpatient care.

The "electronic medical record" (EMR) appears to offer substantial gains in patient safety through access to and management of patients' clinical information. Implementation of the electronic medical record (EMR) would potentially improve the management of information, support for physician decisionmaking, and coordination of care. For example, the EMR with decision support could serve as a "tickler" system to remind providers about abnormal tests or need for follow-up. However, EMR represents a large investment, both financially and in terms of organizational commitment and change, and the regulatory environment for management of individuals' health information is in flux.

The Leapfrog Group and others are recommending action that they believe will improve patient safety, such as the implementation of physician computerized order entry for medications by hospitals. AHRQ has recently supported $5 million in grants to address the role of clinical informatics to promote patient safety. Many of the funded projects focus on information technology, such as decision support, handheld devices, and electronic medical records.

Recommendation 6: Further research should be supported on the role of information technology to improve ambulatory patient safety, including computerized physician order entry and electronic medical records. These technologies should be evaluated within the larger contexts where they would be implemented and used:
  • The processes within which the technology will be embedded (e.g., the medication process).
  • The systems within which the technology will be used (e.g., the physician office practice).

Improving Ambulatory Care as a System

Patients and physicians function today within an ambulatory care "system" that does not provide them with the support they need to manage information, ensure effective communication, and coordinate care. Many of the factors that increase patient risk—and many opportunities to reduce risk—are found in clinical processes, clinical support systems, and administrative support systems. Improving these systems, such as those to ensure that diagnostic tests are tracked and results promptly acted on, will likely draw on the expertise not only of physicians but also other clinicians and practice administrators.

Safer and more effective ambulatory care will likely require better teamwork among clinicians and patients, perhaps with the exception of patients with simple, acute problems. Greater teamwork will require a better understanding of the skills and contributions of each clinical discipline, and may require some redistribution of responsibility and accountability from physicians to other clinicians in the "care team." Teamwork among physicians, nurses, and other clinicians may be particularly important in critical care and complex surgery, but teamwork is also intertwined with communication and coordination in general. In ambulatory care, the "team" must also include the patient and family.

Recommendation 7: Support research to understand teamwork in health care and how greater teamwork contributes to patient safety. Assess approaches to teamwork in health care to understand their contribution to improving patient safety, particularly ambulatory care, and identify or synthesize approaches that are well suited to health care and its culture. This work would require expertise from a number of fields, including business and the social sciences, to understand the human and cultural aspects.

Many physicians subscribe to a "culture of individual accountability" in medicine that can be a barrier to achieving risk and error reduction through improvement in processes and systems as well as through improvements in individuals' knowledge and skills, and can inhibit the development of greater teamwork. Physicians who believe that safety depends primarily on acceptance of individual responsibility and that adverse events are usually the result of individual error will not readily perceive opportunities to improve safety by improving processes and systems, or by greater teamwork and shared responsibility and authority. Physicians' beliefs about individual accountability are shaped during education and training, reinforced by our fault-based medical liability system, and linked to expectations of autonomy.

Even with well designed processes and systems and devices, people must have a commitment to safety—a culture of safety. With a commitment to safety, people will minimize the potential for errors that is always present, and will contribute to improving design of processes, systems, and devices to decrease errors.

Recommendation 8: Support research to assess the degree to which the prevalent culture is a limiting factor in achieving improved patient safety (and quality of care) through greater teamwork and a systems approach to management, coordination, and communication. Identify ways to enable physicians to more easily understand and see the potential of these approaches to improve safety and quality, and to understand their role in leading work to improve.

Most physician practices are relatively small (<10, <5 physicians) and many have very limited access to capital. Data suggest that the most efficient group practice size financially is in the range of 5-15 physicians. Many small physician practices may not have the organizational capability to create the culture and build the infrastructure needed to improve safety (Kovner et al. 2000). What organizational structures for physician practice will enable substantial improvements in infrastructure to support ambulatory care? Will integrated delivery systems be required? Is group practice a good starting point for a viable organizational structure? Can a management services organization (MSO) provide the needed managerial and infrastructural support for a number of independent practices?

Priorities For Research

In addition to recommendations for specific areas of research, several "general principles" for prioritizing research and demonstrations emerged from the conference discussions.

Implementation is the rate limiting step: we need to understand how to apply what we know and learn. Research to understand how to effectively implement changes that will improve patient safety should be given high priority.

Recommendation 9: Support research and demonstrations in ambulatory care that identifies, develops, and disseminate successful approaches to implementing changes that improve patient safety.

Several conference participants suggested that in health care in general, and physician practices in particular, there is pressure to see more patients, provide more services, and to reduce practice costs—so that most physicians believe they have neither the time nor the resources to focus on patient safety, particularly since most believe that their practices are already safe for patients. What are the effects on physicians, nurses, and other staff of feeling that they are on "treadmill" that leaves them with too little time for their patients and their work? Would improving infrastructure to support care reduce risk and reduce stress and burnout?

Conference participants articulated the principle that while improvements in patient safety will be achievable through focused, specific changes in processes and systems (e.g., improving medication order entry), substantial gains in patient safety will often require interdependent changes in clinical, clinical support, and administrative processes and systems (see discussion of the infrastructure of ambulatory care earlier in this synthesis). Changes of this magnitude and complexity will require sustained effort, and sustained support.

Recommendation 10: Provide sustained multiyear support for projects designed to improve patient safety (and quality) through changes in both clinical processes and in clinical support and administrative support processes and systems. Consider multistage projects, with the hypotheses and experimental design for each stage based on what has been learned in previous stages. Consider projects that also attend to "organizational" aspects of care including structure, culture, and compensation. Provide support for attention to managing change, and for increasing our understanding of how to successfully implement changes that improve safety. Anticipate how "lessons learned" and best practices identified can be disseminated and implemented by others. Attend to aspects of the environment that inhibit or promote improvement in safety, including payment mechanisms and the legal and regulatory environment.

Focused studies and experiments provide opportunities to rapidly understand critical risks and to quickly design and test specific interventions to improve safety. Focusing on particular aspects or areas of care about which we have considerable knowledge and/or where we know there is substantial potential to make progress should yield good examples of successful improvement in safety, and models for research and improvement useful in other areas. For example, one might focus on areas of high risk or on common and recurring processes and tasks that entail risk, such as areas that generate a substantial fraction of malpractice claims (e.g., failure to or delays in diagnosing breast cancer) or transitions of patients from one provider to another.

Practice based research networks may provide an excellent setting for research and demonstrations in ambulatory patient safety, particularly for physician practices. There are several models upon which to build, including the experience of the Institute for Clinical Systems Improvement (ICSI) in the Minneapolis-St. Paul area and the collaboratives organized and supported by the Institute for Healthcare Improvement (IHI). Networks or collaboratives provide an opportunity for learning from the experiences of known peers, and should be an excellent "laboratory" for studying the dissemination and adoption of innovations and factors that enable or inhibit that.

AHRQ is supporting 19 Primary Care Practice-Based Research Networks and 9 Integrated Delivery System Research Networks at the regional and national level. Many of these networks have received AHRQ funding to address ambulatory safety.

The External Environment and Resources for Safety

Efforts to further understand risks and incidents and their causes, and to improve patient safety in ambulatory care, will occur within a complex context that includes the tort liability system, Federal and State law, the responsibilities and authority of professions, the organization and financing of care, and other aspects of the structure and culture of health care. And many of the ideas and proposals to improve patient safety will require changes in aspects of the external environment. Because there are stakeholders with a variety of interests and beliefs, there is a need for "communities of stakeholders" to come together in ways that enable each of their constituencies to have a voice, and to find common ground in support of a proposed change.

The legal environment has pivotal influence on reporting incidents, adverse events, and near misses, and on our ability to learn from them and to improve patient safety. Without consensus to make changes in this area, reporting may continue to be scanty and opportunities lost to improve patient safety. What kinds of protection for confidentiality and privacy are needed, with what privilege from discovery and protection from liability? For example, what is the potential for consensus around the position that information developed in connection with reporting systems should be privileged for purposes of Federal and State judicial proceedings and civil matters, and for purposes of Federal and State administrative proceedings, including with respect to discovery subpoenas, testimony, and other forms of disclosure. The rationale driving consensus could be the understanding that if the reporting system supports blame and punishment, then it will not enable improvement in patient safety because reporting will be suppressed by fear, losing the opportunity to learn from incidents and near misses how to change both individual behavior and systems to reduce risks and injury.

The organization and delivery of health care in the United States is inextricable related to and driven by its financing. Incentives provided by its mixed public and private system will help determine rates of change and improvement in patient safety. For ambulatory care, it is apparent that there are presently few financial and economic incentives aimed at improvement in patient safety. The majority of ambulatory physician practices have little incentive to add either capital or labor resources to their practices in order to improve patient care. However, there are indications that this situation is changing. Employers are negotiating contracts with HMOs and through direct contracting that include incentives for measuring and improving quality of care. It is clear that these incentives must be present and significant if they are to induce real changes in practice and provider behavior as they relate to patient safety and quality of care.

We need to identify, or to design and test ways to make a "business case" for improving patient safety; we need to find ways for those who invest time and resources to improve to also receive the (financial and other) benefits of the improvements. Changes in practice patterns will occur very slowly if major changes in payment for care are not made. The business case for improvement must be made around payment and an improved rate of return on investment through savings generated by lowering the cost of rescue and follow-up care to patients injured during the care process. A number of studies support the conclusion that there is a large potential to reduce costs of health care—perhaps as much as 30 to 40 percent of total expenditures—by improving patient safety and quality and efficiency of care. The costs so saved could be used to improve access to care for underserved populations, to fund additional medical research and provide new effective therapies, and to reduce costs to patients, employers, and the public.

Recommendation 11: Model the financial implications of improving safety and quality for various players in the current organization and financing of care, including physicians, medical group practices, hospitals, integrated care systems including staff model group practices that provide prepaid care to populations, traditional health insurers, self insured employers, patients, and the Medicare program. Explore the effects of adverse selection. Develop potential modifications in or alternatives for organization and financing that would align interests to support and reward the various professionals and organizations to improve safety and quality.

Effective and trusting stakeholder engagement is more important to the advancement of ambulatory care safety than safety for inpatient care because of the coordination of information and care in the ambulatory care setting is more complex, and there is a wider distribution of responsibility among external stakeholders. The principal stakeholders include patients, consumers, and the public; physicians and other clinicians, physician practice administrators, employers, purchasers, payers, product makers, legislators, regulators, lawyers, accreditors, liability insurers, educators, and researchers and funders of research. We need to understand their interests and their beliefs, and to identify changes for which a consensus can be reached and commitment to joint action forged.

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Current as of December 2001
Internet Citation: Introduction (continued): An Agenda for Research in Ambulatory Patient Safety. December 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/events/other/ptsafety/executive-summary2.html