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The US Agency for Healthcare Research and Quality’s activities in patient safety research

Gregg S. Meyer, James Battles, James C. Hart, Ning Tang
DOI: http://dx.doi.org/10.1093/intqhc/mzg068 i25-i30 First published online: 6 December 2003

Abstract

Purpose. To update the international community on the US Agency for Healthcare Research and Quality’s (AHRQ) recent and current activities in improving patient safety.

Data sources. Review of the literature concerning the importance of patient safety as a health care quality issue, international perspectives on patient safety, a review of research solicitations, and early results of funded studies.

Study selection. A representative sample of patient safety studies from those currently being funded by AHRQ.

Results. In response to a growing interest in patient safety in general and a recent US Institute of Medicine report on patient safety in particular, the US Agency for Healthcare Research and Quality has refocused its quality research mission. In the fiscal year 2002, AHRQ spent US$55 million on patient safety research. This investment was spread across six complementary research areas: (1) health systems error reporting, analysis, and safety improvement research demonstrations; (2) Clinical Informatics to Promote Patient Safety (CLIPS); (3) Centers of Excellence for patient safety research and practice (COE); (4) Developmental Centers for Evaluation and Research in Patient Safety (DCERPS); (5) The Effect of Health Care Working Conditions on Quality of Care; and (6) Partnerships for Quality: Patient Safety Research Dissemination and Education. Internal teams of researchers at AHRQ have published studies on patient safety, such as documenting the impact of medication errors. In addition to funding research on patient safety, AHRQ is an integral partner in several national and international collaborations to form strategic synergies that build upon each member organization’s strengths, reduce redundant efforts, and benefit from each other’s successes. As evidence on patient safety is generated, AHRQ also serves the important mission of disseminating information to the public.

Conclusion. The patient safety research field has undergone a period of rapid evolution. It is now incumbent upon the international health care quality improvement community to translate the future results of this research investment into improved safety for patients.

  • patient safety
  • quality
  • research
  • US Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality (AHRQ) is a US federal agency under the direction of Health and Human Services. AHRQ’s mission is to enhance the quality, appropriateness, and effectiveness of health care services, and access to such services, through broad-based scientific research and initiatives to improve clinical practice, patient safety, and the organization, financing, and delivery of health care services. As one of the two research agencies in the US Department of Health and Human Services, AHRQ’s budget of US$306 million in the fiscal year 2002 is relatively modest compared with its sister agency, the National Institutes of Health (NIH), which maintains a robust $23.5 billion budget. The purpose of this article is to update the international community on AHRQ’s recent and current activities in improving patient safety.

Research agenda setting and funding

AHRQ has a long history of supporting research on patient safety, as some of the seminal research in this area was funded by AHRQ’s predecessor agencies, the National Center for Health Services Research and the Agency for Health Care Policy and Research. While the predecessor agencies did not explicitly prioritize patient safety research, AHRQ’s 1999 Congressional reauthorization expanded its mandate to include patient safety, explicitly recognizing the Agency’s lead role on quality in general and safety issues in particular [1]. In December 1999, AHRQ released a targeted research solicitation that yielded six Systems-Related Best Practices grants. This marked the first time that the funding of patient safety initiatives was part of a broad strategic plan, rather than a consequence of surviving the competition amongst broad health services research proposals. Although the solicitation had been in development for nearly a year, its public release came just 2 weeks after the release of the landmark US Institute of Medicine (IOM) report on patient safety, entitled To Err Is Human [2]. That report galvanized interest in patient safety as a lead issue in health care quality, and received wide attention in the medical and lay literature in the United States.

Within 2 weeks of the release of the IOM report, the President of the United States called for a comprehensive federal response to the patient safety challenge. The Quality Interagency Coordination (QuIC) Task Force, comprised of federal agencies with roles in providing, purchasing, or researching health care, developed a report to the President entitled Doing What Counts [3], which describes >100 actions that could be taken by federal Agencies to facilitate patient safety improvements. Both the IOM report and the QuIC’s response called for a substantial investment in patient safety research, with AHRQ taking a lead role in agenda setting and funding.

In September 2000, the QuIC sponsored the National Summit on Medical Errors and Patient Safety Research to set the research agenda. In the past, the research agenda traditionally relied upon the opinions of a small number of renowned researchers. This patient safety research summit, however, represented a fundamental shift in developing a research agenda. The QuIC turned to a variety of users—including >100 provider, purchaser, researcher, policymaker, and patient stakeholders, both public and private, individuals and groups—to provide written and oral testimony. In addition to the US stakeholders, the summit included members of the international community, with senior health officials from the UK, New Zealand, and Australia.

In their testimony, the users identified the salient questions, which, if answered by research, would assist them in their efforts to improve patient safety. A representative sample of research questions are provided below (a list of all research questions identified at the national summit can be found on the QuIC website: www.quic.gov):

  1. Epidemiology of errors. What are the types of errors and who is at risk for errors? What are particular system vulnerabilities that lead to increased medical errors? What are the barriers to studying errors? What human factors lead to errors? How do we know which outcomes are caused by errors?

  2. Infrastructure to improve patient safety. What are the proper roles for different interest groups in promoting patient safety? What should be the common vocabulary? What infrastructure is needed? How can data be integrated?

  3. Information systems. What useful data sources exist? What data should be collected and how? How do we measure success of a reporting system?

  4. Knowing which interventions should be adopted. What level of evidence is required? What can we learn from other industries? What effect does training have on safety? How can research on safety be integrated into training promptly? What are the organizational changes that affect safety?

  5. Adopting safe practices and using information from research. How can we create a business case for safety? How can we improve communication among health professionals? Why are interventions adopted and why not? How can useful information be provided effectively?

The questions generated at this summit have formed the core patient safety agenda for numerous public and private organizations, including AHRQ [4]. Fourteen public- and private-sector organizations that fund patient safety research were represented at the summit, and each has pledged to use these research questions to shape their future research priorities. AHRQ continues to work with these groups to ensure that a coordinated private–public action plan will enable complementary efforts to fill our knowledge gaps, with minimal redundancy.

The growth of the patient safety research field in the last 2 years has been extraordinary [5]. In the fiscal year 2001, the US Congress earmarked $50 million of AHRQ’s $270 million budget for patient safety research, a huge leap from $2 million in the fiscal year 2000. The bolus of funding in 2001, followed by a further increase to $55 million in 2002 and $60 million in 2003, has made AHRQ the world’s largest patient safety research funder. Nevertheless, the current investments fall short of the $100 million per annum recommended in the IOM report [2].

Funded projects in progress

AHRQ has used the research questions identified in the Patient Safety Research Summit to direct the agency’s research agenda. The research questions represent a mixture of fundamental research needs and applied research goals. The QuIC and AHRQ have attempted to strike a balance between basic and applied research by organizing research objectives based on timing and priority. Short-term projects (6 months to 2 years) were identified by users as having the most pressing needs. Medium-term projects (2–5 years) may require some initial funding for planning and start-up, but the full benefit of the research results will require the use of information from some of the short-term projects. Long-term project (>5 years) objectives will be met only after the results of the few preliminary short- and medium-term projects are used to develop the long-term research plans. Basic and applied research objectives fall in each of these categories.

To operationalize the research investment, AHRQ developed a series of six complementary research solicitations [called Requests for Applications (RFAs)] that enable funding for short-term and some medium-term research projects, as well as basic and applied research, to be undertaken in parallel. These included:

  1. health systems error reporting, analysis, and safety improvement research demonstrations;

  2. Clinical Informatics to Promote Patient Safety (CLIPS);

  3. Centers of Excellence for patient safety research and practice (COE);

  4. Developmental Centers for Evaluation and Research in Patient Safety (DCERPS);

  5. The Effect of Health Care Working Conditions on Quality of Care; and

  6. Partnerships for Quality: Patient Safety Research Dissemination and Education.

Based upon the applications submitted, AHRQ funded 94 research projects addressing a broad array of the issues identified at the National Patient Safety Research Summit. Characteristics of each of the research programs and examples of funded projects are presented below [a complete listing of funded projects is available at www.ahrq.gov (see Figure 1 for all websites listed)].



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Figure 1

Websites related to patient-safety activities at AHRQ.

Error reporting, analysis, and safety improvement demonstrations

As people around the world strive to improve their nations’ health care systems, we face an obvious lack of information about the prevalence and etiology of medical errors, as well as the effects of these errors. Effective error reporting systems are a prerequisite for improvement [6]. It is impossible to design intelligent systems, protocols, or processes to reduce errors if we do not first know where errors are occurring and why. Mandatory and voluntary error reporting systems are present in most health care facilities, however, there are significant barriers to widespread use. Many states have passed laws that require reporting of adverse events that result in serious injury or patient death. Many of these incidents remain unreported due to the fear of malpractice suits and shame within the profession. Other incidents and near misses should be reported via voluntary error reporting systems. However, evidence shows significant barriers to widespread use, such as the burden of reporting mechanisms, fear of litigation, and professional shame [7].

In February 2001, AHRQ issued an RFA to begin closing these information gaps. We currently support 24 research projects that examine different methods of collecting data on errors, or analyzing data that have already been collected to identify factors that put patients at risk for medical errors. These research projects focus on a variety of medical settings, including hospitals, outpatient clinics, pharmacies, and primary care facilities, and specific patient populations, such as the underserved and those insured by Medicare or Medicaid.

A variety of methods of error reporting are currently being studied for their effectiveness, as well as their barriers to acceptance and widespread use. AHRQ is particularly interested in exploring the use of information technologies, which have the potential to improve the safety and overall quality of health care dramatically. For example, one research grant focuses on best practices in reporting systems and learning from the generated data. The specific aims of this grant are as follows.

  1. To expand their integrated event reporting system to facilitate reporting of errors by patients in an outpatient setting.

  2. To test novel generalizable informatics methods to manage and support learning from large numbers of reports in an effective and efficient manner.

  3. To demonstrate the value of reporting by showing its effects on patient safety, organizational culture, and economic outcomes.

  4. To show the value of near-miss reporting on reductions in sentinel events by addressing the causes of near misses.

  5. To improve health care delivery processes and staff training using failure mode and effects analysis, systems redesign, safety curricula, and simulation-based team training.

  6. To discover which modes of safety information dissemination are valued by customers, purchasers, policy makers, providers, and regulatory agencies, and explore the practical pros and cons of alternative strategies to develop and disseminate such information [8].

Clinical Informatics to Promote Patient Safety (CLIPS)

Among the testimony received at the National Patient Safety Research Summit was the admonition that the application of information technology and automation may not be a panacea for all aspects of the safety challenge. The CLIPS RFA, released in late February 2001, seeks to develop and test the use of innovative technologies, such as hand-held electronic medication and specimen management systems, automated medication dispensing systems, computerized bar-coded patient bracelets, and training simulations in medical education. The objective of this RFA is to assess the extent to which such innovations contribute to measurable and sustainable improvements in patient safety and quality of care in a variety of medical settings.

For example, many physicians use a personal data assistant (PDA) in their daily practice; there are currently >100 software titles designed to assist physicians. A current study assesses the impact of using hand-held electronic devices to order and print prescriptions, compared with a baseline level of error using standard hand-written prescriptions [9]. Another project among the 22 that were funded studies the effects of PDA and pharmacology reference software usage on prescribing practices [10]. Physician decision support systems (DSS) offer substantial potential to reduce errors and improve quality. Such systems can offer physicians patient-specific reminders of recommended procedures such as pap smears or colonoscopies, can suggest treatment protocols for specific diagnoses based upon best practice evidence, and can warn physicians of drug interactions and important contraindications. A team of researchers will examine barriers to clinician use of hand-held devices and assess the impact of DSS on patient safety, targeting the risks of inappropriate prescribing of medications [11].

Centers of excellence for patient safety research and practice

AHRQ also funds Patient Safety Research Centers of Excellence, which comprise multidisciplinary teams of researchers in diverse care settings and populations. These centers bring together highly skilled researchers who work together to determine the root causes of errors, develop new research tools and methods, investigate interventions, and develop education and implementation programs. These centers are also responsible for disseminating their results. Due to the continuity of the skilled research teams, these centers can adapt to new research projects, enabling them to pursue a number of different projects in a relatively short period of time. Three Centers of Excellence in Patient Safety were established in 2001. One center proposes to adopt techniques from the aviation industry, such as videotaping teams in action to improve communication and teamwork, and investigating how data on errors and near misses are collected and how organizations use such information [12].

DCERPS

These research grants, offered in an RFA in November 2000, are designed to increase the US capacity to conduct fruitful health services research, and translate findings into practice. During the 3-year term of the grants, the 15 participating centers are expected to develop multidisciplinary teams of researchers, form partnerships with delivery systems for research, and plan and conduct a patient safety research study. Upon completion of the 3-year grant, the DCERPS are expected to be positioned to compete effectively for future research grants from AHRQ and other organizations. As an example, one DCERPS will investigate the effects of medical errors on children in diverse settings including intensive care units, emergency rooms, urban and rural pediatric practices, and outpatient pediatric primary care centers that serve minority populations [13].

The effect of health care working conditions on quality of care

The effects of working conditions have been well studied in many industries, perhaps most notably in the airline industry. However, the impact of working conditions in the health care industry is largely unknown. The RFA released in late March 2001 funds research that seeks to identify, characterize, and measure directly the effect of working conditions on health care workers’ ability to provide safe, high-quality care. Elements of working conditions being examined include staffing levels, work load, working hours, shift rotation patterns, physical environment, workflow design, and organizational culture.

For example, US medical residents are often cited as working 80–110 hours per week, with 30–38 hours on on-call shifts every 2–4 nights. Residents maintain these strenuous hours for months at a time. Sleep-deprived residents continue to provide medical care, and anecdotal evidence suggests that they may pose a significant risk to patients’ safety. One funded project is testing the hypothesis that patient safety, as measured by the total number of medical errors, will be significantly reduced by implementation of a night float system in which residents are provided with 10 hours of protected sleep during on-call nights [14].

Patient Safety Research Dissemination and Education

AHRQ’s Dissemination and Education RFA, released in May 2001, is designed to accelerate the rate at which patient safety research findings are translated into standard practice. These grants support educational programs, the development of model curricula, and outreach efforts, which will bring current and emerging evidence on patient safety to providers. These projects are often led by organizations or groups with the immediate capacity to influence the organization and delivery of health care, as well as to measure and evaluate the impact of their improvement efforts. Such organizations include health care professional organizations, provider groups, and practice networks.

For example, one funded study seeks to determine whether cardiac catheterization simulation models help medical students and physicians learn clinical skills more quickly, especially in uncommon clinical scenarios, without harm to patients [15]. Another project seeks to raise patient safety awareness, and improve attitudes and behaviors among the physicians who are members of a professional society through an on-line continuing medical education program [16].

The products of all AHRQ-sponsored patient safety research will be available in the public domain. As these projects mature over the coming 2–3 years there will be an exponential increase in the evidentiary base for improving patient safety. Updates on the progress of these projects can be found on the AHRQ website at www.ahrq.gov.

Strategic collaborations

To facilitate coordination of national efforts to improve patient safety, several task forces have formed de novo. These collaborations form strategic synergies that build from each member organization’s strengths, reduce redundant efforts, and allow us to benefit from each other’s successes. AHRQ is integrally involved in many collaborations, three of which are described below: the QuIC, the Patient Safety Task Force, and the US–UK binational agreement on quality and safety.

The Quality Interagency Coordination Task Force (QuIC)

The QuIC is a federal interagency task force formed in 1998 by Presidential executive order to develop a national strategy to improve the quality of care in the United States. Eleven federal departments and agencies comprise the task force: Department of Commerce, Department of Defense, Department of Health and Human Services, Department of Labor, Department of Veterans Affairs, Federal Bureau of Prisons, Federal Trade Commission, National Highway Transportation and Safety Administration, Office of Personnel Management, Office of Personnel Management, Office of Management and Budget, and the United States Coast Guard. As the lead agency in the Department for Health and Human Services for health care quality, the Director of AHRQ chairs most of the QuIC meetings and the Agency serves as the organizing center for QuIC activities.

As noted above, Doing What Counts [3], the QuIC’s response to the IOM patient safety report, included a comprehensive program of >100 actions that could be taken by federal departments and agencies to facilitate improvements in patient safety. At the time of writing, substantial progress has been made on >90 of these actions. For example, federal health care delivery systems such as the Department of Veteran’s Affairs and Department of Defense hospitals are aggressively pursuing patient safety initiatives, serving as testing grounds and role models for the private sector. Computerized order entry systems, bar coding for medical delivery, pediatric medication, resuscitation equipment color-coding schemes, and programs to reduce errors in high-hazard medical environments such as intensive care units are currently underway in these settings [17].

Patient Safety Task Force

The Patient Safety Task Force (PSTF) consists of representatives from the following agencies in the US Department of Health and Human Services (HHS): AHRQ, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and Center for Medicare and Medicaid Services (CMS, formerly known as HCFA). This task force is a collaborative effort to: (1) develop a coordinated and integrated data collection system for medical errors and adverse events; (2) coordinate research and analysis efforts; and (3) promote collaboration on reducing the occurrence of injuries that result from medical errors. At the core of the task force’s mission is an effort to take full advantage of patient safety data already being collected prior to developing new data reporting requirements. As the lead agency in HHS for health care quality, AHRQ serves as the coordinating agency for all task force meetings, initiatives, and outreach.

Many states, federal agencies, accrediting bodies, and other organizations already collect error reporting data, but the lack of coordination of these efforts results in an undue burden on health care workers, which discourages comprehensive reporting and fragments the nationwide effort to improve patient safety. To improve error reporting, the task force supports the development of computer networks, user-friendly reporting systems, and standards for coding the content of the reports. The task force seeks to develop a system that provides a consistent and easy-to-use format for error reporting, provides reliable and valid information, and maintains confidentiality for both patients and providers.

US–UK binational agreement

For the past 3 years, the US and the UK have conducted annual conferences with senior health officials from AHRQ and other organizations aimed at furthering trans-Atlantic collaboration in health care improvement. These meetings, held under the joint sponsorship of the Commonwealth Fund and the Nuffield Trust, have promoted dialogue between the two governments and focused on three strategic areas: national quality reporting, information technology, and patient safety. In October 2001, these efforts were formalized by the signing of a joint statement of intent by US Secretary of Health and Human Service Tommy Thompson, and the then UK Secretary of State for Health Alan Milburn.

Of the three areas, progress in patient safety has been the most rapid. To date, this has included the incorporation of prominent researchers from the UK in AHRQ grant reviews and US researcher participation on grant reviews for the new National Health Service National Patient Safety Agency. More recently a jointly funded study of safety in labor and delivery has been undertaken, and a binational conference on patient safety research methodology was held in autumn 2002.

Public outreach

Consistent with our mission to expedite improvements in patient safety, AHRQ has developed several programs to educate the public about patient safety concerns.

In conjunction with the QuIC, AHRQ composed a list of ‘Five Steps to Safer Health Care’, which are simple evidence-based steps that patients can take when receiving medical care to help prevent errors from occurring. AHRQ and the QuIC are working to make the ‘Five Steps’ widely available to the public, especially at points of care. Briefly, the Five Steps to Safer Health Care are:

  1. speak up if you have questions or concerns;

  2. keep a list of all the medicines you take;

  3. make sure you get the results of any test or procedure;

  4. talk with your doctor and health care team about your options if you need hospital care; and

  5. make sure you understand what will happen if you need surgery.

A full description of the five steps, which is in the public domain, is available at www.ahrq.gov/consumer/5steps.htm.

As the results of funded research become available over the coming years, AHRQ will work with its partners to develop other products to educate the public at large.

Future directions

AHRQ will continue to lead and support US effort in research on patient safety. Future efforts include continued funding of research areas identified at the National Summit on Patient Safety Research, including medium- and long-term projects, as well as continued collaboration with private and public sector agencies and the international community on identifying and translating best practices in the clinical setting. AHRQ will continue to fulfill its responsibility to disseminate research findings in the public domain and educate the lay public about ways to protect themselves from medical errors. All of these efforts are critical for advancing our knowledge about improving patient safety and translating this knowledge into practice. This will require continued and increased support by the US Congress for AHRQ’s budget on patient safety research.

Conclusions

Patient safety research is a nascent but rapidly developing field. Here the exciting initiatives being undertaken by the US Agency for Healthcare Research and Quality have been detailed, but it is important to keep these efforts in context. To date, the depth and scope of patient safety research has been limited in the face of the enormous challenges enumerated by the US Institute of Medicine and the UK National Health Service, among others. Experience from other industries, including nuclear energy, aviation, and industrial manufacturing, indicates that health care has a long way to go in developing a robust evidentiary base to support safety improvement.

Continued support of patient safety research is far from assured. Although safety has been an issue that has resonated in both the professional and the lay communities, we must recognize that safety improvement is a decades-long task. As with quality in general, we must recognize that simply conducting good research is just the beginning; what patients and providers are looking for is a measurable improvement. As the results of the currently funded research become available, it is incumbent on the clinical quality improvement community to work with due diligence to ensure that findings are translated into practice as rapidly as possible. Only with effective translation can the ultimate goal of safety research—making health care safer for patients—be realized.

Footnotes

  • Address reprint requests to Gregg S. Meyer, Medical Director, Massachusetts General Physicians Organization, Bulfinch 205, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. E-mail: gmeyer{at}partners.org

    The opinions and assertions contained herein are those of the authors alone and are not to be construed as official or as reflecting the views of the Agency for Healthcare Research and Quality or the US Department of Health and Human Services.

References

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