THE EFFECT OF HEALTH CARE WORKING CONDITIONS ON QUALITY OF CARE Release Date: March 26, 2001 RFA: RFA-HS-01-005 Agency for Healthcare Research and Quality (formerly AHCPR) Letter of Intent Receipt Date: April 20, 2001 Application Receipt Date: May 21, 2001 PURPOSE The Agency for Healthcare Research and Quality (AHRQ) is seeking applications for research grants that will examine the effect of working conditions on health care workers ability to provide safe, high-quality care. These grants are intended to identify, characterize, and directly measure the effect of the health care work environment on the safety and quality of care provided by health care workers. In collaboration with other Federal agencies involved in the Quality Interagency Coordination (QuIC) Task Force, AHRQ has held two conferences to seek evidence documenting the effects of key elements of working conditions such as staffing levels, working hours, physical environment, workflow design, and organizational culture on the quality of care provided to patients. These conferences demonstrated that while research has linked many aspects of working conditions to the quality of the goods or services produced in other industries, there is limited evidence for this correlation in health care. Therefore, the Agency is seeking applications that will: 1) explore the relationship between working conditions that affect health care workers and the safety and quality of care they provide and 2) test innovative approaches to working conditions that have been effective in improving the quality of a product or service in industries other than health care. Increasing our understanding of how working conditions affect health care workers and the resultant risks of errors and quality of services for patients is of major importance to the health care industry, particularly those who manage or oversee health care organizations, and set policies that affect the physical or organizational working conditions, for health care workers. Recent efforts to reduce costs and streamline the delivery of care have led to significant changes in the healthcare workplace. These changes in working conditions have affected health care workers, and many believe that they have had an effect on the quality of the care provided. Because the experience of other industries indicates that differences in the equipment and physical characteristics of the work space, changes in work process, and differences in staffing can affect the quality of the products or services they produce, it may be reasonable to hypothesize that changes in the health care workplace may be affecting the quality of care. However, research is needed to understand if those effects on quality actually exist, what they are, and how successful interventions can be encouraged. The applications funded in response to this Request For Applications (RFA) will begin to develop systematic knowledge of the impact of the physical environment, workflow design, workforce staffing and organizational culture on patient safety and quality of care. Therefore, applicants must be able to demonstrate that they will measure the impact of working conditions on health care workers and on clinical performance. In AHRQ’s FY01 appropriations, Congress explicitly set aside $10 million for initiatives targeting health care workforce and quality improvements. This RFA is the Agency’s largest project in response to this directive, but there will be additional projects, including conferences and evidence reports that will also support further work and understanding of this issue. This RFA builds on research funded by AHRQ on assessing and improving quality of care and also complements a series of integrated research solicitations from AHRQ in FY 01 that focus explicitly on patient safety. AHRQ is interested in applications to design and test best practices for reducing errors in multiple settings of care, develop the science base to inform these efforts, improve provider education to reduce errors, capitalize on the advances in information technology to translate proven effective strategies into widespread practice, and build the capacity to further reduce errors. Further information on all RFAs is available at http://www.ahrq.gov/fund/funding.htm. RFAs released as part of this program include: 1) Health System Error Reporting, Analysis, and Safety Improvement Demonstrations ---- to support large demonstrations in States, health care systems, and networks of providers (both integrated delivery systems and primary care networks) to test reporting strategies and patient safety interventions. 2) Clinical Informatics to Promote Patient Safety (CLIPS) ---- to develop and test the use of appropriate technologies to reduce medical errors, such as hand-held electronic medication and specimen management systems and prescription pads, training simulators for medical education, bar-coding of prescription drugs, patient bracelets, and automated dispensing of medication in a hospital setting. 3) Centers of Excellence for Patient Safety Research and Practice ---- to establish multidisciplinary teams of researchers, health care facilities, and organizations in geographically diverse locations (including rural and urban areas) which will determine the causes of medical errors, develop new knowledge to support the work of the demonstrations. 4) Developmental Centers for Evaluation and Research in Patient Safety ---- to develop new multidisciplinary research teams to improve the nation’s capacity in patient safety research, to expand the patient safety knowledge base, and to establish mechanisms to assure that new knowledge is incorporated into actual practice and that its impact is assessed. 5) Patient Safety Research Dissemination and Education ---- to fund researchers and organizations (e.g., professional associations, hospital groups, national organizations) to develop, demonstrate, and evaluate new approaches to improving provider education in order to reduce errors. Examples include but are not limited to developing curricula for continuing education, simulation models, and other provider training strategies based on new knowledge of patient safety. Research themes under this RFA and others to be released by the Agency are generated by a variety of activities, including public and private sector national summits and research agenda-setting activities on quality, medical errors, and patient safety, the aforementioned conferences on working conditions, and meetings with key stakeholders. A summary of the research themes emerging from the National Summit is available at http://www.quic.gov/summit/resagenda.htm. Applicants are required to review this information and indicate how their proposed research will meet the needs articulated in the Preliminary Research Agenda from the National Summit and Working Conditions conferences. Definitions For the purpose of this RFA, definitions of the key areas of research are as follows: Working conditions ---- the characteristics of the health care workplace and workforce, including the physical environment, workflow design, workforce staffing and organizational culture Health care workers ---- workers employed in the direct care of patients in health care settings, including, but not limited to: nurses, physicians, pharmacists, physician assistants, nursing assistants, and other health care providers. Medical error ---- the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems. (QuIC, 2000, http://www.quic.gov). Patient Safety ---- the risk of injury to a patient from medical errors. The enhancement of patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors (QuIC, 2000, http://www.quic.gov). Quality improvement ---- projects designed to improve patient care by ensuring that the right care is delivered to the right patient at the right time in the right way. Specific projects may be targeted toward encouraging the proper use of procedures that have been overused, underused, or misused. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private nonprofit organizations, including universities, clinics, units of State and local governments, healthcare organizations (including professional societies and organizations of health care workers), and eligible agencies of the Federal government. For the purpose of this RFA, AHRQ, by statute, can make grants only to non-profit organizations, however, for-profit organizations may participate in grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages women, members of racial and ethnic minority groups and persons with disabilities to apply as Principal Investigators. Special preference will be accorded to applications from investigators who have not been funded by AHRQ as a Principal Investigator within the last 2 years. MECHANISM OF SUPPORT This RFA will use the R01 mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. AHRQ is interested in funding 1-to 2-year projects but will consider projects of up to 3 years. The earliest possible award date is September 28, 2001. This RFA is a one-time solicitation. Future unsolicited applications, including competing continuation applications, will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures. FUNDS AVAILABLE AHRQ expects to award up to $7.5 million total costs (direct costs plus facilities and administrative costs) in fiscal year 2001 to support the first year total costs of approximately 20 projects under this RFA. Up to $3 million total costs will be set aside for applications from healthcare organizations, including professional societies, organizations of healthcare workers (including physicians, nurses, pharmacists, nursing assistants, physician assistants and other healthcare workers), healthcare purchasers, local/State organizations, and other health care organizations (including hospitals, ambulatory care sites, and integrated delivery systems). These projects should test the impact of innovative approaches to working conditions that have been effective in improving the quality of a product or service in industries other than health care. These projects may involve partnerships between researchers and health care organizations. Up to $500,000 total costs will be set aside for applications from existing primary care Practice-Based Research Networks (PBRN). For the purpose of this RFA, a PBRN is defined as a group of ambulatory practices devoted principally to the primary care of patients, affiliated with each other (and often with an academic or professional organization) in order to investigate questions related to community-based practice. This definition includes a sense of ongoing commitment to the research endeavor, and an organizational structure that transcends a single study. This opportunity is not limited to PBRNs with current AHRQ funding. These networks will be expected to examine the impact of working conditions in ambulatory settings, including work hours and emergency coverage, as well as the relationship of information transfer between health care providers across shifts or during transitions of care on quality of care. Across these categories, a minimum of $2 million will be reserved for projects focused on patient safety, with the remainder of the funds allocated for projects or discrete project components more generally focused on quality of care. The actual number of applications funded is dependent on the number of high quality applications and their individual budget requirements. It is not the intent of AHRQ that the awards be equal in size. The average award size will be approximately $300,000 total costs per year, with a maximum ceiling of $500,000 total costs. Any exceptions to the ceiling must be approved prior to submission or the application will be returned without review. Any applicant who will require more than $500,000 total costs per year must contact Helen Burstin, MD (hburstin@ahrq.gov) to receive prior approval. Although the financial plans of AHRQ provide for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Should additional funds become available, however, and if AHRQ receives a sufficient number of meritorious applications, AHRQ reserves the right to fund additional applications under this RFA. Funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds. RESEARCH OBJECTIVES Background AHRQ has an ongoing focus on research targeted toward improving the quality of patient care. In 1998, the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry presented its Final Report to the President of the United States, which focused on improving and sustaining the quality of health care in the United States. One of the outcomes of the President’s Quality Commission was the creation of a multi- agency Federal task force, the Quality Interagency Coordination Task Force (QuIC), to coordinate activities and plans for quality measurement and improvement across all Federal agencies involved in health care. One specific area within quality of care that has received renewed emphasis is patient safety. In November 1999, the Institute of Medicine (IOM) issued its report, To Err is Human. It synthesized the available evidence on patient safety and noted that medical errors are a leading cause of death and injury (Kohn, 1999). The report called for "a comprehensive and strong response to this most urgent issue facing the American people" (Kohn, 1999). In December 1999, AHRQ issued an RFA (HS-00-007) that focused on systems- related best practices to improve patient safety. In particular, the RFA’s purpose was to test the effectiveness of the transfer and application of best practices to improve patient safety through the reduction of preventable systems-related medical errors with high prevalence and severe consequences. AHRQ’s 1999 reauthorization language specifically directed the Agency to conduct and support research and build public-private partnerships to (1) identify the causes of preventable health care errors and patient injury in health care delivery, (2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety, and (3) disseminate such effective strategies throughout the health care industry. The QuIC’s report to the President on Federal actions to improve patient safety and reduce medical errors and their impact on patients which laid out a road map for action including more than100 activities (QuIC, 2000). This plan addresses issues such as national focus and leadership, identifying and learning from errors, setting performance standards and expectations for safety, building public and purchaser awareness, working with providers, using decision-support systems and information technologies, using standardized procedures, addressing and strengthening standards, and integrating data for reporting and analysis (QuIC, 2000). The QuIC Task Force also recognized the potential role of working conditions on health care quality. As part of QuIC’s initiative, AHRQ has co-sponsored two conferences with other QuIC agencies (one in 1999 and one in 2000), that explored the evidence for an effect of health care working conditions on quality of care. The first conference, in October,1999 Effect of Working Conditions on Quality of Care, was designed to explore what is known and what needs to be known about the relationship between working conditions and quality. Conference participants presented the aspects of health care working environment that influence the quality of patient care, identified the skill sets needed to investigate the issues of working conditions and quality of care, discussed needed specification of the measures of both working conditions and quality, and developed a preliminary research agenda on working conditions and quality of care. Building on insights gained the previous year, the second conference, held in October, 2000 Enhancing Working Conditions and Patient Safety: Best Practices, examined the effect of working conditions on a specific aspect of health care quality - patient safety. Participants presented evidence-based approaches to improve both working conditions and patient safety, described the barriers they encountered, and offered practical examples of improvements that might be replicated by others. The 2000 conference participants echoed many of the information needs identified in 1999 as barriers to implementation. While the QuIC conferences have furthered our understanding of the effect of working conditions on quality of care, participants in both meetings agreed that the evidence needed to prove an association between the two was weak. The conferences suggested that there has been too little research measuring and evaluating the impact of interventions intended to improve quality through improvements in the healthcare workplace. Participants also concluded that few studies have been conducted that clarify the causal pathways between working conditions and the ability of health care workers to provide high quality and safe care. Physical Environment The environment encompasses both the built environment, as well as the operational characteristics of the workplace. Though some studies of the physical environment have been associated with improvements in health care working conditions, few studies have examined the indirect effect of these changes on quality of care. At the QuIC-sponsored conferences, many providers, organizational leaders, and policy makers expressed interest in learning more about the impact of the physical environment on the health care workers, and its secondary impact on their ability to provide safe, high- quality health care. Human factors studies and other research have provided vital insights on ways in which work space design features can help or hinder the accomplishment of work (Ulrich, 1992). Little research has been done to help the health care industry understand the effect of the physical environment on the performance of health care workers and its impact on outcomes for patients. For example, while research has examined how aesthetics of the health care environment, such as color, lighting, art, and music may affect patients, it could be hypothesized that these factors may combine to encourage productive work or enhance the attention of health care workers, potentially resulting in quality improvement. The concept of the built environment as a therapeutic environment for patients and providers that could influence health care quality also requires more research. However, little work has been done to understand how these factors might affect health care workers, and importantly, how the influence of these factors on workers can affect the quality of the care they provide. Operational characteristics of the workplace could also influence quality of care, through an effect on workflow and ease of operation to the tasks being done. Physical environments that place needed technology within easy access of the healthcare worker and the patient may have significant impact on the quality of care provided by the healthcare worker. For purposes of this RFA, the physical environment encompasses the design of the physical plant and equipment, the built environment, the aesthetics of the health care environment, and how that design facilitates or hinders health care workers in carrying out their responsibilities. The Agency is seeking applications that will measure the effect of aspects of the physical environment, built environment, aesthetics, and workflow design on the safety and quality of care delivered in various health care settings. Work Hours and Staffing Work performance may be substantially influenced by multiple work factors, including how work is organized, the mix and type of health care personnel, and the existence of clearly defined work processes. Much of the current debate of healthcare working conditions focuses on several high profile issues: work staffing, including provider-to-patient ratios and provider mix, and work hours, including the effect of fatigue and sleep deprivation. The relationship between the number and distribution of selected health care workers and quality of care has been the focus of researchers and the media. Since health professionals rarely work in isolation, most studies suggest that simple ratios of health care workers to patients do not provide sufficient explanatory power to quality patient care. Though many state governments have begun to legislate nurse staff ratios, the evidence base for these mandates is fairly thin. There are limited data to suggest that higher nurse-to-patient ratios were associated with lower rates of adverse events (Kovner, 2000). In addition to a growing nursing shortage, a recent study by the American Nursing Association found that more than half of all nurses had significant concerns about their ability to provide high quality care. In addition, the mix, type, and experience of health care staff may have significant effects on the safety and quality of care provided. Research on working conditions in other industries, such as aviation, have provided evidence of the correlation between aviation safety and work hours, including the effect of factors such as fatigue, sleep deprivation, and shift work (Graeber, 1988, Sexton, 2000). The quality of patient care may be affected by a failure of will whereby the provider knows what care should be provided, but the will to provide care is hampered by fatigue and sleep deprivation (Robins, 1995). While some research on health care work hours has been conducted, the research has provided ambiguous evidence and conflicting conclusions. For example, Deaconson (1988) and others concluded that sleep deprivation among residents did not adversely affect their ability to provide appropriate patient care. On the other hand, several smaller, more recent studies have demonstrated the negative effects of fatigue, sleep deprivation and shift work among health care providers on the quality of care (Fitzpatrick, 1999, Smith-Coggins, 1997, Richardson, 1996). Attempts to legislate work hours have not been very successful. For example, the Bell regulations on work hours for housestaff called for an average work week of no more than 80 hours. Yet, a 1998 survey in New York State demonstrated that 37% of all residents exceeded 85 hours per week and 20% of all residents worked more than 95 hours per week. (Annenberg Proceedings, 1999). Further research is needed to develop an evidence base on how work hours and work staffing affect the quality of care. AHRQ is interested in applications that will measure the effect of these work factors on the quality of care, particularly its safety, delivered in various health care settings. Efforts to evaluate strategies that improve quality of care by applying the evidence base from other industries are particularly welcome. Organizational Culture Culture has been defined as the set of values, beliefs, and ways of thinking embraced by members of an organization (Daft, 1992). Each organization has its own distinctive culture, and the cultures at different operating units within an organization may vary (Leatt, 2000). Strong cultures can have significant influence on organizational performance. Unfortunately, there is no extensive research to examine the impact of organizational culture in the health care workplace on quality of care. One study found that a participatory, flexible, and risk-taking organizational culture was positively associated with the implementation of continuous quality improvement (Shortell et al. 1995). In another study, a supportive group culture was found to be significantly associated with better functional health status 6 months after coronary artery bypass graft surgery (CABG) but had little impact on other outcomes (Shortell, 2000). A recent field study of healthcare organizations also reported that a culture shift from solo workers to teamwork and promoting open communication has successfully helped a cancer institute improve patient safety (Paul, 2000). Organizational culture is significantly influenced by environmental, individual, and organization-wide factors. A strong match between organizational culture, strategic focus, and the external environment can enhance organizational performance (Denison, 1990). As the environment becomes increasingly competitive, healthcare organizations adopt various strategies, such as downsizing, reengineering, and restructuring, to improve organizational effectiveness and efficiency (Leatt, 1997). Consolidation among hospitals and physician practices continue to rise. All these organizational changes can have an impact on organizational culture, which, in turn, may influence employees morale and patient care. Leaders also have significant roles in shaping organizational culture. AHRQ is interested in applications that will 1) identify what cultural attributes or which type of organizational culture (i.e., group, developmental, rational, and hierarchical) have significantly positive impact on quality of care, 2) examine how quality of care is affected by the interaction of organizational culture with various environmental and organization-wide factors (e.g., leadership, organizational structure, incentive system, strategic focus), and 3) identify effective strategies for developing or sustaining an organizational culture that is committed to quality of care. Objectives and Scope Projects submitted in response to this RFA should address the effect of working conditions for health care workers on patient safety and quality of care. These projects must identify, characterize, and measure aspects of the work environment that influence both the health care provider and quality of patient care. Projects may also explore the methodologic challenges of assessing causal relationships for strategies and programs intended to improve healthcare working conditions and quality of care. For intervention studies, investigators should be able to measure and document changes in the quality of patient care, such as improvement in patient safety, as a result of the intervention proposed. The research plans should include evidence of institutional commitment, ties to the delivery system, and use of multi- disciplinary teams, when appropriate. AHRQ is interested in projects that draw on proven innovations in working conditions in other industries, such as aviation and manufacturing, that have demonstrated improvement in the quality of their product or service. Alternative strategies to work schedules and working conditions learned from other industries and applied to health care are welcome. AHRQ is interested in supporting projects from healthcare organizations such as applications from professional societies, organizations of healthcare workers (including physicians, physician assistants, nurses, pharmacists, and other health professionals), healthcare purchasers, local/state government organizations, and other health care organizations, such as hospitals, integrated delivery systems, and ambulatory care facilities. These health care organizations will be expected to apply innovative approaches from the evolving evidence base on working conditions in other industries to health care, including proven approaches to working hours and schedules, work staffing, the physical environment, and the culture of the workplace. For example, a project could translate an approach to shift work from other industries to a health care setting. Projects can be conducted in any health care setting, such as hospitals, long term care, and ambulatory care facilities. Investigators are encouraged to investigate the effect of working conditions on quality of care with all types of direct care providers, such as, physicians, nurses, pharmacists, therapists, aides and medical residents and others. AHRQ is particularly interested in projects that are generalizable to other settings and types of providers. In addition, projects that test interventions or assess working conditions that may be of particular importance to the quality of care received by at-risk populations, such as AHRQ’s priority populations (women, children, elderly and minorities, residents of the inner city and rural areas, persons with special health care needs), are desirable. Applicants are encouraged to include investigators from research disciplines that utilize expertise from human factors psychology, organizational management, and other fields that have already concentrated on significantly improving the quality of their work product (e.g., aviation and manufacturing). Investigators are encouraged to research working conditions where the study results will be applicable and generalizable to situations beyond that of the study. For quality improvement projects, it is expected that these rojects will have control groups or utilize time series analyses. It will also be critical that these improvement initiatives collect substantial baseline data on staffing and quality of care. Though these improvement strategies in working conditions may impact on intermediate outcomes, such as cognitive ability on direct testing, AHRQ requires that these applications specifically examine the impact of these strategies on patient care outcomes and quality indicators. Applicants should consider how to maximize the generalizability of their results to other health care settings. Though innovative research in hospital settings is encouraged, AHRQ seeks a mixed portfolio of different organizational and health care settings. Therefore, applicants who examine innovative approaches in non-inpatient settings, such as ambulatory care settings, long-term care facilities, and community-based sites are particularly encouraged. Recognizing the inherent risk of transitions between healthcare settings, AHRQ especially welcomes applications that examine the effect of working conditions, such as call schedules and emergency coverage arrangements, as well as the relationship of information transfer between health care providers across shifts or during transitions of care on quality of care. Research Methods Regardless of study design or research methodology employed, the outcome of interest for all studies must relate to the quality of care provided to patients. The research methods for proposed projects should be rigorous, use state-of-the-art methodologies, and be grounded in appropriate theoretical frameworks. Hypothesis-testing projects should clearly present competing hypotheses. It is expected that most projects will rely on quantitative methods, though qualitative studies of organizational culture will be considered. Though this RFA does not identify a specific study design, health care organizations applying for the set-aside funds must perform intervention studies that examine the impact of innovative strategies in health care working conditions on quality of care. A key consideration in the review of applications will be the ability of the proposed project to examine factors that directly influence both the health care provider and the delivery of patient care, including the safety and quality of care. For intervention studies, applicants should carefully outline their plans to capture the impact of interventions they wish to test through the collection of quality measures and outline a strategy for determining whether a lack of impact was due to a failure of the intervention or to other factors. Any substantial change in the features of the intervention during the course of observation should be noted and examined for its independent contribution to any change in quality measures. Attrition from the sample should be examined for any connection with quality of care. Applications comparing interventions that were subject to experimental designs, prospective collection of data, and rigorous collection of potentially mediating variables are encouraged. An alternative to prospective designs would be retrospective collection of the quality measures in the population under study prior to the beginning of an intervention (changes in outcomes may take a longer period of time). After the intervention begins, these measures should be assessed at least annually. The means for collecting information on the features of each improvement strategy, its impact on the quality measures, and the size and characteristics of the population affected should be described carefully. Applicants should assess the generalizability resulting from their choice of strategies, geographic areas, delivery systems, and providers and patients for study. Applicants should consider how they might maximize the generalizability of their findings across organizational settings and conditions. Two examples of ways to advance this goal would be (a) research consortia incorporating multiple intervention sites and (b) studies that focus on two or more conditions. Applications that evaluate quality improvement strategies across a variety of settings (including inpatient care, outpatient/ambulatory care, and long-term care) as well as across geographic regions and different types of facility ownership such as government, nonprofit, and for-profit entities are desirable. Applications should include a detailed plan outlining the dissemination strategy for any results from the project, including specific plans to promote the adoption of successful improvement strategies in non-study organizations and settings. Policy Relevance and Dissemination Studies under this RFA are expected to contribute to our basic understanding of quality of care, including patient safety, and produce information in formats useful to individuals involved in improving the quality of health care delivery and formulating public policy. Applicants should be concrete in describing (1) the operational, public policy, and other audiences most interested in the supported research and (2) how applicants anticipate their results may be used for applied and public policy purposes. Proposed dissemination strategies should not be limited to publication in peer-reviewed journals but may encompass a variety of approaches, such as translating results into non-technical monographs and distributing them through associations of private and public officials, educating legislators, public administrators, health plan executives, employers, and others in seminars, and outreach to the mass media. In addition, applicants should plan to attend an annual conference with other quality of care and patient safety grantees supported under the broader AHRQ program which will be organized by a central coordinating center (see SPECIAL REQUIREMENTS). SPECIAL REQUIREMENTS To enhance the effectiveness of the grant recipients for this RFA and other investigators, AHRQ plans to hold an annual conference for its investigators conducting research on improving the healthcare workplace and quality of care. This conference may be included as part of or conducted in conjunction with the annual conference for patient safety investigators. Applicants should plan on attending this annual conference which will enable investigators to: (1) discuss their projects and share strategies with other researchers in overcoming hurdles to their research, (2) discuss applied and public policy issues relevant to quality of care projects, including patient safety, and (3) receive input from AHRQ program staff and key stakeholder groups. For budgetary purposes, awardees should plan for at least one representative to travel to the Washington, DC area for conference presentations that will be timed with annual submission of applications for continued funding. Applicants should present a relevant plan, include involved personnel, budget justifications, and timetables appropriate to participating in such annual conferences. Data Privacy All information about identifiable individuals or organizations obtained for the research purpose of carrying out a demonstration project supported pursuant to this RFA under AHRQ’s statutory authority is protected by a federal confidentiality statute, section 924 of the Public Health Service Act , 42 USC 299c-3(c). Under this law, the only permissible uses or disclosures of the information are those agreed to by the subject individuals and organizations or by those who supply the information to the researchers. There are substantial statutory penalties (up to $10,000) for improper use or disclosure of this information. Thus, 42 USC 299c-3(c) provides a Federal statutory basis for resisting any Federal or state court order or subpoena to the extent that carrying out the order or subpoena would violate the protective restrictions of the statute. Upon request, AHRQ will provide legal assistance in defending adherence to these statutory confidentiality protections with respect to identifiable data obtained in carrying out Agency research activities. Note that identifiable data obtained by AHRQ-supported researchers is protected by this law when it is obtained to carry out AHRQ-supported research, but this law would not protect against access to this same information in medical records if it were gathered and recorded there for other purposes. If providers collect certain information solely for purposes of this research, it should be so marked and if necessary to protect its confidentiality, kept separately. Note also that this law does not protect or restrict aggregate and nonidentifiable statistical or data analysis and conclusions developed by the researchers that would not disclose information about any identifiable individuals or establishments Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook, Generally Accepted Principals and Practices for Securing Information Technology Systems, and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHRQ grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making research materials, data bases, results, and algorithms available for verification or replication by other researchers, and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings through the media and other appropriate channels in coordination with AHRQ’s Office of Health Care Information but relies on grantees to publish research results in peer- reviewed journals and to market grant-supported products. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ’s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO’s website http://www.access.gpo.gov/nara/cfr/index.html). INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHRQ that women and members of minority groups be included in all AHRQ- supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994, and updated August 2, 2000. A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these guidelines. Investigators may obtain copies from the above sources or from the AHRQ contractor, listed under INQUIRIES, or from the NIH Guide Website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html. AHRQ encourages investigators to consider including children in study populations, as appropriate. AHRQ program staff may also provide additional information concerning these policies (see INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by April 20, 2001, that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA to which the application may respond. Although a letter of intent is not required, is not binding, and does not enter into consideration of any subsequent application, the information allows AHRQ staff to estimate the potential review workload and avoid conflict of interest in the review. AHRQ will not provide responses to letters of intent. The Letter of Intent is to be sent to: Kelly Morgan Program Analyst Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Boulevard, Suite 201 Rockville, MD 20852 Telephone (301) 594-1782 FAX: (301) 594-3721 E-mail Address: kmorgan@ahrq.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. The PHS 398 type size requirements (p. 6) will be enforced rigorously, and non-compliant applications returned. In part, the PHS 398 states that the application must be clear, readily legible, and conform to all of the following requirements: 1) the height of the letters must not be smaller than 10 point, 2) type density must be no more than 15 characters per inch (cpi), and 3) no more than six lines of type must be within a vertical inch. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. AHRQ is not using the Modular Grant Application and Award process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award process, and prepare applications according to instructions provided in form PHS 398 (rev. 4/98). Under a new policy that took effect February 1, 2001, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application. The AHRQ Revised Policy for IRB of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html) All investigators proposing research involving human subjects should read this revised policy. In order to expedite the funding of approved applications, AHRQ requires that all applications submitted in response to this RFA have IRB approval prior to application submission. Applications kits are available at most institutional offices of sponsored research. They may be downloaded from http://grants.nih.gov/grants/funding/phs398/phs398.html. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: grantsInfo@nih.gov. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must also be typed on line 2 of the face page and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in .pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled Advance Copy must also be sent to: Kelly Morgan Program Analyst Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Boulevard, Suite 201 Rockville, MD 20852 Telephone (301) 594-1782 FAX: (301) 594-3721 E-mail Address: kmorgan@ahrq.gov Applications must be received by May 21, 2001. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of-mailing is not later than 1 week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. In carrying out its stewardship of human resource related programs, the AHRQ, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications or the impact from Agency-sponsored research. Technical Assistance Workshop AHRQ plans to convene a technical assistance workshop to assist potential applicants. This workshop will give background information and respond to questions about the preparation of an application in response to this RFA. The workshop will be held on April 16, 2001 from 9 to 11 a.m., at AHRQ’s conference center room C - 4th floor, located at 6010 East Jefferson Street, Rockville, MD. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. The workshop will be open to any individual or organization intending to apply. Attendees are encouraged to submit questions prior to the session. A synthesis of pertinent questions and answers discussed at the prospective applicants" meeting will be available from the AHRQ Publications Clearinghouse, listed under "Inquiries," and on the agency"s web page. (http://www.ahrq.gov) For further information on the workshop, contact Kelly Morgan at the address listed above. Application Preparation (for Using HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with the Health Care Financing Administration (HCFA), AHRQ will use this information to develop an estimate of the cost of borrowing the data. This estimate will be included in the estimated AHRQ cost of funding the grant and may affect the fundability of the application. To avoid double counting, applicants should not include the cost of the data in the budget. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with standards set out in OMB Circular A-130, Appendix IIIBSecurity of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. See the Data Privacy section for details on these requirements as well as references to Circular A-130 and its implementation guides from the National Institute of Standards and Technology. In developing research plans, applicants should allow time for refining, approving, and processing their data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their provider require the approval of the HCFA Administrator and may require meeting(s) with HCFA staff. HCFA data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding HCFA data should be directed to the AHRQ program official listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by AHRQ. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria The goals of AHRQ-supported research are to enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The reviewers will be asked to discuss the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are the proposed data sources appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative, challenge existing paradigms or develop new methodologies or technologies? 4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the project (or work plan) well organized? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 6. Policy Relevance. Will the project provide Federal, State, and clinical policymakers, and others participating in the formulation of such policy, with the evidence-based information they need to improve aspects of health care quality, such as patient safety? Does the application provide a sound plan for achieving this purpose? 7. Responsiveness to the RFA. Does the application respond closely to the challenges and requirements identified in this RFA? Does the proposed study target the priorities outlined in this RFA? The initial review group will also examine the following: dissemination activities, the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Special Review Criteria In addition to the general review criteria above, the following special review criteria will also be applied: 1. The extent to which the study results will be applicable and generalizable to situations beyond that of the study and contribute to the reduction or elimination of medical errors or improvement in other aspects of quality of care. Projects can be conducted in any setting of care (inpatient, long term, ambulatory, home, and pre-hospital) and with all types of direct care providers (physicians, nurses, pharmacists, therapists, aides and medical residents and others). The Agency is particularly interested in projects that are generalizable to other settings and types of providers. 2. The extent to which the application will test interventions or assess working conditions that may be of particular importance in determining the quality of care received by populations that may be especially at risk. This would include attention to AHRQ’s priority populations. 3. The extent to which the analytic approach draws on the proven innovations and experience of other industries (e.g., aviation, manufacturing) that have made improvements in working conditions that have improved the quality of their product or service. 4. The extent to which the proposed study team reflects the multi-disciplinary approach required to address quality improvement, including patient safety, issues. 5. The evidence of institutional commitment from both the research center(s) and the delivery system(s) to the conduct of the project and interest in utilizing the results of the project to improve the working conditions and the quality of care delivered within its own facility(ies). Evidence of institutional commitment includes, but is not limited to, a commitment to provide past, current, and/or future financial support for planning and research activities, to allow key personnel to devote time to the research project, and to facilitate communication between the various research entities. In particular, applications will be assessed based on their capacity to address the questions of interest to all levels in an organization, including the managers who must decide to implement a change and the personnel who must adapt to the change. 6. The extent to which the study will be able to measure and document changes in the quality of patient care, such as improvement in patient safety, as a result of the intervention proposed. 7. The extent to which the researchers propose to provide useful information to others outside the research project who will be able to encourage adoption of changes in working conditions that will positively affect patient care quality. This includes the ability of the researcher to address issues of concern to policy makers, accrediting bodies, purchasers, patients and patient advocacy groups. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed project as determined by peer review, 2) availability of funds, 3) responsiveness to the goals and objectives of the RFA, 4) portfolio balance, including with respect to the foci of this RFA and AHRQ’s other patient safety projects, and 5) relevance to the formulation of public policy. Special preference will be accorded to applications from principal investigators who are not recent (within 2 years) or current AHRQ funded principal investigators of an AHRQ grant for research related to health care quality. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk that specifies on the label the format used (WP5.1 or WP6.0 is preferable). Applicants must also agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is active or has ended. INQUIRIES Copies of the RFA are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800-358-9295 TDD Service: 888-586-6340 The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Kelly Morgan Program Analyst Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Boulevard, Suite 201 Rockville, MD 20852 Telephone (301) 594-1782 FAX: (301) 594-3721 E-mail Address: kmorgan@ahrq.gov Direct inquiries regarding fiscal and eligibility matters to: Al Deal Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1843 FAX: (301) 594-3210 Email: adeal@ahrq.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 USC 299-299c-7, as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Baldwin PJ, Dodd M, Waite RW. Young doctors health--How do working conditions affect attitudes, health, and performance? Social Science Medicine. 1997,45:1,35-40. The President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry (Commission). Quality First: Better Health Care for All Americans. Final Report to the President. Washington. US Government Printing Office,1998,208. Daft RL. Organizational Theory and Design. St. Paul, MN: West Publishing Company. 1992. Denison DR. Corporate Culture and Organizational Effectiveness. New York: John Wiley & Sons. 1990. Deaconson TF., O Hair DP, Levy M, Lee MB, Schuenenman AL, Condon, RE. Sleep deprivation and resident performance. JAMA. 1988,260:12,1721-1727. Enhancing Patient Safety and Reducing Errors in Health Care--1998 Conference Proceedings from the Annenberg Center for Health Sciences (Annenberg Proceedings).Chicago: National Patient Safety Foundation.1999,297-305. Fitzpatrick JM, While AE, Roberts JD. Shift work and its impact upon nurse performance: current knowledge and research issues. J Adv Nurs . 1999,29(1):18-27. Graeber RC. Aircrew Fatigue and Circadian Rhythmicity. In Human Factors in Aviation. eds. Wiener EL, Nagel DC. San Diego: Academic Press. 1988,6:157- 185. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human, Building a Safer Health System. Washington, D.C.: National Academy Press. 1999. Kovner C, Gergen P. Nurse staffing levels and adverse events following surgery in US hospitals. J Nurs Scholarsh. 1999,30:4,315-321. Leatt P, Baker GR, Halverson PK, Aird C. Downsizing, reengineering, and restructuring: long- term implications for health care organizations. Frontier of Health Services Management. 1997,13(4):3-37. Leatt P, Shortell SM, Kimberly JR. Organization design. Health Care Manag. eds. Shortell SM, Kaluzny AD. Delmar, NY: Thomson Learning. 2000,274-306. Luciano L. A Government Health System Leads the Way. In Reducing Medical Errors and Improving Patient Safety: Success Stories from the Front Lines of Medicine. ed. Findlay S. Washington, DC: The National Coalition on Health Care, and Boston, MA: Institute for Healthcare Improvement. 2000,9-11. Paul C. Back from the brink: Making Chemotherapy Safer. In Reducing Medical Errors and Improving Patient Safety: Success Stories from the Front Lines of Medicine. ed. Findlay S. Washington, DC: The National Coalition on Health Care, and Boston, MA: Institute for Healthcare Improvement. 2000,4-8. Quality Interagency Task Force (QuIC). A Report to the President: Doing What Counts for Patient Safety--Federal Actions to Reduce Medical Errors and Their Impact. February 2000. (http://www.quic.gov/report/) Richardson GS, Wyatt JK, Sullivan JP, Orav EJ, et al. Objective assessment of sleep and alertness in medical house staff and the impact of protected time in sleep. Sleep. 1996,19:9:718- 726. Robins N. The Girl Who Died Twice. New York: Dell Publishing,1995,257. Sexton JB, Thomas EJ, Helmreich R. Error, stress, and teamwork in medicine and aviation: Cross Sectional Surveys. Brit Med J. 2000,320:745-749. Shortell SM, Zimmerman JE, Rousseau DM, et al. The performance of intensive care units: does good management make a difference? Med Care. 1994,32(5):508-25. Shortell SM, Jones RH, Rademaker AW, et al. Assessing the impact of total quality management and organizational culture on multiple outcomes of care for coronary artery bypass graft surgery patients. Med Care. 2000,38(2):207- 17. Smith-Coggins R, Rosekind MR, Buccino KR, Dinges DF, Moser RP. Rotating shiftwork schedules: can we enhance physician adaptation to night shifts?. Acad Emerg Med. 1997, 4:951- 961. Ulrich R. The healing environment: how design impacts wellness. Healthcare Forum J.1992, September/October:20-25.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.