CHANGING PRACTICES, CHANGING LIVES: ASSESSING THE IMPACTS OF THE HRSA HEALTH DISPARITIES COLLABORATIVES RELEASE DATE: April 3, 2002 RFA: HS-02-005 Agency for Healthcare Research and Quality, AHRQ (http://www.ahrq.gov) Health Resources and Services Administration, HRSA (http://www.hrsa.gov) LETTER OF INTENT RECEIPT DATE: May 15, 2002 APPLICATION RECEIPT DATE: June 12, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Agency for Healthcare Research and Quality (AHRQ), in partnership with the Bureau of Primary Health Care (BPHC) of the Health Resources and Services Administration (HRSA), invites applications for cooperative agreement research projects that will assess the HRSA-sponsored Health Disparities Collaboratives (HDCs). These collaboratives, initiated in 1998, represent a major, sustained effort on the part of the BPHC to enhance the quality of care provided through its health centers and ultimately improve the outcomes of underserved people. The HDCs have focused on diabetes, asthma, depression and cardiac disease and sought to narrow the gap between what is known and what is practiced. Participating health centers work together with support from regional and national infrastructure through sharing of knowledge and ideas to learn and apply methodologies for organizational change with the objective of implementing a sustainable and generalizable chronic disease management model. This Request For Applications (RFA) represents AHRQ"s and BPHC"s continuing interest in efforts to translate research evidence into practice and to eliminate racial and ethnic disparities in health and health care. As is well recognized, the quality of care must be improved throughout our health care system, particularly for those who are most vulnerable. While existing studies have identified opportunities for improvement and some of the etiologies for substandard care, questions remain as to how quality can be improved across the diversity of environments in which care is provided. Also, few of the quality improvement efforts that have been initiated have been objectively studied to define their impacts and how they can be improved. Under this RFA, one or more projects will be funded to assess the HDCs effects on the processes and outcomes of care provided at the health centers as well as on the centers themselves. While data suggest that the HDCs have been successful at improving quality and patient outcomes, efforts are needed to study the effects more systematically and to understand the collaboratives" indirect effects, the business outcomes and how the collaboratives have affected the efficiency of care. Also, evidence is needed about their impacts on the commitment of senior leadership to quality improvement efforts, and the development of infrastructure and partnerships between public and private organizations to support clinical excellence. Investigators will have access to data including a core set of quality indicators collected by the BPHC and individual health centers. It is expected that investigators will also need to collect additional quantitative and qualitative data at the health center level. Ultimately, it is hoped that the assessments can provide a basis for making the collaboratives more effective as they continue and are applied to new areas including cancer, preventive services and diabetes prevention, thus reducing health disparities for patients with chronic conditions cared for in the health centers and informing quality improvement efforts more broadly. RESEARCH OBJECTIVES Background As is widely recognized, the gap between what is known to be effective and what is practiced is wide despite concerted efforts to improve the quality of care. For example, amongst Medicare patients with diabetes, only 71% had a Hemoglobin A1c test annually and 69% had an eye examination at least every two years (Jencks, 2000). 61% of children, ages 5-9, and 59% of children, ages 10-17, are prescribed appropriate medications for asthma. Less than half of patients hospitalized for mental illness receive follow up care within a week of discharge and 71% are seen within 30 days of discharge despite evidence that follow up is an important aspect of management(National Committee for Quality Assurance, 2001). The American health care system has also been plagued by the existence of marked racial and ethnic disparities in health and health care. Hispanics and Native Americans have higher rates of death than whites up to age 45 and African Americans have higher death rates than whites up to age 65 (Sorlie, 1995). Hispanics and African Americans undergo lower extremity amputation, a marker of inferior care for diabetes, at higher rates than whites (Collins, 2002). African Americans were 36% less likely than whites to receive inhaled corticosteroids for asthma (Krishnan, 2001). A recent Institute of Medicine report suggests that these weaknesses result from the design of our health care system and that in order to improve the health care quality, systems must be reengineered (Institute of Medicine, 2001). Against this background, HRSA has developed a number of strategies aimed at eliminating racial and ethnic health disparities. One such effort is the Health Disparities Collaboratives (HDCs), initiated by the BPHC in 1998. The Bureau is responsible for funding programs in primary and preventive care for underserved, uninsured and underinsured Americans. These include 12 million people, of which 7 million are minorities. Care is provided by health centers that include Community, Migrant, Homeless, School-based and Public Housing health centers as well as Integrated Service Delivery Networks (ISDNs). Under this effort to improve the quality of care and reduce disparities, health centers and networks were invited to participate in the HDCs--programs that take approximately one year in which participants learn from experts and from one another. Also as part of this effort, BPHC funded one Primary Care Association/Clinical Network team in each of five regional clusters to participate in the HDCs and, worked in collaboration with its grantees, the Institute for Healthcare Improvement and the Centers for Disease Control and Prevention (CDC) to develop infrastructure to support the HDCs. The programs, which have been focused on diabetes, cardiovascular disease, asthma or depression, are based on a learning and improvement model adapted from the Institute for Healthcare Improvement"s Breakthrough Series and a chronic care model developed by the MacColl Institute for Healthcare Innovation with support from the Robert Wood Johnson Foundation"s Improving Chronic Illness Care Initiative (Improving Chronic Illness Care, 2002). Under the learning and improvement model, each center identifies a team of three to five individuals. The team is typically composed of a leader who has the authority to instigate change as well as to allocate time and resources to achieve the team"s aims, a technical expert who knows the subject and existing processes of care, and someone to manage day-to-day improvement and data collection efforts. During Phase I, the team participates in three learning sessions and a final congress with teams from other centers and expert advisors. Ideas and results are shared amongst the teams. Between each learning session is an action period, during which each center develops, implements and evaluates its change ideas, using the Plan- Do-Study-Act strategy. As the team identifies strategies to improve the quality of care for one condition, it also works on ways to apply the strategies to other clinical areas or sites. After the summative congress, the team enters Phase II, a period during which the team"s organization focuses on sustaining achievements made during Phase I and spreading the models throughout the organization and to other health conditions. The chronic care model is population-based, it relies on knowing which patients have a certain condition, ensuring that patients receive evidence- based care for their condition and empowering patients to participate in their own care. Successful implementation of the model is dependent on six inter-related elements. One is patient self-management, whereby patients learn about their disease and how to prevent problems. Patients set goals for themselves and the clinical team supports them in attaining these goals. The second element is decision support such as evidence-based practice guidelines and protocols that are provided to clinicians so that they can apply the most current knowledge to help their patients. The third component is clinical information systems. Health centers create a registry that is used by the care team to guide treatment, anticipate problems and track progress for the entire population with the chronic condition. Fourth, the delivery system must be designed to support improved chronic care. Visits are planned in advance, based on patient"s needs and self-management goals. Group visits allow patients to see their clinicians and meet with others with similar health problems. Organization of care is a critical element. Health centers, including their leaders and clinical champions, commit to improving clinical outcomes and making organizational goals for chronic illness part of their business strategy. Last, health centers form partnerships with state programs, local agencies, schools, faith based organizations, business and social groups (Health Disparities Collaboratives, 2002). Involvement of the individual centers is supported by infrastructure at the State, regional and national levels. This includes federal partnerships with CDC, the Substance Abuse and Mental Health Services Administration, the National Cancer Institute and the Environmental Protection Agency. Examples of state partnerships include those with diabetes control programs. Local partnerships include those with neighborhood and faith-based organizations. Each cluster, with between eight and thirteen States, is led by a state Primary Care Association that provides oversight, management, training, networking and technical assistance to Collaborative participants. National level involvement entails overall leadership for the effort as well as support for Collaborative operations, management and evaluation. Software and technical support are available through the Primary Care Associations and the BPHC. This RFA builds on AHRQ"s interests in translating research into practice and improving the health of vulnerable populations. A series of relevant RFAs and Program Announcements (PAs) have been published during the last few years: the Translating Research Into Practice (TRIP) RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-003.html), published January 8, 1999, the Assessment of Quality Improvement Strategies in Health Care RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-002.html), published January 22, 1999, the Systems-Related Best Practices to Improve Patient Safety RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-00- 007.html), published December 16, 1999, and the Translating Research into Practice II RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-00- 008.html), published December 16, 1999, Translating Research into Practice- Joint Program Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-02-066.html), published February 19, 2002, and the Understanding and Eliminating Minority Health Disparities RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-00-003.html), published October 20, 1999. Potential Data Sources The collection of data by individual participating sites is highly variable in terms of the method of collection and depth, however, there are some elements that have been required for participation in the HDCs including standardized reporting templates of core measures. During Phase I of the collaboratives, participating sites develop registries that are used to track and care for individual patients and enable health centers to monitor the population of patients with a particular condition. The registries are queried monthly and these data, along with self-assessments and narrative descriptions of collaborative activities, are sent to Cluster Directors. Cluster Directors aggregate health center data and prepare a summarized monthly report of the participating centers" activities. At the end of each month, this quarterly report as well as data at the health center level is aggregated nationally and summary graphs are created. During Phase I, compliance with this reporting protocol is high (>90%). During Phase II of the collaboratives, health centers are asked to continue with the same reporting protocol on a quarterly basis. Data collection related to continued activities as well as efforts to spread strategies to other providers or conditions is less complete, however. For each collaborative, there are a number of required core measures as well as a menu of additional measures from which centers are required to select. For example, for the Cardiovascular Disease Collaboratives, each health center is required to report on the percentage of patients with blood pressure <140/90, the percentage of patients who have set a self-management goal, the percentage of patients for whom a blood pressure has been documented at least two times during the last year and the size of the registry. Centers are required to report at least one additional measure from a more comprehensive menu. These include the percentage of patients that are screened for hyperlipidemia, the percentage of patients who have a creatinine during the previous year, the percentage of post-myocardial infarction patients for whom aspirin is prescribed and the percentage of patients that are screened for depression. Teams are also required to assess their level of activity on a scale ranging from 1.0 (forming the team) to 5.0 (outstanding, sustainable results) and report on the development of partnerships such as with community organizations. Patient level data are not reported to the cluster or to BPHC. At least half of participating health centers use software provided by BPHC to collect registry data. The Diabetes Electronic Management System (DEMS) is an example of one such software package. In order to gain access to data at the level of the individual health centers or clusters, investigators will need to form a relationship with the appropriate leadership of the centers or Primary Care Association. A signed data use agreement indicating the availability of the data to the investigator is necessary. In order to obtain data from BPHC, applicants must sign a data use agreement with the Office of Data Evaluation Analysis and Research (contact Charles Daly: cdaly2@hrsa.gov). Prospective data collection may be needed to address certain questions under this RFA. Because the HDCs will continue to be offered during the years of this solicitation, it may be possible to collect data from patients, providers, sites, centers, clusters or the national office during Phases I and II of the collaboratives. In the coming year, new collaboratives will be developed in cancer, preventive services and diabetes prevention. Of note, however, the Paperwork Reduction Act indicates that grantees under a cooperative agreement may need approval from the Office of Management and Budget (OMB) to collect certain data such as surveys from more than nine respondents. Applicants who are interested in collecting data that will require OMB approval should allow for the time necessary to gain approval as they develop their timelines and make contingency plans should the request be disallowed. Details of the Act and procedures to gain approval are available at: http://www.hhs.gov/oirm/infocollect/ Objectives and Methods The focus of this RFA is to understand the impacts of the HDCs such that their effectiveness and efficiency can be enhanced and that efforts to translate research evidence into practice, in general, can be strengthened. While data from the HDCs suggest that most sites involved in the collaboratives experience improvements in their care processes, such data are limited and have not been analyzed with respect to uninvolved sites to determine whether change is attributable predominately to the collaboratives. More broadly, while the knowledge base regarding implementation and quality improvement is growing, there is still considerable uncertainty about the most effective mechanisms for improving quality and how interventions can be matched with particular situations. In developing their study methods, applicants should consider the types of research findings that potential users of this research require in order to decide whether or how to apply the HDC methodology or individual interventions. For example, sufficient information is needed about the context of an intervention to suggest whether findings may be generalizable. Dimensions that may be of interest include patient demographics, health center/site structure, staffing, organization, management, leadership and culture, external partnerships at the local, State and national level, financial influences on patients and providers and non-financial influences on patients and providers. Such evidence may be derived from in depth analysis of existing data as well as prospective collection of data. Data may be quantitative or qualitative, including case studies, interviews, surveys and focus groups. It is expected that some questions will be best addressed using data on structure, whereas others may be best addressed using information on processes including those of the organization, the providers and patients, or outcomes including functional and clinical measures, satisfaction and costs to the patient and system. Sample Study Questions Effectiveness of Interventions Which interventions or combinations of interventions initiated during the improvement cycles had the greatest impact on practice? What are characteristics of effective interventions for low literacy and limited English proficiency patients? What are the effects of intra- and inter-site collaboration? How can positive collaborations be encouraged? Additional Impacts What are indirect effects of participation in the HDCs for the clinics, including impacts on patient and provider retention, impacts on patient and provider satisfaction, and impacts from partnerships such as those with community-based organizations and human service providers? Factors Influencing Effectiveness Which factors enable successful initiation, implementation and sustainment of interventions? What barriers limit the impact of interventions? How does patient race/ethnicity, language or socioeconomic position, including educational attainment and literacy impact effectiveness? What are the roles of leadership in implementing the HDC? What strategies can be used to foster leadership for quality improvement activities? What are the roles and effects of cluster, State and national support such as that coming from diabetes control programs? What are the effects of different types of information technology? What are the effects of the partnerships on the effectiveness of the collaboratives? What are the effects of data quality at the health center level? In what ways are data collected, analyzed and utilized? What factors, including clinical, organizational, structural and interpersonal, predict whether a clinic will experience greater levels of improvement under the HDCs? Economic considerations What are the direct and indirect costs of involvement in the HDCs for the clinics, including the number of hours required for staff involvement (both in general and with respect to reporting measures), hours and resources required for partnerships with local and national organizations, efficiency of clinic operations and utilization of clinic resources (both in general and with respect to other areas of clinical practice that are not directly subject to the quality indicators)? What is the business case for participation in an HDC? How do the collaboratives affect State Medicaid expenditures? What metrics should be considered in establishing a business case for participation? Sustaining and Disseminating Positive Change What factors influence the sustainability of improvements and the spread of improvement methods to sites, clinicians and conditions beyond those involved in the original HDC? How do ISDNs affect the impact, sustainment and spread of the collaboratives? MECHANISM OF SUPPORT This RFA will use the cooperative agreement (U01) award mechanism under which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." BPHC staff, together with AHRQ staff, will assist the grantee with HDC, health center and primary care association coordination, as needed. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is 9/30/2002. FUNDS AVAILABLE AHRQ and HRSA intend to commit approximately $800,000 in FY 2002 to fund one to three new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for total costs of up to $800,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Funding beyond the first year is contingent on availability of funds and satisfactory progress. ELIGIBLE INSTITUTIONS The Institute for Healthcare Improvement and the MacColl Institute for Healthcare Innovation are not eligible to apply for funding under this solicitation. Otherwise, you may submit (an) application (s) if your institution has any of the following characteristics: o For-profit or Non-profit organizations o Domestic and foreign o Public and private non-profit institutions, such as universities, clinics, colleges, and hospitals o Units of State and local governments o Faith-based organizations Important Note: Under recently enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for-profit organizations as well as with public and not-for-profit entities. Thus, for-profit organizations are invited to respond to this notice with research applications for cooperative agreements. Such applications will be administered in accordance with Subpart E of 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter regulation has not yet been amended to reflect these changes in Agency name and authority. (See December 6, 1999, AHRQ reauthorization at http://www.ahrq.gov/hrqa99a.htm). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS Terms and Conditions These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policie statements. Applicants should be familiar with the Agency""s grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. Awardee Rights and Responsibilities The awardee will conduct research in accordance with the terms and conditions of the Notice of Grant Award, and cooperate with other key parties, including the Project Officer, the advisory committee (see below) and other grantees. In working with the advisory committee, PIs will actively participate in the formulation of plans to promote generalizability across projects. Applicants should include information in their application demonstrating their ability to work collaboratively. The progress of work will be reviewed at least annually. Based on periodic review of grantee progress, awards may be terminated in cases of documented under-performance, lack of participation in collaborative activities or human subject ethical issues where the awardee has been given adequate notification about performance and failed to take corrective actions. Semiannual progress reports will be required to be submitted to the Project Officer and advisory committee during the sixth and twelfth month of each year of funding. AHRQ Staff Responsibilities The cooperative agreement (U01) is an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the AHRQ purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative activities are intended to strengthen individual studies and at the same time, generate generalizable results across projects, locations, populations and conditions. AHRQ involvement will include an advisory role in prioritization of research questions and choice of research methods. Because of the likelihood that investigators will use some existing data, investigators will be required to work with AHRQ, with input from BPHC staff, to determine the availability and appropriateness of data and the Agency will facilitate acquisition of such data. AHRQ will also be involved through its participation in the Advisory Committee. Advisory Committee In order to promote collaboration and synergy across projects, investigators will be required to work with an advisory committee that will be composed of three AHRQ representatives, a HRSA representative and an independent consultant. This work will include discussions and other efforts to coordinate and promote synergy across the projects. Most interactions will be via telephone conference and occur approximately quarterly. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the individual awardee, a second member selected by AHRQ, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. Publication Transmittal: General AHRQ Requirements In keeping with the Agency"s efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the AHRQ Office of Health Care Information (OHCI) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OHCI staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OHCI and the press offices of the grantee"s or contractor"s institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OHCI a brief plan describing how the product will be publicized. An OHCI staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into four areas: scientific/research, peer review, data availability, and financial or grants management issues: o Direct your questions regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Daniel Stryer, M.D. Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Telephone: (301) 594-4038 FAX: (301) 594-3211 Email: dstryer@AHRQ.gov o Direct your questions about peer review issues to: Harvey Schwartz, Ph.D. Office of Research Review, Education and Policy Agency for Healthcare Research and Quality 2101 E. Jefferson Ave., Suite 401 Rockville, MD 20852 Telephone: (301) 594-7222 FAX: (301) 594-0154 Email: hschwart@ahrq.gov Direct your questions about HRSA data sources to: Tricia L. Trinite, NP, MSPH Director, Health Disparities Collaboratives Bureau of Primary Health Care 1961 Stout St., Rm. 360 Denver, CO 80294 Telephone: (303)844-7890 FAX: (303)844-2019 Email: ttrinite@hrsa.gov Direct your questions about financial or grant management matters to: Michelle Burr Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1840 FAX: (301) 594-3210 Email: mburr@AHRQ.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Daniel Stryer, MD Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Telephone: (301) 594-4038 FAX: (301) 594-3211 Email: dstryer@AHRQ.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov. 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. Applications submitted in the Modular format will be returned without review. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 be typed on line 2 of the face page fo the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO NIH & AHRQ: 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 "Advanced Copy (s)" must also be sent to: Daniel Stryer, MD Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Telephone: (301) 594-4038 FAX: (301) 594-3211 Email: dstryer@AHRQ.gov APPLICATION PROCESSING: Applications must be received by the receipt dates listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The CSR and AHRQ will not accept any application in response to this RFA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR and AHRQ will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Beginning with applications for AHRQ submitted for the February 1, 2001 receipt date, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application unless otherwise indicated by the Agency (http://grants.nih.gov/grants/guide/notice-files/NOT- HS-00-003.html.) However, given the nature of this project and the speed with which successful applicants will need to begin work, the Agency has determined that IRB approval is required prior to peer review of all applications submitted in response to this RFA. All investigators/applicants proposing research involving human subjects should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. The RFA is also available on AHRQ"s Web site, http://www.AHRQ.gov, (under Funding Opportunities) 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. In carrying out its stewardship of research 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 AHRQ-sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored research. Applicants are to 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 still active. 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 which specifies on the label the format used (WP5.1 or WP6.0 is preferable). Application Preparation (for Using CMS 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 398) the specific files, time periods, and cohorts proposed for the research. In consultation with Center for Medicare and Medicaid Services (CMS), previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. 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 CMS to protect the confidentiality of data in accordance with AHRQ"s confidentiality statue, 42 USC 299c3(c), the Privacy rules at 45 CFR Part 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed. Unless AHRQ is able to negotiate exceptional arrangements, for the sole purpose of assuring that data confidentiality is maintained, included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS"s approval to do so. In developing research plans, applicants should allow time for refining, approving, and processing any CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff. CMS 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 CMS data should be directed to the AHRQ program official listed under INQUIRIES. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA 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 by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA The goals of this AHRQ-supported research are to understand the impact of the HDCs and ways in which they can be made more effective, and, more generally, to improve efforts to translate research evidence into practice and improve the health of vulnerable populations. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important aspect of the collaboratives, racial/ethnic health disparities and implementation? If the aims of your application are achieved, how do they advance potential research users" decision-making regarding whether and how to apply the HDC methodology or individual interventions to improve practice? What will be the effect of this work on care for vulnerable populations, other aspects of quality improvement strategies or other diseases, conditions, settings, or populations? Do the study questions contribute to strengthening senior leadership, infrastructure or local, state and national partnerships? Will findings contribute to an understanding of the care, improvement or collaborative learning models? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Are targeted conditions/populations well-defined and selected? Have all aspects of data collection and management for the project been considered, with appropriate attention to the quality and timeliness of data collection? Will data management and analysis ensure that conclusions are valid? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? Will the approaches advance the development of quality improvement interventions in the context of primary and preventive care for underserved populations? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? Are the numbers and roles of staff for the study defined and justified? Do the investigators have experience with identifying and applying appropriate evaluation methodologies and research designs in health care quality improvement? Does the team have experience in studying underserved populations and community-based primary care? Does the team have experience working with communities in participatory models of research? Do the investigators have experience working with organizations at multiple levels including Federal, State and local-level health care organizations as well as community-based organizations? Do the investigators have experience working with governmental agencies in the performance of research studies? For applicants interested in developing surveys, do the investigators have experience with survey design? (5) ENVIRONMENT: Does the study environment in which your work will be done contribute to the probability of success? Do the proposed analyses take advantage of unique features of the environment or employ useful collaborative arrangements? Is there evidence of institutional support? Are stakeholders at all levels, including the community, adequately involved? (6) BUDGET: the reasonableness of the proposed project budget and the requested period of support in relation to the proposed research ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. Data Privacy 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 explicit or implicit promises made regarding the possible uses and disclosures of such data. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. 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. Identifiable patient health information collected by grantees under this RFA will also be done in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are scheduled to be effective and enforceable in April 2003. They serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, health care plans and providers will require either patient authorization of disclosures to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the researchers. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp/ The awardee 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/. The application of these confidentiality and security standards to subcontractors and vendors, if any, should be addressed. 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 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). o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 15, 2002 Application Receipt Date: June 12, 2002 Peer Review Date: July/August 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS 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 UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00- 048.html). 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 NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Should applicants wish to place data collected under this RFA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under 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 or 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 Collins TC, Johnson M, Henderson W, Khuri SF, Daley J. Lower extremity nontraumatic amputation among veterans with peripheral arterial disease: Is race an independent factor? Med Care 2002 Jan,40(1 Suppl):106-116. Institute of Medicine. Crossing the quality chasm. A new health system for the 21st century. National Academy Press, Washington, DC, 2001. Jencks SF, Cuerdon T, Burwen DR, Fleming B, et al. Quality of medical care delivered to Medicare beneficiaries. A profile at State and national levels. JAMA 2000,284:1670-1676. Krishnan JA, Diette GB, Skinner EA, Clark BD, et al. Race and sex differences in consistency of care with national asthma guidelines in managed care organizations. Arch Intern Med 2001,161(13):1660-8. Sorlie PD, Backlund E, Keller JB. US mortality by economic, demographic, and social characteristics: the National Longitudinal Mortality Study. Am J Public Health 1995,85(7):949-56. Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Mil Quarterly 1996:74(4):511-544. Internet-based References: Health Disparities Collaboratives. http://www.healthdisparities.net/index.html. Improving Chronic Illness Care. http://www.improvingchroniccare.org/index.html. Institute for Healthcare Improvement. http://www.ihi.org/. National Committee for Quality Assurance. The state of managed care quality, 2001. http://www.ncqa.org/somc2001/SOMC_2001_TOC.html. Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Effective Clinical Practice 1998,1(1):2-4. (http://www.acponline.org/journals/ecp/augsep98/cdm.htm)


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