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 301-710-0267,
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)
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
|
|
|
Department of Health and Human Services (HHS)
|
|
|
|
NIH... Turning Discovery Into Health®
|