TRANSLATING RESEARCH INTO PRACTICE - JOINT PROGRAM ANNOUNCEMENT

RELEASE DATE:  February 19, 2002

PA NUMBER:  PA-02-066 (This PA has been deactivated, see NOT-HS-05-009)

EXPIRATION DATE:  July 24, 2004 (for R01s), unless reissued.

PARTICIPATING INSTITUTES AND CENTERS (ICs):
 
Agency for Healthcare Research and Quality, AHRQ
 (http://www.ahrq.gov)
Department of Veterans Affairs, Health Services Research and 
 Development Service

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THE PA

This Translating Research into Practice (TRIP) Program Announcement (PA) is a 
collaborative effort between the Agency for Healthcare Research and Quality 
(AHRQ) and the Health Services Research and Development Service (HSR&D) within 
the Department of Veterans Affairs (VA). Applicants are invited to conduct 
innovative and rigorous research and evaluation projects related to the 
translation of research findings into measurable improvements in quality, 
patient safety, health care outcomes and cost, use, and access.  An explicit 
focus on testing effective strategies for translating research into practice 
has been a priority for the PA sponsors for the past several years.  While 
there are promising initiatives and projects in progress, this PA underscores 
the need for research that can bridge the chasm between promising prototypes 
(e.g., approaches for treating a specific disease in a particular setting or 
work system changes that improve quality or efficiency in a particular 
setting) and generalizable knowledge that can be used in multiple settings and 
lead to systematic improvement on a large scale.  For the purpose of this PA, 
research findings may be translated into evidence-based clinical or 
organizational, structural, and system interventions that then can be assessed 
for their ability to measure change in or improve access to health care, 
patient safety, the quality and/or cost-effectiveness of health care delivery, 
and health care outcomes.  

This PA represents AHRQ"s, and VA"s continued interest in translating research 
evidence into practice and their desire to build on existing research in this 
field.  This collaborative effort will provide an opportunity to compare and 
contrast the challenges of making use of research findings at the public 
policy level, within and across different systems of care, and contribute to 
the goal of identifying effective and efficient interventions that have the 
potential to be used to improve clinical practice, enhance patient safety, and 
sustain practitioner behavior change across populations, multiple health 
conditions, and health care systems.

Two specific priorities under this PA are to: 1) compare the use of 
interventions to translate research into practice across different health care 
systems (e.g., comparison of translation in a VA facility and in a non-VA 
facility using the same design, methods, measures and patient population) and 
2) measure the impact of translation activities (including the testing of 
interventions that foster measurable and sustainable quality and patient 
safety improvement or consistent quality and patient safety at a lower cost).

The inclusion of a VA site is not a requirement of the PA.  If a VA setting is 
included, the PA does provide the opportunity for investigators to focus on 
common translation problems within public and private-sector health care 
delivery organizations/systems and the VA health care system.  The 
investigator must meet the eligibility requirements of VA to be eligible for 
VA funding of the VA site (see VA HSR&D Eligibility Requirements). 

Projects that focus on identified disparities in health status, health care 
quality, and access experienced by certain groups, notably racial and ethnic 
minorities as well as those with low-income, are encouraged.  The PA sponsors 
also encourage projects that focus on women, and the elderly, individuals with 
special healthcare needs, including persons with disabilities, and those who 
need chronic care and end of life health care, and individuals living in 
inner-city, rural, and frontier areas.  AHRQ encourages investigators to 
consider inclusion of children in study populations, as appropriate.  The PA 
sponsors encourage innovative studies that have the potential for broad 
impact, involving multi-disciplinary and multi-facility patient-centered 
approaches, to the translation of evidence into practice.  The study of 
patients with specific conditions, particularly one or more chronic illnesses 
across their continuum of care, is also encouraged.

The National Institutes of Health: National Institute of Mental Health (NIMH), 
National Cancer Institute (NCI), and National Institute of Alcohol Abuse and 
Alcoholism (NIAAA) are interested in co-sponsorship of applications supported 
under this PA.  For inquiries see key staff listed under "WHERE TO SEND 
INQUIRIES."

RESEARCH OBJECTIVES
 
Background

This announcement is intended to solicit applications that jointly support 
AHRQ and VA HSR&D translation of research into practice activities and to 
contribute to the goals set forth in the recent IOM report, Crossing the 
Quality Chasm, March 2001.  AHRQ and VA have supported important work on 
translation of research findings into practice. Information describing 
currently funded AHRQ projects is available upon request from AHRQ. 
Information describing translation projects currently funded by VA, is 
available from VA. (see WHERE TO SEND INQUIRIES).

AHRQ has issued a series of RFAs that support research on the translation of 
research findings/implementation of research findings into sustainable 
improvements in clinical practice and patient outcomes: 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.  This PA extends AHRQ=s interest in these areas and builds 
on the type of research funded under these RFAs.

AHRQ program announcements and grants policy statements (listed above) are 
available through the AHRQ Web site http://www.AHRQ.gov (Funding 
Opportunities) and from the AHRQ Publications Clearinghouse (see Inquires).

The TRIP RFA funded research that generated new knowledge about approaches 
that are effective and cost-effective in promoting the use of research 
evidence in clinical settings and lead to improved health care practice and 
sustained practitioner behavior change.  The Assessment of Quality Improvement 
Strategies in Health Care RFA funded projects that are evaluating strategies 
in widespread use by organized quality improvement systems for improving 
health care quality.  The Systems-Related Best Practices to Improve Patient 
Safety RFA applications are testing the effectiveness of the transfer and 
application of best practices to improve patient safety through the reduction 
of preventable system-related medical errors.  The TRIP II RFA funded projects 
are evaluating strategies for translating research into practice through the 
development of partnerships between researchers and health care systems and 
organizations (e.g., purchaser groups, integrated health service delivery 
systems, academic health systems, managed care programs including HMOs, 
practice networks, and worksite clinics).  In addition to identifying 
effective and efficient strategies to implement research evidence to achieve 
measurable and sustainable improvements in health care, the goal of the TRIP 
II RFA was to develop and identify sustainable and replicable models and tools 
that could be used to translate evidence into practice. 

VA HSR&D is focusing major resources and commitment to improve the quality of 
health care and create innovations that are measurable, rapid, and 
sustainable.  Translation studies are funded by HSR&D via multiple mechanisms 
and cross a continuum from traditional health services research to rigorous 
evaluative quality improvement projects. HSR&D translation solicitations, 
including Service Directed Projects (SDP) and Investigator Initiated Research 
(IIR) solicitations designed to contribute to outcome and system-wide change, 
may be obtained from the following website:  
http://www.va.gov/hsrd.

VA=s Quality Enhancement Research Initiative (QUERI) identifies gaps in 
evidence and practice, compares ideal to existing practice, translates 
evidence into outcome and system improvements, measures the impact of 
improvements, and actively promotes the use of the best available evidence by 
providers, policymakers, managers, patients, and others.  With the inception 
of the QUERI in 1998, special emphasis has been placed on improvements in nine 
priority areas: congestive heart failure, ischemic heart disease, mental 
health, substance abuse, HIV/AIDS, stroke, diabetes, cancer, and spinal cord 
injury.  The Cancer QUERI is a collaborative effort between VA HSR&D and the 
National Cancer Institute.  Because QUERI and other VA HSR&D translation 
activities are comprehensive, data-driven, and outcomes based, performance 
measures and similar tools that promote linkages between research to practice 
are important.  Additional information about QUERI is available on VA web page 
at http://www.va.gov/hsrd/research/queri/overview.cfm and at 
http://www.turner-white.com/pdf/jcom_jan01_queri.pdf.

Objectives and Scope

The objective of this PA is to translate research evidence into practice and 
to inform decisionmaking at the clinical, organization/health care systems, 
and/or public policy levels, with an emphasis on the testing of effective and 
efficient interventions that have the potential to improve clinical practice, 
enhance patient safety, and sustain practitioner behavior change across 
multiple health conditions, populations, and health care systems.  Emphasis is 
placed on projects that introduce changes at the clinical, organization/health 
care systems, and/or public policy levels designed to facilitate rapid and 
widespread adoption of evidence in decisionmaking and/or implementation of 
evidence-based interventions into processes of care and then measure the 
impact of these efforts. 

A special focus of this research is to identify: 1) if an implementation 
strategy that is successful with one clinical condition or patient population 
is equally successful with another clinical condition or population, 
particularly for patients in vulnerable populations and priority populations 
such as children, women, and the elderly, individuals with special healthcare 
needs, including persons with disabilities, those who need chronic care and 
end of life health care, individuals living in inner-city, rural, and frontier 
areas, and/or with comorbid conditions, 2) how the contextual factors of a 
site or organization contribute to a successful or unsuccessful translation 
effort, 3) how generalizable the results of any successful intervention are to 
other health care settings and sites, populations and clinical conditions, 4) 
the characteristics of interventions with high potential for sustainable 
improvements, and what factors enhance the likelihood of rapid and broad 
adoption, 5) the cost-effective strategies designed to put research evidence 
into practice, and 6) how a cost-effectiveness framework can be incorporated 
into decision-making within health care systems and/or at the public 
policy level. 

Two categories of applications are eligible for consideration.   

1) Comparative Studies: Studies conducted concurrently in VA and other settings. 

For this category it is envisioned that a single study will include a 
component conducted in a VA setting and one or more components in a non-
VA/private sector setting. Such a project could be led by one investigator 
with VA eligibility or by a research team that includes a VA-eligible 
investigator to serve as PI for the VA component.  Studies in this category 
will consist of comparable methods, interventions, measures, and target 
populations.  These studies will compare the effect of system, process, and 
other organizational factors on the use of evidence-based quality improvement 
intervention(s) within the VA health care system, to their simultaneous use in 
non-VA settings.  If a Principal Investigator meets the eligibility criteria 
for both AHRQ and VA (see ELIGIBILITY REQUIREMENTS), then he/she may apply as 
a single PI for both VA site(s) and matched non-VA site(s).  Two Principal 
Investigators, one with AHRQ eligibility and one with VA eligibility, may also 
collaborate and apply with matched projects to be operated by each PI at 
his/her respective site.  Each proposal must have two corresponding research 
components: one VA and one private-sector/non-VA (matched according to study 
design, methods, target audiences, and output).  Approval will be needed from 
both VA and the private sector/non-VA Institutional Review Boards (IRB).

2) Translation Studies: Expanding the knowledge base for improvement. 
The second category of proposals includes the total range of translation 
studies called for in this PA.  These studies may be done in either VA or non-
VA settings.  These studies may include: 1) the development and testing of 
study design, methods, or instruments relevant to the translation of evidence-
based interventions into practice and the use of evidence to inform 
decisionmaking, and 2) the translation of existing evidence-based 
recommendations, tools, and/or strategies.  The results of these efforts will 
be evaluated to determine their impact on clinical care (outcomes, processes, 
and/or structural effects), patient safety, or the health care system as 
a whole.

PA sponsors are especially interested in recommendations, tools, and 
strategies that can be used to implement research findings across multiple 
levels of health care delivery and multiple types of health care-related 
systems.  The PA will support research that not only identifies and tests new 
methods for translating research into practice, but also expands the use of 
tested methods of translating evidence-based information across larger 
populations, different health care systems, or different clinical situations. 
 Applications funded under this PA will translate research findings into 
practice via the dissemination, implementation, and evaluation of evidence-
based recommendations, tools and strategies in diverse settings, populations, 
and payment systems.  Levels of health care delivery include hospitals, 
nursing homes, ambulatory clinics, and homes where health care is provided.  
Health care systems of interest to AHRQ include purchaser groups, integrated 
health service delivery systems, academic health systems, managed care 
programs including HMOs, practice networks, worksite clinics, and safety net 
systems, e.g., community clinics.  

PA sponsors are interested in interventions designed to improve clinical care, 
patient safety and clinical outcomes and strategies for sustaining 
improvements.  These interventions may be targeted at the patient level, the 
health care provider level, the health care organizational delivery level, or 
the health care policy level.  They may target specific types of health care 
providers or multiple disciplines.  Evidence-based recommendations, tools, 
and/or strategies may be implemented at the local, State, regional or national 
levels for non-VA studies and at the local, Veterans Integrated System Network 
(VISN), or national level for VA studies. Interventions that address the needs 
of patients with one or more chronic illnesses and multiple types of care 
needs during an episode of illness are encouraged, although interventions 
using the evidence base to improve the clinical outcomes of patients with 
specific conditions, may also be designed.  The use of information technology 
as a critical component of effective translation strategies, as well as 
strategies for using cost-effectiveness analysis as a framework for improving 
health care delivery are also of interest.

Of particular interest are applications that test use of evidence-based 
recommendations, tools, and/or strategies derived from rigorously conducted 
research and measure the impact of translation.  These may include but are not 
limited to findings from Patient Outcome Research Team (PORT) and QUERI 
efforts, United States Preventive Service Task Force recommendations, and 
evidence reports and technology assessments produced by the AHRQ Evidence-
based Practice Centers.

The research applications sought under this PA should focus on applied 
research with the objective of developing sustainable and reproducible or 
generalizable strategies specifically designed to facilitate the use of 
evidence in decisionmaking and to implement existing research findings in 
order to change behavior, improve access, quality, or patient outcomes, 
including quality of life, and promote patient safety.  Quantitative or 
qualitative research methods, including observational designs, may be used.  
The development and/or use of new and/or innovative methodologies designed to 
implement research findings and evaluate which existing methodologies have the 
most significant impact is a priority.  Clinical, organizational, and system-
level interventions, including State-focused or VISN-focused activities, may 
be tested and evaluated.  Approaches to the wide-scale implementation of 
tested evidence-based approaches to improving quality of care should be 
considered.  Of particular interest to AHRQ and VA are the use and evaluation 
of AHRQ or VA-sponsored research findings and products. Development of 
partnerships, such as those between researchers, professional organizations 
and health plans, to achieve improvement in outcomes is encouraged. In 
addition to studies focusing on cost-effectiveness models and methods used 
when translating research into practice, AHRQ, VA, and NIH are also interested 
in the translation of recommendations, tools, and strategies for the 
incorporation of a cost-effectiveness framework and cost-effectiveness studies 
focusing on decision-making within health care systems.

Partnerships 

Relationships with public and private organizations to facilitate development 
and sharing of scientific knowledge and resources are encouraged. Partnerships 
or consortia, such as between academic and other research organizations and 
health plans, professional societies, consumer organizations and purchasers, 
can be formed to perform this research. Such partnerships may help to more 
quickly translate research findings into actual practice settings and help 
ensure that participating health care organizations sustain the intervention 
model as a continuing initiative beyond the end of the funded project.  Roles 
of collaborators should be clearly defined in the application.

Racial and ethnic minority institutions are encouraged to apply for funding 
under this solicitation, and collaboration between minority and other 
institutions is also encouraged. 

Research Methods 

Because the impact on health outcomes of facilitating the use of evidence in 
decision making and translating evidence-based interventions may be difficult 
to measure directly within the desired time frame, focus on intermediate 
outcomes, process measures and resource use is appropriate. However, outcome 
and system links should be documented and the contribution of the proposed 
study results to ultimate outcome and system-wide improvements should be 
established.  Studies that compare the cost and/or cost-effectiveness of 
implementation strategies as well as the development and use of cost-
effectiveness analyses within health care systems to inform resource 
allocation and access to care are encouraged.  Appropriate methods may include 
rigorous qualitative and quantitative measurement using observational or 
quasi-experimental designs.  In order to monitor and account for secular 
changes in practice patterns, studies employing control or comparison groups 
are encouraged, but not required.  The evaluation of interventions previously 
proven effective in one population, setting, or system are encouraged.  
Subgroup analyses to evaluate the impact of translation on subgroups, 
including vulnerable and priority populations such as indigent and rural 
populations, are strongly encouraged.  All research designs and questions 
should be grounded in an appropriate theoretical framework that conceptually 
links existing evidence about the condition with evidence about the 
intervention used for translation. This theoretical framework needs to 
consider the strength of the evidence for the proposed intervention and 
clearly present why the investigator believes that the translation effort will 
result in measurable and sustainable improvements.  

Research Priorities and Cross-Cutting Questions

Research Priorities

The overall objective of this PA is to identify ways to increase the 
successful application of interventions and practices that prior research has 
shown to be effective -- in other words to increase the rate and success of 
innovation diffusion for evidence-based practices.  Our priorities cover two 
types of interventions.  The first category involves clinical interventions, 
such as use of specific medications, technologies, evidence-based clinical 
practice guidelines and protocols, systematic reviews/evidence reports.  The 
research questions for this PA then focus on implementation of these 
practices: what it takes for providers, patients, and clinical system leaders 
to learn about, adopt, and successfully implement these practices in order to 
improve health care outcomes.  The second category involves organizational, 
system or structural interventions: such as the use of dedicated AIDS units in 
hospitals, or open access scheduling.  The research questions here also focus 
on implementation: what it takes for hospital or health plan leaders, or in 
some cases purchasers or policy-makers, to learn about, and successfully 
encourage or implement, these practices in order to improve quality and access 
and/or reduce cost.  In other words, the first category focuses on increasing 
the practice of evidence-based clinical interventions, the second focuses on 
increasing the practice of evidence-based organizational and 
leadership interventions.

Clinical Evidence

A.  Clinical Evidence: Targeting organizational or systems behavior to promote 
the implementation of clinical evidence

The focus of this priority is the dissemination, validation, replication, 
transfer or diffusion of organization or systems strategies for improved care. 
 Strategies could include investments in information technology and decision 
support systems (for use by providers or patients), or other office-based 
systems.   Examples of specific research questions include:

o   For professional organizations that have been involved with implementation 
among their members, what methods have been utilized and what is the evidence 
of the interventions" effectiveness? What factors are associated with a 
professional organization"s involvement in translation of research into 
practice activities? What skills and expertise are needed within a 
professional organization to be successful? What is the process by which a 
professional organization identifies an opportunity, and develops and 
implements an intervention? 

o   How does the structure of health care organizations affect implementation 
of evidence-based tools and information? 

o   What issues are unique to TRIP or QUERI efforts implemented across a range 
of clinical conditions (e.g., chronic illness) compared to a specific clinical 
condition? What strategies successfully facilitate such broad-reaching TRIP or 
QUERI efforts? 

o   What are effective approaches for implementing strategies incorporating 
cost-effectiveness considerations into decision-making within health 
care organizations?

o   Is it feasible to develop and test predictive models of speed and 
effectiveness of adoption and diffusion of candidate clinical quality 
improvements that would provide guidance in considering TRIP and/or 
QUERI efforts? 

o   What are the costs, benefits, and cost-effectiveness of TRIP or QUERI 
activities for an organization? What are specific financial barriers and 
potential strategies to minimize their impact? 

o   What is the effect of implementation of evidence-based tools and 
information on health care organizations in terms of resource use and cost? 

B.  Clinical Evidence: Targeting provider behavior to promote the 
implementation of clinical evidence

The focus of this priority is the dissemination, validation, replication, 
transfer or diffusion of known effective strategies for improved care through 
changes in provider behavior.  All types of clinical providers are encompassed 
in this category.  Examples of specific questions include:

o   Are there underlying similarities/differences across dissemination efforts 
that predict success/failure? Can a model be developed to accurately 
reflect them?

o   What characteristics of continuing education appear to be related to 
behavior change? 

o   Which methods are most effective, cost-effective, and/or sustainable in 
assisting providers to stay abreast of the most recent scientific evidence in 
their areas of clinical specialization?

o   Which factors motivate them, or serve as barriers, to their use of that 
evidence in their clinical decisionmaking? 

o   What role can professional licensure, accreditation, and continuing 
education activities play in effectively using current scientific evidence to 
maintain and enhance clinical performance?

o   How can one motivate and sustain changes in provider behavior necessary 
for evidence-based practice (taking into account differences, if any, related 
to areas of specialization and the stages in a clinician=s career, e.g., 
student, resident, mid-career, etc.)?

o   How can continuing education interventions be modified or augmented to 
increase their impact on  behavior change?

o   Are there inter-disciplinary differences in adopting or sustaining use of 
new evidence and/or changing behavior

o   What strategy or combination of strategies consistently stimulates 
improved behavior change?

o   How have the trends towards Continuous Professional Development and board 
certification affected outcomes or processes of care?

C.  Clinical Evidence: Targeting patient behavior to promote the 
implementation of clinical evidence

The focus of this priority is the dissemination, validation, replication, 
transfer or diffusion of known effective strategies that support the role of 
patients (and their families, friends, or caregivers) in translating research 
into practice.  Examples of specific research questions include:

o   How can patients obtain and understand reliable information regarding 
their medical condition  and alternative treatment options and effectively use 
that information to enhance the quality and outcomes of care they receive?

o   What are the effects of evidence-based clinical information on patient 
safety and patient/consumer quality of life, satisfaction with care, behavior, 
knowledge, and attitudes?

o   How can patients make effective use of their discussions with clinicians 
and other caregivers and participate (to the extent they are comfortable) in 
decisionmaking regarding their course of treatment?

o   How can patients be brought into partnership with health care providers 
and health care organizations in creating and sustaining change?

o   How do different implementation strategies affect patient satisfaction?  
For example, is patient activation a more useful tool for those patients with 
Internet access than for those without?

o   How can new information technology applications (e.g., the Internet, etc.) 
be used to effectively enhance patient understanding and use of research in 
their care-seeking behavior?

Organizational Evidence: Expanding Evidence-based Management and Leadership

A second priority for this PA focuses on the dissemination, validation, 
replication, transfer or diffusion of evidence regarding organizational or 
systems interventions which have been shown to work in at least some settings 
to improve the quality, outcomes, access or cost of care.  Two recent reports 
of the Institute of Medicine (1999, 2001) point to major problems in health 
care safety, effectiveness, patient centeredness, timeliness, efficiency, and 
equity.  Both reports identify poor systems as major causes of these problems, 
and state explicitly that "if we want safer, higher-quality care, we will need 
to have redesigned systems of care " (IOM 2001).

Some of the evidence base for improving systems of care exists already.  AHRQ 
has been the primary sponsor for organizational design research in the past.  
Research projects under a 1997 RFA, "Quality of Care under Varying Features of 
Managed Care Organizations" are in their final stages and AHRQ recently 
announced a new Program Announcement "Impact of Payment and Organization on 
Cost, Quality, and Equity," 
(See http://grants.nih.gov/grants/guide/pa-files/PA-01-125.html) that should add 
to this evidence base.  For example, past research has shown that, in at least 
some settings:

o   Reorganization of practices (use of multidisciplinary teams, careful 
allocation of tasks among team members, and ongoing management of patient 
contacts) can improve outcomes for chronically ill patients (Wagner et al., 
1996, cited in IOM 2001).

o   Increasing RN hours per patient can decrease the incidence of urinary 
tract infection, pneumonia, thrombosis, and pulmonary compromise (Kovner et 
al. 1998).

o   Use of hospital dedicated AIDS units can bring higher patient 
satisfaction, lower nurse burnout, and lower odds of dying within 30 days 
of admission.

o   Use of open access scheduling yields more effective, patient-centered, 
timely, and efficient care (Institute for Healthcare Improvement 2000, cited 
in IOM 2001).

But the next challenge for evidence-based management, as for evidence-based 
medicine, is to identify ways to increase the adoption and use of the evidence 
that exists already.  According to one recent review of evidence-based 
management practices (Kovner, Elton and Billings 2000 p. 4) managers in large 
healthcare organizations are deciding on more and riskier strategic 
interventions based on evidence that is not systematically gathered or 
assessed.  The second priority for this PA, therefore, is to identify and 
test strategies for increasing the successful adoption and implementation of 
proven organizational interventions.

Organizational interventions can occur with different foci -- technological 
improvement, service enhancement, administrative/structural change, and 
personnel development.  In many instances, a combination of these 
interventions is required to effectively achieve the desired improvement.  
These interventions can take place incrementally and some types of changes 
might be easier to implement than others.  More research is needed to 
establish evidence for the effectiveness of different organizational 
interventions and successful implementation strategies. 

Decisions related to organizational interventions also occur at multiple 
levels.  The decision to begin a care coordination program for chronically ill 
patients, for example, might be made by a medical group, the health care 
delivery system to which it belongs, or the health plan that contracts with 
the system.  (See Landon, Wilson and Cleary 1998).  Moving up the chain, the 
decision might also be made or influenced by the public or private payer (the 
Medicaid program, or a large employer).  In the case of broad organizational 
decisions (the use of Primary Care Case Management for enrollees, for example) 
the decision may even be made or at least influenced by Federal, State or 
local policy-makers or managers. 

For any of these types of organizational interventions, or levels of decision-
makers, we would be interested in three broad issues:

A.  Organizational Evidence: Replication.   

If the organizational intervention works in site A, does it work in site B?  
If so, what change in the implementation strategy does it take to make it work 
(for example, a VA site versus a non-VA site, or hospitals versus 
outpatient settings)?

B.  Organizational Evidence: Applicability and/or adaptation for 
priority populations. 

If the organizational intervention works for serving population A, does it 
work for serving population B, and in particular priority populations?  If so, 
what change in the implementation strategy does it need to make it work (for 
example, Caucasian versus African-American, or adults versus children)?

C.  Organizational Evidence: Innovation diffusion and implementation

What does it take for managers and health care leaders of all types of 
organizations to increase their knowledge and take-up of this intervention? 
What does it take for other actors with a major impact on these systems (e.g., 
public and private purchasers, public policy-makers) to increase their 
knowledge and take-up of this intervention?

o   What dissemination strategies are most effective for reaching them?

o   How must translation and dissemination strategies vary from one type of 
decision-maker (e.g., board members, chief executive officers, chief 
information officers, chief financial officers, clinical managers, government 
policy makers) to another?

o   How must translation and dissemination strategies vary from one type of 
organization (e.g., hospitals, home health agencies, long-term care 
facilities, managed care organizations, insurers, purchasers, state 
government, local government, etc.) to another? 

o   How do different types of decision-makers differ from researchers in the 
sorts of  "evidence" they find sufficient for action?

o   What does it take for health care managers and health care leaders to 
implement these strategies successfully?  

o   What kind of tools and technical support do they need?

Cross-Cutting Questions

o   How sustainable are improvements that result from various interventions 
over time?  For example, are improvements resulting from use of audit and 
feedback longer-lasting than those resulting from use of opinion leaders?  To 
what extent are these differences stable across conditions?

o   What are the ethical implications of studies comparing an implementation 
strategy with usual practices? Are there standards for comparison groups? How 
will these implications influence investigator incentives? 

o   What are effective approaches that apply multifaceted strategies to 
implementation of evidence-based tools and information? 

o   What are strategies for identifying, validating, and addressing barriers 
to implementation of evidence-based tools and cost-effectiveness information? 

o   Is there a measurable difference in the effectiveness of evidence-based 
tools and information depending on the match of the race/ethnicity of 
providers and patients? 

o   Is the identification of sub-populations meaningful in identifying the 
effectiveness of evidence-based tools and information? Is culture a more valid 
variable than race/ethnicity? 

Methods: Use and Evaluation

o   Using meta-analytic or systematic review methods, what can one infer from 
the literature on implementation of quality improvement interventions, 
rankings of the effectiveness of different TRIP and/or QUERI interventions, 
alone or in combination? 

o   What are the best methods for studying natural experiments such as 
introduction of legislation mandating new coverage policies?

o   What is the comparative cost-effectiveness of various strategies for 
implementing evidence-based tools and information?

MECHANISM OF SUPPORT  
 
This PA will use the R01 award mechanism for applicants applying for AHRQ.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.

Applicants are encouraged to contact the Agency listed under WHERE TO SEND 
INQUIRIES that matches their research interest, and to seek guidance on other 
potential grant mechanisms that are applicable to each Agency.  The total 
project period for an application submitted in response to this PA may not 
exceed five years. 

AHRQ is not using the Modular Grant Application and Award Process. 

Applicants interested in applying to AHRQ for a small research grant (projects 
requesting total cost of $100,000 or less) (RO3) should consult the program 
contact.  Procedures are outlined in the "AHRQ Small Research Grant Program" 
PA, published in the NIH Guide for Grants and Contracts (NIH Guide) 
January 2, 2001.

ELIGIBLE INSTITUTIONS 

You may submit (an) application (s) if your institution has the following 
characteristics:

1.   Eligible to AHRQ

o Public and private non-profit institutions such as universities and clinics 
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic and foreign
o Faith-based organizations

Note:  AHRQ, by statute, can make grants only to not-for-profit organizations, 
however, for profit organizations may participate in grant projects as members 
of consortia or as subcontractors. Organizations described in section 501(c) 4 
of the Internal Revenue Code that engage in lobbying are not eligible.
 
2.   Eligible to VA HSR&D

o PIs and co-PIs must hold a minimum 5/8ths VA paid appointment 
o Non-PI investigators who collaborate on the project do not need to hold a 
VA appointment

Note:  Further questions about eligibility to be a VA investigator may be 
referred to the VA HSR&D Eligibility Coordinator, Ms. Caryn Cohen, at 202-273-
6812 or caryn.cohen@hq.med.va.gov.  You may also refer to the policy 
Eligibility For VA Research Support available on the VHA R&D web site at 
http://www.va.gov/publ/direc/health/direct/195036.htm or in the following online 
handbook:  
http://www.va.gov/resdev/directive/VHA_Handbook_1200.15_Eligibility.doc.

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 grant support. 

SPECIAL REQUIREMENTS

Policy Relevance and Dissemination

Applications submitted in response to this PA are expected (1) to contribute 
to our basic understanding of how to effectively and efficiently translate 
research evidence into practice leading to measurable and sustained 
improvement, (2) to build capacity - research tools, data, and teams B in 
order to answer related policy relevant questions, and (3) to produce 
information in formats useful to participants in the formulation of clinical 
and public policy.  Applicants should be concrete in describing relevant 
policy implications in terms of (1) the decision-making audiences most 
interested in the proposed research (2) how applicants anticipate their 
results being used and by what audiences and (3) the presence or absence (gap) 
of strong evidence that influences policy development.  

Dissemination strategies should not be limited to publication in peer-reviewed 
journals but may encompass a variety of active approaches, such as translating 
results into non-technical monographs and distributing them through 
associations of private and public officials, educating legislators, public 
administrators, health plan executives, employers, health professionals, and 
others in seminars, and outreach to mass media.  Plans, time lines, personnel, 
and budgets for such dissemination efforts should be explicitly presented. 

Publications 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 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.

Publications Transmittal: General VA Requirements

Investigators are required to send VA HSR&D a copy of each article resulting 
from VA HSR&D- funded research as soon as it is accepted for publication.  
Submit each article by e-mail to:  vhacohsrd@mail.va.gov. For additional 
information and details regarding investigators= responsibilities related to 
publications resulting from VA-supported research, please consult your local 
R&D office and refer to the following website:  
http://www.va.gov/resdev/fr/manualm3.cfm.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants who have read the PA.  Inquiries 
may fall into three areas:  scientific/research, peer review, and financial or 
grants management issues:

1.   AHRQ

o  Direct your questions regarding  AHRQ programmatic issues including 
information on the inclusion of women, minorities, and children in study 
populations to:

Clinical Interventions 

Margaret Coopey, RN, MGA, MPS/ Diane Brown
Center for Practice and Technology Assessment
Agency for Healthcare Research and Quality
6010 Executive Blvd.
Rockville, MD  20852
Telephone:  (301) 594-4022/ (301) 594-4019
FAX:  (301) 594-4027
Email:  mcoopey@AHRQ.gov / dbrown@ahrq.gov

Organizational Interventions

Pamela Owens, Ph.D.
Epidemiologist/Program Officer
Center for Organization and Delivery Studies
AHRQ
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Telephone:  (301) 594-6192
Fax:  (301) 594-2314
Email:  cods@ahrq.gov

2.   VA

o  Direct your questions about VA/QUERI programmatic issues to:

Lynn McQueen, DrPH, MS, RN
Associate Director for HSR&D, QUERI (124Q)
HSR&D, VA Central Office
810 Vermont Avenue, NW
Washington, DC  20420
Phone:  (202) 273-8227
Fax:  (202) 273-9007
E-mail:  lynn.mcqueen@hq.med.va.gov

VA eligibility matters

Caryn Cohen, MS
Health Science Specialist & Eligibility Coordinator (124I)
HSR&D, VA Central Office
810 Vermont Avenue, NW
Washington, DC  20420
Phone:  (202) 273-6812
Fax:  (202) 273-9007
E-mail:  caryn.cohen@hq.med.va.gov

Mental health research at the VA 

Richard Owen Jr., MD
Director, HSR&D Center for Mental Healthcare and Outcomes Research, (152/NLR)
Central Arkansas Veteran Healthcare System
2200 Ft. Roots Drive
North Little Rock, AR  72114
Phone:  (501) 257-1710
FAX:  (501) 257-1707
FTS:  (700) 740-1622
E-mail:  owenrichardr@uams.edu

3.   NIH

o  Direct your questions to NIMH that focus on the translation of research 
evidence in the area of mental health to:

David Chambers, Ph.D.
Dissemination Research Program 
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Blvd., Rm. 7133, MSC 9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3364
FAX:  (301) 443-4045
E-mail:  dchamber@mail.nih.gov

o   Direct your questions to NCI that focus on the translation of research 
evidence in the area of cancer care services to:

Molla Sloane Donaldson, Dr. P.H.
Outcomes Research Branch, ARP, DCCPS
National Cancer Institute
6130 Executive Blvd., MSC 7344
EPN Room 4028
Bethesda, MD  20892-9631
for overnight delivery use: Rockville, MD  20852
Telephone:  (301) 435-1638
FAX:  (301) 435-3710
Donaldsm@mail.nih.gov

o  Direct your questions to NIAAA about Alcohol Abuse and Alcoholism to:

Mike Hilton, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Blvd., MSC 7003
Bethesda, MD  20892-7003
Telephone:  301-443-8753
FAX:  301-443-8774
Email:  mhilton@willco.niaaa.nih.gov

o  Direct your questions about peer review issues to:

Joan Hurley, SRA
ORREP
Agency for Healthcare Research and Quality
2101 E. Jefferson Street, Rm. 4W3
Rockville, MD  20852
Telephone:  (301) 594-6075
Fax:  (301) 594-2329
Email:  jhurley@ahrq.gov

A.   AHRQ

o  Direct your questions about AHRQ financial or grants management matters to:
 
George Gardner
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone:  (301) 594-6826
FAX:  (301) 594-3210
Email:  ggardner@ahrq.gov
 
B.   VA

Direct your questions about VA fiscal matters to:

Teresa Mathis, CRA, MBA
Program Analyst, Operations (124G)
HSR&D, VA Central Office
810 Vermont Avenue, NW
Washington, DC  20420
Phone:  (202) 273-8860
Fax:  (202) 273-9007
E-mail:  teresa.mathis@hq.med.va.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (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 GrrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

State and local government applicants may use PHS 5161-1, Application for 
Federal Assistance (rev. 5/96), and follow those requirements for copy 
submission.  Applicants are encouraged to read all PHS Form 398 instructions 
prior to preparing an application in response to this PA.

Copies of the PA are available from:

AHRQ Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD  20907-8547
Telephone:  1-800-358-9295 
TDD Service:  888-586-6340

The PA is also available on AHRQ"s web site, http://www.AHRQ.gov (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 PA number).  The PA 
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. 

This PA is also available at the following VA website:  
http://www.va.gov/resdev/fr/frrfp/solicitations.cfm.

SPECIAL APPLICATION PROCEDURES:

1.   VA

Projects funded by VA will use VA"s Investigator Initiated Research (IIR) 
mechanism.  All investigators who meet VA eligibility criteria and wish to be 
considered for VA funding will be required to fill out and submit specific VA 
budget forms as an appendix of the application.  The required forms must be 
included with the PHS form 398 and include: VA Forms 10-1313-3 and 10-1313-4 
addressing the First Year Request and Budget Justification (see  
http://www.va.gov/resdev/fr/forms.cfm website to obtain these forms). All 
research to be completed at a VA facility requires local Research &Development 
(R&D) Committee and Associate Chief of Staff for Research approval at time of 
submission.  Studies involving human subjects must be accompanied by the 
consent form. VA Form 10B1086, Agreement to Participate in Research By or 
Under the Direction of VA, that will be presented to each subject or legally 
responsible representative prior to the subject=s participation in the study. 
 A completed and current VA Form 10-1223, Report of Subcommittee on Human 
Studies, dated no earlier than one year before the receipt date of the 
application, may be submitted with the application, but must be received prior 
to release of any VA funding.  Questions about VA forms may be directed to any 
VA medical facility"s Office of Associate Chief of Staff for Research and 
Development or to Ms. Becky Kellen at 202-273-8260 or becky.kellen@hq.med.va.gov.

2.   AHRQ

Beginning with applications for AHRQ funding 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).  
All investigators/applicants proposing research involving human subjects should 
pay particular attention to the instructions in the form PHS 398 regarding human 
subject involvement. 

Application Preparation (for Using Center for Medicare and Medicaid Services 
(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 PHS 398) the specific 
files, time periods, and cohorts proposed for the research.  In consultation 
with Centers for Medicare and Medicaid Services (CMS), formerly 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 award at the time funding decisions are made.  To 
avoid double counting, applicants should not include the cost of the data in 
the budget. 

Applicants should be aware that for individually identifiable Medicare and 
Medicaid data, Principal Investigators and their awardee institutions will be 
required to enter into a Data Use Agreement (DUA) with CMS to protect the 
confidentiality of data in accordance with OMB Circular A-130, Appendix 
III--Security of Federal Automated Information Systems.  The use of the data 
is restricted to the purposes and time period specified in the DUA.  At the 
end of this time period, the awardee is required to return the data to CMS or 
certify that the data have been destroyed. 

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 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. 

Awardees must also comply with the confidentiality requirements of Section 924 
(c) of the PHS Act (42 U.S.C. 299c-3(c).  See the Data Privacy section for 
details on these requirements as well as references to Circular A-130 and its 
implementation guides for the National Institute of Standards and Technology.

In developing research plans, applicants should allow time for refining and 
processing their data requests.  Approval may take six months from the date 
submitted to complete.  Applications proposing to contact beneficiaries or 
their providers require the approval of the CMS administration 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.

In carrying out its stewardship of health care related programs, the AHRQ will 
request information essential to an assessment of the effectiveness of Agency 
research programs.  Accordingly, award recipients are hereby notified that 
they may be contacted after the completion of awards for periodic updates on 
publications resulting from AHRQ grant awards, and other information helpful 
in evaluating the impact of sponsored research. 

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 RECEIPT DATES:   Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines, 
which are available at http://www.ahrq.gov (Funding Opportunities).

SPECIFIC INSTRUCTIONS FOR MODULAR GRANTS APPLICATIONS:

1.   AHRQ

AHRQ is not using the modular grant application and award process.  Applicant 
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 398.  Applications submitted in the 
modular format will be returned without review.

BUDGET INSTRUCTIONS:

AHRQ

AHRQ uses the detailed budget for research grant applications.  Applicants for 
funding from AHRQ should use PHS form page 4 and form page 5 and follow the 
instructions for detailed budget for initial budget period, page 10.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:

For AHRQ

Note that proposed projects with direct costs exceeding $500,000 in any one 
year require permission from AHRQ program staff two months prior to submission 
of the application.

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the same 
as one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one revision of an application already 
reviewed, but such application must include an Introduction addressing the 
previous critique.

On line 2 of the face page of the application, mark the yes box and type the 
PA number and title in the space provided.

The PHS 398 type size requirements (p.6) will be enforced rigorously and non-
compliant applications will be returned. 

PEER REVIEW PROCESS

1.   For AHRQ & VA Applications

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
comprise of both AHRQ and VA-selected reviewers and convened in accordance 
with AHRQ peer review procedures will evaluate applications for scientific and 
technical merit.  Application peer review will be administered by AHRQ with 
AHRQ and VA collaboration on content, review, and funding decisions.

As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have high 
scientific merit will be discussed and assigned a priority score

The peer reviewers will be asked to judge the likelihood that the proposed 
projects will have a substantial impact on the pursuit of the goals specified 
in this PA and will also be evaluated regarding the appropriateness of 
proposed project budget and duration, the adequacy of plans to include both 
genders and minorities and their subgroups as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of subjects, 
the provisions for the protection of human subjects, and the safety of the 
research environment.

Each of the following criteria will be addressed and considered by the 
reviewers in assigning the overall score, weighting them as appropriate for 
each application.  Note that the application does not need to be strong in all 
categories to be judged likely to have a major scientific impact and thus 
attain a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is essential 
to move a field forward.  General review criteria include: 

A.  SIGNIFICANCE:  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced? 
What will the effect of these studies be on the concepts or methods driving 
this field?

B.  APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Are the proposed data sources appropriate and adequate? Does the 
applicant acknowledge potential problem areas and consider alternative tactics? 

C.  INNOVATION:  Does the project employ innovative information technology 
applications, concepts, approaches or methods? Are the aims original and 
innovative? Does the project challenge existing paradigms or test 
methodologies or technologies? Once completed, will the findings contribute 
new and generalizable knowledge?

D.  INVESTIGATOR:  Is the investigator appropriately trained and well suited 
to carry out this work? Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers? Is the project (or 
work plan) well organized? Does the proposed study team reflect the multi-
disciplinary approach required to address the project=s research issues?  

E.  ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional support?

F.  POLICY RELEVANCE:  Will the project provide Federal and State 
policymakers, and others participating in the formulation of such policy, with 
the evidence-based information they need to improve quality and/or patient 
safety?  Does the application provide a sound plan for achieving this purpose? 
 
The scientific review group will also examine issues specifically relevant to 
translation, including issues relevant to proposed dissemination, 
implementation, and evaluation activities.  Review criteria relevant to 
translation include:

a)  The extent that a cogent theoretical framework that unites evidence about 
the condition with evidence about translation is used, strength of evidence is 
considered and reason to believe that the intervention will result in a 
measurable improvement is described. 

b)  The extent that clear definitions of key terms, including "usual care", 
are provided and used consistently especially in text related to any control 
and/or comparison groups.  

c)  The extent to which the study results will be applicable and generalizable 
to situations beyond that of the study and contribute to improved translation 
of research evidence across a range of settings, levels of care, 
and populations. 

d)  The extent to which the translation project will result in sustainable 
improvements in the adoption of research findings into practice.

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) 

DATA SHARING:

Data Privacy: AHRQ and VA Requirements 

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 or implied 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.

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/handbook.pdf.  The application of these 
confidentiality and security standards to subcontractors and vendors should be 
addressed as necessary. 

VA has the following additional requirement for Privacy of Information.  All 
applications must include a letter from the facility Privacy Officer (usually 
the Chief, Medical Administration Service) identifying the PI"s name and 
project title and providing evidence of due regard for the Privacy Act of 1974 
(Public Law 93-579) and intent by the PI to comply. The statement should be 
signed, dated and the signator identified by name, title, and affiliation.  
Privacy Act is not applicable to grants records but to VA facility records.  
After April 2003, patient record information must be maintained in accordance 
with any agreements made with health care providers pursuant to the HHS 
Privacy Regulation 45 CFR Parts 100 and 164.

Rights in Data: AHRQ Requirements

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).

All VA investigators affiliated with the project must be aware of and follow 
VA policies regarding VA support acknowledgment.  Specifically, all 
publications and presentations based on research supported by VA must 
acknowledge VA support, and the investigator"s VA affiliation must appear, 
before any other (see exception below), in the following form: "The research 
reported here was supported by the Department of Veterans Affairs, Veterans 
Health Administration, Health Services Research and Development Service 
(project no.). Dr. XXX is the (position title) at (location)."  In addition, 
all publications should include a disclaimer similar to this statement:  "The 
views expressed in this article are those of the author(s) and do not 
necessarily represent the views of the Department of Veterans Affairs."

AWARD CRITERIA

Two distinct categories of applications are requested under this PA.  The 
first category of applications (dual/twin projects where comparisons are made 
by implementing the same study inside and outside VA) will be jointly funded 
by VA and AHRQ.  AHRQ will fund the private sector/non-VA site(s) and VA will 
fund studies implemented in VA site(s) unless the PI has less than a 5/8th 
appointment. The second category of applications (general translation/non 
comparison studies of VA and private sector sites) will be funded by AHRQ or 
VA.  VA studies will be funded by either VA or AHRQ and private sector/non-VA 
studies will be funded by AHRQ.  

Applications will compete for available funds with other 
investigator-initiated applications requesting support.  Final award decisions 
regarding VA funding will be made by the Director, VA HSR&D.  Final decisions 
about AHRQ funding will be made by the Director of AHRQ. The following will be 
considered in making funding decisions: quality of the proposed project as 
determined by peer review and how well it fits the funding agency=s 
priorities, program balance, and availability of funds. 

REQUIRE FEDERAL CITATIONS

A.  INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS:   
It is the policy of AHRQ and VA that women and members of minority groups be 
included in all AHRQ and VA 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.  The AHRQ policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 101-43). However, the subject population of VA 
research should reflect the demographics of the veteran population and the 
constraints of VA population are recognized, as described in VHA Handbook 
1200.9, "Inclusion of Women and Minorities in Research" 
http://www.va.gov/resdev/directive/Women_and_minorities.doc.

Specific AHRQ 

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.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and /or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethic groups, including subgroups if applicable, and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences. 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.

B. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:

AHRQ encourages investigators to consider including children in study 
populations, as appropriate. 

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

Specific VA Requirements

Considering the constraints of VA patient population, applicants for VHA 
research support are expected to include women and minorities in their study 
populations.  Special efforts shall be made to include women and minority 
groups in studies of diseases, disorders, and conditions that affect them.  
All investigators proposing research involving human subjects and who are 
seeking VA funding should read VHA Handbook 1200.9, "Inclusion of Women and 
Minorities in Research" found at the following website, 
http://www.va.gov/resdev/directive/Women_and_minorities.doc.  VA restrictions 
regarding research on children are explained in the following directive: VHA 
Directive 2001-028, "Research Involving Children" 
(http://www.va.gov/publ/direc/health/direct/12001028.pdf).

C. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMAITON ACT: 
For AHRQ)   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.  It is not likely that data gathered under projects 
supported through this initiative will be used as a basis for federal 
regulation or action having the force and effect of law. However, should 
applicants wish to place data collected under this PA 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.

D. 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 
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.

E. AUTHORITY AND REGULATIONS:  For AHRQ, this program is described in the 
Catalog of Federal Domestic Assistance, Number 93.226.  Awards are made under 
authorities in Title IX of the Public Health Service Act (42 USC 299-299c-7) 
as amended by P.L. 106-129 (1999).  AHRQ 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. 

All VA support will be subject to all applicable VA and Federal guidelines and 
regulations governing expenditures of VA funds.

The PHS strongly encourages all grant and contact 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 case, 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 

Aiken, L. Organization and Outcomes of Inpatient AIDS Care, Medical Care 2000l 
37(8):760-72.

Demakis JG, McQueen L, Kizer KW, Feussner JR. Quality enhancement research 
initiative (queri): a collaboration between research and clinical practice.  
Medical Care 2000, 38(6Supplement):117-125.

Eisenberg JM. AHRQ update: putting research to work: reporting and enhancing 
the impact of health services research. Health Services Research 2001, 
36(2):x-xvii.

Feussner JR. Linking experimental research methods and health services 
research: everything is possible. Effective Clinical Practice 2000, 3(3):  
138-140.

Feussner JR.  Priorities for patient-centered research. Medical Care 
1999,37(9):843-845.

Institute for Healthcare Improvement.  2000.  Idealized Design of Clinical 
Office Practices. Online.  Available at http://www.ihi.org/ihi.

Institute of Medicine (IOM). Committee on Health Care in America.  Crossing 
the quality chasm: A new health system for the 21st century.  National Academy 
Press: Institute of Medicine 2001.

Institute of Medicine (IOM) Kohn, Linda T., Corrigan, Janet M., and Donaldson, 
Molla S. (Eds) To err is human: Building a safer health system.  National 
Academy Press: Institute of Medicine 2000.

Kizer KW. Clinical practice guidelines. Federal Practitioner 1998,52-58.

Kovner AR, Elton JJ, Billings J.  Evidence-Based Management.  Frontiers [date] 
16:4: 6-26.

Kovner C. Gergen PJ.  Journal of Nursing Scholarship 1998, 30(4) 315-321.

Krumholz HM, Herrin J. Quality improvement studies: the need is there but so 
are the challenges. The American Journal of Medicine 2000, 109:501-503.

Landon BE, Wilson IB, Cleary PD.  A Conceptual Model of the Effects of Health 
Care Organizations on the Quality of Medical Care.  JAMA 1998, 279(17):  
1377-1382.

Management Decision and Research Center.  Clinical practice guidelines.  
Boston: VA Health Services Research and Development Service in collaboration 
with the Association for Health Services Research, November, 1998.

Management Decision and Research Center.  Program evaluation for managers. 
Boston: VA Health Services Research and Development Service in collaboration 
with the Association for Health Services Research, August 1997.

Management Decision and Research Center. Department of Veterans Affairs. 
Clinical practice guidelines Primer. Boston, MA. VA Health Services Research 
and Development Service. 1998, W82.AA1-C641.

Management Decision and Research Center.  Organizational change. Boston: VA 
Health Services Research and Development Service in collaboration with the 
Association for Health Services Research, May 2000.

McGlynn EA, Brook RH. Keeping quality on the policy agenda. Health Affairs 
2001, 20(3):82-90.

McQueen LM, Demakis JG. QUERI: Translating research findings into improved 
patient care. Journal of Clinical Outcomes Management 2001, 8(1):27-29.

Oxman AD. No magic bullet: a systematic review of 102 trials of interventions 
to improve professionals practice. Canadian Medical Association Journal 
1995,153:1423-31.

Shortell SM, Gillies RR, Anderson DA, Erickson KM, Mitchell JB.  Remaking 
health care in America.  San Francisco: Jossey-Bass Publishers, 1996.

Wagner EH, Austin BT, Von Korff MV.  Organizing Care for Patients with Chronic 
Illness.  Milbank Quarterly 1996, 74(4):511-42.

Woolf SH, Grol R, Hutchinson A, Exxles M, Grimshaw J. Clinical guidelines: 
potential benefits, limitations, and harms of clinical guidelines.  British 
Medical Journal 1999,318(7182):527-530.

Woolf SH, DiGuiseppi CG, Atkins D, Kamerow DB. Developing evidence-based 
clinical practice guidelines: lessons learned by the US Preventive Services 
Task Force. Annual Review of Public Health 1996,17:511-538.



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