This Program Announcement expires on July 24, 2004, unless reissued.
(see Erratum in NOT-HS-02-006)

PATIENT-CENTERED CARE:  CUSTOMIZING CARE TO MEET PATIENTS’ NEEDS

Release Date:  July 31, 2001

PA NUMBER:  PA-01-124 (This PA has been deactivated, see NOT-HS-05-009)

Agency for Healthcare Research and Quality
National Institute of Mental Health

PURPOSE

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to 
support and conduct research that improves the outcomes, quality, access to, 
and cost and utilization of health care services. AHRQ achieves this mission 
through health services research designed to: (1) improve clinical practice, 
(2) improve the health care system"s ability to provide access to and deliver 
high quality, high-value health care, and (3) provide policymakers with the 
ability to assess the impact of payment and organizational changes on 
outcomes, quality, access, cost, and use of health care services.  In doing 
so, AHRQ seeks to identify and respond to the information needs of consumers, 
patients, clinicians and other providers, institutions, plans, purchasers, 
and Federal and State policy-makers, and to provide them the information they 
need to make evidence-based decisions.  The National Institute of Mental 
Health (NIMH) is also co-sponsoring this Program Announcement (PA). 

One critical set of issues facing public and private policy-makers concerns 
the challenge of redesigning processes of care to enhance delivery of 
patient-centered care. For the purposes of this PA, patient-centered care is 
defined as health care that establishes a partnership among practitioners, 
patients and their families (when appropriate) to ensure that decisions 
respect patients’ wants, needs and preferences and solicit patients’ input on 
the education and support they need to make decisions and participate in 
their own care.  (See Ref.# 1) A recent report from the Institute of Medicine 
(IOM), Crossing the Quality Chasm, noting a “quality chasm” between the 
health care we have and the health care we could have, points out that this 
gap is attributable in part to the fact that too often patients must adapt to 
the customs and usual procedures of health care organizations and 
professionals, rather than receiving services designed to focus on 
individual’s needs and preferences.  (See Ref.# 2) Prior research has 
demonstrated that patients who are active participants in their care 
experience better outcomes than those who are not similarly engaged, yet 
promising approaches to engage individuals as co-managers of their health and 
health care have not been broadly applied.  (See Ref. # 3) In addition, 
growing use of information and communications technologies could be used to 
respond to the IOM’s recommendation that the organizing concept of patient 
care be expanded from the interactions that occur within the boundaries of a 
clinical encounter.  Thus, essential dimensions of patient-centered care 
include but are not limited to customized information, communication, and 
education, coordination and integration of care across conditions and 
settings, and over time, shared decision-making of clinicians with patients 
and families, self-efficacy and self-management skills for patients, 
patient’s experience of care, effective provider-patient partnership, and 
enhanced cultural competence of health care providers. 

The intent of the PA is to support redesign and evaluation of new care 
processes that lead to greater patient empowerment, improved patient-provider 
interaction, easier navigation through healthcare systems, and improved 
access, quality, and outcomes.  Specific strategies could include, but are 
not limited to, electronic clinical communication, self-management programs, 
web-based applications for patients and/or health care providers, and shared 
decision-making programs.  Researchers are encouraged to propose projects 
that emphasize chronic illness, episodes of care that extend beyond 
hospitalization, longitudinal care, and priority populations (e.g., inner-
city areas, rural areas, including frontier areas, low-income groups, 
minority groups, women, children, the elderly, and individuals with special 
health care needs, including individuals with disabilities and individuals 
who need chronic care or end-of-life health care).  Further explorations of 
patient-centered care models among minority populations are especially 
encouraged.  Development and evaluation of new approaches to promote patient-
centered care as well as projects that expand and evaluate the use of 
programs previously found to be promising in select settings and 
circumstances are both encouraged under this PA.  

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 “Health People 2010" at 
http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic or foreign, public or private not-
for-profit organizations, including universities, clinics, units of State and 
local governments, and eligible agencies of the Federal government.  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.

AHRQ encourages investigators who are women, members of minority groups and 
persons with disabilities to apply as Principal Investigators.

MECHANISM OF SUPPORT

The mechanism of support for this PA will be the research project grant 
(RO1).  Responsibility for planning, direction and execution of the proposed 
project will be solely that of the applicant.  The total project period for 
an application submitted in response to this PA may not exceed five years.

Some of the topics or development of projects may be more suitable for a 
small project grant (projects requesting total costs of $100,000 or less) 
(R03).  Applicants are encouraged to apply under the procedures outlined in 
the “AHRQ Small Research Grant Program” PA, published in the NIH Guide for 
Grants and Contracts (NIH Guide) January 2, 2001.

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 Inquiries).

RESEARCH OBJECTIVES

Background

Patient-centeredness is a characteristic of the relationship between the 
clinician and the patient.  In contrast to care that is clinician-centered or 
disease-focused, patient-centered care customizes treatment recommendations 
and decision making in response to an individual patient’s preferences and 
beliefs.  Within the report, “Crossing the Quality Chasm: and in the report 
recommending a framework for the National Health Care Quality Report, the IOM 
has included patient-centeredness as an essential component of quality care.  
(See Ref.#s 1&2)  In this context, patient-centeredness includes both the 
patient’s experience of care and the presence of an effective partnership 
between clinician and patient (and the patient’s family, when appropriate).  
Recent efforts to assess the patient’s experience of care, including the 
Consumer Assessment of Health Plans Survey (CAHPS), now used by consumers to 
choose plans and by health care organizations to identify opportunities for 
improvement, have begun to identify important dimensions of patient-centered 
care.  However, efforts to identify which factors promote more effective 
clinician-patient partnerships have received less attention.  

An effective clinician-patient partnership should be the product of a 
relationship in which the clinician’s recommendations are informed by an 
understanding of the individual patient’s needs and the context in which he 
or she lives (e.g., home life, job, family relationships) to enhance the 
patient’s ability to act on the information provided.  Additional features of 
an effective clinician-patient partnership include informed, shared decision 
making and development of patient knowledge and skills needed for self-
management of chronic illness, including mental illlness.   Patients vary in 
the degree of autonomy and involvement with health care decision making 
desired, some want a high degree of involvement while others prefer to rely 
completely on a clinician’s recommendation.  (See Ref. # 1) When a more 
patient-centered approach is preferred, there is limited information on the 
willingness or ability of providers to learn and adopt these changes into 
routine practice.  Individuals of different races, cultures, genders and ages 
have different preferences and beliefs, and physicians have been found to 
vary in the extent to which they demonstrate a participatory decision making 
style.  (See Ref.# 4) The degree of trust that patients have in clinicians, 
and ideally, the provision of culturally competent care are also essential 
components of patient-centered care. (See Ref. #s 4 & 5) 

Multiple studies have demonstrated that patients who are involved with their 
care decisions and management have better outcomes than those who are not.  
(See Ref. #s 6-9) Patient self-management, particularly for chronic 
conditions, has been shown to be associated with improvements in health 
status and decreased utilization of services.  (See Ref. # 10) For example, 
one randomized controlled trial of a shared decision making program for 
benign prostatic hypertrophy showed that patients engaged in shared decision 
making reported significantly higher levels of satisfaction with their 
decisions than those who did not participate in the program.  (See Ref. # 11) 

Despite recognition that patient-centeredness is increasingly recognized as 
an important professional evolution, (See Ref. # 12) and holds enormous 
promise for improving quality and outcomes of care for chronic illnesses, 
studies have demonstrated substantial opportunities for improvement.  
Assessments of audiotaped clinician-patient encounters have shown that the 
majority of interactions do not meet minimal criteria for informed decision 
making, (See Ref. # 13) and use of innovative approaches to engage patients 
in their care, particular patients with one or more chronic illnesses, have 
not yet become a routine part of clinical care.  (See Ref. # 14) There is 
also an important role for patient-centeredness in the timely use of 
appropriate preventive services.  As patients become more involved in their 
own prevention needs, with a greater emphasis on personal responsibility, 
they can advocate for their primary and secondary prevention needs.

Objectives and Scope of Activity

To improve the delivery of patient-centered care as an essential component of 
high quality care, AHRQ seeks to support research in four areas related to 
patient-centered care, including: (1) innovative approaches to care, (2) 
improved chronic illness care, (3) shared decision making and (4) patient-
clinician communication.  

1) Innovative Approaches to Care:

The IOM’s “Crossing the Quality Chasm” report indicates that the health care 
delivery system is organized around the usual customs of clinicians and the 
dictates of payment mechanisms, resulting in care that is fragmented and 
inefficient from the perspective of individual patients. In addition, the 
content of care is primarily defined as the reimbursable exchange that occurs 
within the context of a clinical encounter (outpatient visit, 
hospitalization) in a specified setting rather than the response of 
clinicians to patients’ needs that occurs over time and across settings. 
Advances in information and communication technologies now offer new 
opportunities for rethinking and evaluating new opportunities for maximizing 
effective clinician-patient exchange to achieve patient-centered care.  
Reports of innovative efforts to re-engineer processes of care have focused 
on the use of web-based technologies for communication and inter-visit 
follow-up, micro-systems of care focused on patients’ needs, and enhanced 
coordination of care across settings and providers.  While these innovative 
strategies have face validity, there is very little systematic, peer-reviewed 
research that documents how, when and under what circumstances they affect 
patients and families’ experiences of participation in their care. 

There is also interest in innovative arrangements that result in “seamless” 
care for patients and families.  For example, patients with chronic 
conditions, such as diabetes mellitus or depression, may benefit from 
integrated delivery models that enhance communication and effectively 
integrate generalist and specialist care.  There are also specialized models 
of care that explicitly place patients at the center of complex evaluation 
and treatment planning, such as cancer care or the evaluation of a breast 
lump.  While there are some data that suggest improved patient perceptions of 
care, it is not clear that these arrangements impact on quality or outcomes 
of care.  The role of clinician as “navigator” for patients through the 
health care system - across different settings and providers – needs to be 
examined. 

AHRQ’s recently published PA, the Impact of Payment and Organization on Cost, 
Quality and Equity has identified payment mechanisms and organizational 
factors that facilitate or impede such efforts as a high priority area of 
research.  This PA focuses on research that results in enhanced understanding 
of the content of such innovations and how their adoption affects the 
delivery of care from the patient’s perspective and its impact on patients’ 
participation in their care.  Specifying how the impact of these efforts can 
be assessed is an essential component of the research encouraged by this PA.  
For example, coordination of care from the patient’s perspective has been 
challenging to measure reliably.  In addition, studies of innovative 
approaches to patient care should include assessment of the extent to which 
such innovations are adopted and modified throughout the adoption phase.

Illustrative questions might address:

o For which patients, and which conditions, are innovative strategies, such 
as group visits and enhanced electronic communication, most helpful?

o How and which components of practice re-engineering result in improved 
coordination and integration of care?  What is the impact of practice 
redesign on patients’ experience of and participation in care?

o What is the result of these innovative approaches on patient outcomes and 
quality of care?

o How can patients’ perceptions be effectively incorporated in efforts to 
redesign the processes of care?

2) Chronic Illness Management:

Numerous reports confirm that the burden of illness attributable to chronic 
illness is growing, in part due to the successes of acute medical care, and 
that improved management of chronic illness represents one of the most 
pressing challenges confronting health care in the 21st century.  Studies 
demonstrating the importance of modifying health behaviors (e.g., smoking, 
exercise, diet) and application of evidence-based practices to chronic 
illness management consistently find substantial opportunities for 
improvements in care.  However, there is an emerging consensus that the role 
of patients (and families, as appropriate) as co-managers of their health and 
health care has been under-estimated and under valued as a critical component 
of improvement efforts.  Lorrig and others have shown that patients who 
participate in self-management programs for chronic illness experience 
measurable increases in health status compared with patients who do not 
participate, they also report greater confidence in their ability to manage 
their illness(es) and decreased utilization of clinician visits.  (See Ref. # 
7) The Chronic Care Model developed by Ed Wagner and colleagues similarly 
emphasizes the importance of activated patients in achieving substantial 
improvements in care. The promising findings demonstrated by these and other 
studies, however, have not been broadly replicated, raising questions about 
their generalizability and substainability.  In addition, it is not clear to 
what extent selected components of these programs have been successfully 
integrated with other components of clinical care.

The challenges offered by the need to improve chronic illness care have 
stimulated multiple programs in Disease Management that attempt to integrate 
multiple dimensions of chronic illness care in a single program organized 
around a single disease condition, many report including components that are 
consistent with a patient-centered approach to care, as defined for this PA.  
Since there are few peer-reviewed evaluations of these programs, it is not 
known to what extent the components of these programs that emphasize patient 
participation are effective, and for which patients.  (See Ref. # 15) 
Moreover, since many individuals have more than one chronic condition, a 
critical question is which patients are most likely to benefit from and be 
engaged by disease-specific programs as compared with broader efforts that 
focus on multiple chronic conditions.  Given the high prevalence of mental 
illnesses, it is particularly important to consider the role of disease 
management programs in the context of co-existing mental illness.  Enhanced 
understanding of this issue is particularly relevant to the nation’s growing 
elderly population, for whom the experience of multiple chronic conditions is 
especially high.  Specific models that are effective for vulnerable 
populations at greatest risk for complications from chronic illness require 
further consideration.

Illustrative questions include:

o How can efforts to improve chronic illness management most effectively 
engage patients’ participation?  

o How is the implementation of efforts to enhance patients’ experience of 
and participation in their chronic illness care best assessed?

o How can strategies to enhance patients’ involvement in chronic illness 
care be most effectively integrated with all parts of clinical care?

o How can programs shown to be effective in select circumstances and 
populations be tailored to the special needs of persons who are members of 
racial or ethnic minority populations, those with low educational attainment 
and those with low literacy levels?

o How can greater involvement of community-based organizations, such as 
faith-based and other community organizations, improve chronic disease 
management?

o Which approach to chronic illness management – disease-focused or 
patient-centered – is most effective in promoting patient participation, and 
for which patients? 

o How can strategies to improve chronic illness care effectively engage all 
members of the health care team?

3) Shared Decision Making:

An important force in contemporary medicine for the past thirty years is the 
recognition of the role that many patients want to play in decision making 
with clinicians. No longer does the public want or expect physicians to make 
decisions independent of patient involvement.  Instead, physicians now 
recognize that to serve their patients best, they need to involve patients in 
the decision making process.  For many clinical decisions, no one 
intervention is clearly associated with enhanced quality of life or survival, 
but there are tradeoffs among different types of outcomes, such as length of 
survival, pain relief or preservation of function.  In other cases, 
interventions with substantial side effects offer modest but real survival 
benefits.  In each instance, the patient"s perspective is essential to 
informed decision making, particularly to weigh the value or importance of 
the various possible outcomes of care.

Shared decision making programs have been developed to assist clinicians and 
patients with clinical decisions involving two or more equally effective 
alternatives with different risks and benefits.  In some instances, these 
programs have been shown to result in improved patient satisfaction with the 
decision making process.  Proponents of such programs have also reported that 
patients may be more risk averse than their clinicians and that overall 
health care utilization may decrease.  A report commissioned by AHRQ in 1995 
indicated that the potential for this approach to influence the dynamics of 
clinician-patient decision making greatly exceeded available evidence of how 
and for which patients and decisions these programs are most effective.  
Recent efforts to include informed decision making for management of 
menopause as a dimension by which the performance of health plans is assessed 
suggest a clear need to understand how complex information can be most 
effectively communicated to patients facing decision alternatives associated 
with different risks and benefits.  Moreover, proliferation of health-related 
information on the Internet and elsewhere implies that more individuals will 
be exposed to information of varying credibility and quality independent of 
their encounters with the clinicians.  There are no rigorous evaluations of 
how increased information about health care treatments can be integrated into 
the patient-clinician decision process, which patients are most likely to 
benefit from shared decision making, or the mechanism by which these programs 
enhance patients’ experiences of or participation in their care.

Illustrative questions include:

o For which types of decisions can shared decision making programs be used 
most effectively – and how can they be integrated with clinical care?  
Factors that predict clinicians’ propensity to support this approach are of 
particular interest.

o How can complex information about risks and benefits of alternative 
treatments be most effectively communicated to patients (and families, where 
appropriate)?

o How can patients’ preferences for treatments, particularly for mental 
illness, be incorporated into clinician-patient decision making?

o How should information about risks and benefits be communicated – and by 
whom?  How does this vary for patients of different ethnic or racial 
backgrounds, education and literacy levels?

o What is the mechanism by which shared decision making approaches work – 
improved patient knowledge, enhanced self-efficacy, and/or other pathways?

4) Patient-Clinician Communication:

Numerous studies confirm the importance of effective patient-clinician 
communication as well as the need for improvements in this arena.  For 
example, (See Ref. # 5) Safran’s research assessing primary care performance 
has shown that patient’s trust in clinicians and their assessment of his or 
her clinical credibility are highly predictive of individuals’ willingness to 
attempt necessary lifestyle changes as well as their experiences of primary 
care.  Other research has shown that physicians’ communication styles can 
facilitate participatory decision making, are associated with the probability 
of experiencing a malpractice claim, and are likely to be an important 
component of providing culturally competent care.  Most research suggests 
that despite good intentions, there are ample opportunities for clinicians to 
improve their communication skills, though few studies have explicitly linked 
communication skills with care that is culturally and linguistically 
appropriate.  Though often linked with communication, there are many 
unresolved issues within the domain of cultural competency that require 
further research.  It is not yet known how new opportunities for exchange of 
information between patients and clinicians or health care organizations 
intersect with clinicians’ in-person communication skills to enhance 
patients’ experience or and participation in their care. In addition, few 
studies of patient-clinician communication have addressed the health system 
context in which these exchanges occur.  With the digital age, it will be 
important to measure the willingness of patients and providers to use 
alternative, more dyssynchronous forms of communication, such as e-mail.  As 
personal health information is increasingly available to patients, through 
mechanisms such as open access to electronic medical records, it will be 
important to assess the impact on patient-clinician communication.

Illustrative questions include:

o How does patient access to and use of web-based technologies and other 
modalities (e.g., Direct-to-Consumer advertising) for health information and 
education influence what they need from encounters with clinicians?

o How can clinicians use web-based and hand-held technologies to promote 
patient involvement in their care?

o For which patients is e-mail communication with clinicians most 
effective?  How does use of e-mail substitute for and/or effect the content 
of encounters with clinicians? 

o How can these new modalities for information exchange be most effectively 
used to enhance patient participation in care by members of racial or ethnic 
minorities, those with low educational attainment or low literacy levels?

o How can culturally competent communication be reliably assessed?

Methods

Individual projects may use a combination of rigorous qualitative and 
quantitative methods.  Qualitative methods may be especially useful in 
studying complex multi-tiered organizations and can either be used alone to 
deepen understanding of how organizational characteristics are connected to 
the quality and efficiency of health services or to complement quantitative 
methods and thereby strengthen the research design.  For a detailed 
discussion of the use of qualitative methods in health services research, see 
“Health Services Research”, 1999, Issue No. 5, Part II.  Quantitative methods 
should be rigorous and use state-of-the-art methodologies.  Projects using 
such methods should be grounded in appropriate theoretical frameworks.  
Hypotheses-testing projects should present competing hypotheses clearly. 

AHRQ encourages basic methodologic research, including methods and tool 
development as well as more applied research.  For example, the development 
of new measurement tools to permit accurate and valid estimates of patient 
participation in care, new approaches for assessing and defining health care 
utilization and assessment of alternative strategies for evaluating the 
success of patient-centered care are encouraged, as are the development and 
application of conceptual frameworks that enhance our understanding of how 
efforts to promote patient-centered care are effective in enhancing patients’ 
experience of and participation in their care. 

AHRQ also encourages partnerships with private and public organizations to 
facilitate development and sharing of scientific knowledge and resources, 
including cost-sharing mechanisms, projects that will produce results within 
2-3 years, and results that can be integrated rapidly into practice or 
policy.  AHRQ encourages investigators to consider evaluations of Federal- 
and state-level initiatives (e.g., demonstrations) intended to enhance 
patient-centered care.  Investigators from primary care practice-based 
research networks are strongly encouraged to apply for funding related to 
patient-centered primary care.

Investigators interested in large studies are urged to contact program staff.  
(See Inquiries) Specifically, proposed projects with direct costs exceeding 
$500,000 in any one year require permission from AHRQ program staff 2 months 
prior to submission of the application.

For research designed to use existing data, AHRQ encourages the use of data 
from the Medical Expenditure Panel Survey (MEPS) and other AHRQ data.  The 
MEPS is a rich data source for health care utilization, expenditure, 
insurance coverage and source of payment information, directly linking data 
about persons and their families with information obtained from their 
employers and health care providers.  For the survey year 2000, MEPS  
administered CAHPS items well as health status (SF-12 and EQ-5D) and items 
measuring attitudes to health and health care to all sampled adults.  A 
parent answered CAHPS and Living with Illness measures about each of their 
children.  These data will be released during 2002.  Researchers who wish to 
use non-public MEPS data, such as county-level data from the Health Resources 
and Services Administration’s Area Resource File should  examine the 
requirements of the CCFS Data Center.  Additional information on MEPS is 
available from the Data section of the AHRQ website http://www.ahrq.gov.

In addition, AHRQ has identified, as a special focus of research, issues 
related to enhancing patient-centered care for the following priority 
populations: low income groups, racial and ethnic minority groups, women, 
children, the elderly, individuals with special health care needs, including 
individuals with disabilities and those who need chronic care and end-of-life 
care, and individuals living in inner-city, rural and frontier areas.  
Research focused on specific conditions is also encouraged. 

SPECIAL REQUIREMENTS

Policy Relevance and Dissemination

Studies under this PA are expected (1) to contribute to our basic 
understanding of the impact of efforts to enhance patient-centered care, (2) 
to build capacity – research tools, data, and teams-- 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 (1) the decision-making audiences most 
interested in the proposed research and (2) how applicants anticipate their 
results being used and by what audiences.  Dissemination strategies should 
not be limited to publication in peer-reviewed journals but may encompass a 
variety of approaches, such as translating results into non-technical 
monographs and distributing them through associations of private and public 
officials, educating legislators, public administrators, health plan 
executives, employers, and others in seminars, and outreach to mass media.  
Plans, time lines, personnel, and budgets for such dissemination efforts 
should be explicitly presented.

Data Privacy

Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a-
1(c)), information obtained in the course of any AHRQ-supported study that 
identifies an individual or entity must be treated as confidential in 
accordance with any promises made or implied regarding the use and purposes 
of the data collection.  Applicants must describe in the Human Subjects 
section of the application procedures for ensuring the confidentiality of 
such  identifying information.  The description of the procedures should 
include a discussion of who will be permitted access to the information, both 
raw data and machine readable files, and how personal identifiers and other 
identifying or identifiable data will be safeguarded.

The grantee should ensure that computer systems containing confidential data 
have a level and scope of security that equals or exceeds those established 
by the Office of Management and Budget (OMB) in OMB Circular No. A-130, 
Appendix III - Security of Federal Automated Information Systems.  The 
National Institute of Standards and Technology (NIST) has published several 
implementation guides for this circular.  They are: An Introduction to 
Computer Security: The NIST Handbook, Generally Accepted Principals and 
Practices for Securing Information Technology Systems, and Guide for 
Developing Security Plans for Information Technology Systems.  The circular 
and guides are available on the web at
http://csrc.nist.gov/publications/nistpubs/800-12/.  

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 Federal government license to use 
these products and materials for AHRQ purposes. In accordance with its 
legislative dissemination mandate, AHRQ purposes may include, subject to 
statutory confidentiality protections, making research materials, data bases, 
and algorithms available for verification or replication by other 
researchers, and subject to AHRQ budget constraints, final products maybe 
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 in peer-reviewed journals and to market grant-supported products.

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
Website 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.

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

AHRQ program staff may also provide additional information concerning these 
policies (see also INQUIRIES).

APPLICATION PROCEDURES

Applications are to be submitted on the research grant application form PHS 
398 (rev. 5/01) available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.
Although applicants are strongly encouraged to use the 05/01 revision of the PHS 
398 as soon as possible, the 4/98 version may be used for receipt dates until 
January 9, 2002.  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.

Submit a signed, typewritten original of the application, including the 
checklist, and five signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040-MSC 7710
Bethesda, MD  29892-7710
(20817 for express/courier service)

AHRQ is not using the Modular Grant Application and Award process.  
Applicants for funding from AHRQ should prepare applications according to 
instructions provided with form PHS 398 (rev. 5/01).  

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.)  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 PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format. Although applicants are encouraged to begin using the 
5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to 
accept applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

AHRQ applicants are encouraged to obtain application materials from the AHRQ 
Publications Clearinghouse (see INQUIRIES).

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.

AHRQ encourages applicants to review all application form 398 instructions 
prior to completing an application.  The PHS 398 type size requirements (p.6) 
will be enforced rigorously and non-compliant applications will be returned.  

Receipt dates for R01 grant applications are three times annually: October 1, 
February 1, and June 1.  The last date for submitting initial R01 
applications in response to this PA is June 1, 2002.  R03 grant applications 
are received on March 24, July 24, and November 24. The last date for initial 
R03 applications in response to this PA is July 24, 2002.

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 standards set out in 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 grantee 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.

Grantees must also comply with the confidentiality requirements of Section 
903(c) of the PHS Act.  See the Data Privacy section for details on these 
requirements as well as references to Circular A-130 and its implementation 
guides from the National Institute of Standards and Technology.

In developing research plans, applicants should allow time for refining, 
approving, and processing their data requests.  Requests may take 6 months 
from the time they are submitted to complete.  Applications proposing to 
contact beneficiaries or their 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.

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 sponsored research.  

AHRQ expects grant recipients to keep the Agency informed of publications or 
the impact from Agency sponsored research.  Applicants must also agree to 
notify AHRQ immediately when a manuscript based on research supported by the 
grant is accepted for publication, and to provide the expected date of 
publication as soon as it is known, regardless of whether or not the grant 
award is active or has ended. 

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).

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and 
responsiveness to the PA by AHRQ staff.  Incomplete and/or non-responsive 
applications or applications not following instructions given under 
“Application Procedures” will be returned to the applicant without further 
consideration.  Accepted applications will be evaluated for scientific and 
technical merit by an appropriate peer review group convened in accordance 
with standard AHRQ peer review procedures.  Applications that are complete 
will be evaluated for scientific and technical merit by an appropriate peer 
review group convened in accordance with AHRQ peer review procedures.  As 
part of the initial merit review, all applications will receive a written 
critique and also may undergo a process in which only those applications 
deemed to have high scientific merit will be discussed and assigned a 
priority score.

General Review Criteria

The reviewers will be asked to discuss the following aspects of the 
application in their written critiques in order to judge the likelihood that 
the proposed projects will have a substantial impact on the pursuit of these 
goals.  Each of these criteria will be addressed and considered by the 
reviewers in assigning the overall score, weighting them as appropriate for 
each application.  Note that the application does not need to be strong in 
all categories to be judged likely to have a major scientific impact and thus 
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.

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

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

3. Innovation.  Does the project employ innovative information technology 
applications, concepts, approaches or methods?  Are the aims original and 
innovative?  Does the project challenge existing paradigms or develop new 
methodologies or technologies?
 
4. 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 patient safety issues?
 
5. Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

6. Policy Relevance.  Will the project provide Federal and State 
policymakers, and others participating in the formulation of such policy, 
with the evidence-based information they need to improve patient safety?  
Does the application provide a sound plan for achieving this purpose?

The initial review group will also examine: proposed dissemination 
activities, 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 and animal subjects,  and the safety of the research environment.

In addition, the following criteria will be applied:

o The extent to which the study results will be applicable and 
generalizable to situations beyond that of the study and contribute to the 
reduction or elimination of medical errors across a range of settings, levels 
of care, and populations.

o The extent to which meaningful and sustainable linkages between 
researchers and change agents (e.g., organizations, institutions, 
practitioners, policy makers, patients and patient advocacy groups) are in 
place and used to accelerate the adoption of findings into practice.

AWARD CRITERIA

Applications will compete for available funds with other investigator-
initiated applications requesting AHRQ support.  The following will be 
considered in making funding decisions: quality of the proposed project as 
determined by peer review, how well it fits AHRQ priorities, program balance 
and availability of funds.

INQUIRIES

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, 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.

AHRQ welcomes the opportunity to clarify any issues or questions from 
potential applicants who have read the PA.  Written and telephone inquiries 
concerning this PA are encouraged.   Direct inquiries regarding programmatic 
issues, including information on the inclusion of women, minorities, and 
children in study populations to:

Helen Burstin, MD / Kelly Morgan
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Boulevard
Rockville, MD  20852-4908
Telephone:  (301) 594-1782
Fax:  (301) 594-3721
Email:  hburstin@ahrq.gov / kmorgan@ahrq.gov

Carolyn Clancy, MD / Joanne Book
Center for Outcomes and Effectiveness Research
Agency for Healthcare Research and Quality
6010 Executive Boulevard 
Rockville, MD  20852-4908
Telephone:  (301) 594-4039
Fax:  (301) 594-3211
Email:  cclancy@ahrq.gov / jbook@ahrq.gov

For additional information on MEPS, email mepspd@ahrq.gov

For NIMH applicants, direct inquiries regarding programmatic issues to:

Junius J. Gonzales, M.D.
Services Research and Clinical Epidemiology Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Blvd., MSC 9631
Bethesda, MD  20892-9631
301-443-3364
jgonzale@mail.nih.gov 

Direct inquiries regarding fiscal and administrative 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

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.226.  Awards are made under authorization of Title IX of the Public Health 
Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999).  Awards 
are administered under the PHS Grants Policy Statement and Federal 
Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

REFERENCES

1. Institute of Medicine (IOM). Margarita P. Hurtado, Elaine K. Swift, and 
Janet M. Corrigan,  (Eds). Committee on the National Quality Report on Health 
Care Delivery, Board on Health Care Services.  Envisioning the National 
Health Care Quality Report. National Academy Press: Institute of Medicine. 
2000.

2. 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.
 
3. Holman H, Lorig K. Patients as partners in managing chronic disease. 
Partnership is a prerequisite for effective and efficient health care. BMJ 
2000 Feb 26,320(7234):526-7.

4. Cooper-Patrick L, Gallo JJ, Gonzales JJ, Vu HT, Powe NR, Nelson C, Ford 
DE. Race, gender, and partnership in the patient-physician relationship. JAMA 
1999 Aug 11,282(6):583-9.

5. Safran DG, Taira DA, Rogers WH, Kosinski M, Ware JE, Tarlov AR. Linking 
primary care performance to outcomes of care. J Fam Pract 1998 Sep,47(3):213-
20.

6. Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman 
EA. Chronic care clinics for diabetes in primary care: a system-wide 
randomized trial. Diabetes Care 2001 Apr,24(4):695-700.

7. Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, 
Carver P, Sixta C. Quality improvement in chronic illness care: a 
collaborative approach. Jt Comm J Qual Improv 2001 Feb,27(2):63-80.

8. Greenfield S, Kaplan S, Ware JE Jr. Expanding patient involvement in 
care. Effects on patient outcomes. Ann Intern Med 1985 Apr,102(4):520-8.

9. Greenfield S, Kaplan SH, Ware JE Jr, Yano EM, Frank HJ. Patients" 
participation in medical care: effects on blood sugar control and quality of 
life in diabetes. J Gen Intern Med 1988 Sep-Oct,3(5):448-57.

10. Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, 
Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic 
disease self-management program can improve health status while reducing 
hospitalization: a randomized trial. Med Care 1999 Jan,37(1):5-14.

11. Barry MJ, Fowler FJ Jr, Mulley AG Jr, Henderson JV Jr, Wennberg JE. 
Patient reactions to a program designed to facilitate patient participation 
in treatment decisions for benign prostatic hyperplasia. Med Care 1995 
Aug,33(8):771-82.

12. Laine C, Davidoff F. Patient-centered medicine. A professional 
evolution. JAMA 1996 Jan 10,275(2):152-6.

13. Braddock CH 3rd, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. 
Informed decision making in outpatient practice: time to get back to basics. 
JAMA 1999 Dec 22-29,282(24):2313-20.

14. Wagner EH. Chronic disease management: what will it take to improve 
care for chronic illness? Eff Clin Pract 1998 Aug-Sep,1(1):2-4.

15. Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A survey of 
leading chronic disease management programs: are they consistent with the 
literature? Manag Care Q 1999 Summer,7(3):56-66.

16. Cohen, J, K. Beauregard, A. Monheit, S. Cohen, et al.,  “The Medical 
Expenditure Panel Survey: A National Health Information Resource,” Inquiry 
(Winter 1996/97).  Health Services Research,1999,5(Part II).

17. NIMH’s references - Bridging Science and Service 
(http://www.nimh.nih.gov/research/bridge.htm), Translating Behav Science 
into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm).


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