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 301/710-0267, 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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