and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
DEMONSTRATING THE VALUE OF HEALTH INFORMATION TECHNOLOGY
RELEASE DATE: November 21, 2003
RFA Number: RFA-HS-04-012 (see NOT-HS-04-001)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
Agency for Healthcare Research and Quality (AHRQ)
(http://www.ahrq.gov)
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Library of Medicine (NLM)
(http://www.nlm.nih.gov)
NOTE: The policies, guidelines, terms, and conditions stated in this
announcement may differ from those used by NIH.
CFDA NUMBER: 93.226 (AHRQ) and 93.879 (NLM)
LETTER OF INTENT RECEIPT DATE: February 6, 2004
APPLICATION RECEIPT DATE: April 22, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
o References
PURPOSE OF THE RFA
The Agency for Healthcare Research and Quality (AHRQ) announces the
availability of research grants to assess the value derived from the adoption,
diffusion, and utilization of health information technology (HIT) to improve
patient safety and quality of care. AHRQ is seeking proposals that elucidate
the value of HIT from a variety of perspectives, including patients,
providers, purchasers, payers, policymakers, or other important stakeholders
and decision makers. The main objective of this RFA is to support projects
that will increase our knowledge and understanding of the value of HIT, which
includes clinical, safety, quality, financial, organizational, effectiveness,
efficiency, or other direct or indirect benefits that may be derived from the
use of HIT in the delivery of health care. The findings from this initiative
should provide these stakeholders with information needed to make better and
more informed clinical, purchasing, and other important health care decisions
regarding the use of HIT in their environment. The other objective of this
RFA is to support the development of models or other tools that can be used to
help demonstrate the value of HIT or to advance the adoption of HIT.
For the purpose of this RFA, “value” is defined as clinical, organizational,
financial, or other benefits derived from the adoption, utilization, and
diffusion of HIT less the costs of achieving these benefits. Specific aspects
of value may include things such as: reduction in medical errors; improved
use of effective and recommended interventions; decreased use of inappropriate
or ineffective interventions; increased use of clinical guidelines and
evidence-based clinical decisions; improvements in access to care and quality
of care; improvements in provider productivity; more efficient use of
personnel; reductions in costs (total costs or costs related to specific
activities and functions); enhanced revenues; better coordination of care
among providers; improved patient involvement and satisfaction; and greater
transparency and accountability of provider operations. These potential
benefits must be weighed against the costs and potentially detrimental
consequences of HIT adoption.
Applicants are encouraged to submit proposals that examine the value of HIT in
diverse health care settings (e.g., inpatient hospitals, outpatient clinics,
nursing homes, home health, and community care), consider the perspective of
various stakeholders (e.g., patients, providers and health care
organizations), and include priority populations (e.g., 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). AHRQ is also specifically
interested in applications that will examine the value of new and emerging
HIT, as well as applications that explore the unique barriers faced by rural
and small community providers in adopting HIT and opportunities for overcoming
these barriers.
The National Library of Medicine (NLM) supports research in biomedical
informatics, bioinformatics, computational biology and health information
sciences in such areas as : representation of medical knowledge in computers;
organization and retrieval issues for image databases; enhancement of human
intellectual capacities through virtual reality, dynamic modeling, artificial
intelligence, and machine learning; medical decision-making; linguistic analyses
of medical languages and nomenclatures; management of information in disasters;
and approaches to linking genome and phenome data. In the area of clinical
informatics, NLM is particularly interested in ways computers and networks
bring value to the delivery of health care, the management of health
information, and the support of informed decisionmaking by consumers, patients,
health care providers, and health care administrators. Other fundamental areas
of interest include context-appropriate information to guide learning and
decisions; standards based information management that employs standard
vocabularies and information exchange protocols; and digital libraries.
This RFA is one in a series of solicitations to be issued by AHRQ in FY 2004
on the use of HIT to improve patient safety and quality of care. The
solicitations form an integrated set of activities designed to explore
strategies for successful organizational and community-wide planning and
implementation of HIT solutions and to demonstrate the value of HIT in patient
safety and quality of care. The FY ’04 HIT initiative will place particular
emphasis on the challenges facing rural and small communities in integrating
HIT into their health care delivery systems. In addition to this RFA, other
grants and contracts to be released as part of this program include:
1. Transforming Healthcare Quality through Information Technology (THQIT)
Planning Grants - planning grants to provide organizations and communities
with the resources needed to develop their capacity to compete for AHRQ (and
other funding agencies) implementation grants and further develop their HIT
capabilities for improving patient safety and quality of care. Planning grants
will enable these entities to begin planning and developing their HIT
infrastructure and data sharing capacity among clinical provider organizations
in their communities.
2. Transforming Healthcare Quality Through Information Technology (THQIT)
Implementation Grants - implementation grants aimed at providing resources to
community partners who have successfully completed the planning process and
plan to implement HIT in their practice setting. These projects must also
include an evaluation of the effects of HIT on important patient safety and
quality measures. The objective of this RFA is to support implementation and
diffusion of HIT and to assess the extent to which HIT contributes to
measurable and sustainable improvements in patient safety and quality of care.
Research resulting from this RFA should inform AHRQ, providers, patients,
payers, policymakers, and the public about how HIT can be successfully
implemented in diverse health care settings and lead to safer and better
health care.
3. Health Information Technology Resource Center (HITRC) - The center will
provide technical assistance to grantees; serve as a repository for best
practice assimilation and diffusion; help develop, maintain and export
executable knowledge for clinicians and patients; offer expert HIT support for
providers and communities; perform and sponsor educational activities; and
develop and disseminate tools to help providers and organizations utilize HIT
to improve patient safety and quality of care.
In July 2003, AHRQ convened a diverse group of approximately 50 experts who
helped the Agency to identify gaps in knowledge relating to the use of HIT and
provided recommendations on important thematic areas for AHRQ’s HIT
initiatives in FY 2004. Among the panel’s many recommendations were the need
for more research on the impact of HIT on important health-related outcomes;
more research on HIT in diverse healthcare settings; the need to support local
and regional HIT collaborative projects that would lead to standards-based
data sharing across healthcare delivery sites; the need to demonstrate the
value of HIT in improving patient safety and quality of care, including
direct/indirect and tangible/intangible benefits; the need to study incentives
and disincentives to the adoption and use of HIT; the need for technical
assistance to providers, organizations, and communities in order to implement
HIT successfully in their environment; and the need to develop evidence-based,
executable knowledge content and decision-support tools to support clinical
decision-making. The panel also encouraged collaboration between AHRQ and
other Federal agencies, such as the Office for Rural Health Programs (OHRP) at
the Health Resources and Services Administration (HRSA) and the Center for
Medicare and Medicaid Services, to leverage the resources, expertise, and
experiences of these diverse Federal agencies and increase the program’s
chances of success. Finally, the panel stressed the need for developing
collaborative partnerships and HIT programs that are viable and sustainable.
A summary of the proceedings is available on the AHRQ website at
http://www.ahrq.gov/data/hitmeet.htm.
RESEARCH OBJECTIVES
Definitions
For purposes of this RFA, the following definitions will apply:
1. Health Information Technology is broadly defined as the use of
information and communication technology in healthcare and includes, but is
not limited to, electronic health records, personal health records, e-mail
communication, clinical alerts and reminders, computerized provider order
entry, computerized decision support systems, hand-held computers, electronic
information resources technology, and electronic monitoring systems.
2. Value of Health Information Technology is defined as clinical,
organizational, financial, or other benefits derived from the adoption,
diffusion, and utilization of HIT less the costs of achieving these benefits.
o Financial benefits include cost reduction, revenue enhancement and
productivity gains.
o Clinical benefits include advances in care processes, improved patient
outcomes, improvements in safety and quality, and better monitoring of
diseases and other health risks.
o Organizational benefits include improvements in organizational
effectiveness – as evidenced in work and quality improvement processes;
communication among individuals, groups and organizations; satisfaction of
needs and expectations of patients, providers, and other stakeholders;
capacity to adapt to changing technical and operating conditions, such as
fluctuations in patient load, acuity, and emergency conditions; and
organizational risk mitigation.
o Costs include equipment, personnel, training, hardware, software,
modeling, networks, configuration, linking, or other costs incurred to achieve
HIT implementation and interoperability. Changes that adversely affect
organizational or individual revenue or resources such as lost productivity,
decreased revenue, or reduced clinical efficiency can also be considered to be
a “cost” to the system.
3. Electronic Health Record Systems are defined by the Institute of
Medicine’s Letter Report on the Key Capabilities of an Electronic Health
Record System (http://www.iom.edu/report.asp?id=14391). EHR systems include
the ability to collect longitudinal data for and about a person in an
electronic format; immediate electronic access to person and population level
information by authorized users; provision of knowledge and decision-support
tools that enhance the safety, quality and efficiency of health care; and
support of efficient processes for health care delivery.
4. Clinical decision support systems (CDSS) are defined as computer
applications that assist clinicians in the management of their patients at the
point-of-care by integrating medical knowledge with patient characteristics
and generating patient-specific recommendations. CDSS can take the form of
computerized reminders, alerts, guidelines, order sets or other similar tools.
5. Patient Safety refers to the absence of the potential for, or occurrence
of, healthcare associated injury to patients. Patient safety can result from
the avoidance of medical errors as well as taking action to prevent errors
from causing injury. AHRQ patient safety activities involve four major
components: identifying threats; identifying and evaluating effective
practices; education dissemination, and implementation interventions that
enhance patient safety; and maintaining vigilance.
o Medical Errors are defined as mistakes made in the process of care that
result in, or have the potential to, result in harm to patients. Mistakes
include the failure of a planned action to be completed as intended or the use
of a wrong plan to achieve an aim. Medical errors can result from an action
that is taken (error of commission) or an action that is not taken (error of
omission).
o Medication Error is defined as preventable inappropriate use of medication
including inappropriate prescribing, dispensing, or administering.
o Adverse Event is defined as an untoward, unintended (usually), and
unanticipated (usually) outcome that occurs in association with health care.
Preventable adverse events are a subset of adverse events that are judged to
have been avoidable if appropriate and reasonable steps had been taken. For
example, an anaphylactic reaction to penicillin is an adverse event. It is a
preventable adverse event if the patient’s allergy to penicillin is noted in
his or her chart or if the patient knows of his or her history of penicillin
reactions and is capable to communicating it to the clinician.
o Preventable Injury is defined as harm that could be avoided through
reasonable planning or proper execution of an action.
o Quality, with respect to health care, is defined as doing the right thing,
at the right time, in the right way, for the right person, and having the best
possible results. It means striking the right balance in the provision of
health services by avoiding overuse (e.g., getting unnecessary tests or
procedures), under use (e.g., not being screened for high blood pressure or
not being treated with a beta-blocker when clinically indicated), or misuse
(e.g., being prescribed drugs that have dangerous interactions or being given
the wrong dose of a medication).
o Healthcare Environment is defined as the structures and processes employed
to provide health care. They reflect the characteristics of the facility
(e.g., size, location, specialty, licensure, certification, equipment, working
conditions) and the organization (e.g., personnel mix and experience, lines of
authority, leadership, policies and procedures, governance, culture).
o Rural Hospitals are defined as acute care hospitals physically located in
a rural or non-metropolitan area within the borders and confines of any state
or U.S. territory.
o Rural and/or non-metropolitan areas are defined as geographic regions that
either:
Reside within a county or area not designated by the Office of Management and
Budget as a Metropolitan Statistical Area (MSA) or Metropolitan New England
City or Town Area (MNECTA).
http://www.census.gov/population/estimates/metro-city/03msa.txt
or
Reside within a non-metropolitan region of an MSA or MNECTA designated county
or area as defined by the Economic Research Service (ERS) of the United States
Department of Agriculture (USDA) Rural-Urban Commuting Area codes (RUCA).
Non-metropolitan areas will be defined by a RUCA code of between 4 and 10.
http://www.ers.usda.gov/briefing/rural/data/desc.htm
o Small Hospitals are defined as acute care hospitals containing no more
than 100 licensed beds or fewer than 6,000 inpatient admissions in the most
recent 12-month period.
Partnerships are defined as a collaborative working relationship between three
or more organizations formalized through one or more written agreements that
contain at a minimum the following elements: 1) substantial and meaningful
contributions of personnel, expertise, money, equipment, facilities or other
important resources to and from each of the partners; and 2) sharing of
clinical and research data across healthcare delivery sites.
Background
In 1998 the Committee on the Quality of Health Care in America, established
within the Institute of Medicine (IOM), was appointed to identify strategies
for achieving substantial improvement in the quality of health care in
America. The committee’s first report, To Err is Human: Building a Safer
Health System, was released in November 1999 and focused on issues relating to
patient safety [1]. The study found that 44,000 to 98,000 people die in U.S.
hospitals each year as a result of medical errors.
In March 2001, the Committee released a follow-up report, Crossing the Quality
Chasm: A New Health System for the 21st Century, which addressed a broader
range of quality issues and provided a strategic direction for redesigning the
health care delivery system [2]. They reported that the U.S. health care
system is plagued by serious quality problems resulting from an outmoded and
inadequate delivery system, which is incapable of providing high-quality care
to its population in a consistent manner. The Committee went so far as to
state:
“In its current form, habits, and environment, American health care is
incapable of providing the public with the quality health care it expects and
deserves.”
In particular, HIT was identified as one of the four critical forces that
could significantly improve health care quality.
“There must be a renewed national commitment to building an information
infrastructure to support health care delivery, consumer health, quality
measurement and improvement, public accountability, clinical and health
services research, and clinical education.”
In addition, the National Committee on Vital and Health Statistics (NCVHS) and
the President’s Information Technology Advisory Committee have recommended the
development of a National Health Information Infrastructure (NHII) to improve
safety, reduce costs and enhance the quality of healthcare.
Over the past 30 years, research has demonstrated that HIT can improve patient
safety and quality of care. For example, at LDS Hospital in Salt Lake City, a
computerized physician order entry (CPOE) system with decision support reduced
the incidence of adverse drug events related to antibiotic administration by
75% [3]. It also significantly reduced orders for drugs for which patients
reported allergies and adverse effects that were caused by antibiotics [4].
At the Regenstrief Institute for Health Care in Indianapolis, researchers
demonstrated that automated computerized reminders increased orders for
recommended interventions from 22% to 46% [5]. At the Brigham and Women’s
Hospital in Boston, use of a CPOE system with decision support led to
increased use of appropriate medications for high-risk clinical situations,
such as an increase in the use of subcutaneous heparin to prevent venous
thromboembolism, from 24% to 47%. Medication errors were also reduced by 19%
to 84% [6]. A 1998 systematic review of the literature that assessed the
effects of 68 computer-based clinical decision support systems demonstrated a
beneficial, though variable impact on physician performance in 43/65 studies
(66%) and a beneficial effect on patient outcomes in 6/14 studies (43%) [7].
In a more recent study, the Center for Information Technology Leadership
(CITL) at Harvard recently projected that the adoption of advanced
computerized physician order entry systems in ambulatory care settings could
eliminate more than two-million adverse drug events and prevent more than
190,000 hospitalizations per year; this improvement in quality and safety
could also generate billions of dollars in savings in the healthcare systems
[8].
Despite this evidence, physicians, hospitals and other healthcare facilities
have lagged behind most industries in their adoption of HIT systems. Although
accurate data are not available, it is estimated that less than 10% of
facilities across the United States have comprehensive HIT systems in place
and use them to provide clinical care. Reasons for this paucity of investment
in HIT include misaligned financial incentives, high cost of investing in HIT
systems, current evidence on HIT is limited to a few sites with “home grown”
legacy systems, limited data that HIT improves important outcomes, potentially
disruptive effects on clinical workflow, cultural barriers, and competing
priorities. In addition, little is known about the relationship between HIT
and financial or other economic aspects of healthcare.
Healthcare providers, consumers, and decision makers do not often have the
knowledge or resources needed to make major HIT purchasing or utilization
decisions. Key information that is needed to make informed decisions, such as
improvements in various aspects of safety and quality of care, direct and
indirect return on investment, effects on clinical workflow, and effects on
individual or system efficiency are currently missing or incomplete. Although
information is often available on the upfront costs for purchase and
implementation of various HIT components, data on indirect costs and other
important cost components are often not available. Further, information on
the short- and long-term benefits of HIT investment and utilization is scant
or nonexistent. Finally, health care purchasers are reluctant to provide
incentives for the use of HIT without more evidence that HIT substantially
improves safety and quality or that it provides a significant return on
investment. The lack of financial incentives for HIT investment, lack of
high-quality evidence that HIT improves important outcomes in diverse health
care settings, lack of widespread industry experience, and the limited number
of useful and generalizable models create formidable barriers to the adoption
and use of HIT.
Fortunately, efforts are currently underway in both the private and public
sector to accelerate the rate of HIT adoption. Many health care systems have
already implemented, or are planning to implement, electronic health records
(EHRs), computerized provider order entry (CPOE) systems with clinical
decision support, bar coding systems, automated medication dispensing systems,
personal health records, or other HIT tools to improve patient safety and
quality of care. Some of the more recent efforts are even being spearheaded
by the payers. For example, the Bridges to Excellence program was launched by
three large employer groups and will reward participating providers who use
EHRs in the care of patients with diabetes and heart disease and who achieve
certain levels of high-quality care. Another initiative, which is being
developed by the Leapfrog Group in partnership with AHRQ and the Center for
Medicare and Medicaid Services (CMS), will promote the use of e-prescribing,
e-lab management and e-reminders in the ambulatory care setting.
Additionally, CMS recently announced the Physician Group Practice
Demonstration and the Premier Hospital Demonstration, two large demonstration
projects that involve the use of HIT to improve quality of care, reduce costs,
and support the reporting of quality, administrative, and systems data to CMS.
While these efforts are encouraging, there is still a tremendous need for
more information on the value of HIT to assist providers, patients, payers,
policymakers, and other health care decision makers.
Providers and patients in rural, small, and other underserved communities are
struggling with similar issues as those described above. In addition, these
communities face other challenges such as a poor or non-existent IT
infrastructure, lack of available capital for HIT investment, poor payer mix,
lack of providers and specialty care, and patients who must often seek care
across long distances, which create an even greater challenge in demonstrating
the value of HIT in these communities.
Objectives and Scope
AHRQ announces the availability of research grants to assess the value derived
from the diffusion, adoption and utilization of HIT to improve patient safety
and quality of care. Specifically, AHRQ is seeking proposals that elucidate
the value of HIT from a variety of perspectives, including patients,
providers, purchasers, payers, policymakers, or other important stakeholders
and decision makers. The main objective of this RFA is to support projects
that will increase our knowledge and understanding of the value of HIT, which
includes clinical, safety, quality, financial, organizational, effectiveness,
efficiency, or other direct or indirect benefits that may be derived from the
use of HIT in the delivery of health care. The findings from this initiative
should provide these stakeholders with information needed to make better and
more informed clinical, purchasing, and other important health care decisions
regarding the use of HIT in their environment. The other objective of this
RFA is to support the development of models or other tools that can be used to
help demonstrate the value of HIT or to advance the adoption of HIT.
The agency is specifically seeking the following types of projects:
Projects that will increase our knowledge and understanding of the value of
HIT. Value can include clinical, organizational, financial, or other benefits
of HIT. These may take the form of research projects that examine direct and
indirect, tangible and intangible, and quantitative or qualitative aspects of
the value proposition of HIT. They may also take the form of demonstration
projects that help define, assess, and illustrate various components of HIT
value. AHRQ is interested in projects that explore the value of current or
emerging HIT. Clarifying the costs and benefits of community-wide efforts to
promote interoperability of clinical data exchange is a priority for this
solicitation.
Models and other tools that address clinical, financial, economic,
organizational, effectiveness, efficiency or other aspects of HIT value and
lead to a better understanding of how HIT provides value to patients,
providers, payers, or other components of the healthcare system. For example,
an applicant may propose to develop and test a simulation model that
demonstrates return on investment (ROI), economic impact, effect on safety and
quality, or other important aspects of HIT value in different health care
settings and under variable conditions. AHRQ anticipates that tools developed
under this initiative would be made available to health care decision-makers
and provide them with the ability to utilize current and emerging evidence to
delineate the value of HIT and guide HIT investment and implementation
decisions in their own health care environment.
AHRQ is interested in supporting local and regional collaborative partnerships
that include a diverse array of health care settings (e.g., primary care,
outpatient clinics, inpatient hospital, nursing home, home health, and
community care) and account for the needs, objectives, and perspectives of
patients, providers, healthcare organizations, and other stakeholder groups.
AHRQ is also especially interested in projects that include priority
populations. It is important that research projects, models, tools, and other
activities that are funded through AHRQ’s HIT portfolio are generalizable
across various types of populations, geographic areas, and health care
settings.
Research areas that are of particular interest to AHRQ include but are not
limited to:
1. What are the economic implications of HIT adoption, diffusion, and
utilization at the individual, local, regional, national, health system, or
organizational level?
- Does HIT positively affect local, state, national, community, provider,
payer, or organizational health expenditures through improvements in safety,
quality, effectiveness or efficiency?
- Can HIT mitigate risk and liabilities and improve the medical malpractice
environment through improved data collection, documentation, communication,
decision support, safety, quality of care, or other means?
- What is the business case for HIT? Can HIT provide a meaningful return on
investment (ROI)? Should ROI be the driver for HIT investment or should
investment in HIT be part of the cost of doing business (e.g., part of the
cost of providing safe, high-quality health care)?
- Can HIT result in cost savings through improvements in safety, quality,
organizational improvements, workflow re-engineering, system efficiencies, and
more effective provision of health care services and interventions? What are
the different types of savings that can be realized through the use of HIT?
Do different savings accrue to different stakeholders, and, if so, can the
benefits be quantified across the various stakeholders?
- Does HIT facilitate revenue enhancements through such mechanisms as
increased productivity, more appropriate use of personnel and resources,
improved documentation and billing, etc.?
- What are the financial and economic barriers to HIT implementation and
use? What are the incentives and disincentives for investing in HIT? What are
some methods or strategies for creating incentives and overcoming the
disincentives?
- What are the financial and organizational impacts of improving patient
safety and quality of care through HIT?
- Is HIT cost effective? Do the safety, quality, and financial benefits
justify the costs of implementation and maintenance and the impact on the
organization and stakeholders affected by the adoption of HIT?
- What are the advantages and disadvantages of HIT adoption and use among
various stakeholders and across different health care settings?
2. What is the value proposition for investing in HIT for rural and small
communities?
- Are there unique aspects of rural and small communities, providers,
patients, etc. that facilitate or hinder the adoption of HIT in these
settings?
- What are the clinical, safety, quality, financial, organizational or other
benefits of HIT adoption in rural and small communities?
- Are there specific aspects of HIT that provide more value than others in
these settings?
- Are there certain business models for HIT adoption that would lead to
successful implementation and use of HIT in these settings?
- What are the financial and economic barriers to HIT implementation and use
in rural and small communities? What are the incentives and disincentives for
investing in HIT? What are some methods or strategies for creating incentives
and overcoming the disincentives?
3. What is known about best practices in the use of HIT? What has been
successful, what has failed, and why have some initiatives succeeded and
others failed? Are there factors that predict success or failure? What are
the lessons learned over the past 30 years of HIT adoption? Can lessons
learned from these successes and failures be applied to other care settings?
4. What are the tangible and intangible benefits of uniform standards for
health information exchange, system interoperability, and data sharing? What
are the potential problems and what are ways to address these concerns?
- Among the various types of health care settings (e.g., inpatient
hospitals, outpatient clinics, nursing homes, home health, etc.); among the
various stakeholders (providers, patients, payers, etc.); or among different
geographic locations or service areas (e.g., rural areas, small communities,
metropolitan areas, cities, states, etc.)
5. Creation and diffusion of knowledge regarding the value of HIT
- Creating new knowledge and evidence regarding the benefits of HIT in
various health care settings.
- Development and evaluation of methods, tools, and strategies to disseminate
information about the current state of the health care delivery system (e.g.,
safety, quality, efficiency, appropriateness of care, and other attributes) to
consumers, providers, purchasers, payers, policymakers, or other decision-
makers.
- Development and evaluation of methods, tools, and strategies to
disseminate information about the evidence for HIT in improving safety and
quality to consumers, providers, purchasers, payers, policymakers, or other
decision-makers.
- Development and evaluation of toolkits and other resources that can be
used by consumers, providers, purchasers, payers, policymakers, or other
decision-makers to help them understand the value of HIT and assist them to
make HIT purchasing and implementation decisions.
Overall, AHRQ is looking to support research, demonstration projects, tools,
or other activities that will improve our knowledge and understanding of the
value of HIT in health care and advance the use of HIT to improve patient
safety and quality of care.
MECHANISM OF SUPPORT
This RFA will use the R01 award mechanism, in which the Principal Investigator
will be solely responsibility for planning, directing, and executing the
proposed project. The total project period for an application submitted in
response to this RFA may not exceed three years. This RFA is a one-time
solicitation. Future unsolicited, competing continuation applications based
on this project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review process. The
anticipated award date is September 30, 2004. At this time, it is not known
if this RFA will be reissued. Applications that are not funded in the
competition described in this RFA may be resubmitted as new investigator-
initiated applications (R01) using the standard receipt dates for new
applications described in the instructions of the PHS 398 application.
AHRQ is not using the Modular Grant Application and Award Process.
Applications submitted in modular format will be returned without review.
FUNDS AVAILABLE
AHRQ intends to commit up to $10,000,000 (ten million dollars) in FY 2004 to
fund a minimum of 20 new grants in response to this RFA. An applicant may
request a project period of up to three years and a budget of up to $500,000
per year in total costs. Applications that request budgets greater than
$500,000 per year in total costs will be returned without review.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will vary. Although the financial plans of AHRQ currently provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of scientifically
meritorious applications.
Cost sharing and matching are not required of applications submitted in
response to this RFA.
ELIGIBLE INSTITUTIONS
Your institution may submit (an) application (s) if it has one or more of the
following characteristics:
o Non-profit organization
o Domestic organization
o Public and private non-profit institution, such as a university, clinic,
college, or hospital
o Unit of State and local government
o Tribe or Tribal Organization
o Faith-based or community-based organizations
Because this RFA is principally intended to support the adoption and diffusion
of HIT in the U.S., no awards will be made to foreign institutions. Foreign
organizations may participate in projects as members of consortia or as
subcontractors.
Organizations described in sections 501(c) 4 of the Internal Revenue Code that
engage in lobbying are not eligible.
Institutions and partnerships that are considered safety net providers are
encouraged to apply.
Practice-based research networks, such as Integrated Delivery Systems Research
Networks (IDSRNs) and Primary Care Practice-Based Research Networks (PBRNs)
are eligible and encouraged to apply. The ISDRNs are a model of field-based
research that links experienced health services researchers with large health
care delivery systems to conduct user-driven research on an accelerated
timetable. A PBRN is a group of clinical practices devoted to the primary care
of patients and with the research capacity to conduct health services research
related to community-based practice.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to develop
and submit an application. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for AHRQ programs.
The principal investigator should be an experienced senior level person and
should devote a considerable and meaningful portion of his/her time to this
project (at least 25%).
SPECIAL REQUIREMENTS
Studies and projects under this RFA are expected to produce evidence, tools,
models, and other information or resources that can be utilized by public and
private entities to improve the safety, quality, effectiveness and efficiency
of health care. AHRQ recognizes that rural and small community hospitals,
clinics, and other components of these health care settings often face unique
challenges in terms of knowledge, experience, personnel, infrastructure,
resources and other needs that are not addressed by traditional health
services research funding opportunities. Therefore, AHRQ strongly encourages
researchers with experience in working with rural or small underserved
communities to submit proposals focusing on issues applicable to these
settings. For proposals that are not focused on rural or small community
settings, AHRQ encourages proposals that will generate knowledge, tools, or
other end-products that are applicable across multiple health care settings.
Strategies for the dissemination of knowledge, tools, or other end-products
that may result from the research should be discussed in the proposal and not
simply limited to presentations at academic meetings or publications in peer-
reviewed journals. AHRQ is interested in broader mechanisms of disseminating
research findings, tools, or other end-products to a wide range of potential
end-users.
The Principal Investigator and at least one key program staff member from the
project are required to attend two annual grantee meetings in the Washington
D.C. area. Travel to these annual meetings should be included in the
project’s budget.
AHRQ is committed to supporting public-private partnerships that will result
in interoperable, standards-based data sharing across multiple care sites and
lead to measurable, generalizable and sustainable improvements in patient
safety and quality of care. Where applicable, investigators are encouraged to
comply with Federal health information interoperability standards that have
been adopted by the Federal Government’s Consolidated Health Informatics (CHI)
Initiative. CHI is a collaborative effort between the Department of Health
and Human Services, the Veterans Affairs/Veterans Health Administration, the
Department of Defense, and other Federal agencies to adopt government-wide
health information standards. The first set of CHI standards were announced
on March 21, 2003 and include: Health Level 7 (HL7) messaging standards;
Logical Observation Identifier Name Codes (LOINC) to standardize the
electronic exchange of clinical laboratory results; National Council on
Prescription Drug Programs (NCDCP) standards for retail pharmacy transactions;
Institute of Electrical and Electronics Engineers 1073 (IEEE1073) standards
that allow for health care providers to plug medical devices into information
and computer systems; Digital Imaging Communications in Medicine (DICOM)
standards that enable retrieval and transfer of images and associated
diagnostic information. More information on CHI can be found at:
http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm
Projects funded under this RFA are considered part of the AHRQ HIT portfolio.
As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health
Information Technology Resource Center (HITRC). The HITRC will provide a
variety of services, including coordinating the activities of awardees across
all of the HIT patient safety RFAs. All awardees under this RFA are expected
to participate in the activities of the HITRC, including participation in
periodic conference calls and an annual meeting of all awardees in the
Washington, D.C. area.
When appropriate and feasible, AHRQ expects awardees to work with each other
to identify collaborative opportunities that can contribute to the overall
success of their projects and the overall success of AHRQ’s HIT and patient
safety initiatives. These collaborative relationships may be facilitated
through the HITRC, initiated by the awardees through self-identified
opportunities, or developed via other mechanisms during the life of the
project.
RAND is under contract to AHRQ to serve as its Patient Safety Evaluation
Center. RAND’s evaluation contract activity is not intended to evaluate the
specific performance of individual patient safety projects but rather to
provide an objective, comprehensive, and longitudinal view of AHRQ’s patient
safety initiatives. This work is being accomplished by characterizing AHRQ’s
(1) progress in achieving its goals, (2) effects of patient safety
interventions undertaken within the patient safety initiative on important
health-related outcomes, and (3) diffusion of new knowledge and practices
beyond patient safety initiative participants. The RAND team will conduct
interviews with the principal investigators and other key personnel that are
responsible for each of the patient safety grants and will conduct occasional
site visits to learn more about new interventions and tools being developed
and implemented. Agreeing to full cooperation with the RAND evaluation team
is a requirement (prerequisite) for receiving AHRQ patient safety grant
support.
PRIORITY POPULATIONS
The Healthcare Research and Quality Act of 1999
(http://www.ahrq.gov/hrqa99a.htm) reauthorized AHRQ and directed the Agency,
in carrying out its mission, to conduct and support research and evaluations,
and to support demonstration projects, with respect to the delivery of health
care in inner-city and rural areas (including frontier areas); and health care
for priority populations, which include 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. To implement this directive, AHRQ published a
notice in the NIH Guide on February 28, 2003, establishing a new Agency policy
on the Inclusion of Priority Populations in health services research (see
http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this RFA who seek funding from AHRQ should address the
requirements of including priority populations as specified in the Notice.
PUBLICATION TRANSMITTAL: GENERAL AHRQ REQUIREMENTS
In keeping with the Agency’s efforts to translate the results of AHRQ-funded
research into practice and policy, grantees and/or contractors are to inform
the Office of Communications and Knowledge Transfer (OCKT) when articles from
their studies are accepted for publication in the professional literature.
Grantees and contractors should also discuss any ideas about other
dissemination and marketing efforts with OCKT staff. The goal is to ensure
that efforts to disseminate research findings are coordinated with other
Agency activities to maximize awareness and application of the research by
potential users, including clinicians, patients, healthcare systems,
purchasers and policymakers. This is critical when outreach to the general
and trade press is involved. Contact with the media will take place in close
coordination with OCKT and the press offices of the grantee’s or contractor’s
institutions. In cases when products are created (such as annual or final
reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to
submit to OCKT a brief plan describing how the product will be publicized. An
OCKT staff person will be assigned to each product and will coordinate the
implementation of the plan, especially issues related to printing, electronic
dissemination, and outreach to the media.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions regarding scientific/research issues, including
information on the inclusion of women, minorities, and children in study
populations to:
Eduardo Ortiz, M.D., M.P.H.
Senior Advisor for Clinical Informatics
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1585
FAX: (301) 427-1597
Email: EORTIZ@AHRQ.GOV
Valerie Florance, Ph.D.
Program Officer
Program Management Branch
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4882
FAX: (301) 402-2952
EMAIL: floranv@mail.nlm.nih.gov
o Direct your questions about peer review issues to:
Patricia Thompson
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
FAX: (301) 427-1562
Email: pthompso@ahrq.gov
o Direct your questions about financial or grant management matters to:
George Gardner
Grants Management Specialist
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1453
FAX: (301) 427-1462
Email: ggardner@AHRQ.gov
Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301, 6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: (301) 402-0421
moweryd@mail.nlm.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows AHRQ staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Eduardo Ortiz, M.D., M.P.H.
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1585
FAX: (301) 427-1597
Email: EORTIZ@AHRQ.GOV
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B;) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398
document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
To ensure equity among applicants, however, applicants using the Form PHS 398
must observe page number and font size requirements specified in the form.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SUPPLEMENTARY INSTRUCTIONS:
Application Preparation
The following supplemental instructions to the form PHS 398 should be used to
guide the preparation of the application:
In the Description (page 2) indicate which specific Area (s) of Interest, as
listed in the Objectives and Scope section, the proposed project intends to
concentrate on.
Detailed Budget. In general, allowable budget items for these projects are
limited to a portion of the salaries of the project staff including the PI,
consultation fees, key administrative and clerical support personnel, as
allowable under the appropriate cost principles, telephone and IT costs,
copying, mailing and other justifiable operating expenses directly related to
conducting the project, travel and per diem expenses for outside
consultants/advisors, and supplies. The travel and lodging expenses for up to
two study representatives (PI and one other) to attend two yearly meetings in
the Washington, D.C. area should be included in the budget request.
Project Plan. This narrative part of the application should not exceed 25
pages and must contain the following elements:
Section I. Area of Interest
1. Describe the proposed area of interest as referenced in the Objectives
and Scope section of this RFA.
2. Describe the PI’s previous experience in this area.
3. Describe the importance and potential use of the knowledge, evidence,
model, tool or other products that will result from this effort.
4. Discuss how this project will add to current knowledge/understanding in
this area.
5. Provide a set of long-term outcome goals and explicitly state how the
project will support the achievement of these goals. For example, AHRQ’s
long-term goals for the FY2004 HIT initiative include the following:
- Support the successful deployment of hospital HIT practices that reduce
medical errors and improve patient safety.
- Increase the identification and reporting of medical errors and adverse
events.
- Decrease the number of actual errors and adverse events.
- Increase the number of hospitals utilizing EHRs and CPOE with CDSS to
reduce medication errors.
- Increase the number of non-hospital providers utilizing EHRs and CPOE with
CDSS.
6. The application must also address how the applicant will monitor their
progress toward the goal(s) they specify and how those goals further the
accomplishment of the agency’s goals.
Section II. Proposed Study
1. Detailed description of the project design and methodology.
2. Description of the project’s objectives and outcomes.
3. Description of how the project’s success will be evaluated, including
specific measures to determine success.
4. Describe the stakeholders and health care settings that will be involved,
including the rationale for their selection.
5. Describe the project’s timelines, including critical milestones.
6. Description of the PI’s involvement and responsibility with the study,
along with other key co-investigators.
7. Description of institutional support for the project, including support
from key partners. Letters of support or memorandums of understanding, if
applicable, should be referenced.
8. If the project involves collaboration with a vendor or other commercial
company, the relationship should be described, including a letter from the
commercial partner indicating the partner’s level of commitment to the
project.
Applicants are encouraged to make use of AHRQ’S Healthcare Cost and
Utilization Program (HCUP). The HCUP includes databases covering 1988-1999.
These databases were created through a Federal and State industry partnership
to build a multi-State healthcare data system. The main HCUP databases contain
discharge-level information for inpatient hospital stays in a uniform format
with privacy protections. The Nationwide Inpatient Sample (NIS) is a
nationwide probability sample of about 1000 hospitals. The State Inpatient
Databases (SID) contain inpatient records for all community hospitals in 22
States. Other HCUP databases contain ambulatory surgery data from nine States.
These databases can be directly linked to county-level data from the Health
Resources and Services Administration’s Area Resource File and to hospital-
level data from the Annual Survey of the American Hospital Association.
This does not preclude the use of secondary data sources or primary data
collection.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
AHRQ is not using the Modular Grant Application and Award Process. Applicants
for funding from AHRQ should ignore application instructions concerning the
Modular Grant Application and Award Process and prepare applications according
to instructions provided in form PHS 398. Applications submitted in the
Modular format will be returned without review.
SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten
original of the application, including the checklist, and three signed
photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for express/courier service)
At the time of submission, two additional copies of the application must also
be sent to:
Eduardo Ortiz, M.D., M.P.H.
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1585
FAX: (301) 427-1597
Email: EORTIZ@AHRQ.GOV
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review. However, when a previously unfunded application, which was
originally submitted as an investigator-initiated application, is submitted in
response to an RFA, it must be prepared and submitted as a NEW application.
That is, the application for the RFA must not include an Introduction section
describing the changes and improvements made to the previously unfunded
application, and the text must not be marked to indicate changes in response
to the reviewers. While the investigator may obviously still benefit from the
previous review, the RFA application must be submitted as a NEW application
and should not discuss the reviewers’ comments or changes made by the
Principal Investigator to address the reviewers’ concerns.
Although there is no immediate acknowledgment of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
Applicants are encouraged to read all PHS Forms 398 instructions prior to
preparing an application in response to this RFA. The PHS 398 type size
requirements (p.6) will be enforced rigorously and non-compliant applications
will be returned. It is very important to note that limitations on number of
pages and size of font must be observed; applications violating these
requirements will be returned without review.
Institutional Review Board (IRB) approval of human subjects is not required
prior to peer review of an AHRQ application. The “AHRQ Revised Policy for IRB
Review of Human Subjects Protocols in Grant Applications” was published in the
NIH Guide on September 27, 2000
(http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
The RFA is also available on AHRQ’s Web site at: http://www.AHRQ.gov, (click
on Funding Opportunities)
Application Preparation (for Using CMS Data)
Purchase of CMS public-use data, if required, should be discussed in the
application narrative and included in the budget. Projects will ordinarily
not use CMS (Medicare or Medicaid) data involving individual identifiers.
However, 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 the Center for Medicare and Medicaid Services (CMS),
previously called the Health Care Financing Administration (HCFA), AHRQ will
use this information to develop a cost estimate for obtaining the data. This
estimate will be included in the estimated total cost of the grant at the time
funding decisions are made.
Applicants should be aware that for individually identifiable Medicare and
Medicaid data, Principal Investigators and their grantee institutions will be
required to enter into a Data Use Agreement (DUA) with CMS to protect the
confidentiality of data in accordance with AHRQ’s confidentiality statue, 42
USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable,
and standards set out in OMB Circular A-130, Appendix III–Security of Federal
Automated Information Systems. The use of the data will be restricted to the
purposes and time period specified in the DUA. At the end of this time
period, the grantee will be required to return the data to CMS or certify that
the data have been destroyed.
Unless AHRQ is able to negotiate exceptional arrangements included in the DUA,
the User is required to submit a copy of all findings within 30 days of making
such findings to CMS, for the sole purpose of assuring CMS that data
confidentiality is maintained. The User further agrees not to submit these
findings to any third party (including, but not limited to, any manuscript to
be submitted for publication) until receiving CMS’s approval to do so.
In developing research plans, applicants should allow time for refining,
obtaining approval, and processing of their CMS data requests. Requests may
take 6 months from the time they are submitted to complete. Applications
proposing to contact beneficiaries or their providers require the approval of
the CMS Director and may require meeting(s) with CMS staff.
CMS data are provided on IBM mainframe tapes using the record and data formats
commonly employed on these computers. Applicants should either have the
capability to process these tapes and formats or plan to make arrangements to
securely convert them to other media and formats.
Questions regarding CMS data should be directed to the AHRQ program official
listed under INQUIRIES.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, AHRQ may request
information essential to an assessment of the effectiveness of Agency research
programs. Accordingly, grant recipients are hereby notified that they may be
contacted after the completion of awards for periodic updates on publications
resulting from AHRQ grant awards and other information helpful in evaluating
the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications as
well as the known uses and impact of their Agency-sponsored research.
Applicants are to agree to notify AHRQ immediately when a manuscript based on
research supported by the grant is accepted for publication, and to provide
the expected date of publication as soon as it is known, regardless of whether
or not the grant award is still active.
To receive an award, applicants must agree to submit an original and 2 copies
of an abstract, executive summary, and full report of the research results in
the format prescribed by AHRQ no later than 90 days after the end of the
project period. The executive summary should be sent at the same time on a
computer disk which specifies on the label the format used (Word Perfect, or
Word, or ASCII format).
The past cooperation of applicants with regard to the submissions described in
this section may be considered by AHRQ to assess applicants’ potential for
responsible stewardship of awarded funds.
TECHNICAL ASSISTANCE
AHRQ encourages applicants to take advantage of a technical assistance
conference call sponsored by AHRQ program staff. This conference call will
provide interested potential applicants with background information and
response to questions about the preparation of an application in response to
this RFA. Participants are encouraged to submit questions via email prior to
the conference call. Please submit up to five questions with your name and
the name of your institution to HITValueRFA@AHRQ.gov by January 13, 2004.
Questions of a similar topic and nature may be grouped at the sole discretion
of AHRQ staff. The conference call is open to any individual or organization
intending to apply. Participation is not a prerequisite to applying. The
conference call will take place on January 15, 2004 at 1:00 Eastern Standard
Time. To register to participate in the call, please send your request to:
HITValueRFA@AHRQ.gov by January 13, 2004.
Transcripts of the conference call will be available seven business days after
the call. Please send your request for a copy of the transcripts to
HITValueRFA@AHRQ.gov.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness and
responsiveness to the RFA. Incomplete and/or non-responsive applications or
applications not following instructions given in this RFA will be returned to
the applicant without further consideration. Applications that are complete
and responsive to the RFA will be evaluated for scientific and technical merit
by an AHRQ Special Emphasis Panel (SEP) in accordance with standard AHRQ peer
review procedures.
As part of the merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review from an appropriate national advisory council
or board.
REVIEW CRITERIA
In the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
o Budget
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. The application does not need to be strong in all
categories to be judged likely to have a major scientific impact and thus
deserve a high priority score. For example, 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 the study address an important problem outlined in
this RFA? If the aims of your application are achieved, is the proposed work
likely to result in accelerated adoption, diffusion and utilization of HIT?
Will it improve the safety and quality of health care? Will the project
provide clinicians, patients, payers, policymakers, or other important
stakeholders with evidence, models, or other tools that will add to the
understanding of the value of HIT?
(2) APPROACH: Are the conceptual framework, design, methods, interventions,
measures, and analyses adequately developed, well integrated, and appropriate
to the aims of the project? Does the application acknowledge and address
potential problem areas and consider alternative strategies and tactics?
Where applicable, are the needs of rural and small communities being
addressed?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or propose to develop new methodologies, technologies,
models, or tools? Where applicable, will the proposed work increase knowledge
and facilitate the advancement of HIT in rural and small communities?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to your level of experience
as the principal investigator and to that of the other researchers? Does the
proposed study team reflect an appropriate array of knowledge and skills
needed to successfully accomplish the aims of the project? Is the time
commitment of the principal investigator and co-investigators reasonable and
sufficient to accomplish the aims of the project? Are roles of the
investigators clearly delineated?
(5) ENVIRONMENT: Does the environment in which the work will be conducted
contribute to the likelihood of success? Is there evidence of institutional
support? Are there any plans for working collaboratively with other provider
organizations, health care purchasing groups, HIT developers/vendors, State or
local governments, professional organizations, advocacy groups, or other
entities that can enhance the probability of success?
(6) BUDGET: Is the proposed budget and the requested period of support
reasonable in relation to the proposed research?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
o INCLUSION: The adequacy of plans to address the need of both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
aims of the project. Adequacy of attention to other populations of special
priority to AHRQ (see discussion on Priority Populations in the section on
Special Requirements, above, and Inclusion Criteria included in the section on
Agency Policies and Requirements, below.)
Finally, peer reviewers will be asked to specifically comment in these two
areas: 1) technical merit of the proposed project; and 2) potential for any
knowledge, models, tools or other end-products resulting from the project to
be useful to health care decision makers and stakeholders. The final priority
scores will reflect the peer reviewers’ overall assessments based on their
judgments of these two areas as well as the other review criteria described
above.
1. In evaluating the technical merit of the proposed project, peer reviewers
will consider:
- Clarity and appropriateness of the project’s goals and objectives.
- Extent to which the application defines a problem or knowledge deficit
that needs to be addressed.
- Extent to which the proposed project has clear and unambiguous goals
consistent with AHRQ’s stated goals.
- Quality of the research and evaluation methodology, including the
appropriateness of the outcome metrics used to gauge the project’s success.
- Qualifications of the PI to lead the project, including his/her expertise
in the subject area and his/her research, leadership and administrative
skills.
- Qualifications, appropriateness, and contributions of key project
personnel.
2. The potential for knowledge, models, tools or other end-products
resulting from the project to be useful to health care decision makers and
stakeholders.
- Identification of the target audiences to be impacted by the end-products.
- Clear description of the knowledge, models, tools, or other end-products
that will be generated from the project.
- The utility of these end-products to populations or health care settings
beyond the study sites and the ability of an awardee to develop and
disseminate these end-products in a timely manner.
ADDITIONAL REVIEW CONSIDERATIONS
DATA SHARING:
Data Confidentiality
Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(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 explicit or implicit promises made regarding the possible
uses and disclosures of such data. There are now civil monetary penalties for
violation of this confidentiality statute. [42 U.S.C.299c-3(d)) In the Human
Subjects section of the application, applicants must describe procedures for
ensuring the confidentiality of the identifying information to be collected.
The description of the procedures should include a discussion of who will be
permitted access to the information, both raw data and machine readable files,
and how personal identifiers and other identifying or identifiable data will
be restricted and safeguarded. Identifiable patient health information
collected by grantees under this RFA will also be managed in accordance with
42 CFR Parts 160 and 164, Federal regulations pertaining to the privacy of
protected health information. These privacy regulations, developed by the
Department of Health and Human Services pursuant to the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), became mandatory for
covered entities on April 14, 2003. These regulations serve to limit the
disclosure of personally identifiable patient information by covered entities
and define when and how such information can be disclosed (e.g., to
researchers). Thus, for example, health care plans, clearinghouses, and
providers who engage in HIPAA-covered electronic transactions will require
either patient authorization of disclosures of identifiable information to be
made to researchers or waivers of such authorizations obtained from an IRB or
Privacy Board (defined in the regulations) upon being satisfied that any
identifiable health information will be appropriately safeguarded by the
investigators. Additional information about the regulations, their
implementation, and alternative methods for permissible disclosures to
researchers (limited data sets with data use agreements, de-identified data
sets, data about deceased persons, and data use to develop research protocols)
can be obtained from: http://www.aspe.hhs.gov/admnsimp or
http://www.hhs.gov/ocr/hipaa/.
The awardees 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) have published several
implementation guides for this circular. They are: An Introduction to Computer
Security: The NIST Handbook; Generally Accepted Principals and Practices for
Securing Information Technology Systems; and Guide for Developing Security
Plans for Information Technology Systems. The circular and guides are
available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/.
The applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be addressed
in the application.
Rights in Data
AHRQ grantees may copyright, unless otherwise provided in grant awards, or
seek patents, as appropriate, for final and interim products and materials
including, but not limited to, methodological tools, measures, software with
documentation, literature searches, and analyses, which are developed in whole
or in part with AHRQ funds. Such copyrights and patents are subject to a
worldwide irrevocable Federal government license to use and permit others to
use these products and materials for government purposes. In accordance with
its legislative dissemination mandate, AHRQ purposes may include, subject to
statutory confidentiality protections, making project materials, databases,
results, and algorithms available for verification or replication by other
researchers; and subject to AHRQ budget constraints, final products may be
made available to the health care community and the public by AHRQ or its
agents, if such distribution would significantly increase access to a product
and thereby produce substantial of valuable public health benefits.
Ordinarily, to accomplish distribution, AHRQ publicizes research findings but
relies on grantees to publish research results in peer-reviewed journals and
to market grant-supported products.
AHRQ's Office of Communication and Knowledge Transfer (OCKT) wishes to be
consulted in advance of publication in order to coordinate these issuances
with other AHRQ dissemination activities. Important legal rights and
requirements applicable to AHRQ grantees are set out or referenced in the
AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries
and from the GPO's website (http://www.gpoaccess.gov/cfr/index.html).
RECEIPT AND REVIEW SCHEDULE
Technical Assistance Call: January 15, 2004
Letter of Intent Receipt Date: February 6, 2004
Application Receipt Date: April 22, 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS:
It is the policy of AHRQ that women and members of minority groups and their
sub-populations are included in all AHRQ-supported research projects involving
human subjects, unless a clear and compelling rationale and justification are
provided that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html).
A complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.
To the extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the AHRQ
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web
site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may
also provide additional information concerning these policies (see INQUIRIES).
AHRQ also encourages investigators to consider including children in study
populations, as appropriate.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
If no Federal act is taken, having the force and effect of law, in reliance
upon an AHRQ-supported research project, the underlying data is not subject to
this disclosure requirement. Furthermore, even if a Federal regulation action
is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b),
disclosure of statutorily protected confidential identifiable data from such
study is exempted from disclosure under "the (b)(3) exemption." It is
important for applicants to understand the scope of this requirement and its
limited potential impact on data collected with AHRQ support. Proprietary
data might also be exempted from FOIA disclosure requirements under "the
(b)(4) exemption", for example, if it constituted trade secrets or commercial
information collected. NIH has provided general related guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does
not include discussion of the exception applicable to confidential
identifiable data collected under AHRQ’s authorities.
Should applicants wish to place data collected under this RFA in a public
archive, which can provide protections for the data (e.g., as required by the
confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-
3(c)) and manage the distribution of non-identifiable data for an indefinite
period of time, they may. The application should include a description of any
archiving plan in the study design and include information about this in the
budget justification section of the application. In addition, applicants
should consider how to structure informed consent statements or other human
subject protection procedures to permit or restrict disclosures of
identifiable data, as warranted.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued the last modification
the "Standards for Privacy of Individually Identifiable Health Information",
was mandated by the "Privacy Rule," on August 14, 2002. This regulation was
mandated by the Health Insurance Portability and Accountability Act (HIPAA) of
1996 which governs the protection of individually identifiable health
information. It is administered and enforced by the DHHS Office for Civil
Rights (OCR). Mandatory compliance with the Privacy Rule (for those classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with covered entities. The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a
set of decision tools that may be used to determine whether a researcher is a
staff of a covered entity. Project Officers will assist grantees in resolving
questions about the applicability of HIPAA requirements.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance, Number 93.226. Awards are made under Title IX of
the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129
(1999). Awards are administered under the PHS Grants Policy Statement and
Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
REFERENCES
1. Kohn LT, Corrigan JM, Donaldson MS, Eds. To err is human: building a
safer health system. Washington, D.C. National Academy Press, 1999.
2. Corrigan JM, Donaldson MS, Kohn LT, Eds. Crossing the quality chasm: a
new health system for the 21st century. Washington, D.C. National Academy
Press, 2001.
3. Evans RS, Classen DC, Pestotnik SL, Clemmer TP, Weaver LK, Burke JP. A
decision support tool for antibiotic therapy. In: Gardner RM, ed. Proceedings
from the Nineteenth Annual Symposium on Computer Applications in Medical Care.
Philadelphia, PA: Hanley and Belfus; 1995:651-55.
4. Evans RS, Pestotnik SL, Classen DC, Clemmer TP, Weaver LK, Orme JF, et
al. A computer-assisted management program for antibiotics and other
antiinfective agents. N Engl J Med. 1998;338:232-38.
5. Overhage JM, Tierney WM, Zhou XH, McDonald CJ. A randomized trial of
“corollary orders” to prevent errors of omission. JAMIA. 1997;4:364-75.
6. Bates DW, Leape LL, Cullen DJ, Laird N, Peterson LA, Teich JM, et al.
Effect of computerized physician order entry and a team intervention on
prevention of serious medication errors. JAMA. 1998;280:1311-16.
7. Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical
decision support systems on physician performance and patient outcomes. JAMA.
1998;280:1339-45.
8. Center for Information Technology Leadership. The Value of Computerized
Provider Order Entry in Ambulatory Settings. March 2003.
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