CLINICAL INFORMATICS TO PROMOTE PATIENT SAFETY
Release Date: February 22, 2001
RFA: RFA-HS-01-006
Agency for Healthcare Research and Quality (formerly AHCPR)
Letter of Intent Receipt Date: April 6, 2001
Application Receipt Date: April 23, 2001
PURPOSE
The Agency for Healthcare Research and Quality (AHRQ) announces the
availability of Research Demonstration and Dissemination Projects (R18) on the
use of clinical informatics and information technology (IT) to reduce medical
errors and improve patient safety. Specifically, AHRQ seeks projects to
develop and test the use of innovative technologies, such as hand-held
electronic medication and specimen management systems, training simulators for
medical education, computerized bar-coding, patient bracelets, smart cards,
and automated medication dispensing systems in clinical settings. The main
objective of this RFA, Clinical Informatics to Promote Patient Safety (CLIPS),
is to assess the extent to which such innovations, when applied in various
health care settings, contribute to measurable and sustainable improvements in
patient safety and quality of care. Research resulting from this RFA will
help us to better understand the opportunities and barriers to using IT to
improve the process and outcomes of care for patients and providers.
Researchers are encouraged to propose projects that emphasize non-inpatient
health care settings (including ambulatory and long-term care settings) and
priority populations. AHRQ is strongly committed to supporting research in
priority populations, which include women, children, elderly, minority, rural,
urban, and low-income populations, as well as patients with special health
care needs and disabilities. Applicants will be required to develop projects
that use rigorous scientific methods to assess the effect of the IT innovation
on medical error rates and other measures of patient safety. It is expected
that a successful project will evaluate IT tools that alert providers to
information that may be critical to the provision of high quality care,
develop strategies to address barriers to successful adoption of innovative IT
applications, document the costs and resources associated with the IT
applications, or evaluate transferability to other settings. The objective of
this RFA is to assess the extent to which innovative IT applications, when
applied in various health care settings, contribute to measurable and
sustainable improvements in patient safety.
This RFA is one in a series of research solicitations to be issued by AHRQ
over the next several months. The solicitations form an integrated set of
activities to design and test best practices for reducing errors in multiple
health care settings, develop the science base to inform these efforts,
improve provider education to reduce errors, capitalize on the IT advances to
translate proven effective strategies into widespread practice, and build
capacity to further reduce errors. In addition to CLIPS, RFAs to be released
as part of this program include:
1) Health System Error Reporting, Analysis, and Safety Improvement
Demonstrations - to support large demonstrations in states, health care
systems (including systems that integrate acute and long-term care), and
networks of providers (e.g., integrated delivery systems and primary care
networks) to test reporting strategies and patient safety interventions.
2) Centers of Excellence for Patient Safety Research and Practice - to
support established cross-cutting teams of researchers and health care
facilities and organizations in geographically diverse locations (including
rural and urban areas), which will determine the causes of medical errors and
develop new knowledge to support the work of the demonstrations.
3) Developing Centers for Patient Safety Research and Practice - to develop
new multidisciplinary research teams to improve the nation’s capacity in
patient safety research, to expand the patient safety knowledge base, and to
establish mechanisms to assure that new knowledge is incorporated into actual
practice and that its impact is assessed.
4) Effect of Working Conditions on Patient Safety - to develop an
understanding of how the environment of care impacts the ability of providers
to improve safety (e.g. the effect of fatigue, stress, sleep deprivation, and
shift work on cognitive ability and the relationship to patient safety) and
how the interactions between the built environment impacts the provision of
safe care.
5) Patient Safety Research Dissemination and Education - to fund researchers
and organizations (e.g., professional associations, hospital groups, national
organizations) to develop, demonstrate, and evaluate new approaches to
improving provider education in order to reduce errors, such as applying new
knowledge on patient safety to curricula development, continuing education,
simulation models, and other provider training strategies.
At the heart of this competitive demonstration program is a portfolio of
projects that test the effectiveness and costs of diverse reporting strategies
and IT innovation on the identification, management, and reduction of medical
errors. These activities are supported and amplified by: 1) the
establishment of multidisciplinary centers of excellence in patient safety, 2)
targeted efforts to understand the impact of provider education, skills,
staffing, and organization on error rates, 3) partnerships with health
systems networks, professional organizations, states, and other groups to
build capacity for error reduction activities, disseminate effective
strategies, and coordinate public and private efforts, and 4) cross cutting
activities that capitalize on data already collected by Federal or State
governments which can be enhanced to support research and action in patient
safety.
Additional components of the Agency’s patient safety initiative will build on
existing Agency programs. AHRQ will also support a coordinating center to
provide guidance and facilitate interaction between the entities funded under
the Agency’s patient safety programs. The coordinating center will assure
explicit translation of the new knowledge from the safety centers of
excellence and informatics research projects to the demonstration sites. The
coordinating center will also facilitate data transfers from the demonstration
sites to the centers of excellence and process reporting data for transmittal
to AHRQ.
Research themes under this RFA have been generated through a variety of
activities including key stakeholder meetings as well as public and private
sector national summits and research agenda setting activities on medical
errors, patient safety, and informatics. For example, the Agency sponsored a
National Summit on Medical Errors and Patient Safety Research on September 11,
2000, and findings from the summit also contributed to the research themes. A
summary of the summit is available on the Agency’s web page
(http://www.ahrq.gov/). Research themes also developed from ongoing
activities of the Quality Interagency Coordination Task Force (QuIC) and its
report to the President -- Doing What Counts for Patient Safety - Federal
Actions to Reduce Medical Errors and Their Impact (http://www.quic.gov/). In
carrying out its responsibilities, the National Forum for Health Care Quality
Measurement and Reporting may also influence themes for this research
initiative.
In responding to this RFA, applicants should address the following central
research topics: (1) the role of informatics in improving clinical decision-
making, reducing errors, and advancing patient safety, (2) barriers to
acceptance and adoption of health information technology for improved patient
safety and quality, (3) utilization of effective strategies to improve
patient safety while maintaining patient confidentiality.
Definitions
For the purpose of this document:
Clinical informatics is broadly defined as the use of computers and
information technology in the provision of patient care. It includes, but is
not limited to, electronic records, electronic communication, computerized
decision support systems, physician order entry, web-based applications, and
hand-held wireless devices.
Medical error is defined as the failure of a planned action to be completed as
intended or the use of a wrong action to achieve an aim. Errors can include
problems in practice, products, procedures, and systems (Quality Interagency
Coordination Task Force, 2000)
Patient safety applies to initiatives designed to prevent adverse outcomes
from medical errors. The enhancement of patient safety encompasses three
complementary activities: preventing errors, making errors visible, and
mitigating the effects of errors (Quality Interagency Coordination Task Force,
2000).
Adverse events are defined as undesirable and unintended incidents in care
that may result in adverse outcomes or may require additional care efforts to
thwart an adverse outcome.
Preventable adverse events are a subset of adverse events that are judged to
have been avoidable if appropriate and reasonable steps had been taken. An
anaphylactic reaction to penicillin is an adverse event. It is a preventable
adverse event if the patient’s intolerance of penicillin is noted in his or
her chart and that chart is available to the clinician, or if the patient
knows of his or her reaction to penicillin and is able to communicate it to
the clinician.
Adverse outcomes are defined as undesirable and unintended outcomes of care
such as death, disability, or temporary disability.
Near misses are events in which the unwanted consequences were prevented
because there was a recovery by identification and correction of the failure
(Van der Schaaf). Such a recovery could be by a planned or unplanned barrier.
The term close calls is often used synonymously with near misses.
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.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, public and private non-profit
organizations, including universities, clinics, units of State and local
government, firms and foundations. For the purpose of this RFA, AHRQ will
make grants only to non-profit organizations, however, for-profit
organizations, such as IT vendors may only participate in grant projects as
members of consortia or as subcontractors. Foreign institutions are not
eligible to apply. Organizations described in section 501(c)4 of the Internal
Revenue Code that engage in lobbying are not eligible.
AHRQ encourages women, members of racial and ethnic minority groups, and
persons with disabilities to apply as Principal Investigators.
AHRQ strongly encourages collaboration with researchers from Historically
Black Colleges and Universities, Hispanic Serving Institutions, and other
minority and minority serving institutions. Information on minority
institutions is available at http://www.hr.doe.gov/ed/index.html.
MECHANISM OF SUPPORT
Projects supported under this initiative will use the Research Demonstration
and Dissemination Project (R18) grant mechanism. Responsibility for the
planning, direction, and execution of the proposed project will be solely that
of the applicant. The focus of the applications should be on the evaluation
of clinical informatics tools. It is not the intent of this RFA to support
extensive development of new IT tools, but rather to demonstrate and evaluate
the application of IT strategies that patients and providers may use to
improve patient safety. The total project period for an application submitted
in response to this RFA may not exceed 5 years. The earliest possible award
date is September 28, 2001.
This RFA is a one-time solicitation. There are no plans to reissue this RFA
at any time.
FUNDS AVAILABLE
AHRQ expects to award up to $3.5 million in total costs (i.e., including
facilities and administrative costs) in fiscal year 2001 to support 10-14
projects with an average of $250,000-$300,000 per application for the first
year R18s selected under this initiative. In addition, one or two projects
may be funded as a collaboration with the HRSA/HIV/AIDS bureau. The focus
would be to work with non-hospital based (community based) Ryan White medical
care grantees who target underserved populations such as homeless, communities
of color, women, youth, uninsured and multiple diagnosed clients. The actual
number of applications funded is dependent on the number of high quality
applications and their individual budget requirements. It is not the intent
of AHRQ that the awards be equal in size. Although the financial plans of
AHRQ provide for this program, awards pursuant to this RFA are contingent upon
the availability of funds for this purpose. Should additional funds become
available, however, and if AHRQ receives a sufficient number of meritorious
applications, the Agency reserves the right to fund additional applications
under this RFA. The anticipated level of continuation funding across the
awarded R18s for subsequent approved project years is at an equivalent level
(i.e., about $3.5 million per year for total costs of the initiative).
However, funding beyond the initial budget period will depend upon annual
progress reviews by AHRQ and the availability of funds.
RESEARCH OBJECTIVES
Background
For the past thirty years, AHRQ, and its predecessors (the National Center for
Health Services Research, NCHSR , and the Agency for Health Care Policy
Research, AHCPR ) have investigated and funded much of the seminal research
in patient safety. In the late 1990s, as medical errors and patient safety
issues moved higher on the national public policy agenda, AHRQ began to take
on a leadership role in this area. For example, when the President’s Advisory
Commission on Consumer Protection and Quality in the Health Care Industry
presented its Final Report to the President of the United States on Quality
First: Better Health Care for All Americans (1998), reduction of medical
errors was listed as one of its top priorities. A year later, The Institute
of Medicine released its report on medical errors and patient safety, To Err
is Human, and called for a strong, comprehensive response to this urgent issue
(Kohn, et al, 1999).
In early 2000, the Quality Interagency Coordination Task Force (QuIC), with
AHRQ as lead agency, responded with its report to the President, Doing What
Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their
Impact. This report, which outlined a road map for action including more than
100 activities, addressed issues such as national focus and leadership, as
well as identifying and learning from errors, setting performance standards
and expectations for safety, building public and purchaser awareness, working
with providers, using decision-support systems and information technologies,
using standardized procedures, addressing and strengthening standards, and
integrating data for reporting and analysis (QuIC, 2000).
When Congress reauthorized (and renamed) the Agency in late 1999, it
specifically directed the Agency to conduct and support research and build
public-private partnerships to (1) identify the causes of preventable health
care errors and patient injury in health care delivery, (2) develop,
demonstrate, and evaluate strategies for reducing errors and improving patient
safety, and (3) disseminate such effective strategies throughout the health
care industry. AHRQ"s reauthorization also directed the Agency to evaluate
informatics applications, decision support systems, and computerized patient
records to reduce medical errors, improve patient safety, and promote quality
improvement in diverse patient settings.
Role of Informatics in Patient Safety
As the delivery of health care becomes increasingly complex, the reliance on
effective systems to prevent medical error will be increasingly critical.
However, health care continues to take place in systems with little
standardization and few safeguards, especially when compared to other
industries (Bates, 2000). In this complicated environment, it is not
surprising that medical errors would occur.
The vast amount of medical information, coupled with the rapid growth in new
pharmacotherapies and technologies, increasing time constraints placed on
health care providers, mounting pressures to reduce costs, and suboptimal
systems for delivering care, make it virtually impossible for individual
clinicians to provide high-quality, error free care on a consistent basis. As
stated by a leader in health care informatics, humans are inherently fallible
information processors (McDonald, 1976). This reliance on imperfect memory
can lead to compromised patient safety and increased rates of medical errors
(Leape, 1994). As health care becomes increasingly more complex, information
systems are needed to assist providers in making the best possible clinical
decisions.
As attention has turned to the role of systems in preventing medical errors
and injuries, evidence has become available that computerized decision support
systems can help to improve patient safety. The data processing capacity of
computers has been harnessed by a number of electronic systems designed to
assist in clinical decision-making. These systems range from computerized
reminders about preventive services to alerts about drug-drug interactions to
specific guidelines and therapeutic recommendations.
There are numerous examples of clinical informatics applications that have
been demonstrated to improve patient safety at a few premier medical
institutions. At LDS Hospital in Salt Lake City, a computerized decision
support system with physician order entry has reduced the incidence of adverse
drug events related to antibiotic administration by 75% (Evans, 1995). This
system also significantly reduced orders for drugs for which patients reported
allergies and adverse effects caused by antibiotics (Evans, 1998). At the
Regenstrief Institute for Health Care in Indianapolis, researchers
demonstrated that automated computerized reminders increased orders for
recommended interventions from 22% to 46% (Overhage, 1997). The physician
order entry system at Brigham and Women’s Hospital has clearly demonstrated
its role in reducing medical errors and improving patient safety.
Investigators demonstrated that use of the physician order entry 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 percent to 47 percent. Errors related
to medication dosing were reduced by 23 percent, errors in medication choices
by 44 percent, errors in delays by 77 percent, errors in ordering by 19
percent, transcription errors by 84 percent, known allergy errors by 56
percent, and overall serious medication errors by 55 percent (Bates, 1998).
Perhaps most importantly, these changes persisted at the 1- and 2-year follow-
up periods. (Teich, 2000)
A recent systematic review 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%) (Hunt, 1998). However, some
applications, such as diagnostic expert systems, have met with disappointing
results (Berner 1994, Kassirer 1994).
While these examples illustrate that physician order entry systems and
decision support can help reduce medication errors, improve prescribing
patterns and guide treatment decisions, only a small number of health care
systems in the United States have such systems in place. Though these systems
require significant up-front capital investment, these costs may be superseded
by annual savings of $5-10 million per year (Bates, 1998).
While recent innovations in information technology have been touted over the
past several years in the lay and industrial press, many of these applications
have not been adequately evaluated in the health care arena. For example,
wireless hand-held computers, also referred to as personal digital assistants
(PDA) offer great potential in health care. In preliminary studies, these
devices have demonstrated an improvement in the detection and prevention of
adverse events (Shabot, 2000). PDAs, pagers, and other small portable
electronic devices, such as digital cellular phones with wireless access, are
promising new applications with the potential for improving the quality of
healthcare.
There are many other cutting edge technologies that could have a significant
impact on medical errors and patient safety. Medication bar codes and
automated dispensers are being utilized in some healthcare settings to reduce
errors. The use of scannable patient bracelets containing drug, allergy and
other medical information is also generating interest. Such devices could
help ensure that medications, blood products, and other therapeutics that are
administered to patients are appropriate. They could also be used to generate
alerts about allergies, drug-drug interactions, and other potential problems
before erroneous administration occurs. The Veterans Administration has been
a national leader in the use of some of these technologies.
Smart cards, electronic devices the size of credit cards that store and
process medical information on a microprocessor chip, may also lead to safety
improvements. This technology would give patients a portable means of
carrying their own medical information, which could then be accessed
electronically by their provider or healthcare facility. Interactive smart
cards could also generate alerts about potential adverse events resulting
from medication and other types of errors. This technology remains in the
early stages of development and has not been utilized or evaluated to a
significant degree in the clinical setting.
While clinical informatics has demonstrated promise in patient safety and
quality improvement, greater evaluation and research of these technologies are
needed. Through support of diffusion of health information technologies to
other healthcare settings, as well as support for research on the
effectiveness of innovative information technology tools to improve patient
safety, this RFA hopes to provide opportunities to harness the power of
technology for improving healthcare delivery and outcomes.
Objectives and Scope
This RFA provides research opportunities to demonstrate the effectiveness of
clinical informatics tools in improving quality of care. Research
demonstration projects supported under this RFA should seek to generate new
knowledge that can be used by providers, patients, payers, and policymakers to
promote the use of information technology to reduce medical errors and improve
patient safety. Applicants are encouraged to develop partnerships with
developers and commercial vendors of IT tools and systems.
AHRQ is especially interested in research on the development and use of
technologies that reduce medical errors, such as hand-held electronic
medication and specimen management systems, bar coding of medications,
automated medication dispensers, training simulators for medical education,
and patient-specific identifiers (e.g., bracelets, smart cards).
AHRQ is also interested in further research on the opportunities and barriers
to using information technology for improving the process and outcomes of care
for patients and providers. While evidence is accumulating that real-time
decision support tools, such as physician order entry, may result in improved
patient safety, further research is needed to develop tools that optimize
decision support and that assess their impact on other aspects of care such as
satisfaction, productivity, outcomes, and overall quality. Researchers are
encouraged to propose projects that evaluate the impact of IT on clinically
important outcomes and to emphasize different health care settings and
priority populations.
Research in the following specific areas will be considered:
1. Evaluate the use of appropriate technology to improve patient safety:
a) The effect of clinical IT tools in reducing medical errors and improving
the quality of patient care.
b) Real-time IT decision support systems that alert providers to information
that may be critical to the provision of high quality care.
c) The use of evidence-based, real-time decision support systems on
patient/provider decision-making, patient safety, and outcomes.
d) Standardized data elements required in information systems that allow the
identification and classification of medical errors across health care
settings.
e) The impact of a minimum patient data set across information systems and
health care settings on patient safety.
f) The use of interactive technology, such as electronic mail, web-based
medical records, hand-held wireless devices, computer kiosks, and electronic
patient assessment tools that facilitate informed shared decision-making and
patient safety.
g) Data exploration technologies (e.g., data mining) to assess patterns of
medical errors within health care systems.
h) The strengths and limitations of existing systems in providing
information on patient safety and medical errors in different health care
settings, including hospital, ambulatory care, home care, and long-term care
facilities.
2. Assess barriers to acceptance and adoption of health information
technology for improved patient safety and quality by providers and patients:
a) The impact of IT on efficiency, productivity, time management, workload,
satisfaction (patient and provider), training, and return on investment.
b) The influence of human factors on the acceptance and utilization of
decision support systems.
c) The sociology/culture of health care professionals that limit greater
acceptance of new technology.
d) The costs of informatics solutions, cost-effectiveness, value and return-
on-investment of health information technology for improving the quality and
safety of health care.
e) Development of effective strategies to overcome identified barriers.
3. Utilize effective strategies to improve patient safety while maintaining
patient confidentiality:
a) Patient and provider preferences regarding privacy and use of medical
information and explore methods of ensuring data security.
b) The trade-offs between maintaining the confidentiality of personal health
information and using data to improve patient safety and quality of care.
Methods:
Individual R18 projects may use a combination of qualitative and quantitative
methods. Qualitative and quantitative methods should be rigorous and use
state-of-the-art methodologies. Projects using such methods should be
grounded in appropriate theoretical frameworks. Hypothesis-testing projects
should clearly present competing hypotheses. Qualitative methods can be used
on their own to heighten understanding of health care delivery systems or to
complement quantitative methods and thereby strengthen the research design.
Policy and Practice Relevance and Dissemination
Studies under this RFA are expected to contribute to our basic understanding
of medical errors and patient safety, build capacity to answer associated
questions of policy relevance, and produce information that is useful to
participants in delivering safer health care and to decision makers in
formulating public policy. Applicants should be concrete in describing how
their research results would translate into safer and higher quality health
care. Dissemination strategies for effective informatics applications should
not be limited to publication in peer reviewed journals but may encompass a
variety of approaches, such as translating results into nontechnical
monographs (e.g., healthcare guides to key features of physician order entry
systems) and distributing them through associations of private and public
officials, educating legislators, public administrators, health plan
executives, employers, professional leaders, patients and patient advocacy
groups, and others in seminars, partnerships, and collaboration with health
care delivery organizations to implement results, and outreach to the media.
In addition, applicants should budget for and plan to attend an annual
conference with other centers of excellence and demonstration centers
supported under the broader AHRQ patient safety program. These meetings will
be organized by a central coordinating center.
SPECIAL REQUIREMENTS
Data Privacy
All information about identifiable individuals or organizations obtained for
the research purpose of carrying out a demonstration project supported
pursuant to this RFA under AHRQ’s statutory authority is protected by a
federal confidentiality statute, section 924 of the Public Health Service Act
, 42 USC 299c-3(c). Under this law, the only permissible uses or disclosures
of the information are those agreed to by the subject individuals and
organizations or by those who supply the information to the researchers.
There are substantial statutory penalties (up to $10,000) for improper use or
disclosure of this information. Thus, 42 USC 299c-3(c) provides a Federal
statutory basis for resisting any Federal or state court order or subpoena to
the extent that carrying out the order or subpoena would violate the
protective restrictions of the statute. Upon request, AHRQ will provide legal
assistance in defending adherence to these statutory confidentiality
protections with respect to identifiable data obtained in carrying out Agency
research activities.
Note that identifiable data obtained by AHRQ-supported researchers is
protected by this law when it is obtained to carry out AHRQ-supported
research, but this law would not protect against access to this same
information in medical records if it were gathered and recorded there for
other purposes. If providers collect certain information solely for purposes
of this research, it should be so marked and if necessary to protect its
confidentiality, kept separately. Note also that this law does not protect or
restrict aggregate and nonidentifiable statistical or data analysis and
conclusions developed by the researchers that would not disclose information
about any identifiable individuals or establishments
Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(c)), information obtained in the course of any AHRQ-study that identifies an
individual or entity must be treated as confidential in accordance with any
promises made or implied regarding the possible uses and purposes of the data
collection. In the Human Subjects section of the application, applicants must
describe 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 restricted and 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/handbook.pdf.
The application of these confidentiality and security standards to
subcontractors and vendors should be addressed as necessary.
Rights in Data
AHRQ grantees may copyright or seek patents, as appropriate, for final and
interim products and materials including, but not limited to, methodological
tools, measures, software with documentation, literature searches, and
analyses, which are developed in whole or in part with AHRQ funds. Such
copyrights and patents are subject to a worldwide irrevocable Federal
government license to use and permit others to use these products and
materials for government purposes. In accordance with its legislative
dissemination mandate, AHRQ purposes may include, subject to statutory
confidentiality protections, making research materials, data bases, results,
and algorithms available for verification or replication by other researchers,
and subject to AHRQ budget constraints, final products may be made available
to the health care community and the public by AHRQ or its agents, if such
distribution would significantly increase access to a product and thereby
produce public health benefits. Ordinarily, to accomplish distribution, AHRQ
publicizes research findings through the media and other appropriate channels
in coordination with AHRQ’s Office of Health Care Information but relies on
grantees to publish research results in peer-reviewed journals and to market
grant-supported products.
Important legal rights and requirements applicable to AHRQ grantees are set
out or referenced in the AHRQ’s grants regulation at 42 CFR Part 67, Subpart A
(Available in libraries and from the GPO’s website
http://www.access.gpo.gov/nara/cfr/index.html).
INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS
It is the policy of AHRQ that women and members of minority groups be included
in all AHRQ-supported research projects involving human subjects, unless a
clear and compelling rationale and justification are provided that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research.
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).
A complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the
extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the AHRQ
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide
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).
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent by April 6,
2001. It should include a descriptive title of the proposed research, the
name, address, and telephone number of the Principal Investigator, the
identities of other key personnel and participating institutions, and the
number and title of the RFA in response to which the application may be
submitted. Although a letter of intent is not required, is not binding, and
does not enter into consideration of any subsequent application, the
information that it contains allows AHRQ staff to estimate the potential
review workload and to plan the review. AHRQ will not provide responses to
letters of intent.
The Letter of Intent is to be sent to:
Eduardo Ortiz, M.D., M.P.H.
Senior Service Fellow
Agency for Healthcare Research and Quality
Center for Primary Care Research
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone 301-594-6236
Fax 301-594-3721
E-mail eortiz@ahrq.gov
APPLICATION PROCEDURES
The research grant application form PHS 398 (4/98) is to be used in applying
for these grants. State and local government applicants may use PHS 5161-1,
Application for Federal Assistance (rev. 5/96), and follow those requirements
for copy submission. The PHS 398 type size requirements (p. 6) will be
enforced rigorously, and non-compliant applications returned. In part, the
PHS 398 states that the application must be clear, readily legible, and
conform to all of the following requirements: 1) the height of the letters
must not be smaller than 10 point, 2) type density must be no more than 15
characters per inch (cpi), and 3) no more than 6 lines of type must be within
a vertical inch. Applicants are encouraged to read all form PHS 398
instructions prior to preparing an application in response to this RFA.
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 (rev. 4/98).
The AHRQ Revised Policy for IRB of Human Subjects Protocols in Grant
Applications was published in the NIH Guide on September 27, 2000. All
investigators proposing research involving human subjects should read this
revised policy.
(http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html)
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).
Given the nature of this project and the speed with which
successful applicants will need to begin work, the Agency has determined that
IRB approval is required prior to peer review of all applications submitted in
response to this RFA. All investigators/applicants proposing research
involving human subjects should pay particular attention to the instructions
in the form PHS 398 regarding human subject involvement.
AHRQ applicants are encouraged to obtain application materials from the AHRQ
Publications Clearinghouse (see INQUIRIES). The Grant Application Form (PHS
398) is also available online at the following URL:
http://grants.nih.gov/grants/funding/phs398/phs398.html.
The RFA label and line 2 of the PHS 398 (4/98) form should both indicate the
RFA number. The RFA label must be affixed to the bottom of the face page of
the application. 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 must also be typed on line 2 of the face
page and the YES box must be marked. The sample RFA label available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
A complete, signed, typewritten original of the application, including the
Checklist, and three signed, legible photocopies, must be submitted 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 or courier service)
At the time of submission, two additional copies of the application, labeled
Advance Copy must also be sent to:
Eduardo Ortiz, M.D., M.P.H.
Agency for Healthcare Research and Quality
Center for Primary Care Research
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone 301-594-6236
Fax 301-594-3721
Email eortiz@ahrq.gov
Applications must be received by April 23, 2001. An application received
after the deadline may be acceptable if it carries a legible proof-of-mailing
date, assigned by the carrier, and the proof-of-mailing is not later than 1
week prior to the deadline date. If an application is received after that
date, it will be returned to the applicant without review.
Conference for Prospective Applicants
AHRQ plans to convene a special technical assistance workshop to assist
potential applicants. The purpose of this conference is to give background
information and respond to questions about the preparation of an application
in response to this RFA. The workshop will be held on March 12, 2001, at
AHRQ, 6010 Executive Blvd., Conference C, Rockville, MD, 20852 from 8:30 a.m.
to 12:00 p.m. Attendance is not a prerequisite to applying. Attendees must
pay for their own travel and accommodation costs. The workshop will be open
to any individual or organization intending to apply. Attendees are encouraged
to submit questions prior to the session. A synthesis of pertinent Questions
and Answers discussed at the prospective applicants meeting will be available
from the AHRQ Publications Clearinghouse, listed under Inquiries, and the
Agency’s web page. Further information on the conference will be published
through the Agency’s website at http://www.ahrq.gov.
Application Preparation (including use of HCFA Data)
For applications that propose to use Medicare or Medicaid data that are
individually identifiable, applicants should state explicitly in the "Research
Design and Methods" section of the Research Plan (form PHS 398) the specific
files, time periods, and cohorts proposed for the research. In consultation
with 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 HCFA to protect the
confidentiality of data in accordance with OMB Circular A-130, Appendix
III--Security of Federal Automated Information Systems. The use of the data
is restricted to the purposes and time period specified in the DUA. At the
end of this time period, the grantee is required to return the data to HCFA or
certify that the data have been destroyed. Grantees must also comply with the
confidentiality requirements of Section 903(c) of the PHS Act.
In carrying out its stewardship of assistance programs, 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.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness and
responsiveness. Incomplete applications will be returned to the applicant
without further consideration. Applications that are complete but are not
responsive to the RFA will be returned to the applicant without further
consideration, applicants may submit this project as an investigator initiated
R01 grant application to AHRQ to compete with other unsolicited applications
at the next review cycle. Applications that are complete and responsive to
the RFA will be evaluated for scientific and technical merit by an appropriate
peer review group convened by AHRQ in accordance with the review criteria
stated below.
All applications will be judged on the basis of the scientific merit of the
proposed project and the documented ability of the investigators to meet the
RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed
project is important, it will not be the sole criterion for evaluation of a
study. Other considerations, such as importance and timeliness of the
proposed study and access to patients/data will be part of the evaluation
criteria.
As part of the merit review, all applications will receive a written critique.
Those applications deemed to have the highest 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 research 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 and will be weighted 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 IT 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?
7. Responsiveness to the RFA. Does the application respond closely to the
challenges and requirements identified in this RFA? Do the proposed studies
appropriately target priorities identified at the QuIC Patient Safety Research
Summit?
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, children, 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 all other applications.
The following will be considered in making funding decisions: 1) scientific
merit as determined by peer review, 2) availability of funds, 3) balance among
target populations, with priority given to understudied populations, and among
program areas, 4) balance among geographic areas, and 5) balance among all
program areas.
INQUIRIES
Copies of the RFA and copies of the grant application form PHS 398 (rev. 4/98)
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
This RFA 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 RFA number). The RFA will be sent at the end of
the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week.
For comments or problems concerning AHRQ InstantFAX, please call (301) 594-6344.
AHRQ welcomes the opportunity to clarify any issues or questions from
potential applicants who have obtained and read the RFA. Written and
telephone inquiries concerning this RFA are encouraged. Direct inquiries
regarding programmatic issues, including issues related to the inclusion of
women, minorities, and children in study populations, should be addressed to:
Eduardo Ortiz, MD, MPH
Senior Service Fellow
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Boulevard, Suite 201
Rockville, MD 20852
Telephone (301) 594-6236FAX: (301) 594-3721
E-mail Address: eortiz@ahrq.gov
Direct inquiries regarding fiscal and eligibility matters to:
George (Skip) Moyer
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD 20852
Telephone: (301) 594-1842
FAX: (301) 594-3210
Email: smoyer@ahrq.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance,
Number 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 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. 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.
2. Bates DW. Using information technology to reduce rates of medication
errors in hospitals. Br Med J. 2000, 320: 788-790.
3. Berner ES, Webster GD, Shugerman AA, Jackson JR, Algina J, Baker AL, et
al. Performance of four computer-based diagnostic systems. N Engl J Med.
1994,330:1792-96.
4. 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
5. Evans RS, Pestotnik SL, Classen DC, Clemmer TP, Waever LK, Orme JF, et
al. A computer-assisted management program for antibiotics and other
antiinfective agents. N Engl J Med. 1998,338:232-38.
6. 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.
7. Kassirer JP. A report card on computer-assisted diagnosis the grade: C.
N Engl J Med. 1994,330:1824-25.
8. Kohn LT., Corrigan JM., Donaldson MS., eds. To Err is Human, Building a
Safer Health System. Washington, D.C.: National Academy Press, 1999.
9. Leape LL. Error in medicine. JAMA. 1994, 272(23): 1851-1857.
10. McDonald CL. Protocol-based computer reminders and the non-
perfectability of man. N Engl J Med. 1976,295:1351-55.
11. Overhage JM, Tierney WM, Zhou XH, McDonald CJ. A randomized trial of
corollary orders to prevent errors of omission. JAMIA. 1997,4:364-75.
12. Quality Interagency Task Force. Report to the President: Doing what
counts for patient safety-Federal actions to reduce medical errors and their
impact. February, 2000. (http://www.quic.gov/report/)
13. Shabot MM, LoBue M, Chen J. Wireless clinical alerts for physiologic,
laboratory, and medication data. Proceedings of the 2000 Annual Symposium of
the American Medical Informatics Association, 789-93.
14. Teich JM, Merchia PR, Schmiz JL, Kuperman GJ, Spurr CD, Bates DW.
Effects of computerized physician order entry on prescribing practices. Arch
Intern Med. 2000,160:2741-47.
15. Van der Schaaf TW, Lucas DA, Hale AR, eds. Near miss reporting as a
safety tool. Oxford: Butterworth and Heinemann. 1991.
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