TRIALS ASSESSING INNOVATIVE STRATEGIES TO IMPROVE CLINICAL PRACTICE THROUGH 
GUIDELINES IN HEART, LUNG, AND BLOOD DISEASES

Release Date:  June 29, 2001

RFA:  RFA-HL-01-011

National Heart, Lung, and Blood Institute
 (http://www.nhlbi.nih.gov)

Letter of Intent Receipt Date:  September 12, 2001
Application Receipt Date:       October 12, 2001

PURPOSE

The National Heart, Lung, and Blood Institute invites applications for 
research project (R01) grants to evaluate interventions that represent 
innovative strategies that can be employed in clinical practice to improve 
implementation of national, evidence-based clinical practice guidelines for 
the treatment of heart, lung and blood diseases and conditions. The 
application should propose an intervention that employs innovative strategies 
to address multiple barriers to guideline implementation or factors enhancing 
guideline adherence. Interventions should focus on delivery of medical care 
and should target the medical practice or hospital unit, the physician, or 
other providers through, for example, policies, programs, resources, 
procedures, and/or education.  A range of payment systems (fee-for-service, 
managed care, and public health) may be included as appropriate.  Applications 
should contain a detailed description of the proposed intervention, which 
should be feasible for delivery in a medical-care setting, along with evidence 
of its feasibility in that setting.  Phase 1 will comprise needs assessment 
for the purpose of refining intervention design and implementation plan.  In 
Phase 2, the intervention strategies will be evaluated in controlled trials of 
physicians, practices, or clinics. The primary outcome measure should evaluate 
the impact of the intervention on physician or provider implementation of the 
selected guideline, using appropriate delivery (process of care) measures.

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 priority areas.  This Request for Applications (RFA), 
Trials Assessing Innovative Strategies to Improve Clinical Practice through 
Guidelines, is related to the priority areas of access to high quality health 
services and heart disease and stroke.  Potential applicants may obtain a copy 
of "Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government. Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) regular research 
grant (R01) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this RFA may 
not exceed 5 years.  This RFA is a one-time solicitation.  Future unsolicited 
competing continuation applications will compete with all investigator-
initiated applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is July 1, 2002.

FUNDS AVAILABLE 

The National Heart, Lung, and Blood Institute intends to commit approximately 
$2,500,000 in FY 2001 to fund 6 to 10 new grants in response to this RFA. 
Approximately $24,000,000 in total costs is available over 5 years for this 
RFA program.  An applicant may request a project period of up to 5 years.  
Budgets in excess of $500,000 direct costs per year must be strongly 
justified. Because the nature and scope of the research proposed may vary, it 
is anticipated that the size of each award will also vary. Specifically, the 
annual budgets for Phase 1 are anticipated to be lower than those of Phase 2. 
Although the financial plans of the NHLBI 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 meritorious applications. At this time, 
there are no plans to reissue this RFA.

RESEARCH OBJECTIVES

Background

Evidence-based clinical practice guidelines, as defined by the Institute of 
Medicine, "are systematically developed statements to assist practitioner and 
patient decisions about appropriate health care for specific clinical 
circumstances." (1) Nearly all guidelines have been produced under the 
auspices of a relevant professional organization (e.g., medical specialty 
society, government agency, health care organization, or health plan).  The 
guideline development process typically includes a verifiable, systematic 
literature search and review of existing evidence published in peer-reviewed 
journals to identify proven therapies and define their appropriate 
utilization.  Guidelines must be applied based on individual patient needs 
using professional judgment.

A substantial and well-controlled body of published evidence demonstrates that 
a number of therapies for heart, lung, and blood diseases are effective in 
reducing morbidity and mortality. Many national evidence-based guidelines have 
been developed for the treatment of cardiovascular, lung and blood diseases, 
yet they remain inadequately followed in routine clinical practice. Although 
many gaps remain in physicians' adherence to these guidelines, both the 
precise reasons for the gaps and the ways of closing the gaps remain 
uncertain.

For example, large proportions of dyslipidemic patients receiving 
lipid-lowering therapy are not achieving National Cholesterol Education 
Program (NCEP) low-density lipoprotein cholesterol (LDL-C) target levels (2). 
 Numerous randomized clinical trial results supported the development of 
national guidelines to administer beta-blockers shortly after acute myocardial 
infarction, but it has been reported that only about half of such patients are 
prescribed beta-blockers (3).  These results could be extrapolated to estimate 
that 18,000 people die each year due, in part, to failure to receive beta-
blockers after acute myocardial infarction (4).

In addition, recent studies have demonstrated substantial differences in 
physician decision-making for cardiac diagnostic and therapeutic interventions 
after controlling or adjusting for socioeconomic status and reimbursement 
system. Disturbing differences by patient race and sex in referral for 
diagnostic cardiac testing have been seen when these were the only factors 
that differed among "hypothetical" patients (5). Utilization of proven 
therapies such as aspirin and beta-blockers after myocardial infarction has 
been demonstrated to be lower in minorities for no discernible reasons such as 
contraindications, co-existing illnesses, or inability to pay. Although these 
disparities in care among majority and racial/ethnic minorities have been 
clearly demonstrated, reasons behind them and possible avenues for modifying 
them have not. 

Recent studies have focused on the relation of patient-level factors as major 
determinants of such differences, more commonly patient demographics (e.g., 
those which lead to disparities), less often patient knowledge and attitudes 
or those of the patient's family. However, the physician, other providers, and 
the health care system have rarely been closely examined. Most studies of 
barriers to implementation of guidelines have been limited to examining a 
single barrier (6). Barriers can be classified into categories including 
awareness, familiarity, agreement, self-efficacy, outcome expectancy, inertia, 
external or systemic, and environmental factors (6). Physician treatment 
decisions and their implementation may be influenced by cognitive and 
affective processes, even if evidence-based practice guidelines exist. 

It seems unlikely that major initiatives to reduce health disparities and 
improve medical care can be successful while so little is known of the reasons 
for differences in use of effective treatments, especially regarding 
potentially modifiable factors such as physician knowledge, attitudes, and 
behaviors. While health care organizations are required by accrediting bodies 
to conduct quality assurance and quality improvement activities, they are 
rarely developed using systematic data collection or evaluated using an 
intervention trial framework. Additionally, few studies have been supported to 
develop and evaluate interventions to promote more widespread adoption of 
evidence-based clinical treatment guidelines in medical practice.

Areas of Emphasis

This RFA will support a series of studies to evaluate innovative strategies to 
improve implementation of national, evidence-based clinical guidelines for the 
care of one or more target conditions, limited to heart, lung or blood 
diseases or conditions.  Excluded are guidelines that are not national 
(including those developed for specific health care delivery institutions), 
based in countries other than the United States, not clinical or targeted only 
at patients. Clinical guidelines developed by the NHLBI, which can be accessed 
at http://www.nhlbi.nih.gov/guidelines/index.htm, are of particular interest. 
Examples of guideline topics include, but are not limited to, the following: 
o beta blocker, aspirin, blood pressure control, and lipid reduction in 
post-myocardial infarction patients; 
o blood pressure control in older adults; 
o thrombolytic therapy after acute myocardial infarction;
o hydroxyurea therapy in sickle cell disease; 
o the use of iron chelation therapy in thalassemia;
o use of inhaled corticosteroids to treat patients with persistent asthma and
o directly observed therapy for tuberculosis.

Target of intervention

The intervention must be designed to target primarily the physician, provider 
or system level (e.g., policies, programs, resources and/or procedures at the 
practice or hospital unit level), to enhance the appropriate utilization of 
specific clinical guidelines for patient care. Justification for selection of 
a particular guideline should be provided, as should justification for the 
specific physician or provider group(s) to be targeted, for example, 
documentation of low guideline adherence for the proposed condition or 
treatment to be studied. Grant applications are sought from investigators at 
primary care clinics, managed care organizations and hospitals with large, 
stable patient populations and significant proportions of minorities and 
patients with the target conditions, or from academic institutions working 
collaboratively with such institutions. Applications should provide detailed 
information on the physicians, other health care providers, and medical 
systems to be studied.  Applications should also provide detailed information 
on the patient population.  

Project Phases

Applications in response to this RFA have 2 phases; all must propose research 
to evaluate interventions that seek to improve clinical guideline 
implementation for heart, lung, or blood diseases or conditions.  Phase 1 is 
intervention refinement and Phase 2 is intervention implementation and 
evaluation.  Applicants should describe the proposed intervention in their 
application, although some refinements may be made based upon the needs 
assessment. Applicants should present available background material relevant 
to the proposed intervention, and in certain instances may be able to justify 
an innovative quality improvement intervention (Phase 2) that can be 
implemented with a relatively brief Phase 1.

The application must specify the condition(s) to be studied, the guideline to 
target, details of the proposed intervention, needs assessment approaches for 
refining the intervention, and the proposed analyses. Detailed justification 
for sample sizes for both phases is required, as are assurances that project 
sample sizes can be obtained.  

Phase 1:  Intervention refinement

Phase 1 will use needs assessment approaches to identify barriers to guideline 
implementation and adherence, factors enhancing guideline adherence, and best 
practices in an effort to refine the intervention. Needs assessment may 
include interviews, surveys, or focus groups of providers, patients, or 
others. Physician and other health care provider assessments may include: 1) 
knowledge of, attitudes toward, and beliefs regarding risk, presentation, and 
course of target conditions and any differences in these by race/ethnicity or 
other patient characteristics; 2) knowledge of, attitudes toward, and beliefs 
regarding current treatment strategies, their efficacy for the target 
conditions, and the evidence base for current treatment guidelines; 3) 
attitudes toward importance of diagnosing or treating disorders in 
racial/ethnic minorities, women, and older adults; 4) concerns about a 
patient's ability to reimburse the provider for expensive care; 5) time 
pressures and other professional demands; 6) perceived incentives; and 7) 
relevant skills. Prescribing patterns of physicians and other characteristics 
such as their care setting, mode of reimbursement, subspecialty training and 
years since training completed may also be examined for relationships to care 
delivered to various patient groups. Phase 1 will also refine the intervention 
design and the intervention implementation strategies, for example, through 
pilot testing.

The focus of this RFA is provider behavior, however, in addition to proposing 
a provider study, investigators may propose to conduct limited patient needs 
assessments that are directly relevant to the patient-physician interaction 
for the target condition or to the targeted physician behavior. For example, 
patient data could include: 1) demographic and socioeconomic factors; 2) 
insurance status and access to health care; 3) current health status and 
treatment; 4) social support, self-efficacy, and care-giving status; 5) 
knowledge of risk factors and manifestations of target conditions; 6) 
understanding of effective treatments, their costs and adverse effects; and 7) 
attitudes toward treatment, prevention, and health care providers. It may be 
helpful to include family members (spouses, parents of young patients or 
offspring of elderly patients) in the needs assessment process. Health care 
decision-makers or administrators may be interviewed one-on-one or in focus 
groups to understand their knowledge, perceptions or beliefs about barriers to 
guideline implementation or adherence, and contributing factors. 

Secondary analysis of existing data on, for example, prescribing patterns, use 
of procedures, or other topics, may be used when available data permit. 

Phase 2: Intervention Implementation and Evaluation

Applicants should specify the intervention to be evaluated in Phase 2, which 
will be refined using the results of the needs assessment and feasibility 
assessment. The intervention should address multiple barriers to guideline 
implementation or factors enhancing guideline adherence. It is desirable that 
a range of payment systems (fee-for-service, managed care, and public health) 
be included as appropriate. Applicants should propose an innovative approach 
to enhancing implementation of guidelines by physicians or providers, either 
by tailoring a proven guideline implementation method to achieve special needs 
(i.e., specialty or practice-specific needs) OR by using a novel intervention 
that, while based in theory and supported by previous literature in the area, 
represents a new approach that is uniquely suited to the specific clinical 
area.  Examples of interventions follow, but are not a restrictive list. 
Approaches could include incentives directed at the physician, reminder 
systems, or use of case managers. Physician-oriented interventions may include 
use of opinion leaders, academic detailing, educational strategies, use of 
incentives, or physician-directed reminder systems. Patient-oriented 
approaches should be directed at changing or influencing physician or provider 
behavior, for example, empowerment strategies.
 
Design of evaluation and outcomes

The interventions should be evaluated in at least 4 practices or clinics.  The 
study design should be a controlled trial or quasi-experimental study, with 
allocation of physicians, practices or clinics to intervention and comparison 
groups by the investigator.  Although the design should match the intervention 
focus (e.g., physician-targeted interventions randomize physicians, practice-
targeted interventions randomize practices, etc.) the design should also 
minimize or prevent contamination of the comparison group, which may mean 
allocating at a higher level.  The unit of assignment should be the unit of 
analysis, and the statistical analysis and power calculations should match the 
design, i.e., they should take into account the unit of assignment.  

A single primary outcome should be specified.  If multiple primary outcomes 
are desired, adjustment for multiple comparisons should be made. The objective 
of the intervention to be evaluated and the primary outcome of interest should 
be provider behavior with respect to the appropriate utilization of evidence-
based guidelines. Appropriate delivery (process of care) measures may be 
obtained from medical record review, administrative data, or patient report, 
depending upon the condition selected for study. Secondary outcomes, if any, 
and the process evaluation methods for phase 2 should be specified. Cost-
effectiveness analysis is encouraged as a secondary outcome.

Recommendations for responsiveness

Applicants responding to this solicitation must propose a study that evaluates 
the effects of an innovative quality improvement intervention on clinical 
practice.  The proposed research must evaluate interventions that seek to 
improve implementation of a national evidence-based clinical practice 
guideline for the treatment of heart, lung or blood diseases and conditions.  
Adopting the following recommendations will strengthen an application and make 
it more competitive:

o The study population should be physicians and/or other health care 
providers, and should be characterized with respect to mode of practice and 
payment system.    

o The selection of clinical guideline should be justified, based upon its 
source, evidence basis, and relevance to the clinical site and patient 
population. 

o The measurement of provider behavior should be based upon well-defined, 
valid and reliable instruments. The primary outcome measure should evaluate 
the impact of the intervention on the providers’ implementation of the 
selected guideline, using appropriate delivery of care measures obtained from 
record review, administrative data or patient reports, depending upon the 
condition selected for study. 

o The application should propose a specific randomized or quasi-
experimental design to evaluate the effectiveness of one or more innovative 
practice improvement strategies.

o Evidence of the feasibility of the intervention(s), its acceptability to 
the clinicians who will be targeted, and its ability to address the particular 
barriers to guideline implementation or factors enhancing guideline adherence, 
relevant to the population selected, should be provided.

o Substantial data should be provided on the magnitude of the health 
problem in the specified clinical population, treatment practices, adherence 
to guidelines by providers, characteristics of the patient population, the 
data sources available, previous approaches to intervention, and needs 
assessment.

Project Schedule

The maximum duration of the proposed research will be five years.  Variations 
in the project length within this period and variations of program phases may 
occur due to differences in the time needed for recruitment, intervention, and 
follow-up.  For certain topics, Phase 1 information may already be available, 
and can be presented in the application in support of the need for the Phase 2 
study.  The projected timetable is:

Phase 1 (up to 2 years):  Needs assessment for protocol refinement, 
intervention refinement, piloting of interventions in selected practice 
settings.

Phase 2 (2 to 4 years):  Recruitment of practice settings and physicians, 
allocation, intervention delivery and follow-up, measurement, preliminary data 
analysis

Close-out (6 months to 1 year):  Final data analysis and publication 

REFERENCES

1) Institute of Medicine. (1990). Clinical Practice Guidelines: Directions 
for a New Program. M.J. Field and K.N. Lohr (eds.) Washington, DC: National 
Academy Press (page 39).

2) Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment 
project (L-TAP): a multicenter survey to evaluate the percentages of 
dyslipidemic patients receiving lipid-lowering therapy and achieving low-
density lipoprotein cholesterol goals. Arch Intern Med. 2000;160:459-467.

3) McLaughlin TJ, Soumerai SB, Willison DJ, et al. Adherence to national 
guidelines for drug treatment of suspected acute myocardial infarction: 
evidence for undertreatment in women and the elderly. Arch Intern Med 
1996;156:799-805.

4) Soumerai SB, McLaughlin TJ, Spiegelman D, Hertzmark E, Thibault G, 
Goldman L.  Adverse outcomes of underuse of beta-blockers in elderly survivors 
of acute myocardial infarction. JAMA 1997; 277:115-21.

5) Schulman KA, Berlin JA, Harless W, et al. The effect of race and sex on 
physicians' recommendations for cardiac catheterization.  N Engl J Med. 1999 
Feb 25;340(8):618-26.

6) Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why 
don't physicians follow clinical practice guidelines? A framework for 
improvement. JAMA 1999;282:1458-65.

SPECIAL REQUIREMENTS

Annual meetings

Applicants funded under this RFA will be required to attend meetings in which 
study plans, findings and issues of common interest and concern will be shared 
and discussed.  Investigators will meet:  (1) at the beginning of funding to 
discuss study plans and share problems and solutions; (2) annually until the 
end of the study, to share experiences in the needs assessment, design, 
recruitment and implementation of the interventions; (3) after completion of 
the analyses to share results and materials.  Applications should include in 
their budgets funds for attending (1) an initial meeting at or near the time 
of award; (2) an annual meeting thereafter until the end of funding.  For 
budgeting purposes, applicants should assume that the meetings would be for 2 
days in Bethesda, MD, at the National Institutes of Health and require the 
attendance of the Principal Investigator and up to one other person. 

Use of existing studies

Applicants should consider taking advantage of other projects (e.g. quality 
improvement projects) that could be expanded by adding a randomized or quasi-
experimental design with an evaluative component.  Such projects might provide 
access to unique populations as well as reduce the costs of conducting 
research.  

Final report

At the completion of the project, the Principal Investigator (PI) must provide 
a report to the NHLBI Project Office with: (1) detailed recommendations 
concerning the practice improvement intervention(s) evaluated, based on the 
study's findings; (2) a complete description of the intervention(s) used in 
the study, to include a description of the rationale for the intervention(s), 
a description of the intervention procedures used (e.g., manual of 
procedures), and any intervention materials used; (3) training, certification, 
and quality control procedures for ensuring effective implementation of the 
practice improvement intervention(s); and (4) description of how the 
interventions could be tailored for other modalities, populations, or 
diseases.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for 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 are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

Please specify the approximate percentage of women and each minority group 
expected in the total sample.  

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

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

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

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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. 
 It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application. 
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 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 the review of 
a subsequent application, it is very important to NHLBI because the 
information that it contains allows Institute staff to estimate the potential 
review workload and plan the review.

The letter of intent is to be sent to Dr. Beebe at the address listed under 
INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, 
MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: 
GrantsInfo@nih.gov.

Budgets should be in the standard (non-modular) format with a detailed budget, 
because it is expected that budgets for the Phase 2 years of the project will 
exceed $250,000 in annual direct costs.

The RFA label available in the PHS 398 (rev. 4/98) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html 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 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.

Please note that color figures or photos present in the body of the grant 
application should also be present in the appendix, or high-quality 
reproductions of the pages containing color or half-tone figures should be 
included in the appendix.  The reviewers will receive a black-and-white copy 
of the grant application together with the appendix.

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
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application as well as 
all five collated sets of Appendix material must be sent to Dr. Deborah Beebe 
at the address listed under INQUIRIES.  It is important to send these copies 
at the same time that the original and three copies are sent to the Center for 
Scientific Review (CSR).

Applications must be received by 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.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an introduction addressing the previous critique.

Principal investigators should not sent supplementary material without first 
contacting the Scientific Review Administrator (SRA).  The SRA will be 
identified in the letter sent to you indicating that your application has been 
received.  If you have not yet received such a letter, contact, Dr. Deborah 
Beebe at the address listed under Inquiries.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NHLBI staff.  Incomplete and/or non-responsive applications 
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 appropriate peer review group convened by the NHLBI 
in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest scientific 
merit, generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level review by the 
NHLBI National Advisory Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application 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 in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have 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 this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project propose an innovative approach to enhancing 
implementation of guidelines by physicians or providers, either by tailoring a 
proven guideline implementation method to achieve special needs (i.e., 
specialty or practice-specific needs) OR by using a novel intervention that, 
while based in theory and supported by previous literature in the area, 
represents a new approach that is uniquely suited to the specific clinical 
area? 

(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 (if any)?

(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) Translation:  Do the intervention strategies evaluated have the ability to 
be translated into primary care settings (e.g. by using interventions that 
address generalist physicians, or that make use of providers other than 
physicians) or to be broadly applied by the target specialty (e.g., for 
critical care or emergency medicine)?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research. 

o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

Schedule

Letter of Intent Receipt Date:    September 12, 2001
Application Receipt Date:         October 12, 2001
Peer Review Date:                 February/March 2002
Council Review:                   May 9-10, 2002
Earliest Anticipated Start Date:  July 1, 2002

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.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Marcel E. Salive	
Division of Epidemiology and Clinical Applications

National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 8126, MSC 7936
6701 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0380
FAX:  301-480-1669
Email: SaliveM@nih.gov

Ms. Virginia Taggart
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 10214
6701 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0202
e-mail:  TaggartV@nih.gov

Ms. Carol Webb
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 9174
6701 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0515
e-mail:  WebbCA@nhlbi.nih.gov

Dr. Duane Bonds
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 10148
6701 Rockledge Drive
Bethesda, MD  20892
Telephone: (301) 435-0055
FAX: (301) 480-0868
e-mail: BondsD@nhlbi.nih.gov

Direct inquiries regarding review issues and letter of intent, and send two 
copies of the application to:

Dr. Deborah Beebe
Chief, Review Branch
Division of Extramural Affairs
NHLBI, NIH
6701 Rockledge Drive
Room 7178
Bethesda, MD  20892-7924 (20817 for express mail)
Telephone:  301-435-0270
FAX:  301-480-3541
e-mail:  BeebeD@nhlbi.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carol Dangel
Grants Operations Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7140, MSC 7926
Bethesda, MD  20892-7926
Telephone: (301) 435-0177
Email: DangelC@nhlbi.nih.gov


AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.937, (NHLBI).  Awards are made under authorization of Sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant 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.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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