Translational Research Centers for Diabetes Control Within Managed-Care Settings; Availability of Funds for Fiscal Year 1998

Federal RegisterJun 29, 1998

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 98086]

Translational Research Centers for Diabetes Control Within

Managed-Care Settings; Availability of Funds for Fiscal Year 1998

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1998 funds, and invites cooperative

agreement applications for a multi-center, collaborative, diabetes

translational research initiative within managed-care settings to (1)

evaluate the extent to which healthcare providers and healthcare

delivery systems implement accepted standards of diabetes care (e.g.,

American Diabetes Association), which can reduce the burden of diabetes

and its complications; (2) explore the factors that affect variations

in implementing quality diabetes care; and (3) develop and test

strategies aimed at closing the gap between existing practice and

optimal standards of care.

The collaborative studies will consist of two phases. Phase 1 (12

months)--Planning, collaborative development of the protocol(s), and

development of the manual of operations. Phase 2 (48 months)--Conduct

of studies selected by the Steering Committee, analysis, and reporting

of the results.

Under a Request for Contract, FY 1998 funds will be made available

to fund one Data Coordinating Center (DCC). The organization funded for

the DCC will not be eligible to receive funds under this Program

Announcement. The DCC will collaborate with the recipients under this

announcement in the design and writing of the study protocol(s) and

consent forms, creation of the data collection forms, and writing of

the manual(s) of operations. In addition, it will assist with the

development of the operational plans, develop a system to collect,

manage, and store scientific data, management and analysis, and

collaborate with the Translational Research Centers in reporting of

results.

CDC is committed to achieving the health promotion and disease

prevention objectives of Healthy People 2000, a national activity to

reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of Diabetes and Chronic

Disabling Conditions. (For ordering a copy of Healthy People 2000, see

the section Where to Obtain Additional Information.)

Authority

This program is authorized under sections 301(a) and 317(k)(2) of

the Public Health Service Act, as amended (42 U.S.C. 241(a) and 247b

(k)(2)). Applicable program regulations are found in 42 CFR Part 51b--

Project Grants for Preventive Health Services.

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and to promote the non-use of all tobacco products, and

Pub. L. 103-227, the Pro-Children Act of 1994, prohibits smoking in

certain facilities that receive Federal funds in which education,

library, child care, health care, and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants are public and private nonprofit domestic

organizations operating within managed-care settings and providing

services to a minimum of 5,000 people with diabetes. Thus, managed-care

organizations, teaching hospitals, universities, colleges, and research

institutions are eligible to apply. Applicants claiming nonprofit

status must include evidence of nonprofit status with their

application.

Minority individuals and women are encouraged to apply as Principal

Investigators. Institutions caring for large numbers of racial and

ethnic minority groups with diabetes are especially encouraged to

apply.

Funding Preference: A funding preference will be given to

applications under the following conditions: Women, racial, and ethnic

minority populations to be accessed by the applicant--to ensure that

the selected Diabetes

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Translational Research Centers will together have a good balance of

racial and ethnic minority groups.

Applicants must have direct access to a population of at least

5,000 people with diabetes or access through a partnership, operating

within a managed-care setting.

Institutions may apply as a single entity or in a collaborative

partnership. In this regard, applicants are encouraged to form

collaborative arrangements with investigators at minority institutions

or minority investigators at other institutions. However, only one

institution will be named as the recipient of grant funds in a

partnership.

The expertise appropriate for the Translational Research Center

applications includes a knowledge of the clinical, epidemiological, and

health services research aspects of diabetes. All eligible applicants

must have diabetes-related research capacity within a managed-care

setting, i.e., access to large numbers of patients with diabetes

(minimum of 5,000); strong multi disciplinary research groups, access

to good data systems, access to academic skills in health services

research, epidemiology, survey design, behavioral sciences, and health

economics.

Eligibility characteristics must be clearly specified with

appropriate documentation in the Application Requirements section of

your application (see Application Content).

Note: Effective January 1, 1996, Pub. L. 104-65 states that an

organization described in section 501(c)(4) of the Internal Revenue

Code of 1986 which engages in Lobbying activities shall not be

eligible for the receipt of Federal funds constituting an award,

grant (cooperative agreement), contract, loan, or any other form.

Availability of Funds

Approximately $800,000 is available in FY 1998 to fund up to four

Translational Research Centers. It is expected that the average award

during the planning phase (Year 1) of this project will be $200,000

(including direct and indirect costs), ranging from $150,000 to

$250,000. However, it is anticipated that additional funds may be

available in FY 1999 to increase the average award for Year 01 to

approximately $500,000, ranging from $300,000 to $700,000.

Please plan your project in anticipation of these additional funds.

It is expected that awards will begin on or before September 30, 1998,

and will be made for a 12-month budget period within a project period

of up to 5 years. Funding estimates may vary and are subject to change.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds. At this

time, CDC anticipates that there will not be a renewed competition

after five years.

Use of Funds

Allowable Uses: Funds are awarded for a specifically defined

purpose and must be targeted for implementation and management of the

project. Funds can support personnel, services directly related to the

project, and the purchase of hardware and software for data collection,

analysis, and project management and evaluation purposes.

Prohibited Uses: Cooperative agreement funds under this program

announcement cannot be used for (1) construction, (2) renovation, (3)

the purchase or lease of passenger vehicles or vans, (4) to supplant

non-federal funds that would otherwise be made available for this

purpose, or (5) cost of regular patient care.

Restrictions on Lobbying: Applicants should be aware of

restrictions on the use of Health and Human Services (HHS) funds for

lobbying of Federal or State legislative bodies. Under the provisions

of 31 U.S.C. Section 1352 (which has been in effect since December 23,

1989), recipients (and their subtier contractors) are prohibited from

using appropriated Federal funds (other than profits from a Federal

contract) for lobbying Congress or any Federal agency in connection

with the award of a particular contract, grant, cooperative agreement,

or loan. This includes grants and cooperative agreements that, in whole

or in part, involve conferences for which Federal funds cannot be used

directly or indirectly to encourage participants to lobby or to

instruct participants on how to lobby.

In addition, the FY 1998 Department of Labor, Health and Human

Services, and Education, and Related Agencies Appropriations Act, (Pub.

L. 105-78) states in section 503(a) and (b) that no part of any

appropriation contained in this Act shall be used, other than for

normal and recognized executive-legislative relations, for publicity or

propaganda purposes, for the preparation, distribution, or use of any

kit, pamphlet, booklet, publication, radio, television, or video

presentation designed to support or defeat legislation pending before

the Congress or any State legislature, except in presentation to the

Congress or any State legislature itself. No part of any appropriation

contained in this Act shall be used to pay the salary or expenses of

any grant or contract recipient, or agency acting for such recipient,

related to any activity designed to influence legislation or

appropriations pending before Congress or any State legislature.

Background

A considerable body of evidence exists for the efficacy of

interventions (e.g., glycemic control, cardiovascular disease (CVD)

risks reduction, screening for diabetes complications) to reduce the

avoidable burden of diabetes. Nevertheless, the effectiveness,

generalizability, feasibility, and sustainability of several of these

interventions in real-life settings are less than clear. Furthermore,

several reports suggest that considerable gaps exist between existing

practice and recommended standards of diabetes care for people with

diabetes. For example, the American Diabetes Association has

recommended standards of care for several aspects of diabetes

management (American Diabetes Association, Clinical Practice

Recommendations 1998, Diabetes Care 1998;21 (Suppl.1). However,

national estimates from the Behavioral Risk Factor Surveillance System

indicate that the population of Americans receiving appropriate

diabetes care practices such as foot and eye examinations, glycosylated

hemoglobin, and other preventive care evaluations fall short of the

recommended standards.

Managed care represents a revolution in the way health care is

funded, organized, and delivered in the United States, and has affected

the way in which diabetes treatment and control are conducted in both

the private and public sectors. In the public sector, many health

departments are in some stage of transition from directly delivering

clinical services to using other delivery models that involve managed

care. Thus, managed-care providers play a key role in the way people

with diabetes are diagnosed and managed for increasing numbers of

Americans. With more diagnostic and treatment services for diabetes

being conducted in managed care, new partnerships are needed between

managed-care health plans and public health agencies to design and

implement essential and innovative diabetes-related services.

Furthermore, managed-care (by virtue of coordinating all care for

persons with diabetes) is probably the closest approximation to

population medicine currently available in the United States. Managed-

care, therefore, offers significant opportunities to understand and

test intervention effectiveness and cost-effectiveness within a real-

life context,

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as well as the public health impact of system wide interventions.

Purpose

The purpose of this diabetes translational research initiative is

to initiate a multicenter, collaborative program of applied population-

based research related to diabetes, and to develop a knowledge base

through published research in scientific literature and handbooks for

professional associations that will improve the process, delivery, and

outcome of diabetes services within managed-care settings. The

knowledge base to be developed will address methods for and assessment

of effectiveness, cost-effectiveness, generalizability, feasibility,

and sustainability of interventions. Such a knowledge base may include

a variety of activities covering the range of diabetes interventions,

including diabetes screening and diagnosis; treatment approaches,

glycemic control, CVD risk reduction, and screening for diabetes

complications.

This program will improve the availability, accessibility, quality

of process, effectiveness, cost-effectiveness, and health outcomes of

diabetes-related services provided by managed-care health plans. The

benefit of this program will be the establishment of new partnerships

and relationships among managed-care health plans and between managed-

care health plans and public health agencies. Thus, the challenges of

improving diabetes control services may be collaboratively assessed in

a manner to have a national public health impact. The other goals of

this program will include provision of data for policy development,

assessment, and capacity-building at the State and local levels with

respect to managed care and the CDC Diabetes Control Program's ability

to develop appropriate diabetes control policies and to conduct

diabetes surveillance in a changing health environment.

Program Requirements

Work performed under this cooperative agreement will be the result

of collaborative efforts among the funded Translational Research

Centers and the Data Coordinating Center. Recipients will be

responsible for implementing research methods and study design,

analysis, use of data, and dissemination of results via peer-reviewed

scientific publications or other related material.

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities under A., below,

and CDC will be responsible for carrying out the activities described

under B., below.

A. Recipient Activities

1. Participate in the protocol development, data collection,

quality control, final data analysis and interpretation, the

preparation of publications, and presentation of findings.

2. Establish a Steering Committee that will be the primary

governing body of the study and will be comprised of each of the

Principal Investigators from the Translational Research Centers and the

Data Coordinating Center. The Steering Committee will have primary

responsibility for developing common study protocols, facilitating the

conduct and monitoring of the studies, and reporting the study results.

3. Work cooperatively with the other Translational Centers, the

Data Coordinating Center, and agree to follow the common protocol(s)

and manual(s) of operations developed in Phase 1 of the study by the

Steering Committee.

4. Transmit all relevant study data to a central Data Coordinating

Center for data editing, formatting, combination, and primary analysis.

5. Collaborate with other health organizations, community groups,

etc., as necessary to accomplish program activities.

6. Maintain an effective and adequate management and staffing plan.

The success of the program will depend on recruiting and hiring staff

in a timely manner. Staff should have the education, background, and

experience to successfully conduct the activities proposed in this

application.

B. CDC Activities

1. Support and stimulate the recipients' activities by

collaborating and providing scientific and public health consultation

and assistance in the development of activities related to the

cooperative agreement. Consistent with this concept, the tasks and

activities in carrying out the studies will be shared among the

recipients and the CDC.

2. Establish a Data Coordinating Center that will serve as a

resource for standardized assessment, analysis, reporting, and that

will assist in the design and writing of study protocol(s) in

collaboration with the Research Centers.

3. Assist in the coordination of activities between the Diabetes

Translational Research Centers and the Data Coordinating Center.

4. Facilitate communication among recipients and assist in quality

control, interim data monitoring, final data analysis and

interpretation, and coordination and performance monitoring.

5. Serve as a consultant to the Steering Committee.

Technical Reporting Requirements

An original and two copies of the following reports must be

submitted to the Grants Management Branch, CDC.

A. Semiannual progress reports are required of all cooperative

agreement recipients. The first semiannual report is required with each

year's noncompeting continuation application and should cover program

activities from date of the previous report (or date of award for

reporting in the first year of the project). The second semiannual

report is due 30 days after the end of each budget period and should

cover activities from the date of the previous report. Progress reports

should address the status of all recipient activities above, including:

1. A comparison of actual accomplishments to the objectives

established for the period.

2. The reasons for slippage if established goals were not met.

3. Other pertinent information essential to evaluating progress.

4. Data pertaining to various project activities.

B. A financial status report (FSR) is required no later than 90

days after the end of each budget period. The final financial status

report is required no later than 90 days after the end of the project

period. Please submit the original and two (2) copies of all reports to

the Grants Management Branch, CDC.

Notification of Intent To Apply (Preapplication Letter)

To assist CDC in planning and executing the evaluation of

applications submitted under this Program Announcement (98086), a

nonbinding letter of intent-to-apply is requested from potential

applicants. Although not a prerequisite of the application, the letter

should be submitted to Bernice A. Moore, Epidemiology and Statistics

Branch, Division of Diabetes Translation, National Center for Chronic

Disease Prevention and Health Promotion, Centers for Disease Control

and Prevention (CDC), Mailstop K-10, 4770 Buford Highway NE., Atlanta,

GA 30341-3717, telephone (770) 488-5855; fax (770) 488-5966; or

Internet or CDC WONDER E-mail at [email protected]. It should be postmarked

no later than one month before the planned submission deadline (due not

later than July 15, 1998. The letter should identify the Program

Announcement number, the

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name and address of the applicant's institution, and telephone number

of a contact person. The letter of intent does not influence review or

funding decisions, but it will enable CDC to plan the review more

efficiently.

Application Content

It is anticipated that applications for Diabetes Translational

Research Centers within this initiative will focus on important aspects

of the process and outcome of care for people with diabetes. Process of

care may include diabetes screening and diagnosis; treatment

approaches; glycemic control; cardiovascular disease (CVD) risks

reduction; screening for diabetes complications; and outcome of care

may include quality of life and avoidable morbidity and death among

people with diabetes. In addition, the extent and causes of variation

in implementation of accepted standards of diabetes care may be

explored at three levels--individuals, healthcare providers, and health

care delivery systems. Emphasis should be on identifying important and

potentially modifiable factors that contribute to the failure to use

recommended standards of diabetes care, and on designing and testing

(using rigorous scientific approaches) cost-effective strategies aimed

at achieving optimal care. Furthermore, in keeping with the philosophy

of Translational Research, designs should emphasize intervention

effectiveness which span diverse populations and a variety of

healthcare approaches (e.g., type of managed care), leading to findings

with high generalizability. Thus, good translational research will

require multicenter participation and represent populations of diverse

age, ethnicity, socioeconomic status, and severity of diabetes.

Furthermore, strategies aimed at achieving optimal diabetes care should

aim for generalizability, sustainability and cost-effectiveness.

Each applicant must propose the research questions and study

designs that best address the objectives of this initiative and are

most appropriate for their patient population. The outcome of this

initiative should result in the following questions:

1. What are the current levels of care provided to people with

diabetes, and how does it compare with the recommended standards of

diabetes care (e.g., American Diabetes Association)?

2. What is the health-related quality of life for people with

diabetes and what factors influence patient satisfaction and quality of

life?

3. What are the major factors that influence the process, delivery,

effectiveness, costs, and sustainability of interventions aimed at

glycemic control, and conventional CVD risk factor (elevated blood

pressure, dyslipidemia, smoking, overweight, physical inactivity)

reduction among people with diabetes?

4. What are the major factors that influence the process, delivery,

effectiveness, costs, and sustainability of interventions aimed at the

early detection of microvascular complications of diabetes (e.g.,

retinopathy, nephropathy)?

Collaborative protocols to study the above questions will be

developed by a Steering Committee composed of the recipients and the

Principal Investigator of a Data Coordinating Center selected under a

separate Request for Contract. The collaborative study protocol(s) will

move into the implementation stage with the concurrence of the Steering

Committee.

It is not the intent of this Program Announcement to solicit

elaborately detailed research plans for the above proposed

collaborative studies because the final protocols will be

collaboratively developed by the investigators during the planning

phase (Phase 1).

Specific Instructions

All applicants must develop their applications in accordance with

PHS Form 5161-1 (Revised 5/96), information contained in this Program

Announcement, and the format and page limitations that follow. Provide

a clear and succinct description and supportive references regarding

how each of the statements apply in your application:

1. Experience in one or more of the following areas: Health

economics research, health services research, epidemiological research,

or health information systems research.

2. Employs or can engage investigators in the fields of economics,

health services research, or information systems research who have

direct experience at establishing, working with, and researching

diabetes-related topics, and with a corresponding record of substantial

publication in the peer-reviewed scientific literature.

3. Ability and willingness to designate one experienced and

published investigator as the project's principal investigator.

4. The principal investigator for this project has access to a

population of at least 5,000 people with diabetes who are cared for

within a managed-care setting, and has access to research

infrastructure and to basic data necessary to carry out this project.

5. Describe the composition of the proposed study population (for

example, addressing the inclusion of women and members of minority

groups and their subpopulations in the section that will describe the

research design). A copy of the CDC policy on Women, Racial and Ethnic

Minorities is enclosed with the application kit for guidance.

6. Nonprofit organizations must document their status on

application PHS Form 5161-1 (Revised 5/96), Part D of the Checklist.

Responses to the above may follow the Table of Contents in your

application, but must appear as the first page(s) of the text of your

application and be titled, Application Requirements. Eligibility

characteristics must be clearly specified with appropriate

documentation in the Application Requirements section of your

application.

The application narrative must include the following sections in

the order presented below:

A. Rationale for the research question(s) chosen to be addressed

(not to exceed 1 page):

Describe the research question(s) chosen to be addressed and the

rationale for this selection. Include an explanation of why this

question is a priority for the investigator(s) and what types of

interest, experience, or expertise the investigator(s) brings to the

particular problem inherent in the chosen research question(s).

The extent to which the rationale for the chosen research question

(1) is based on public health importance, (2) is based on the

experience and expertise of the investigator(s), and (3) clearly

communicates the anticipated value to the purpose of the Diabetes

Translational Research Initiative.

B. Objectives of the research (not to exceed 4 pages):

Itemize the objectives and timelines of the research in relation to

the chosen research question(s), and describe: (1) The extent to which

the objectives of the chosen research question(s) are numerically

measurable, specific, realistic, time-phased, and suitable for

development into a collaborative, multicenter study protocol; the

extent to which applicant presents a detailed operational plan for

initiating and conducting the project that clearly and appropriately

addresses all Recipient Activities; (2) the extent to which the

applicant clearly identifies specific assigned responsibilities and

time commitment of all key professional personnel; (3) the extent to

which the plan clearly describes applicant's technical approach and

methods for conducting the proposed studies and

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extent to which the approach and methods are appropriate and adequate

to accomplish the objectives; (4) the extent to which applicant

describes collaboration with CDC and others during the various phases

of the project and shows commitment to a multicenter, collaborative

approach.

C. Design of the research (not to exceed 3 pages):

The extent to which the proposed methodology of the research is

scientifically sound, realistic, appears likely to answer the chosen

research question(s), and will produce generalizable findings; and, if

appropriate, the degree to which the applicant has included women,

racial and ethnic minority populations in the proposed research to

include:

1. The proposed plan for the inclusion of both sexes and racial and

ethnic minority populations for appropriate representations.

2. The proposed justification when representation is limited or

absent.

3. A statement whether the design of the study is adequate to

measure differences when warranted.

4. A statement whether the plans for recruitment and outreach for

study participants include the process of establishing partnerships

with community(ies) and recognition of mutual benefits.

D. Background and experience of the principal investigator,

coinvestigators, and the applying institution, organization, or agency

(not to exceed 3 pages):

Describe the educational and professional background of the

principal investigator, and document the relevant experience of the

principal investigator and qualifications of the applying institution,

organization, or agency for carrying out health economics, health

services, or information systems research. Specifically, emphasize the

experience of the principal investigator in participating in

collaborative, multicenter research projects, and describe the data

sources that are available to the investigator. Describe the population

and number of people with diabetes within the managed-care health plan,

and provide details of the managed-care structure, organization,

financing, and percentage of the Medicaid population under contract.

Provide a brief description of how the project will be organized, and

indicate the proposed staffing plan.

E. Access to a large number of people with diabetes

(5000) cared for within managed care (not to exceed 2

pages):

Describe the extent to which (1) the population used in carrying

out this research project is sufficiently typical of people with

diabetes around the country or accurately represents special groups of

people with the disease--so that a solution to the collaborative

research question(s) will have the broadest possible application; (2)

the principal investigators have sufficient access to well developed

data sources and ability to use it for the purposes of carrying out

this research project; and (3) if applicable, attach evidence of

collaboration specifying the commitment of the parties involved and

provide details, including the terms of access to data and to

populations and any specified limits to collaboration for the purposes

of this project.

F. Budget and budget justification (not to exceed 5 pages):

Provide a detailed, line-item budget with justification that

demonstrates the request is consistent with the purpose and objectives

of this program. The budget for Phase I of the study should be clearly

delineated. Budgets should allow for approximately three persons,

including the Principal Investigator, to attend Steering Committee and

Subcommittee meetings. The detailed budget for Phase I should be

estimated on the basis of monthly meetings during Phase 1.

G. Human Subjects:

Whether or not exempt from DHHS regulations, if the proposed

project involves human subjects, describe (in an appendix) adequate

procedures for the protection of human subjects. Also, ensure that

women, and racial and ethnic minority populations are appropriately

represented in applications for research involving human subjects.

Typing and Mailing

All pages must be clearly numbered and a complete index to the

application and its appendixes must be included. Do not bind, staple,

or paper clip any pages of any copy of the application, including

appendixes. Do not include any bound documents (e.g., pamphlets or

other publications) in the appendixes. Do not include cardboard,

plastic, or other page separators between the sections. The entire

application must be typewritten, single-spaced, and in unreduced type

(12-point fonts) on 8\1/2\'' by 11'' white paper, with at least 1''

margins, including headers and footers, and printed on one side only.

Evaluation Criteria (Total 100 Points)

Applications will be reviewed and evaluated according to the

following criteria:

A. Rationale for the Research Question(s) Chosen to be Addressed

(15 points)

Describe the research question(s) chosen to be addressed and the

rationale for this selection. Included in this should be an explanation

of why this question is a priority for the investigator(s) and what

types of interest, experience, or expertise the investigator(s) brings

to the particular problem inherent in the chosen research question(s).

The extent to which the rationale for the chosen research question

(1) is based on public health importance, (2) is based on the

experience and expertise of the investigator(s), and (3) clearly

communicates the anticipated value to the purpose of the Diabetes

Translational Research Initiative.

B. Objectives of the Research (20 points).

(1) The extent to which the objectives of the chosen research

question(s) are numerically measurable, specific, realistic, and time-

phased, and suitable for development into a collaborative, multicenter

study protocol. The extent to which the applicant presents a detailed

operational plan for initiating and conducting the project that clearly

and appropriately addresses all Recipient Activities; (2) the extent to

which the applicant clearly identifies specific assigned

responsibilities and time commitment of all key professional personnel;

(3) the extent to which the plan clearly describes applicant's

technical approach and methods for conducting the proposed studies and

the extent to which the approach and methods are appropriate and

adequate to accomplish the objectives; and (4) the extent to which

applicant describes collaboration with other translation centers during

the various phases of the project, and shows commitment to a

multicenter, collaborative approach.

C. Design of the Research (20 points).

The extent to which the proposed methodology of the research is

scientifically sound, realistic, appears likely to answer the chosen

research question(s), and will produce generalizable findings; and, if

appropriate, the degree to which the applicant has included women,

racial and ethnic minority populations in the proposed research to

include:

1. The proposed plan for the inclusion of both sexes and racial and

ethnic minority populations for appropriate representations.

2. The proposed justification when representation is limited or

absent.

3. A statement whether the design of the study is adequate to

measure differences when warranted.

4. A statement whether the plans for recruitment and outreach for

study participants include the process of

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establishing partnerships with community(ies) and recognition of mutual

benefits.

D. Background and Experience of the Principal Investigator and of

the Applying Institution, Organization, or Agency (20 points).