Prevention Epicenters Program; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for a cooperative agreement program for Prevention Epicenters. CDC is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010”, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus areas of Access to Quality Health Services and Immunization and Infectious Diseases. For the conference copy of “Healthy People 2010”, visit the internet site http://www.health.gov/healthypeople.

The purpose of the program is to assist healthcare organizations and institutions to support established Prevention Epicenters or to develop new Prevention Epicenters as part of the CDC's Prevention Epicenters (PE) program. The PE program is designed to develop, implement, and evaluate the effectiveness of epidemiologically-based strategies to improve healthcare quality and assure patient safety by preventing adverse events associated with healthcare including, but not limited to, healthcare-associated infections, and antimicrobial resistant infections. (See Attachment II Background for more information.)

The goals of the PE program are to: (1) Support activities which lead to improvements in information system capacity to monitor healthcare system performance and healthcare outcomes. Such activities should expand the use of information technology to acquire, integrate, process, analyze, and report information, and use information technology to develop and implement innovative interventions to prevent infections and other adverse health events; (2) be a national resource for building epidemiologic capacity in healthcare outcomes research. PE program activities should extend the capacity of healthcare epidemiology and infection control programs to address patient safety, cost effectiveness, prevention effectiveness, healthcare outcomes monitoring, and performance measurement; and (3) support activities which develop an infrastructure to address the above goals in the broadest spectrum of healthcare delivery settings, including acute care hospitals, long-term care facilities, rehabilitation programs, dialysis centers, home healthcare programs, ambulatory care programs, and others.

Specific objectives for the pilot and developmental phases of the project will include identifying (1) appropriate populations, (2) outcome measures, (3) data collection methods, and (4) interventions to be instituted in year 2 of the project.

Each Prevention Epicenter will be established within a healthcare network or system, integrated healthcare delivery system (IDS), or managed care organization (MCO) which serves a large and diverse group of people. Through the network, system, or organization, the Prevention Epicenter should have access to patients in a variety of healthcare settings (e.g., long-term care, rehabilitation, home health care, ambulatory care, dialysis centers, etc.). The population served by the components of the system should be definable based on the network's, system's, or organization's knowledge of historical patterns of use of services by patients and/or the demographics of enrollment in managed healthcare plans served by the network, system, or organization. Prevention Epicenters will work together as part of a national multi-center collaborative research and demonstration program in the areas of patient safety and healthcare outcomes research.

B. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit organizations, State and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

Note:

Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

Approximately $2,000,000 is available in FY 2000 to fund approximately 10 awards (up to eight competing continuations and one or two new Prevention Epicenters). It is expected that the average award for the existing Prevention Epicenters will range from approximately $100,000 to $450,000, depending on the activities funded per site, and the average award for new Prevention Epicenters will range from approximately $75,000 to $250,000. More funds are available for existing Prevention Epicenters because they are mature, fully-functional programs and new Prevention Epicenters might need up to 12 to 24 months to become fully-functional and able to participate in all activities.

It is expected that the awards will begin on or about September 30, 2000, and will be made for a 12-month budget period within a project period of up to 5 years. The funding estimate may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Funding Preferences

1. Although applications for new programs are encouraged, funding preference will be given to the competing continuation applications over applications for programs not already receiving support under the existing Prevention Epicenter program. The current awardees already have the infrastructure needed to continue the Prevention Epicenter program.

2. To achieve appropriate representation in the Prevention Epicenters program, funding preference may be given to approved applications that would enhance the racial, ethnic, socioeconomic, and/or geographic diversity of the program.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities).

1. Recipient Activities

a. Establish and/or operate a Prevention Epicenter that is consistent with the purposes of the program.

b. Establish collaborative and cooperative relationships with other public and private organizations that have an interest in outcomes research, disease management, prevention effectiveness, prevention of adverse health outcomes, patient safety, and healthcare quality in order to maximize access to, and participation of, relevant study populations.

(1) Collaborate with other Prevention Epicenters to establish a PE program advisory committee and participate in the project planning activities.

(2) Collaborate with other Prevention Epicenters on one or two core program activities. Core program activities are defined as activities intended to become multicenter collaborative projects addressing the three goals of the PE program.

(3) Propose and conduct one or more investigator-initiated projects. Investigator initiated projects may address issues of local interest or concern that are in keeping with the goals of the PE program. In addition to focusing on defined patient populations, investigator-initiated projects may address issues that include, but are not limited to: healthcare personnel behavior modification, healthcare personnel safety, laboratory-based assessment and interventions, and the monitoring and control of antimicrobial resistance.

(4) Manage, analyze, and interpret data, and publish and disseminate important medical and public health information stemming from Prevention Epicenter projects in collaboration with other PE program sites.

(5) Monitor and evaluate scientific and operational accomplishments and progress in achieving the purpose of this program.

2. CDC Activities

a. Collaborate, as appropriate, with the recipient in all stages of the program, and provide programmatic and technical assistance.

b. As requested, participate in data collection, analysis, and interpretation of data from Prevention Epicenter projects. Provide scientific collaboration.

c. As requested, participate in the dissemination of findings and information stemming from Prevention Epicenter projects.

d. Participate in improving program performance through consultation based on information and activities of other projects.

e. As requested, perform laboratory evaluation of specimens or isolates (e.g., molecular epidemiologic studies, evaluation of diagnostic tools) obtained in Prevention Epicenter projects.

f. As requested, facilitate communication of data and results among Prevention Epicenters.

g. Assist in the development of research protocols for IRB review by all cooperating institutions participating in the research project.

The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

E. Application Content

Use the information in the Program Requirements, Other Requirements and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should not be more than 25 single-spaced pages printed on one side, with one inch margins and unreduced font. Applications should follow the PHS 398 (rev. 4/98) application and Errata sheet, and should include the following information.

1. Submission of an application for at least two but no more than three project activities in total. Each activity proposal, including the proposed multicenter collaborative projects (core program activities), and investigator-initiated activities, should be clearly identified in a distinct portion of the Operational Plan. Although the activities proposed may address distinct issues and needs, they may be implemented in an integrated manner such that staff members work on more than one activity, or supplies and equipment are shared.

Note:

Approximately 50-80 percent of resources will go to the core, multicenter collaborative activities.

2. Provide a line-item budget and narrative justification for all requested costs, and separate line-item budgets for each proposal submitted to conduct core program activities and investigator-initiated activities. Budgets should be consistent with the purpose, objectives and research activities, and include:

a. Line-item breakdown and justification for all personnel, i.e., name, position title, annual salary, percentage of time and effort, and amount requested.

b. For each contract: (1) Name of proposed contractor, (2) breakdown and justification for estimated costs, (3) description and scope of activities to be performed by contractor, (4) period of performance, (5) method of contractor selection (e.g., sole-source or competitive solicitation) and (6) method of accountability.

c. A brief five-year budget projection should be submitted that clearly separates and distinguishes direct from indirect costs.

d. A description of any financial and in-kind contributions from nonfederal sources.

Additionally, for each proposed activity (core and investigator-initiated) include a one-page, single-spaced, typed abstract. The heading should include the title of the cooperative agreement, project title, organization, name and address, project director, and telephone number. This abstract should include a workplan identifying activities to be developed, activities to be completed, and a time-line for completion of these activities.

F. Submission and Deadline

Letter of Intent

In order to enable CDC to determine the level of interest in the program announcement, a non-binding letter-of-intent to apply is requested from potential applicants. Your letter-of-intent should identify program announcement number 00059, and include the following information: (1) Name and address of institution, and (2) name, address, telephone number, e-mail address, and fax number of contact person. On or before June 9, 2000, submit the letter-of-intent (original and two copies) to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and five copies of PHS 398 (OMB Number 0925-0001) and adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are in the application kit.

On or before July 11, 2000, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information Section of this announcement.

Deadline: Applications shall be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or

(b) Sent on or before the deadline date and received in time for submission to the independent review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.)

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

Each competing continuation Prevention Epicenter and new application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

Competing Continuation PE Centers

1. Establishment of Prevention Epicenter (30 points)

a. Productivity

Extent to which the competing continuation Center has used program resources to successfully conduct research and demonstration projects as evidenced by submission of abstracts to national scientific meetings; presentations at local, regional and national conferences, meetings, and other settings for information exchange; and publications in scientific journals, lay media, public or healthcare provider information and educational sources.

b. Institutionalization

Extent to which the Prevention Epicenter has been established within the home institution and network/system/organization as evidenced by collaboration with other departments, institutions, and components of the network/system/organization; support from officials and representatives of the home institution and networks; recognition in internal publications and documents; and collaboration as a Prevention Epicenter with entities outside the network/system/organization.

2. Existing Capacity (30 points)

Description of existing capacity to conduct outcomes research and prevention effectiveness research in the areas of healthcare-associated infections and other adverse events associated with healthcare.

a. Description of applicant's experience and documentation of accomplishments in conducting healthcare outcomes research and quality improvement activities, including projects and studies involving: database integration; outcomes data acquisition, validation, and analysis; cost-and resource-effectiveness and cost-utility assessment; performance measurement and performance improvement; quality of care assessment and intervention clinical and laboratory process and outcomes assessment; and provider and patient behavior change studies and interventions. (A list of relevant papers and abstracts should be included in an appendix.)

b. Description of applicant's experience and documentation of accomplishments in conducting surveillance, applied epidemiologic research, applied laboratory research, and prevention research in the areas of healthcare-associated infections and other adverse events (e.g., antimicrobial drug resistant infections, device-related infections, medication errors, etc.) A list of relevant papers and abstracts should be included in an appendix.

c. Demonstration of applicant's ability to develop and maintain strong cooperative relationships with medical, public health, laboratory, academic, and community organizations that are either public or private, local or regional. Evidence of applicant's ability to solicit and secure programmatic collaboration, and financial and technical support from such organizations.

d. Demonstration of support from non-applicant participating agencies, institutions, organizations, laboratories, individuals, consultants, etc., mentioned in the operational plan. Applicant should provide (in an appendix) letters of support which clearly indicate each collaborator's willingness to participate in studies and other activities with the Prevention Epicenter. The letters should clearly define the roles of these collaborations.

e. Demonstration of applicant's ability to participate in multicenter research and demonstration studies.

3. Operational Plan (35 points)

a. The extent to which the applicant's plan for establishing, operating, and maintaining the Prevention Epicenter clearly describes the proposed activities and clearly identifies the roles and responsibilities of all participating individuals, agencies, organizations, and institutions.

b. The extent to which the applicant describes plans for collaboration with other PE program sites in the establishment and operation of the PE program and individual Prevention Epicenter projects, including participation in advisory committee and subcommittee activities, as well as project design/development (e.g., protocols), management and analysis of data, and synthesis and dissemination of findings.

c. Description and quality of applicant's partnerships with necessary and appropriate individuals, departments, agencies and organizations for establishing and operating the proposed Prevention Epicenter projects.

d. Consistency of the proposed projects with regard to Prevention Epicenter program goals.

e. Description of the operational plan for conducting core multicenter collaborative projects, including the extent to which: (1) The project is consistent with one or more of the stated goals of the PE program, (2) the objectives of the proposed project are specific, measurable, and time-phased; (3) the plan clearly describes applicant's technical approach/methods for conducting the proposed project(s); and (4) the plan is adequate to accomplish the stated objectives.

f. Description of the operational plan for conducting one or two investigator-initiated projects, including the extent to which: (1) The project is consistent with one or more of the stated goals of the PE program, (2) the objectives of the proposed project are specific, measurable, and time-phased; (3) the plan clearly describes applicant's technical approach/methods for conducting the proposed project(s); and (4) the plan is adequate to accomplish the stated objectives.

g. Identification of applicant's key professional personnel to be assigned to the Prevention Epicenter and to specific projects as well as key professional personnel from other participating or collaborating institutions, agencies, organizations outside of the applicant's agency that will be assigned to PE activities (provide curriculum vitae for each in an appendix). Clear identification of applicants' respective roles in the management and operation of the Prevention Epicenter and in individual projects. Descriptions of participants' experience in conducting work similar to that proposed in this announcement.

h. Description of all support staff and services to be assigned to the Prevention Epicenter.

i. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes (1) the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation, (2) the proposed justification when representation is limited or absent, (3) a statement as to whether the design of the study is adequate to measure differences when warranted and (4) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

4. Evaluation (5 points)

a. Quality of plan for monitoring and evaluating scientific and operational accomplishments of the Prevention Epicenter and of individual Center projects.

b. Quality of plan for monitoring and evaluating progress in achieving the purpose and overall goals of this cooperative agreement program.

5. Budget (not scored)

Extent to which the line-item budget is detailed, clearly justified, and consistent with the purpose and objectives of this program.

6. Human Subjects (not scored)

Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

New Applicants

1. Understanding the objectives of the PE program (5 points)

a. Demonstration of a clear understanding of the background and objectives of this cooperative agreement program.

b. Demonstration of a clear understanding of the requirements, responsibilities, problems, constraints, and complexities that may be encountered in establishing and operating the Prevention Epicenter.

c. Demonstration of a clear understanding of the roles and responsibilities of participation in the PE program.

2. Description of the healthcare network or system, IDS, or MCO in which the Prevention Epicenter is situated and the population served by the network/system/organization (10 points)

a. Clear definition of the components of the network/system/organization, their relationship to the Prevention Epicenter, the geographic area and the population base in which the Prevention Epicenter will operate.

b. Clear description of the populations served, the health care services provided, and the healthcare settings within which defined population(s) receive care, as they relate to the proposed activities of the PE program.

c. Clear description of the management information systems of the network/system/organization, with emphasis on the level of integration of patient level electronic data sources within and between facilities, including electronic data bases containing clinical, administrative, laboratory, pharmacy, and other data. Description of the availability and accessibility of such data for outcomes-type research.

d. Extent to which the population base is diverse demographically.

3. Description of existing capacity to conduct outcomes research and prevention effectiveness research in the areas of healthcare-associated infections and other adverse events associated with healthcare (35 points)

a. Description of applicant's experience and documentation of accomplishments in conducting healthcare outcomes research and quality improvement activities, including projects and studies involving: database integration; outcomes data acquisition, validation, and analysis; cost- and resource-effectiveness and cost-utility assessment; performance measurement and performance improvement; quality of care assessment and intervention clinical and laboratory process and outcomes assessment; and provider and patient behavior change studies and interventions. (A list of relevant papers and abstracts should be included in an appendix.)

b. Description of applicant's experience and documentation of accomplishments in conducting surveillance, applied epidemiologic research, applied laboratory research, and prevention research in the areas of healthcare-associated infections and other adverse events (e.g., antimicrobial drug resistant infections, device-related infections, medication errors, etc.) A list of relevant papers and abstracts should be included in an appendix.

c. Demonstration of applicant's ability to develop and maintain strong cooperative relationships with medical, public health, laboratory, academic, and community organizations that are either public or private, local or regional. Evidence of applicant's ability to solicit and secure programmatic collaboration, and financial and technical support from such organizations.

d. Demonstration of support from non-applicant participating agencies, institutions, organizations, laboratories, individuals, consultants, etc., mentioned in the operational plan. Applicant should provide (in an appendix) letters of support which clearly indicate each collaborator's willingness to participate in studies and other activities with the Prevention Epicenter. The letters should clearly define the roles of these collaborations.

e. Demonstration of applicant's ability to participate in multicenter research and demonstration studies.

4. Operational Plan (45 points)

a. The extent to which the applicant's plan for establishing, operating, and maintaining the Prevention Epicenter clearly describes the proposed activities and clearly identifies the roles and responsibilities of all participating individuals, agencies, organizations, and institutions.

b. The extent to which the applicant describes plans for collaboration with other PE program sites in the establishment and operation of the PE program and individual Prevention Epicenter projects, including participation in advisory committee and subcommittee activities, as well as project design/development (e.g., protocols), management and analysis of data, and synthesis and dissemination of findings.

c. Description and quality of applicant's partnerships with necessary and appropriate individuals, departments, agencies and organizations for establishing and operating the proposed Prevention Epicenter projects.

d. Consistency of the proposed projects with regard to Prevention Epicenter goals.

e. Description of the operational plan for conducting core multicenter collaborative projects, including the extent to which: (1) the project is consistent with one or more of the stated goals of the PE program, (2) the objectives of the proposed project are specific, measurable, and time-phased; (3) the plan clearly describes applicant's technical approach/methods for conducting the proposed project(s); and (4) the plan is adequate to accomplish the stated objectives.

f. Description of the operational plan for conducting one or two investigator-initiated projects, including the extent to which: (1) The project is consistent with one or more of the stated goals of the PE program, (2) the objectives of the proposed project are specific, measurable, and time-phased; 3) the plan clearly describes applicant's technical approach/methods for conducting the proposed project(s); and (4) the plan is adequate to accomplish the stated objectives.

g. Identification of applicant's key professional personnel to be assigned to the Prevention Epicenter and to specific projects as well as key professional personnel from other participating or collaborating institutions, agencies, organizations outside of the applicant's agency that will be assigned to PE activities (provide curriculum vitae for each in an appendix). Clear identification of applicants' respective roles in the management and operation of the Prevention Epicenter and in individual projects. Descriptions of participants' experience in conducting work similar to that proposed in this announcement.

h. Description of all support staff and services to be assigned to the Prevention Epicenter.

i. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes (a) the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation, (b) the proposed justification when representation is limited or absent, (c) a statement as to whether the design of the study is adequate to measure differences when warranted and (d) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

5. Evaluation (5 points)

a. Quality of plan for monitoring and evaluating scientific and operational accomplishments of the Prevention Epicenter and of individual Center projects.

b. Quality of plan for monitoring and evaluating progress in achieving the purpose and overall goals of this cooperative agreement program.

6. Budget (not scored)

Extent to which the line-item budget is detailed, clearly justified, and consistent with the purpose and objectives of this program.

7. Human Subjects (not scored)

Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of

1. progress reports (semiannual);

2. financial status report, no more than 90 days after the end of the budget period; and

3. final financial status and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where To Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7 Executive Order 12372 Review

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301(a) and 317(k)(2) of the Public Health Service Act, [42 U.S.C. sections 241(a) and 247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

J. Where to Obtain Additional Information

For this and other CDC announcements, please see the CDC home page on the Internet: http://www.cdc.gov (click on “Funding”). To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Gladys Gissentanna, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number 770-488-2753, Email address gcg4@cdc.gov

For program technical assistance, contact: Steve Solomon, M.D., Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, N.E. Mailstop A-07, Atlanta, GA 30333, Telephone number 404-639-6476, Email address sls1@cdc.gov