02-11555. A Research Study to Assess Multifaceted Fall Prevention Intervention Strategies Among Community-Dwelling Older Adults; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year FY 2002 funds for a cooperative agreement for a Research Study to Assess Multifaceted Fall Prevention Intervention Strategies Among Community-Dwelling Older Adults. This Program Announcement addresses the “Healthy People 2010” focus area, Injury and Violence Prevention. A copy of “Healthy People 2010” is available at the following Internet site: http://www.health.gov/​healthypeople.

The purpose of this funding is to develop and implement scientifically-based multifaceted fall prevention strategies and evaluate their effectiveness in community settings. This program is intended to stimulate collaborative research by creating a community planning infrastructure in which State Health Departments, aging services and researchers partner with, for example, community groups, aging centers, health care providers, clinicians, and social service agencies to develop, implement, and evaluate comprehensive community-based fall prevention strategies. This announcement seeks to support cross-disciplinary, multi-level research that will enhance the capacity of communities to deliver comprehensive multifactorial interventions. To accomplish this, applicants will need to develop model service delivery infrastructures that include partnerships between public health agencies and networks that serve the aging community to implement the study.

In addition to developing and evaluating scientifically-based comprehensive fall-prevention strategies, it would be useful to understand the barriers to conducting research that involves collaborative efforts across agencies and among multiple partners, as well as the barriers to implementing community-based fall prevention interventions.

Measurable outcomes of this research study will be in alignment with the following performance goals for the National Center for Injury Prevention and Control (NCIPC), described as a priority area in the NCIPC Research Agenda: to develop, evaluate, and study the dissemination of community-based interventions to prevent falls among older community-dwelling adults.

B. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, technical schools, research institutions, hospitals, managed care organizations and other public and private nonprofit organizations, community-based organizations, faith-based organizations, State and local governments or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

Other required eligibility criteria include the following:

1. The recipient must provide evidence of effective and well defined collaborative relationships within the performing organization and with community partners that will ensure implementation of the proposed activities. The collaboration must include at least a State Health Department, an academic institution and an aging services agency. The applicant must include documentation, such as letters of support, that describes the specific commitments and responsibilities that will be undertaken by the collaborating organizations.

2. The recipient must provide evidence of prior experience in designing, conducting, and analyzing multifaceted fall prevention studies among older adults and evidence of prior experience with randomized controlled trials. In addition, the recipient must provide evidence of access to a population of non-institutionalized seniors and experience with accessing and linking appropriate community level data with clinical, medical, pharmacy and falls data. The applicant must include documentation such as publications from peer reviewed journals.

Note:

Title 2 of the United States Code section 1611 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, or loan.

C. Availability of Funds

Approximately $750,000 will be available in FY 2002 to fund one award. It is expected that the award will begin on or about September 30, 2002 and will be made for a 12 month budget period within a project period of up to three years, in two phases. Funding estimates may change.

Phase I, conducted during the first year, will be dedicated to identifying and building community infrastructures, to assessing community readiness and developing partnerships, building capacity, identifying, accessing and linking data, and designing appropriate interventions to be implemented during Phase II. At the end of Phase I, noncompetitive continuation funding will be available for Phase II, contingent upon successful progress in Phase I, approval of an appropriate research design including acceptable fall prevention strategies, and detailed plans and budget for implementing and evaluating the community-wide fall prevention interventions. Phase II, conducted during years two to three, will be dedicated to implementing and evaluating the comprehensive community-based interventions.

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.

D. Program Requirements

Overall Study Objectives

1. Develop strategies and establish mutually beneficial collaborations among state health departments, academics, and the community using a systems approach. Identify agencies and organizations with the infrastructure to support research-based interventions, the capabilities to develop linked electronic data bases, and a willingness to work together to establish local priorities and plan strategies to reduce falls and fall-related injuries in the community.

2. Design a randomized multifaceted fall prevention intervention study among functionally competent, community-dwelling adults aged 65 years or older. The interventions must include at least two components that address modifiable risk factors that have been shown scientifically in community settings to reduce falls among older persons (e.g., gait and strength training; exercise programs with balance training as one component; review and modification of medications, especially psychotropic medications). In addition, interventions should include one or more components that are strongly associated with increased fall risk but have not been well studied in the community setting (e.g., identification and treatment of postural hypotension; vision screening and correction; and improved home lighting.) Community partners must be involved in selecting, developing, and implementing the intervention components.

3. The study would utilize a strong experimental or quasi-experimental research design (e.g., randomization, stratification) to identify the optimal type, duration and intensity of exercise for fall prevention while controlling for potential confounding factors within the study population, such as co-morbidities and functional limitations.

4. Outcome measures based on multi-year follow up should include frequency and severity of falls and fall-related injuries (collected monthly), adherence to and compliance with the various intervention components, medical care utilization, intervention effectiveness among both high and low risk populations, changes in fear of falling and self-efficacy, and the program's cost effectiveness.

5. Activities should be specifically designed to stimulate community ownership and investment in sustaining the program, if effective, beyond the funding period.

In conducting activities to achieve the purposes of this program, the recipient will be responsible for the activities under “Recipient Activities,” and CDC will be responsible for the activities listed under “CDC Activities.”

Recipient Activities: (Phase I)

1. Develop a plan to determine community readiness and infrastructure to undertake fall prevention activities, how the community will be involved in decision making about the intervention design and components, and the approach that will be used to identify and assess the data and data linkage systems necessary to conduct and evaluate a falls prevention intervention.

2. Implement a plan for obtaining community input and building partner cooperation, assess community readiness, and identify mutually beneficial activities and linkages to a broad range of collaborators in the community. Develop and utilize a community advisory group consisting of a broad range of professionals, clients, older adults, care-givers, and providers to give the project ongoing guidance and direction.

3. Develop collaborative relationships with organizations, agencies and programs that serve older adults. Partnerships must include organizations that provide medical and/or health care services as well as maintain electronic data base records, and have access to community-dwelling older adults, such as geriatricians, injury control researchers, managed care organizations, and hospitals.

4. Identify the best formats and channels for delivering interventions to ensure acceptability and adoption by community-dwelling seniors.

5. Develop a research and evaluation plan for Phase II based on the results and activities from Phase I, including the rationale and specific components of the interventions, identification and recruitment of program and control groups including randomization procedures, intervention implementation methods, strategies for obtaining, managing, and analyzing data, and methods of controlling for co-morbidities and multiple risk factors. Develop tools to maximize recruitment and retention of older adults into the study.

6. Travel to Atlanta annually to present a briefing to NCIPC staff describing progress to date.

Recipient Activities: (Phase II)

1. Conduct a research study to address the objectives in Section A under “Purpose” by implementing and evaluating a randomized controlled study of multifaceted fall prevention interventions among community-dwelling adults aged 65 or older. Research is sought on strategies that combine both previously tested and effective approaches as well as promising components into comprehensive programs designed to reduce falls and fall risks.

2. Identify appropriate personnel for the project. Skills and experience of project personnel must include: (1) Experience implementing and managing theory-driven intervention studies; (2) experience working with older adults; (3) knowledge of falls, fall risk factors and prevention strategies; (4) knowledge of behavioral theory; (5) experience with medical data and data linkage; (6) expertise in analysis of complex data sets; (7) evaluation expertise; (8) experience in working with community-based organizations; and (9) experience in conducting participatory research.

3. Utilize collaborative relationships established during Phase I to accomplish the project goals.

4. Collaborate and obtain approval for the study design and methods from CDC Injury Center staff. Prepare and submit the approved study protocols to the CDC, institutional, and local IRB review board(s). Activities must be conducted in compliance with Protection of Human Subjects (45 CFR 46).

5. Establish procedures to maintain the rights and confidentiality of all study participants, including securing any assurances necessary to conduct research involving human subjects.

6. Conduct data management activities including data collection and data linkage. Data collection may include medical record reviews, telephone and in-person interviews, and process measures. Data management must include security of data, assurance of participant confidentially, data editing, quality control procedures, and data entry.

7. Analyze and disseminate results through reports, presentations, and publications.

8. If effective, broadly disseminate the program through established partnerships with community programs, health providers, and social services that serve older adults.

9. Travel to Atlanta annually to provide briefings to NCIPC staff describing study status and progress to date.

CDC Activities:

A cooperative agreement reflects an assistance relationship between the Federal Government and the recipient in which substantial programmatic involvement is anticipated about the scientific and/or technical management of this research during its performance. With this in mind, CDC will perform the following during Phases I and II:

1. Provide up-to-date scientific information, technical assistance, and guidance in the design and conduct of the research.

2. Provide technical assistance to awardees in developing data collection instruments and a centralized system for data management.

3. Review plans for intervention development and implementation.

4. Assist in developing a research protocol for annual Institutional Review Board (IRB) review by all cooperating institutions participating in the research study. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research study, including analyses, is completed.

5. Assist in ensuring human subjects assurances are in place as needed.

6. Provide technical assistance on intervention design, development and delivery, data collection methods, and data quality assurance.

7. Assist in analysis and dissemination of results including the preparation of manuscripts, as needed.

8. Monitor and evaluate the scientific and operational accomplishments of the project. This will be accomplished through periodic site visits, telephone calls, electronic communication, technical reports and interim data analyses.

9. Convene meetings of recipients for the exchange of information.

E. Content

Letter of Intent (LOI)

A LOI is required for this program. The Program Announcement title and number must appear on the LOI. The narrative should be no more than three single-spaced pages, printed on one side, with one inch margins, and unreduced 12 point Times Roman (or equivalent size) font. Your LOI will be used to prepare for the special emphasis panel (SEP) that will review the scientific merit of the applications, and should include the following information: Program Announcement Number 02151; name and address of institution; name and telephone number of a contact person; specific objectives to be addressed by the proposed project; and a brief description of project plans.

Applications

The Program Announcement title and number must appear in the application. 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 address each, preferably in order, with sufficient detail. Applicants may submit only one proposal.

The narrative should be no more than 25 (81/2″ x 11″) double-spaced pages, printed on one side, with one inch margins on four sides, unreduced 12 point Times Roman (or equivalent size) font, and a page number at the bottom of each page. The narrative should consist of, at a minimum, Aims and Background, Goals and Objectives, Research Design and Methods, Collaborations, Community Capacity, and Budget.

Applications with more than 25 pages will be returned and not reviewed. Please provide only attachments or appendices that are directly relevant to this request for funding. Include sample forms and data collection instruments. The budget and attachments/appendices, including letters of support, are not included in the count for the 25 page limit. All pages, including appendices, should be numbered sequentially. To document eligibility, the narrative must contain the following sections in the order presented below:

1. Abstract (1 page recommended):

Provide a brief abstract of the project. The abstract must reflect the project's focus and the length of the project period (maximum of (3) years) for which assistance is being requested (see “Availability of Funds” for additional information).

2. Specific Aims and Background (3-5 pages recommended):

List the aims and the specific research questions this application is intended to address. Briefly sketch the background leading to the present study. Provide background information to document the capacity to accomplish this study as demonstrated by relevant past or current research studies in injury prevention.

3. Goals and Objectives (3-5 pages recommended):

Provide information to support the scientific basis for the present proposal, the theoretical or conceptual framework based on a critical evaluation of existing knowledge about fall risk factors and intervention strategies, the hypotheses to be tested, the specific goals of the research study (including measurable objectives for each of these goals), and the project time-line.

4. Research Design and Methods (10-15 pages recommended):

a. Describe the research design and the procedures to be used to accomplish the specific aims of the study.

b. Describe the intervention development process, content and delivery, including specific intervention protocols or plans for the development of intervention protocols.

c. Describe the identification, recruitment, and retention of community-dwelling older adults.

d. Describe how data will be collected. Provide power calculations to justify the sample size(s) and anticipated effect size(s). Describe data quality assurance plans.

e. Describe the measures that will be used to evaluate the impact of the various interventions including functional, behavioral, and biological measures. Outcomes should include the following: (1) Morbidity outcomes (e.g., fall and fall injury rates), (2) functional outcomes (e.g., changes in balance and strength, (3) behavioral changes (e.g., changes in numbers or types of medications, corrections in vision, changes in home lighting), (4) social cognitive outcomes (e.g., changes in fear of falling and self-efficacy), and (5) cost-benefits estimates.

f. Describe the data analysis plan including a justification for the statistical techniques chosen to analyze these data.

g. Provide a detailed time-line for the first year of the study as well as a projected time-line for the subsequent two years.

h. Describe the nature and extent of collaboration with CDC and/or others during various phases of the project.

5. Collaborations (3-5 pages):

Describe the proposed personnel and collaborative activities needed to accomplish the proposed activities including existing community partnerships. Personnel should include a range of disciplines and may include (but are not limited to) university scientists, medical and/or health care providers, injury control researchers, professional organizations, and staff from participating community-based organizations. The combined members of the research team must provide evidence of expertise in analytic research and evaluation, and familiarity with and success in providing services to older adults.

6. Community Capacity (6-8 pages):

Provide evidence of effective and well defined working relationships within and between the performing organization and community partners. The applicant should describe their experience in developing community partnerships and the existing and proposed network collaborations as well as the community's current and anticipated capacity to disseminate multi-level intervention programs.

Provide evidence of the availability of appropriate scientific oversight necessary to fulfill research study and intervention implementation objectives. These will include development, implementation, evaluation of the intervention, recruitment and retention of participants, and collection and management of project related data, and experience in delivering behavioral and/or community level interventions. Evidence of the experience and capacity of the project team should include an attachment with curriculum vitaes and position descriptions for all key staff.

7. Human Subject Involvement:

Describe procedures that will provide for the protection of human subjects. Address how these procedures adequately address the requirements of 45 CFR 46 for the protection of human subjects.

8. Inclusion of Women and Racial and Ethnic Populations:

Describe the proposed plan for the inclusion of both sexes and racial and ethnic minority populations. Describe the proposed justification when representation is limited or absent. Include a statement as to whether the design of the study is adequate to measure differences when warranted.

F. Submission and Deadline

Letter of Intent (LOI)

On or before June 1, 2002, submit the LOI, on the applicant's letterhead, to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0920-0428). Forms are available in the application kit and at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm.

Application forms must be submitted in the following order:

Cover Letter

Table of Contents

Application

Budget Information Form

Budget Justification

Checklist

Assurances

Certifications

Disclosure Form

Human Subjects Certification

Indirect Cost Rate Agreement

Narrative

On or before 5 p.m. Eastern Time June 24, 2002, submit the application to:

Technical Information Management-PA02151, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.

Deadline: Letters of Intent and applications will be considered as meeting the deadline if they are received before 5 p.m. Eastern Time on the deadline date. Applicants sending applications by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Applications which do not meet the above criteria will not be eligible for competition and will be discarded. Applicants will be notified of their failure to meet the submission requirements.

G. Evaluation Criteria

Applications

CDC staff will review the application first for eligibility, responsiveness to the purpose of this program announcement (as described in Section A) and completeness as outlined under “Eligible Applicants” and “Program Requirements.” Applications from ineligible entities as well as incomplete and nonresponsive applications will be returned to the applicant without further consideration. It is important that the applicant's abstract reflects the project's focus because the abstract will be used to help determine the responsiveness of the application.

Applicants are required to provide Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of Effectiveness must relate to the performance goals as stated in Section A “Purpose” of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These Measures of Effectiveness will be submitted with the application and will be an element of evaluation.

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC:

1. Aims and Background (10 percent)

Aims of this study and the specific research questions this application is intended to address. Background information that demonstrates the applicant's knowledge of the field and capacity to carry out the study including relevant past or current injury prevention research activities.

2. Goals and Objectives (20 percent):

Information that forms the basis for the present proposal, the theoretical or conceptual framework based on a critical review of existing knowledge about fall risk factors and intervention strategies, the hypotheses to be tested, the specific goals of the research study (including measurable objectives for each of these goals), and the project time-line.

3. Research Design and Methods (35 percent):

a. The adequacy of the proposed research design and procedures to be used to accomplish the specific aims of the study including justifiable sample sizes.

b. The plans for the development of the interventions, including methods for obtaining community input and assessing community readiness, and how these data will be used in the development, content and delivery of specific interventions.

c. How target and control populations will be selected and how they will be accessed, recruited and retained.

d. The plans for data collection and data management including security of data, assurance of participant confidentially, data entry, editing, and quality assurance procedures.

e. Evaluation of the study and the measurable outcomes to be used to evaluate the impact of the proposed interventions.

f. A statistical analysis plan appropriate for the study design and for evaluating the interventions.

g. A strategy to adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes the: (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; and (3) a statement as to whether the design of the study is adequate to measure differences when warranted.

4. Collaborations (15 percent):

The qualifications and appropriateness of the proposed personnel. The experience and capacity of the project team to accomplish the proposed activities and to provide appropriate scientific oversight necessary to fulfill research study and intervention dissemination objectives. The inclusion of multidisciplinary teams including (but not limited to) State health departments or agencies, university scientists, aging services agencies, medical and/or health care providers, injury control research centers, professional organizations, and staff from community-based organizations.

5. Community Capacity (20 percent):

Experience in developing community partnerships, evidence of community expertise with strong existing and proposed network collaborations, effective and well defined working relationships within and between the performing organization and other partners, and evidence of community capacity to promote and disseminate multi-level intervention programs using a variety of approaches including education and media support.

6. Human Subjects (Not scored):

Restate the strategies for the recruitment and retention of human subjects and how the applicant will obtain appropriate consent when necessary. Are the procedures proposed adequate for the protection of human subjects and are they fully documented? Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? (Not scored: however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.)

7. Budget (Not scored):

The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of funds. All budget categories should be itemized and appropriately justified.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Semiannual progress reports (The progress report will include a data requirement that demonstrates measures of effectiveness.)

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

3. Final financial 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 II of the announcement.

AR-1 Human Subjects Requirements

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

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-13 Prohibition of Use Certain Gun Control Act.

AR-14 Accounting System Requirements

AR-15 Proof of Non-Profit Status

AR-21 Small, Minority, And Women-owned Business

AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 317 and 301 of the Public Health Service Act, (42 U.S.C. 241 and 247b) and CFR part 51b. The Catalog of Federal Domestic Assistance number is 93.136.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address, http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For business management technical assistance, contact: Nancy Pillar, 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: 770-488-2721 e-mail address: [e-mail].

For program technical assistance, contact: Judy Stevens, Ph.D., Technical Adviser, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS K-63, Atlanta, GA 30341-3724, Telephone number: [phone] e-mail address: [e-mail].

Dated: May 3, 2002.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.