RFA-CE-25-027_20240829.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL

Evaluate STEADI-based Fall Prevention in Assisted Living Facilities

RFA-CE-25-027

12/02/2024

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview

Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Injury Prevention and Control Notice of Funding Opportunity (NOFO) Title Evaluate STEADI-based Fall Prevention in Assisted Living Facilities Activity Code Applications in response to this Notice of Funding Opportunity (NOFO) will be funded using the U01 activity code for a research cooperative agreement.

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-CE-25-027

Assistance Listings Number(s) 93.136 Category of Funding Activity HL - Health NOFO Purpose This NOFO is intended to fund the adaptation, implementation, and evaluation of the effectiveness of CDC’s Stopping Elderly Accidents, Deaths, and Injuries (STEADI) fall prevention initiative and related tools in nursing home, assisted living facility, or long-term care facility settings (referred to collectively as assisted living facilities). CDC will fund an awardee to adapt the STEADI algorithm and materials for two or more assisted living facilities, implement, and then evaluate the use of those materials and programming.

Of particular interest is research that focuses on populations experiencing high rates of older adult falls and fall injuries within these assisted living facilities. These disproportionately affected populations could include: Tribal populations; rural populations; populations disadvantaged by reduced economic stability or limited education attainment; and populations with cognitive (e.g., dementia, Alzheimer’s disease), comorbidities, or physical limitations.

For the purposes of this research, assisted living facilities are defined as nursing home, assisted living facility, or other long-term care facility settings.

Key Dates Publication Date:

To receive notification of any changes to RFA-CE-25-027, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

11/01/2024 Letter of Intent Due Date: 11/01/2024

While a letter of intent is not mandatory, nor is it binding or a factor in the review of an application, the details it provides help NCIPC staff to plan for the scientific and technical merit peer review process.

Application Due Date:

12/02/2024 12/02/2024

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

03/04/2025 This is an estimated date.

Secondary Review:

05/02/2025 This is an estimated date.

Estimated Start Date:

09/30/2025 Expiration Date:

03/10/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose

The Centers for Disease Control and Prevention's National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research proposals to conduct a well-designed study within two or more assisted living facilities serving a diverse patient population to adapt, implement, and evaluate STEADI-based older adult (age 65+) fall prevention.

Of particular interest is research that focuses on populations experiencing high rates of older adult falls and fall injuries within these assisted living facilities. These disproportionately affected populations could include: Tribal populations; rural populations; populations disadvantaged by reduced economic stability or limited education attainment; and populations with cognitive (e.g., dementia, Alzheimer’s disease), comorbidities, or physical limitations.

Mechanism of Support: The funding mechanism for this Notice of Funding Opportunity (NOFO) will be a Research Cooperative Agreement (U01) https://grants.nih.gov/grants/how-to-apply-application-guide.html

Funds Available and Anticipated Number of Awards: CDC/NCIPC intends to commit approximately up to $700,000 in FY 2025 to fund up one (1) application, pending the availability of funds. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Period of Performance:

The maximum award amount will be $700,000 per award for the first 12-month budget period.

This includes both direct and indirect costs. An applicant may request a period of performance of up to four (4) years. The maximum total project funding amount is $2,800,000 (including both direct and indirect costs) over the expected period of performance, with a maximum of $700,000 per award per year. The period of performance for this award is expected to run from 9/30/2025 to 9/29/2029.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations Institutions/organizations listed in Section III. Eligibility Information 1. Eligible Applicants are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs)

The CDC does not award individuals directly. Individuals possessing the necessary skills, knowledge, and resources to conduct proposed research should collaborate with their institutions to submit a support application. Underrepresented racial and ethnic groups, as well as individuals with disabilities, are especially encouraged to apply.

For applications where the contact PD/PI qualifies as an NIH Early Stage Investigator (ESI), as confirmed through the NIH Investigator Status determination process, and has a commendable peer review score, prioritization may occur during the second level of review (refer to Section V.

Application Review Information 4. Review and Selection Process). Regarding the determination of Investigator Status for the contact PD/PI:

Before submitting an application, PD/PIs should confirm or update the date of their terminal research degree or the conclusion of their post-graduate clinical training in their eRA Commons Profile for accurate identification. NIH systems will automatically determine each investigator's status and reflect it in their eRA Commons personal profile. The ESI status for PD/PIs on any R01 or equivalent application will be indicated at submission. Investigators must ensure their status is accurately represented in their profile. If the status is incorrect, they should reach out to the NIH eRA Service Desk.

Number of PDs/PIs An application may name more than one PD/PI; their names must appear on the face page of the application. However:

• One (1) principal investigator must be designated as the contact PD/PI for all correspondence related to the application.

https://grants.nih.gov/policy/early-stage/index.htm https://www.era.nih.gov/need-help

• All PD/PIs must include their eRA Commons Identification in the Credential Field of the Senior/Key Person Profile Component of the SF-424 (R&R) Application Package.

• Institutions/organizations proposing multiple PDs/PIs must visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF-424 (R&R) Application Guide.

Number of Applications Organizations eligible to apply may submit multiple applications to this NOFO, as long as each is scientifically distinct. However, institutions may only submit one application per contact PD/PI. Only one application for each contact PD/PI will receive funding under this announcement. If multiple applications from the same contact PD/PI are submitted, only the most recent one, based on the time and date stamp at www.grants.gov, will be considered for review. It is the applicant's responsibility to withdraw any duplicate applications before the review date.

Institutions that submit applications proposing essentially the same research to two or more CDC/ATSDR NOFOs will not receive funding for more than one.

Application Type

NEW

Special Date(s) A pre-application teleconference call will be conducted on 10/15/2024 to address questions from prospective applicants regarding NOFO CE-25-027. The call will begin at 2:00 pm Eastern Standard Time (EST) and end at 2:50 pm Eastern Standard Time (EST), or sooner if all questions are addressed. Questions and answers from the discussion will be included in a supplemental document on grants.gov approximately 2-3 weeks after the call.

Participant Access Information:

• Call Date: October 15, 2024

• Call Start Time: 2:00pm Eastern Standard Time (EST)

• Call End Time: 2:50pm Eastern Standard Time (EST)

• Call Leader: Joyce Dieterly, Scientific Program Official

• Webinar Link:

https://cdc.zoomgov.com/j/1616390026?pwd=ekduMFBXK0VwQmh5UDg1V1FSS1M wdz09

• Webinar ID: 161 639 0026

• Passcode: iEN1.Ky2

• Call-In Numbers:

o +1 646 828 7666 US (New York) o +1 646 964 1167 US (US Spanish Line) o +1 669 254 5252 US (San Jose) o +1 551 285 1373 US (New Jersey) o +1 415 449 4000 US (US Spanish Line) https://cdc.zoomgov.com/j/1616390026?pwd=ekduMFBXK0VwQmh5UDg1V1FSS1Mwdz09 https://cdc.zoomgov.com/j/1616390026?pwd=ekduMFBXK0VwQmh5UDg1V1FSS1Mwdz09 o +1 669 216 1590 US (San Jose)

• Dial-In Passcode: 42605831

Application Materials See Section IV.1 for application materials.

Hearing Impaired Telecommunications for the hearing impaired are available at: TTY: 1-888-232-6348.

Section I. Funding Opportunity Description

Section I. Funding Opportunity Description

Statutory Authority Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and Section 391 (a) [42 U.S.C. 280 b (a)] of the Public Health Service Act, as amended.

1. Background and Purpose Background

Older adults are the fastest growing age group in the population comprising 16.8% of the total population in 2020 and expected to reach 22% by 20501. Falls disproportionately affect older adults and often lead to decreased quality of life and increased morbidity and mortality. Fall rates increase with advancing age and are highest among those ages 80 years and older.2 Women have higher rates of reported falls compared to men, while men experience more serious fall injuries and higher death rates from falls. By race and ethnicity, fall rates are highest among non- Hispanic White and American Indian/Alaska Native populations. Several health characteristics are also associated with elevated fall risk, including numerous chronic health conditions (e.g., diabetes, cardiovascular disease, stroke) and neurological disorders (e.g., dementia, Parkinson’s disease). 3

Older adults with cognitive and functional limitations, such as dementia, vision impairment, or gait, balance, and mobility limitations, are at an especially high risk of falls and fall injuries.4 Research indicates that increased fall risk among older adults with cognitive impairments may be attributed to decreased spatial awareness and judgment, increasing the risk of tripping or stumbling due to misjudging distances.5 Deficits in executive function may also contribute to unsteady gait or slow gait, balance issues, and reduced reaction times, further increasing fall risk.

Many older adults living with cognitive or physical disabilities require more experienced around the clock care, such as care in assisted living facilities.

In 2020, more than 1 million older adults were residents of assisted living facilities in the United States.6 As the population continues to age, this number is expected to continue to grow.

Research indicates that more than half of Americans over the age of 65 will develop a disability that requires some form of long-term care services, including those provided in residential care facilities.7

Recognizing the growing number of older adults in these settings and their increased fall risk, in 2022, the “World Guidelines for Falls Prevention and Management for Older Adults: A Global

Initiative” produced updated fall prevention guidelines for older adults with an emphasis on assisted living facilities and care homes.8

A key priority of the Centers for Disease Control and Prevention's (CDC) National Center for Injury Prevention and Control and an objective of HealthyPeople 2030 is to reduce older adult falls. The CDC developed the Stopping Elderly Accidents Deaths and Injuries (STEADI) initiative (www.cdc.gov/STEADI) based on the original American and British Geriatric Societies’ guideline for the prevention of falls in older persons to assist healthcare providers with implementing fall prevention in primary care clinic settings. STEADI has four core components:

screening older adults at least annually to determine if they have a high fall risk, assessing those at risk to identify their modifiable risk factors, intervening by recommending evidence-based strategies for each risk factor, and following up to encourage adherence to recommended strategies. STEADI provides tools, training, and resources for providers to make fall prevention a routine part of clinical care for older adults. STEADI has been expanded for other healthcare settings, such as in outpatient9, inpatient10, and community pharmacy11 settings with guidance for primary care telemedicine to be released by the end of 2024.

While there have been a few initial efforts to adapt STEADI and other falls prevention programming to nursing facilities and long-term care settings,12, 13 there is a lack of implementation and evaluation research. Little is known about the most effective practices and supports needed to optimize fall prevention in these settings. Additionally, attention is needed to adaptations to assisted living facility settings that include community-based prevention strategies such as strength and balance classes with inclusion of all assessments recommended in the STEADI algorithm to comprehensively determine an older adult’s fall risk factors and linkage to clinical support to address risk factors which require clinical intervention (e.g., Medication management, physical therapy for gait and balance issues). Finally, following up with the older adult to ensure that they are able to adopt the recommended strategy and to adjust recommendations as needed is necessary to ensure fall risks are reduced. This NOFO is intended to support work to help fill these important gaps and aligns with CDC NCIPC’s older adult falls research priority of “Improve the likelihood that older adults receive clinical fall prevention care (e.g., screening, assessment, and intervention) at least once a year”.

Purpose:

CDC’s National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research proposals to conduct a well-designed study within two or more assisted living facilities to adapt, implement, and evaluate STEADI-based older adult (age 65+) fall prevention among facility residents aged 65 years and older who are at risk for a fall as determined by a fall screener (e.g. STEADI Stay Independent, Three Key Questions). An assisted living facility as defined by the National Institute on Aging at Long-Term Care Facilities: Assisted Living, Nursing Homes, and Other Residential Care | National Institute on Aging (nih.gov).

Of particular interest is research that focuses on populations experiencing high rates of older adult falls and fall injuries within these assisted living facilities. These populations could include Tribal populations, rural populations, populations disadvantaged by reduced economic stability or limited education attainment, and populations with cognitive (e.g., dementia, Alzheimer’s disease) or physical limitations.

https://www.cdc.gov/steadi/media/pdfs/STEADI-Algorithm-508.pdf https://www.nia.nih.gov/health/assisted-living-and-nursing-homes/long-term-care-facilities-assisted-living-nursing-homes#:~:text=Assisted%20living%20is%20for%20people,extra%20services%20or%20special%20care.

https://www.nia.nih.gov/health/assisted-living-and-nursing-homes/long-term-care-facilities-assisted-living-nursing-homes#:~:text=Assisted%20living%20is%20for%20people,extra%20services%20or%20special%20care.

The primary objectives of this NOFO are:

1. Rigorously assess the feasibility, acceptability, and usability of implementing the components (screen, assess, intervene, follow-up) of STEADI-based fall prevention to create an implementation plan for at least two assisted living facilities.

2. Adapt and implement the STEADI algorithm, tools, and materials, based on the implementation plan, to support the four core components of STEADI-based fall prevention among older adults who screen at risk for a fall within at least two assisted living facilities.

3. Conduct a process and outcome evaluation of the STEADI-based fall prevention implementation in the two facilities. Outcome evaluation should include a control group and the measures should include at least one fall-related outcome (e.g., falls, fall injuries, medically treated falls, or transfers to a hospital for a fall-related injury). Process evaluation should include measures of the feasibility and acceptability of the implementation based on feedback from ALF staff involved in implementation. Process evaluation should also be designed to assist in understanding the outcomes (e.g.

measuring older adult participation in recommended prevention strategies to help understand why certain older adults may have successful outcomes).

Secondary Outcomes:

Secondary outcomes for this project include publications and presentations describing:

• Impacts of the adapted and evaluated prevention program on fall-related outcomes

• How to adapt and implement STEADI-based fall prevention in assisted living facilities

• Suggestions for a modified algorithm and tailored resources, tools, and trainings for assisted living facilities

• Technical assistance strategies and lessons learned for implementing STEADI-based fall prevention in assisted living facilities

Applicants should propose the adaptation, implementation, and evaluation of the components (screen, assess, intervene, follow-up) of STEADI-based fall prevention for assisted living facilities. Applicants should describe how they will adapt the STEADI algorithm with all recommended assessments and strategies including links to clinical support for intervention when needed. This adaption could be of existing trainings, resources, algorithm, tools, and fact sheets or creation of new materials as needed. The applicant should describe how all four STEADI components will be implemented as well as the proposed outcome and process evaluation.

References

1 Vespa J, Medina L, Armstrong DM. Demographic turning points for the United States:

population projections for 2020 to 2060. Current Population Reports 2020. P25-1144..

Available at Demographic Turning Points for the United Sates: Population Projections for 2020 to 2060 (census.gov) https://www.census.gov/content/dam/Census/library/publications/2020/demo/p25-1144.pdf https://www.census.gov/content/dam/Census/library/publications/2020/demo/p25-1144.pdf

2 Kakara R, Bergen G, Burns E, Stevens M. Nonfatal and fatal falls among adults aged ≥65 years—United States, 2020–2021. MMWR Morb Mortal Wkly Rep 2023;72:938–

943. doi: 10.15585/mmwr.mm7235a1

3 Bergen G, Stevens MR, Kakara R, Burns ER. Understanding modifiable and unmodifiable older adult fall risk factors to create effective prevention strategies. Am J Lifestyle Med. 2019 Oct 21;15(6):580-589. doi: 10.1177/1559827619880529.

4 Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009.

5 MacAulay RK, Allaire TD, Brouillette RM, Foil HC, Bruce-Keller AJ, Han H, Johnson WD, Keller JN. Longitudinal assessment of neuropsychological and temporal/spatial gait characteristics of elderly fallers: taking it all in stride. Front Aging Neurosci. 2015 Mar 18;7:34. doi: 10.3389/fnagi.2015.00034.

6 Total Number of Residents in Certified Nursing Facilities | KFF

7 Long-Term Care Services and Supports for Older Americans: Risks and Financing, 2020 Research Brief (hhs.gov)

8 Montero-Odasso M, van der Velde N, Martin FC, Petrovic M, Tan MP, et al. Task force on global guidelines for falls in older adults. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing 2022 Sep 2;51(9):afac205. doi: 10.1093/ageing/afac205. Erratum in: Age and Ageing 2023 Sep 1;52(9): Erratum in: Age and Ageing 2023 Oct 2;52(10): PMID: 36178003; PMCID:

PMC9523684.

9 Eckstrom E, Parker EM, Shakya I, Lee R. Coordinated care plan to prevent older adult falls. Edition 1.1. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 2021. Steadi-Coordinated-Care-Plan.pdf (cdc.gov)

10 Rogers S., Haddad Y.K., Legha J.K., Stannard D., Auerbach A., Eckstrom E. CDC STEADI: Best practices for developing an inpatient program to prevent older adult falls after discharge. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 2021. CDC STEADI: Best Practices for Developing an Inpatient Program to Prevent Older Adult Falls after Discharge

11 Ferreri SP, Blalock SJ, Robinson JM, Renfro CP, Busby-Whitehead J, Burns ER, Haddad Y. STEADI-Rx older adult fall prevention guide for community pharmacists.

Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 2020. CDC STEADI: Evaluation Guide for Older Adult Clinical Fall Prevention Programs

12 Schoberer D, Breimaier HE, Zuschnegg J, Findling T, Schaffer S, Archan T. Fall prevention in hospitals and nursing homes: Clinical practice guideline. Worldviews Evid Based Nurs. 2022 Apr;19(2):86-93. Doi: 10.1111/wvn.12571. Epub 2022 Mar 9. PMID:

35262271; PMCID: PMC9310602.

13 AHRQ’s Safety Program for Nursing Homes: On-Time Falls Prevention. Content last reviewed November 2017. Agency for Healthcare Research and Quality, Rockville, MD.

https://www.kff.org/other/state-indicator/number-of-nursing-facility-residents/?currentTimeframe=3&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D https://aspe.hhs.gov/sites/default/files/private/pdf/265126/LTSSOlAmRB.pdf https://aspe.hhs.gov/sites/default/files/private/pdf/265126/LTSSOlAmRB.pdf https://www.cdc.gov/steadi/pdf/Steadi-Coordinated-Care-Plan.pdf https://www.cdc.gov/steadi/pdf/Steadi-Coordinated-Care-Plan.pdf https://www.cdc.gov/steadi/pdf/STEADI-inpatient-guide-508.pdf https://www.cdc.gov/steadi/pdf/STEADI-inpatient-guide-508.pdf https://www.cdc.gov/steadi/pdf/Steadi-Evaluation-Guide_Final_4_30_19.pdf https://www.cdc.gov/steadi/pdf/Steadi-Evaluation-Guide_Final_4_30_19.pdf https://www.ahrq.gov/patient-safety/settings/long-term-care/resource/ontime/fallspx/intro.html

Healthy People 2030 and other National Strategic Priorities CDC and NCIPC are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2030".

• Reduce fall-related deaths among older adults — IVP-08

• Reduce the rate of emergency department visits due to falls among older adults —OA-03

The proposed research also addresses "Healthy People 2030" goals for injury prevention in Healthy People 2030 health.gov

• Reduce emergency department visits for nonfatal unintentional injuries — IVP-04

• Reduce fatal injuries — IVP-01

This research also aligns with the NCIPC’s Research Priorities regarding older adult falls, available at: (https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html)

• Improve the likelihood that older adults receive clinical fall prevention care (e.g., screening, assessment, and intervention) at least once a year.

Public Health Impact This research will increase knowledge and understanding of the best methods of reducing falls and fall injuries in older adults residing in assisted living facilities. Findings from this research will inform public health action to improve older adult fall prevention and management, including focusing on populations at disproportionate risk. Addressing these research gaps will expand the evidence base for strategies preventing older adult falls and negative post-fall outcomes among disproportionately affected populations and identifying strategies that can result in population-level reductions in older adult falls.

Relevant Work CDC’s research and programs work to prevent older adult falls and help people to maintain optimal mobility and independence as they age. Recently, NCIPC updated research priorities to identify effective strategies for preventing older adult falls. These activities are outlined in the CDC NCIPC Research Priorities report that can be found at: https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html.

CDC has partnered with healthcare providers to produce trainings, tools, and resources for making older adult fall prevention a routine part of clinical care across various settings through their STEADI initiative (www.cdc.gov/STEADI). Implementation and evaluation guides are available for:

• Outpatient settings Outpatient Care | STEADI - Older Adult Fall Prevention | CDC Injury Center

• Inpatient settings Inpatient Care | STEADI - Older Adult Fall Prevention | CDC Injury Center

• Chain pharmacy settings Pharmacy Care (STEADI-Rx) | STEADI - Older Adult Fall Prevention | CDC Injury Center https://health.gov/healthypeople/objectives-and-data/browse-objectives/injury-prevention/reduce-fall-related-deaths-among-older-adults-ivp-08 https://health.gov/healthypeople/objectives-and-data/browse-objectives/older-adults/reduce-rate-emergency-department-visits-due-falls-among-older-adults-oa-03 https://health.gov/healthypeople https://health.gov/healthypeople https://health.gov/healthypeople/objectives-and-data/browse-objectives/injury-prevention/reduce-emergency-department-visits-nonfatal-unintentional-injuries-ivp-04 https://health.gov/healthypeople/objectives-and-data/browse-objectives/injury-prevention/reduce-fatal-injuries-ivp-01 https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html http://www.cdc.gov/STEADI https://www.cdc.gov/steadi/hcp/clinical-resources/outpatient-care.html https://www.cdc.gov/steadi/hcp/clinical-resources/outpatient-care.html https://www.cdc.gov/steadi/hcp/clinical-resources/inpatient-care.html https://www.cdc.gov/steadi/hcp/clinical-resources/inpatient-care.html https://www.cdc.gov/steadi/hcp/clinical-resources/pharmacy-care.html https://www.cdc.gov/steadi/hcp/clinical-resources/pharmacy-care.html

2. Approach CDC’s National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research proposals to conduct a rigorous study to implement and evaluate STEADI-based fall prevention in at least two assisted living facilities among facility residents aged 65 years and older who are at risk for a fall as determined by a fall screener (e.g. STEADI Stay Independent, Three Key Questions). Of particular interest is research that focuses on populations experiencing even higher rates of older adult falls and fall injuries within these assisted living facilities. These disproportionately affected populations could include Tribal populations, rural populations, populations disadvantaged by reduced economic stability or limited education attainment, and populations with cognitive (e.g., dementia, Alzheimer’s disease), comorbidities or physical limitations.

Objectives/Outcomes The primary objectives of this NOFO are:

1. Rigorously assess the feasibility, acceptability, and usability of implementing the components (screen, assess, intervene, follow-up) of STEADI-based fall prevention to create an implementation plan for at least two assisted living facilities.

2. Adapt and implement the STEADI algorithm, tools, and materials, based on the implementation plan, to support the four core components of STEADI-based fall prevention among older adults who screen at risk for a fall within at least two assisted living facilities.

3. Conduct a process and outcome evaluation of the STEADI-based fall prevention implementation in the two facilities. Outcome evaluation should include a control group and the measures should include at least one fall-related outcome (e.g., falls, fall injuries, medically treated falls, or transfers to a hospital for a fall-related injury). Process evaluation should include measures of the feasibility and acceptability of the implementation based on feedback from assisted living facility staff involved in implementation. Process evaluation should also be designed to assist in understanding the outcomes (e.g. measuring older adult participation in recommended prevention strategies to help understand why certain older adults may have successful outcomes).

Secondary Outcomes:

Secondary outcomes for this project include publications and presentations describing results;

and for CDC, new guidance for adapting and implementing STEADI-based fall prevention in assisted living facilities ; suggestions for a modified algorithm and tailored resources, tools, and trainings for assisted living facilities ; and content for a technical assistance and lessons learned document for implementing STEADI-based fall prevention in assisted living facilities .

Research funded under this NOFO is expected to propose adaptation and implementation of STEADI-based fall prevention in two or more assisted living facilities and a rigorous study design to evaluate the process and the effect on fall outcomes. Applicants should specify assessment, implementation, and data analytic plans that are appropriate to the research design and hypotheses, data collection measures, and period of performance, and that anticipate and evaluate the effects of threats to the internal and external validity of the specified research design.

Applicants are expected to propose a methodology to adapt existing assisted living facility processes to include STEADI-based fall prevention and modify data collection systems to facilitate fall prevention and collect process and outcome evaluation data. They should propose an adaptation of the STEADI algorithm to the proposed facilities including all recommended assessments and linkage to clinical support for intervention when needed. The proposed methodology should include plans for adapting STEADI trainings, tools, fact sheets, and other resources for the assisted living facilities setting. The applicant should propose a plan for implementing the adaptation in at least two ALFs and should include a plan for a rigorous evaluation of both the process and the outcomes. The evaluation plan should include both data collection and analysis.

Data and analytic plans should anticipate and evaluate the effects of threats to the internal and external validity of the research design, including adjusting for known fall risk factors (e.g., age, sex, comorbidities) when appropriate.

The research plan should describe the research questions, study design, hypotheses, sample to be studied, recruitment strategies, data collection measures, sources, time points, procedures, analytic strategy, and estimated sample size and power for each proposed hypothesis. The application is expected to identify key outcomes for each research question. Applicants should attend to methods for outcome measurement that reduce bias (e.g., inclusion of multiple forms of measurement, such as through electronic health record documentation as well as patient survey interviews).

Applicants are encouraged to measure any unintended consequences of the approach and potential differential impacts of the approach on subpopulations, if applicable. Additionally, while not required, applicants including any cost of implementation or cost effectiveness data will be score higher.

Data collection, acquisition, and analysis Applicants must identify and describe appropriate data sources and provide evidence of their ability to acquire and/or collect data of sufficient quantity and quality to conduct a rigorous evaluation within the four-year period of performance. Applications should clearly describe and justify:

• Proposed sampling methods

• Sample size

• Power estimates

• Data collection methods for the primary outcome(s) and other proposed secondary measures and subgroup analyses, if appropriate.

https://www.cdc.gov/steadi/media/pdfs/STEADI-Algorithm-508.pdf

The study should be powered to detect differences in a fall-related outcome (e.g., falls, fall injuries, medically treated fall injuries) between the intervention and the control group. The timeline for data acquisition (requests for extant data and/or primary data collection) must be specified.

Appropriate data sources will vary by the approach selected, and the exact specification of the outcome(s) measures. Numerous data sources can be used for the outcome data with examples including:

• Medical records

• Hospital, emergency department or other healthcare facility

• Self-report data

• Administrative data from relevant agencies

• Survey data collected prior to or in the context of the evaluation

The outcome(s) should be measured at the level consistent with the population of interest (i.e., adults age 65 and over in an assisted living facility at risk for a fall).

Population of Focus The focus population for this data collection is adults age 65 and older who live in an assisted living facility and are at risk for a fall. The applicant should describe how risk for fall is determined, such as with the STEADI Stay Independent or Three Key Questions screeners.

Applicants will be required to demonstrate a plan for recruiting a sufficient sample size to separately examine one or more underrepresented group(s).

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

Collaboration/Partnerships It is expected that for all applications, the applicant organization and contact PI will provide the scientific and technical leadership necessary to conduct the proposed research throughout the entire period of performance. It is expected that the proposed research work plan described in the Research Strategy section of the application and the SF-424 Research and Related Budget will demonstrate the applicant organization’s leadership and involvement throughout the entirety of the period of performance. The applicant organization cannot serve as a “pass-through" to fund another entity to conduct the majority of the research or provide the scientific or technical leadership necessary to complete the proposed research project.

Partnerships between the applicant institution and outside entities may be necessary or advantageous to complete the proposed work. The application must clearly describe roles and responsibilities of each partnering entity. This includes demonstration of the applicant’s access to planned data sources and study populations, and all partnerships necessary to complete the proposed project.

The Research Strategy section of the application is expected to clearly describe the roles and responsibilities of each research team member individually and each participating entity. This includes describing how the partnership will allow the applicant to complete the proposed work.

https://www.cdc.gov/steadi/pdf/steadi-brochure-stayindependent-508.pdf

The Research Strategy section of the application must clearly describe the nature and extent of the proposed partnership. This should include the roles and responsibilities of the Principal Investigator(s) and of the outside entities or partner agencies, the existing working relationship, plans for the proposed research, the nature and extent of the involvement to be provided by the applicant institution and outside entity, the outside entity's scope of work, and how the partnership will ensure implementation and sustainability of the proposed evaluation. The Research Strategy section must clearly describe all data sources and the partnerships that are in place to assure data access for all proposed analyses to be completed within the period of performance.

Each partnering entity's roles and responsibilities must be validated with a signed Data Sharing Agreement, Letter of Support (LOS), or Memorandum of Understanding (MOU). These documents must detail the partner's commitment to resources, time, and personnel for the proposed research. Applications lacking a signed Data Sharing Agreement, Letter of Support, or Memorandum of Understanding from each partner may not be recommended for funding (refer to Section V. Application Review Information, 4. Review and Selection Process).

This NOFO aims for diversity among applicant institutions, research investigators, and partnering organizations to ensure research experiences and outcomes benefit all segments of the population and social ecology. Applicant organizations from or conducting research in collaboration or partnership with institutions that have a demonstrated record of or historical commitment to serving underrepresented students, including racial and ethnic minorities, individuals from disadvantaged backgrounds and individuals with disabilities may be considered during the second level of review (see Section V. Application Review Information, 4. Review and Selection Process). Applicants may indicate this in the Research Strategy of their application.

This NOFO supports the involvement of early-stage investigators on the SF-424 Senior/Key Personnel research team to foster experience and expertise in violence prevention research.

Applications must show that the research team possesses the required skills and experience to guarantee the quality and timely execution of the proposed activities. Involvement of students and emerging researchers is recommended. Those intending to integrate training and mentorship into their research should outline their strategies for recruiting, educating, and overseeing trainees/mentees, as well as ensuring the continuous quality of their scientific outputs.

Evaluation/Performance Measurement Applicants are expected to provide a research plan to demonstrate the feasibility of accomplishing the proposed project objectives. Measures must relate to the goals stated in the “Objective/Outcomes” section of this announcement and be able to measure the intended outputs and outcomes described.

Translation Plan The application is expected to clearly how research findings would be shared through publications, including articles in peer-reviewed scientific journals and "Research Briefs" for diverse audiences, as well as presentations at professional conferences, and in institutional and community-based venues. The application should describe how the findings, tools, resources, or other materials created will be made publicly available. Secondary outcomes for this project include publications and presentations describing results.

Applicants should also include plans to appropriately document the STEADI-based fall prevention implementation methods as well as lessons learned. Findings of this research will inform development of an implementation manual and STEADI-based fall prevention resources (e.g., training, tools, fact sheets) adapted for use in an assisted living facility, and facilitate future replication in another research or non-research setting. These plans may include but are not limited to identifying and describing how the four core components (screen, assess, intervene, follow-up) ae implemented , and documenting lessons learned from the study that might inform decisions about future adaptation or modification of the strategy for other settings or populations.

Grant recipients may be required to attend one reverse site visit per year in Atlanta with CDC/NCIPC staff during the period of performance to review their progress and findings and to discuss opportunities for widespread dissemination of their research achievements and lessons learned. Travel costs for attending this meeting must be included in the application's travel budget submitted in response to this NOFO.

3. Funding Strategy N/A

Section II. Award Information

Funding Instrument Type:

CA (Cooperative Agreement) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding:

$2,800,000 Anticipated Number of Awards:

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling:

$700,000 Per Budget Period

Award Floor:

$0 Per Budget Period

Total Period of Performance Length:

4 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Other:

Faith-based or Community-based Organizations

Regional Organizations

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

3. Additional Information on Eligibility Please see Section III. Eligibility Information

4. Justification for Less than Maximum Competition N/A

5. Responsiveness It is the applicant’s responsibility to ensure that the application meets all responsiveness criteria listed in this section. Applications that do not meet all the following Responsiveness criteria will be considered nonresponsive and will not be forwarded for peer review.

1. Applications must propose a study to implement and evaluate STEADI-based fall prevention in older adults living in an assisted living facility who are at risk of a fall as determined by one of the STEADI screeners, Stay Independent or the Three Key Questions. The application should specify both an intervention and control group of at-risk older adults, as evidenced in the Research Strategy section of the Research Plan.

Applications that do not specify an intervention and control group will not be forwarded for peer review.

2. Primary prevention of falls involves prevention before the fall occurs. Secondary prevention involves early fall detection and fall injury prevention. Tertiary prevention involves over the longer term to address trauma or the consequences of the fall. This NOFO is focused on primary prevention of falls among older adults residing in assisted living facilities that screened at risk for a fall. A focus on primary prevention must be clearly specified in the Research Strategy section of the Research Plan. Applications that propose solely secondary or tertiary prevention activities will be considered non-responsive and will not move forward to peer review.

3. Applicants must include documentation that at least one senior member of the research team (Principal Investigator or Co-Investigator) has the following:

• expertise in o older adult fall prevention;

o program implementation and evaluation (process and outcomes); AND o epidemiologic methods and analysis of epidemiologic data that is reflected in the application’s research strategy section;

• The SF-424 Biographical Sketch for the PI or Co-I must include documentation of experience of at least one first-authored,…