Opportunity Information: Apply for RFA AG 14 009
Apply for RFA AG 14 009
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trial of a Multifactorial Fall Injury Prevention Strategy in Older Persons (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
- This funding opportunity was created on Jul 16, 2013 and posted on Jul 16, 2013.
- Applicants must submit their applications by Nov 13, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $30,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education County governments Special district governments Small businesses For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) State governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The National Institutes of Health (NIH) released this funding opportunity, RFA-AG-14-009, to support a single large randomized clinical trial testing a multifactorial strategy to prevent serious fall-related injuries in non-institutionalized older adults. The core idea is not simply to reduce falls in general, but to target the kinds of falls that lead to major harm (for example, injuries that trigger emergency care, hospitalization, loss of independence, or other serious outcomes). NIH is looking for a strategy that is both highly effective and realistically deployable in real-world care, meaning it can be implemented with fidelity in at least one practical service setting (such as primary care, specialty clinics, home-based care programs, or integrated health systems) if the trial shows it works.
A key requirement is that the intervention be a true multifactorial, protocol-driven approach grounded in evidence and built around explicit decision rules. The proposed protocol is expected to spell out, in a reproducible way, how the study will (1) screen a broader older population to identify who is at high risk for falling, (2) conduct structured assessments of those high-risk individuals to pinpoint their specific, individual risk factors, and (3) select and match interventions to address each person’s identified risks. This can include multiple intervention components per participant, tailored to their needs, rather than a one-size-fits-all program. The opportunity emphasizes a complete workflow: identifying risk, diagnosing contributing factors, choosing appropriate interventions, delivering them, and then tracking whether risk factors are actually improving over time.
The announcement also places heavy emphasis on implementation mechanics, especially coordination across the different people and systems involved in an older person’s care. Applicants are expected to describe how they will coordinate delivery of each participant’s set of interventions and how they will handle real clinical complexities, including medication management. In particular, NIH calls out the need for methods that coordinate decisions about potential adjustments in medication prescribing when a patient has multiple prescribers, which is common in older adults and is directly relevant to fall risk (for example, sedatives, antihypertensives, anticholinergics, and polypharmacy more broadly). Beyond initial rollout, the protocol should include ongoing monitoring of each participant’s progress toward reducing risk factors, plus contingency plans: alternative interventions when a person is not improving and procedures for addressing newly emerging risk factors during follow-up.
Another central expectation is meaningful incorporation of patient and stakeholder perspectives. The study design should reflect what matters to older adults and other relevant stakeholders (such as caregivers, clinicians, health systems, and community partners) both in how the protocol is specified and in what outcomes are measured. In practice, this implies attention to outcomes beyond purely clinical endpoints, potentially including function, quality of life, independence, treatment burden, acceptability, and adherence, as well as the feasibility of scaling the approach if it proves effective.
NIH also encourages applicants to consider adaptive design features, meaning trial elements that allow learning from evidence as it accumulates during the study, whether results are trending positive or negative. While the announcement does not prescribe a specific adaptive framework, the intent is to support designs that can responsibly refine aspects of implementation, targeting, or intervention choices in response to interim information, without undermining scientific rigor.
From an administrative and funding standpoint, this is a discretionary opportunity using a U01 cooperative agreement mechanism, which typically implies substantial NIH program involvement during the project (for example, collaboration on milestones, coordination, or oversight beyond what is typical for a standard grant). The agency is NIH, and the activity category is health, with the program area listed under Aging Research (CFDA 93.866). NIH anticipated making 1 award with an estimated total funding level of $30,000,000, and the opportunity did not require cost sharing or matching. The opportunity was posted July 16, 2013, with an original and current closing date of November 13, 2013, and an archive date of December 14, 2013.
Eligibility was broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses and other for-profit organizations, local and state governmental entities, public housing authorities/Indian housing authorities, independent school districts, tribal governments and tribal organizations, and various designated serving institutions (such as HBCUs, HSIs, AANAPISIs, TCCUs, and Alaska Native/Native Hawaiian serving institutions), as well as faith-based and community-based organizations and eligible federal agencies. Foreign institutions were not eligible, and non-U.S. components of U.S. organizations were not eligible; foreign components as defined by NIH policy were not allowed.
Overall, the opportunity is best understood as a call for a highly structured, pragmatic, and scalable clinical trial that tests a comprehensive fall-injury prevention system: one that starts with screening, moves through individualized risk assessment and tailored intervention selection, and then follows through with coordinated delivery, medication-related decision coordination, ongoing monitoring, and structured escalation when participants do not improve. The end goal is evidence strong enough to support real-world adoption of a potent, implementable approach to reducing serious fall injuries in older adults living in the community.
Frequently Asked Questions (FAQs)
What is the funding opportunity RFA-AG-14-009 about?
RFA-AG-14-009 is a National Institutes of Health (NIH) funding opportunity to support a single large randomized clinical trial that tests a multifactorial, protocol-driven strategy to prevent serious fall-related injuries in non-institutionalized (community-dwelling) older adults.
What is the main goal of the trial being funded?
The main goal is to prevent serious fall-related injuries, not just reduce the number of falls overall. The focus is on falls that lead to major harm, such as injuries resulting in emergency care, hospitalization, loss of independence, or other serious outcomes.
How many awards did NIH plan to make under this opportunity?
NIH anticipated making 1 award.
What is the estimated total funding level for this opportunity?
The estimated total funding level was $30,000,000.
What funding mechanism is used for this opportunity?
This opportunity uses a U01 cooperative agreement mechanism, which generally means substantial NIH program involvement during the project (for example, collaboration on milestones, coordination, or oversight beyond what is typical for a standard grant).
Is this opportunity focused on falls in general or fall-related injuries?
It is specifically focused on preventing serious fall-related injuries. The opportunity emphasizes targeting the types of falls that lead to major adverse outcomes rather than focusing only on reducing fall incidence.
Who is the target population for the clinical trial?
The target population is non-institutionalized older adults (older adults living in the community rather than in institutional settings).
What kind of intervention strategy is NIH looking for?
NIH is looking for a true multifactorial, evidence-based, protocol-driven approach that uses explicit decision rules and can tailor multiple intervention components to individual participant needs.
What does "multifactorial" mean in the context of this funding opportunity?
It means the strategy should address multiple contributing risk factors for fall-related injury. Rather than a one-size-fits-all program, the protocol is expected to assess an individual and match interventions to that person’s specific risks, potentially applying multiple intervention components per participant.
What specific workflow elements does the protocol need to include?
The protocol is expected to specify, in a reproducible way, how the study will: (1) screen a broader older population to identify those at high risk for falling, (2) conduct structured assessments of high-risk individuals to identify their specific risk factors, and (3) select and match interventions to address each person’s identified risks. It should also cover delivery, tracking of risk factor change over time, and escalation when participants are not improving.
Does the opportunity require a screening process to identify high-risk participants?
Yes. The protocol is expected to include a process for screening a broader older population to identify individuals at high risk for falling.
Does the opportunity require structured assessments after screening?
Yes. For those identified as high risk, the protocol is expected to include structured assessments designed to pinpoint each person’s individual risk factors.
Does NIH expect interventions to be tailored to individual participants?
Yes. The approach is expected to match interventions to each participant’s specific identified risk factors, allowing multiple components per participant as needed.
What does NIH mean by "protocol-driven" and "explicit decision rules"?
NIH expects the proposed approach to be specified clearly and reproducibly, including decision rules that define how screening results lead to assessments, how assessment findings lead to intervention selection, and how follow-up findings lead to continued, changed, or escalated interventions.
What settings should the intervention be able to work in?
The strategy should be realistically deployable in real-world care and implementable with fidelity in at least one practical service setting. Examples mentioned include primary care, specialty clinics, home-based care programs, or integrated health systems.
How important is real-world implementation in this opportunity?
It is a major emphasis. NIH is looking for an approach that is not only effective, but also practical to implement in real care settings with fidelity if the trial demonstrates benefit.
What does the opportunity say about coordination across providers and systems?
The announcement places heavy emphasis on implementation mechanics and expects applicants to describe how they will coordinate delivery of each participant’s set of interventions across the different people and systems involved in an older person’s care.
Why is medication management specifically emphasized?
Medication management is highlighted as a real clinical complexity relevant to fall risk, especially when older adults have multiple prescribers. The opportunity calls for methods to coordinate decisions about potential medication adjustments in this context, including issues such as sedatives, antihypertensives, anticholinergics, and polypharmacy more broadly.
Does the protocol need to include follow-up monitoring?
Yes. Beyond initial rollout, the protocol should include ongoing monitoring of each participant’s progress toward reducing risk factors over time.
What happens if a participant’s risk factors are not improving?
The opportunity expects contingency plans, including alternative interventions when a person is not improving and procedures for addressing newly emerging risk factors during follow-up.
Are patient and stakeholder perspectives required in the study design?
Yes. The opportunity calls for meaningful incorporation of patient and stakeholder perspectives, including older adults and other stakeholders such as caregivers, clinicians, health systems, and community partners.
How might patient and stakeholder perspectives influence the trial?
Based on the announcement, these perspectives should inform both how the protocol is specified and what outcomes are measured, reflecting what matters to older adults and relevant stakeholders.
What kinds of outcomes are implied beyond clinical endpoints?
The opportunity suggests attention to outcomes beyond purely clinical endpoints, potentially including function, quality of life, independence, treatment burden, acceptability, adherence, and feasibility of scaling the approach if effective.
Does NIH encourage adaptive trial designs for this opportunity?
Yes. NIH encourages applicants to consider adaptive design features that allow learning from accumulating evidence during the study and responsibly refining elements such as implementation, targeting, or intervention choices without undermining scientific rigor.
Is a specific adaptive design framework required?
No. The announcement does not prescribe a specific adaptive framework, but it signals support for designs that can refine aspects of the study in response to interim information while maintaining rigor.
Which NIH program area and CFDA listing apply to this opportunity?
The program area is Aging Research, and the CFDA number listed is 93.866.
Which agency released this funding opportunity?
The agency is the National Institutes of Health (NIH).
What was the posting date for this opportunity?
The opportunity was posted on July 16, 2013.
What were the closing dates for applications?
The original and current closing date listed was November 13, 2013.
When was the opportunity archived?
The archive date was December 14, 2013.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What types of organizations were eligible to apply?
Eligibility was broad across many U.S.-based organization types, including public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); small businesses and other for-profit organizations; local and state governmental entities; public housing authorities/Indian housing authorities; independent school districts; tribal governments and tribal organizations; designated serving institutions (such as HBCUs, HSIs, AANAPISIs, TCCUs, and Alaska Native/Native Hawaiian serving institutions); faith-based and community-based organizations; and eligible federal agencies.
Are foreign institutions eligible to apply?
No. Foreign institutions were not eligible.
Are non-U.S. components of U.S. organizations allowed?
No. Non-U.S. components of U.S. organizations were not eligible.
Are foreign components allowed under NIH policy for this opportunity?
No. Foreign components as defined by NIH policy were not allowed.
How would you summarize the kind of project NIH wanted to fund?
This opportunity is best understood as a call for a highly structured, pragmatic, and scalable randomized clinical trial that tests a comprehensive fall-injury prevention system: screening, individualized risk assessment, tailored intervention selection, coordinated delivery (including medication-related decision coordination), ongoing monitoring, and structured escalation when participants do not improve, with outcomes reflecting what matters to older adults and stakeholders.
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