Division of Geriatrics and Clinical Gerontology
Questions and Answers about the NIA-PCORI Fall Injuries Prevention Partnership RFA
If you are interested in applying for the NIA-PCORI Fall Injuries Prevention Partnership RFA (RFA-AG-14-009), please read the Questions and Answers below for more information. For further questions, contact: Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D. (301-496-6762, Rosaly.email@example.com)
Applications are due November 13, 2013.
- Press release: NIH, PCORI seek applications for falls prevention clinical trial
- Webinar slides (PDF, 227.6K)
What materials should be included into application appendix?
Applicants should include the study protocol and Manual of Procedures. Appendices should not be used to circumvent the 30-page limit of the Research Strategy section.
Is there interest in having community partners that are not part of any healthcare system participate or are only patients and providers that belong to a certain healthcare system allowed to participate in the study?
A community agency that would screen and enroll the participants is a reasonable venue to consider as part of the consortium. The agency would need to collaborate with a healthcare system for medical evaluation of participants enrolled by the community agency.
Should the patients be compensated for their participation in the study?
Yes, they should be compensated either as the study participants or as the partners.
Hospitalized patients are not allowed into the study. Are they eligible after been discharged into community?
Yes, they would be eligible if they remain at risk for falling after discharge.
Is there a definition of “serious fall injury?”
Applicants should propose the definition. Several approaches can be used to develop the definition. For example, a “serious” fall could be one that requires medical attention and generates an insurance claim. Another approach could be to have participants and/or their family members record falls and describe injuries according to a nomenclature developed by the applicant. Other approaches could be used, but all should focus on serious, fall-related injuries that matter to patients.
How will the responsiveness of applications to the RFA be determined?
Before submitting applications for peer review, NIA staff will review them for responsiveness to the criteria listed in the RFA. Those applications that do not meet the criteria will not be submitted for peer review and will be returned to the applicants.
How many applications will be funded?
One application with total costs of up to $30 million will be funded.
How should the age range of study participants be defined?
There is no specific age range for participants selected for this study. Applicants should focus on a high-risk population and propose and justify their selection of the age range. The study should be able to enroll a significant number of participants within a short period of time to meet the RFA’s objectives.
Who will review the grant applications? Will there be a mix of NIA and PCORI reviewers?
Technically, all reviewers will be NIA reviewers, but a percentage of them will represent patients’ and stakeholders’ perspectives. PCORI will submit to NIA a list of candidate reviewers who have previously reviewed PCORI projects. NIA will select reviewers from this group.
What will the second level of review by the National Advisory Council on Aging involve?
The second level of review involves the Council concurring (or not) with the outcome of the initial review.
How will the awardee engage with the NIA advisory committee?
The study will be governed by the Steering Committee, whose role and responsibilities are described in the RFA. In accordance with NIH guidelines, NIA will also appoint a Data and Safety Monitoring Board that will oversee participants’ safety, study progress, and data quality. This Board is advisory to NIA Director.
The RFA states that nursing home residents are not eligible to participate in this study. How are nursing home defined in the RFA, as there a different levels of care?
Residents of assisted living facilities are eligible to participate in the study.
Should study participants be recruited from a general elderly population or are patients with a disease or chronic condition such as stroke or Parkinson’s disease eligible?
Participants should be selected from general population of older people who are at risk for falling. Applications proposing a study in a subset of general elderly population (e.g., patients with stroke or Parkinson’s disease) will not be responsive to RFA and will be returned to the applicants.
How big should the proposed pilot study be?
Applicants should propose a well-designed clinical trial which is responsive to the RFA. It is recognized that all the study elements may not be well established at the time of submission; the protocol development and refinement phase provides for refinement and/or pilot testing of a number of study elements. Applicants should propose and justify tasks that will be performed during the protocol development and refinement phase, which may include, but are not limited to, secondary analysis of existing data sets, pilot testing of select study elements, or similar activities.
Should PHS SF 424 (R&R) Guidelines Part 1, Section 5.5 be followed for the research plan?
All PHS SF 424 (R&R) Guidelines Part 1, Section 5.5 should be followed, except for the Research Strategy section. As stated in the RFA, the Research Strategy section should contain the following section headings: Significance, Patient Centeredness, Approach, Patient and Stakeholder Engagement, and Innovation.
What is the page limit for the Research Strategy section?
The page limit for the Research Strategy section is 30 pages.
Does this RFA encourage partnerships with the Veterans Administration hospital systems and/or the Veterans Health Administration’s Office of Rural Health?
All types of partnerships ensuring successful completion of the project are encouraged.
How many applications are expected?
It is not known. We will accept, but not necessarily review, all applications submitted.
I have been conducting a program called Mobility and Balance Awareness. The program seems to be a good fit for this RFA, but the ability to scale up to this size of a project is challenging. Can you provide some guidance on this topic?
The guidance is provided in the RFA-AG-14-009.
If we are a single hospital system with 10 hospitals and 100 outpatient facilities, could we still qualify if we do not have other non-system sites participating?
If your application satisfies all the RFA requirements, it will be accepted for review.
Can you clarify the indirect costs rate? Should the NIH or the PCORI rate be used or is there a separate rate for this RFA?
Your institution’s standard NIH indirect costs rate should be used.
I am considering an application for the Data Coordinating Center for this RFA. The only reference I could find to the Data Coordinating Center was in the Areas of Joint Responsibility section. Will this require that: 1) I apply as the PD/PI of this study; 2) I join an application with a separate PD/PI for the study and serve as the PD/PI for the DCC; or 3) There will be a separate application for the PD/PI for the DCC?
Applications should be submitted by consortia which includes a Data Coordinating Center among its components. It is not important whether the entity or study component that serves as the DCC is the primary applicant.
Are there PCORI guidelines on “Patient-Centeredness” and “Patient and Stakeholder Engagement?”
PCORI guidelines on “Patient-Centeredness” and “Patient and Stakeholder Engagement” are available at www.pcori.org/research-we-support/pcori-review-criteria/.
How should we budget Years 2-5 since they depend on what happens in Year 1? Will there be some flexibility?
Applications should propose a well-designed and appropriately budgeted study. The budget for Years 2 to 5 should be based on the assumption that Year 1 will be successful, therefore providing continuity to the project. Based on changes made during the protocol development and refinement phase, the grantee will be allowed to appropriately adjust budget for Years 2-5.
Can the development and piloting of a novel instrument be a part of the first year refinement process, or must the technology be demonstrable in its final form before the submission of the application? Also, instrumentation development and refinement might benefit from a more constrained and well-characterized population such as hospitalized patients. Could that be an acceptable exception to the RFA guidelines prohibiting hospitalized populations if used for that very narrow purpose?
Any device that will be used in the study must be approved by FDA when the trial starts, unless it is not FDA-regulated. In addition, such a device must be a part of a multifactorial strategy and must be usable in non-hospitalized populations. It is doubtful that all these conditions could be met, if the development starts during the protocol development and refinement phase. Any device should be validated in diverse populations to be usable in the proposed trial.