Comparative Effectiveness Delivery System Evaluation Grants

Questions and Answers

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Updated with questions received through March 4, 2010.

The following set of questions and answers features responses from the Agency for Healthcare Research and Quality (AHRQ) to questions from the public submitted about the Agency's Funding Opportunity Announcement (FOA) for RFA-HS-10-012: Recovery Act 2009 Limited Competition: Comparative Effectiveness Delivery System Evaluation Grants (R01).

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Question #1: Can applicants submit more than one application in response to this Request for Applications (RFA)?

Answer #1: Applicants may submit more than one application in response to this RFA. Applicants may also simultaneously respond to other AHRQ RFAs, provided each application is scientifically distinct.

Question #2:What is the page limit for the "Research Strategy" section of the application?

Answer #2: The Research Strategy component of the application may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. Applicants should follow the general guidance provided in Standard Form 424 when specific instructions are not provided in the RFA.

Question #3: Are Department of Veterans Affairs (VA) institutions eligible to apply for this and other American Recovery and Reinvestment Act (ARRA) RFAs?

Answer #3: Yes. However, VA institutions should review the Department of Health and Human Services (HHS) Grants Policy Statement section entitled "Grants to Federal Institutions and Allowable Costs and Payments to (or on Behalf of) Federal Employees under Grants" for allowable and unallowable costs (available at http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc#_Toc155580325). (Microsoft® Word® files can be viewed with the free Word® Viewer. ).

Question #4:Is AHRQ willing to fund studies of VA data?

Answer #4: There are no restrictions on the data sources for these grants. Applicants should consult the RFA for other requirements relating to data use and eligibility.

Question #5: Will there be opportunities for more RFAs like this in the future?

Answer #5: RFAs supported by ARRA funds are one-time solicitations that will not be repeated, nor will there be an opportunity to submit revisions of the original application. However, AHRQ has other funding opportunities, many of which are periodically renewed (available at http://www.ahrq.gov/fund/).

Question #6: The RFA states that grantees will evaluate "interventions that have already been implemented in health care and are likely to improve quality and other outcomes." Please clarify what is meant by this.

Answer #6: The phrase implies (but does not formally state) two things: 1) this RFA is about evaluating existing interventions, not about designing an intervention, implementing it, and conducting a preliminary evaluation; and 2) the interventions that are being studied will have been implemented widely enough and long enough to justify carrying out the evaluation.

Question #7: Can any of the funds in the grant be used to pay for the intervention being studied?

Answer #7: Yes.

New Questions and Answers as of March 4, 2010

Question #8: Will the submission date be extended?

Answer #8: If extensions are made for grant solicitations, it will be posted in the NIH Guide and on the AHRQ Web site. It will also appear in the solicitation.

Question #9: The RFA states: “Proprietary components that are critical to the success of the initiative must be accessible at little or no cost to researchers and organizations seeking to replicate the project elsewhere. Applications containing critical proprietary components (e.g., tools, products, technologies) that would significantly deter or prevent the replication of the project's strategies or interventions due to legal or cost constraints will not meet the intent of this FOA. Such applications will be appropriately scored at peer review.” Please expand on “Such applications will be appropriately scored at peer review.”

Answer #9: For information on the peer review process, including scoring, see http://www.ahrq.gov/fund/peerrev/peerproc.htm.

Question #10: Under what circumstances would proprietary components that “significantly deter or prevent the replication of the project's strategies or interventions due to legal or cost constraints” be acceptable?

Answer #10: AHRQ seeks to support research that will produce findings and products that can be adopted and used by a wide range of actors in the health care system. This objective flows from our mission, which is to improve the health of all Americans, and from our responsibility for fostering research of potential value to AHRQ's priority populations (go to http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). We discourage applications in which acquisition of proprietary products is likely to form a significant barrier to adoption of an otherwise valuable practice or procedure.

Question #11: We are planning to use an epidemiological-clinical methodology developed for one infectious disease in clinics that treat a different infectious disease. Should we instead reply to the RFA 10-013 solicitation?

Answer #11: Yes. RFA 10-013 seeks to support implementation, tracking of implementation progress, and assessment of outcomes—whereas RFA 10-012 focuses solely on the third element (assessing interventions or designs).

Question #12: We are planning to evaluate a system design program that fits within the requirements listed on page 2 of the RFA. However, page 5 reads, “investments funded from this appropriation must address at least one of the following topic areas: 1) one of the 100 IOM topic recommendations, 2) one of the MMA 14 priority conditions, 3) one of the AHRQ-identified evidence gaps.“ Do system design issues fall under one of the AHRQ-identified evidence gaps?

Answer #12: The language on page 2 is specific to this solicitation. The language on page 5 applies to all of the ARRA solicitations approved by the Office of the Secretary of HHS. The IOM recommended research on a wide range of delivery practices and improvement techniques. The easiest way to deal with the general requirement is to pay attention to the wording: “appropriation must address at least one of the following topic areas.” The proposed intervention would presumably help address several of the priority conditions that are listed, so applicants should explain how. As for AHRQ-identified evidence gaps, this phrase refers to research and literature reviews published by or supported by AHRQ that point to areas where more evidence is needed. AHRQ Evidence-based Practice reports are examples, but by no means the only source that identifies evidence gaps.

Question #13: Can this RFA fund an international research effort?

Answer #13: Funding for this program is provided under the Recovery Act. The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 total costs (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under the Recovery Act will be for up to 3 years.

Question #14: Can respondents submit an application that was reviewed elsewhere but not funded?

Answer #14: Yes. However, applicants should not use the procedure for submitting a revised application. Instead, applicants should make appropriate changes in the title and contents to align with the RFA and submit the application as a new application.

Question #15: Why does this RFA and other ARRA-supported RFAs bear the heading of "limited competition"?

Answer #15: The term “limited competition” conveys the fact that these solicitations will not be reissued and that no revisions are permitted. Awards for all ARRA-OS RFAs must be made no later than September 30, 2010.

Question #16: How should applicants decide whether to apply to this RFA or to RFA 10-013?

Answer #16: These two RFAs form a pair. RFA 10-012 (R01) calls for research evaluations of designs and improvements that are already in place. In contrast, RFA 10-013 (R18) invites applications to conduct and assess demonstrations of 1) broad strategies and/or specific interventions for improving care by redesigning care delivery, or 2) strategies and interventions for improving care by redesigning payment. The demonstrations will aim to achieve major improvements in care quality (including clinical outcomes and other dimensions), improve access to care, reduce disparities, or improve population-based measures of health outcomes. Thus, RFA 10-013 calls for demonstration design, implementation, research on the implementation process, and research on results.

Question #17: Do the standard AHRQ rules for young investigators apply?

Answer #17: AHRQ does not use the "new investigator" designation (as NIH does). Incorporating senior people into the team or having a senior PI are worth considering as ways of strengthening the application.

Question #18: What are the format requirements?

Answer #18: For questions about AHRQ format requirements, refer to the AHRQ Notice regarding “AHRQ Implementation of Enhanced Peer Review” (available at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-10-002.html).

Another useful site explains the details of new SF424 application form components (and also includes comparisons to the old format). The “Details of Application Changes for Research Grants and Cooperative Agreements” (for due dates on or after January 25, 2010) can be found at http://enhancing-peer-review.nih.gov/docs/application_changes.pdf. (PDF File,106 KB; PDF Help)

Question #19: What is included in “total costs”?

Answer #19: All direct costs and all indirect costs are included in total costs.

Question #20: Does an evaluation of the effectiveness of an electronic health record product fit the RFA?

Answer #20: No. The following statement in the RFA explains the issue: “System designs, interventions, and/or strategies to be investigated may be facilitated by health information technology (IT) applications or may incorporate new forms of health IT. However, the focus of the interventions/strategies should be on the redesign of delivery systems, organizations, and microsystems, rather than on the introduction and testing of a particular health IT application or IT system.”

Question #21: We propose to develop an interactive educational game tailored to patients with the target clinical condition. The goal is to foster self-care management. Does this fit within the scope of the RFA?

Answer #21: This RFA requests evaluations of interventions that are already in place. In contrast, RFA 10-013 invites development and implementation of evidence-based interventions. However, RFA 10-013 envisions introducing strategies and interventions at higher system levels than the educational intervention you propose.

Question #22: Would a comparative assessment of guidelines for persons with the target clinical condition be appropriate?

Answer #22: The objectives of the RFA include gaining scientific evidence about the capacity of system designs, strategies, and interventions to improve delivery-system performance on quality and other outcomes, such as efficiency, cost, access, disparity reduction, and population-based health. It is not clear whether determining what guidelines are in place for the care of adults with the target clinical condition fits this objective. You would need to make a case that the guidelines in place are evidence-based and explain how you would compare their use and impacts.

Question #23: Does the budget allow for funding the development of a disease registry?

Answer #23: Yes, applicants can use some of the budget to fund a registry or other aspects of the intervention. However, if you are planning to implement the intervention and are facing implementation challenges, as well as those of evaluation, then RFA 10-013 is more appropriate.

Current as of March 8, 2010