Summary of Questions and Answers From a Technical Assistance Videocast Held on January 10, 2019.
Participating NIH Staff:
- Dr. Wendy Weber, Branch Chief, Clinical Research Branch, National Center for Complementary and Integrative Health (NCCIH)
- Dr. Linda Porter, Director, Office of Pain Policy, National Institute of Neurological Disorders and Stroke (NINDS)
- Dr. Catherine Meyers, Director, Office of Clinical and Regulatory Affairs, NCCIH
- Dr. Martina Schmidt, Chief, Office of Scientific Review, NCCIH
- Shelley Carow, Chief Grants Management Officer, Office of Grants Management, NCCIH
Q: Where can people obtain information about other funding opportunities related to the HEAL Initiative?
A: NIH has a central HEAL Initiative website that provides this information. https://www.nih.gov/research-training/medical-research-initiatives/heal-…
If you search the Web for “NIH HEAL Initiative” (not just NIH HEAL), that webpage will come up. Tap on “Funding Opportunities.” You’ll find a list, including information on whether a Funding Opportunity Announcement (FOA) is still open or retired. If you click on the notice number, you can go to the individual FOA.
Each FOA has contact information for a primary contact for the FOA itself, as well as scientific contact information for each of the participating institutes and centers (ICs). Many of the individual ICs also have their own webpages explaining how they participate in HEAL, with more specific information about their priorities.
Q: What is the U mechanism?
A: The U mechanism, or cooperative agreement, is a support mechanism that’s in between a grant and a contract. It’s used when there will be substantial Federal scientific or programmatic involvement in the initiative once the award is made. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. All the Health Care System Research Collaboratory projects are cooperative agreements.
Q: Can a proposal submitted under this RFA involve a variety of chronic pain conditions or should it focus on only one?
A: Either option is possible. It is important, though, that there is already evidence that your intervention works for all the conditions you include. So, for example, if there is only evidence for back pain, it would not be appropriate to include all types of musculoskeletal pain. But if there’s evidence that the intervention you want to study works for back pain, neck pain, and knee pain, you could include all of these conditions. It’s important to ensure that the reviewers understand why you’ve included specific conditions in your cohort and that the reasons for including them are well justified.
Q: To what degree can pilot work be conducted during the UG3 phase and can any pilot work be done during the first year of the UH3 phase?
A: In the context of pragmatic trials, “piloting” usually refers to the work investigators do during the planning phase to pilot the ability to successfully get the intervention into the clinical sites or health care systems. The investigators are piloting the intervention and testing its uptake so that when they get to the implementation phase, they’re prepared for full-scale implementation. Solicitations for pragmatic trials typically do not support piloting to create efficacy data on the intervention. It’s expected that efficacy data already exist. The piloting work should be complete prior to the start of the UH3 phase, as the investigators are expected to launch the pragmatic trial at the beginning of the UH3 phase.
Q: Are the workgroups made up of the PIs and co-investigators? Must people be assigned to all of the workgroups at the time of application?
A: Applicants are expected to identify staff members in their applications who would act as representatives to each of the workgroups. The PI can assign themselves or an appropriate co-investigator to represent their project on each of the workgroups.
It’s important to budget time for the representatives to participate in the workgroups—typically, they would attend one meeting a month. Additional details about the workgroups can be found on the Collaboratory website rethinkingclinicaltrials.org.
Choosing workgroup representatives may seem to be a daunting task, but as you assemble your pragmatic trial team you will find that you need a staff member who can address each of these areas of project implementation. You will obtain a great deal of advice and help from the workgroups, so your representative’s participation is important.
Q: Will all applications be assigned to NCCIH, and do they need to include a complementary intervention?
A: All applications will initially be assigned to NCCIH because they will go to the same review panel. However, after review, applications will be transferred to the IC that will administer the award and has the most relevant scientific expertise.
Applications do not need to include complementary approaches. Applications must fit the mission of one of the participating ICs and the goals of the RFA.
Proposals related to all forms of pain management are welcome. The goal of this initiative is to foster better pain management and reduce inappropriate use of opioids.
Q: Are all types of nonpharmacologic interventions acceptable?
Q: Is primary prevention of opioid use an acceptable outcome rather than a specific pain syndrome?
A: The focus of this particular RFA is pain management. Reduction of opioid use could be one of the outcomes a study looks at. However, if this is your main interest, other FOAs, either within or outside the HEAL Initiative, may be better suited for your proposed project. Please talk with a program officer at the appropriate IC to make sure your application is responsive to the RFA.
Q: Is it necessary to budget for a statistician or will one be provided by the Coordinating Center?
A: You will definitely need a statistician for both the design stage of your trial and the development of the analytic plan. The Coordinating Center is a resource center, not a data coordinating center for your trial. It will not collect, store, or analyze your data. Your application needs to include full information about the ways in which you will obtain and analyze your data, which is why you will need to budget for a biostatistician.
Q: Is it true that the Trials Innovation Network will be part of this initiative and provide implementation support?
A: No, the PRISM RFA will not use the Trials Innovation Network. That network is going to be involved in a different program under the HEAL Initiative, the Pain Management Effectiveness Research Network (https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-021.html). Those trials will use the centers set up through the National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Awards (CTSA) system.
Q: Given that there are two stages, the UG3 and UH3, how should the aims and research strategy sections of the application be structured?
A: Page 1 of the application must include specific aims for each of the two stages. Typically, investigators divide the remaining 12 pages into two discrete descriptions, first the UG3 and then the UH3. In the RFA, there is a list of things that must take place in each phase. You can use this as a guide. Information already provided for the UG3 need not be repeated in the UH3 section; you can just refer back to it. If your project meets the definition of a clinical trial, you also have the opportunity to provide additional details, such as inclusion/exclusion criteria and details of the protocol, in the Study Record.
Q: If the planning activities in the UG3 are not completed within 12 months, can the time be extended?
A: The PI should contact the program official if additional time is needed to complete the UG3 milestones. An extension of up to 12 months may be possible. Typically, when an extension is allowed, it would be a no-cost extension. The application should propose activities in the UG3 planning phase that can be completed in 12 months.
Q: Must the three health care systems all be participating members of the NIH Collaboratory or members of the Health Care Systems Research Network?
A: No. Organizations that have not previously participated in Collaboratory projects are welcome. The Collaboratory has worked with organizations that provide health care but might not be considered typical health care systems, such as dialysis providers and corporations that provide health care.
However, all participating health care systems must be large-scale health care delivery organizations with electronic records, and investigators must have ready access to the electronic records needed to assess study outcomes. The definition of a health care system in the RFA was intentionally left a little open so that investigators can propose ideas that might not have been anticipated. If you are unsure whether an organization you want to work with is acceptable, please contact a program officer.
Note that for this RFA, it is important for results to be generalizable and applicable to a broad patient population. Typically, sites from multiple regions around the country would be included in a study. However, no foreign sites can be included, although foreign consultants are acceptable.
Q: If the evidence that an intervention is effective for certain pain conditions is of low or moderate quality, but the overall evidence for interventions for that type of pain is low, can those conditions be included in a study? What about nonspecific conditions that do not fit into well-defined diagnostic criteria? Can these conditions be included?
A: The purpose of this FOA is to study the implementation of interventions that have already been shown to be effective for a particular condition and where the evidence justifies investigation of large-scale implementation within health care systems. It’s not the intent of this FOA to extrapolate findings to broader groups of patients. Other FOAs may be more appropriate for situations where the current evidence is of low or moderate quality. Please contact a program officer for more information.
The one situation where an intervention with moderate-quality evidence of effectiveness might be acceptable within this FOA is when evidence-based guidelines recommend the intervention despite the quality of the evidence.
Conducting implementation research on nonspecific chronic pain conditions is challenging. Please discuss your ideas with a program officer.
Q: Should applicants identify which NIH IC they would want their application to go to if the proposal passes the first review and scores well?
A: You may do this, and it would be helpful for NIH to have this information.
Q: If the application has multiple PIs, does each PI have to contribute 20 percent effort?
A: All the PIs together need to commit to at least 20 percent. The requirement is for the combination, not each individual. Note that 20 percent is the minimum. Applicants should budget for the amount of time that each of the PIs will actually devote to the project. Investigators in the Collaboratory are usually very actively engaged in their projects.
Q: If staff will be hired, must they be in place at the beginning, or can they be hired for the UH3 phase? Can research funds be used to hire the person who will deliver the intervention or will the health care system deliver it?
A: Because pragmatic trials are embedded within routine health care in the health care system, the intervention would be delivered by clinicians already working within that system. So, it’s not anticipated that clinicians would need to be hired for these implementation trials. These are not traditional randomized controlled trials in which independent research delivery of care is developed. The purpose of these pragmatic trials is to determine whether the intervention works as part of the routine care provided by the health care systems.
During the planning year, investigators can work in the field to train the clinicians who will ultimately deliver the intervention, rather than hiring clinicians.
Study staff, such as research assistants, can be hired after a project is funded. It is not necessary to have staff available at the time of application.
Q: Would a physical therapy practice system qualify as a health care system?
A: Please contact a program officer to discuss this more thoroughly. The system might qualify if it is a nationwide or multiple regional system. A single practice probably would not meet the definition of a health care system.
The definition provided within the RFA specifies that the participating systems should be large-scale health care delivery organizations that have electronic health records. A freestanding physical therapy network might not have access to all the necessary aspects of the electronic records.
Q: Health care systems are sometimes reluctant to obtain signatures from all institutional officials on detailed budgets for all years of a study prior to engaging with us during the planning year. Is it acceptable to submit a proposed detailed budget that has been discussed with each health care system and obtain signatures from all institutional officials as part of the just-in-time documents instead of at the time of application?
A: NIH does ask for letters of support from the health care systems in your application. And we do ask for a detailed budget with your application, although this may need to be modified slightly before the start of the UH3 phase. This information cannot wait until the just-in-time stage. Subcontracts need to be signed off and submitted with the application.
Questions specific to a particular IC will be answered in direct responses to the individuals who submitted them.
Ms. Carow: Most questions that arise prior to the submission of an application should be directed to a program official rather than a grants management officer.
Dr. Schmidt: Applicants should make sure to follow the directions in the FOA and to address the specific issues that the FOA asks for in the application. This makes it easier for reviewers to assess your application.
Dr. Meyers: There’s tremendous experience and enthusiasm at NIH for moving this program forward, as is evident from the number of participating ICs. Leveraging the Collaboratory will help make this program a success. The Collaboratory is very familiar with the life cycle of pragmatic trials and has developed much experience and expertise in this area. Applicants should take advantage of the Collaboratory’s knowledge.
Dr. Weber: Applicants who are not sure which initiative is the best fit for their research interest should reach out to program staff. There are many current initiatives. We can help you identify the most appropriate funding opportunity. One specific funding opportunity that may be of interest to today’s audience involves pragmatic trials for acupuncture for low-back pain in older adults, to be conducted within health care systems. A technical assistance webinar for that FOA will take place on February 7. The acupuncture FOA is designed to fill a specific gap in the literature; NIH is partnering with the Centers for Medicare and Medicaid Services on that initiative.