Summary of Q&A from the Technical Assistance Videocast "HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)”
Participating Federal Government Staff:
- Dr. Wendy Weber, Branch Chief, Clinical Research Branch, National Center for Complementary and Integrative Health (NCCIH)
- Dr. Robin Boineau, Medical Officer, Office of Clinical and Regulatory Affairs, NCCIH
- JoAnna Baldwin, Senior Technical Advisor, Coverage and Analysis Group, Centers for Medicare & Medicaid Services (CMS)
- Dr. Martina Schmidt, Chief, Office of Scientific Review, NCCIH
- Dr. Basil Eldadah, Branch Chief, Geriatrics Branch, Division of Geriatrics and Clinical Gerontology, National Institute on Aging (NIA)
Q: Does the principal investigator (PI) of an application have to be from an academic institution?
A: No, the PI does not need to be from an academic institution. As long as the PI meets the eligibility criteria listed in the Request For Applications (RFA), they are welcome to apply.
Q: What are the expectations for collaboration with the Health Care Systems Research Collaboratory program funded currently at Duke University?
The intention is to work with the Collaboratory program by participating in the working groups, providing your expertise, and gaining feedback on your planned study from other working group members. The Collaboratory provides help when you have questions and will provide advice as you move forward. The PIs, co-investigators, and biostaticians who serve on the working groups have a tremendous amount of experience doing pragmatic clinical trials. For example, as part of the biostatistics and study design group, you’ll have access to a whole team of biostatisticians who are all doing pragmatic trials. Or you might be guided to revise study plans if needed—changing a study design from cluster to noncluster or vice versa. As you review each of the different studies funded through the Health Care Systems Research Collaboratory, everyone gets feedback, all with the goal to improve the rigor and quality of the science.
The intention is not to have the Health Care Systems Collaboratory Coordinating Center serve as a data coordinating center for the trial. Each application should include its own biostatistician, data coordination, data quality, and data analysis.
Q: Are feasibility studies allowed to pilot the implementation methods during the UG3 phase?
A: Yes, feasibility studies are allowed, and we often encourage the team to pilot the different measures that you’re planning, identify any issues that will need to be worked out, or refine elements that haven’t been assessed before in the health care system.
Q: Is there a specific definition that should be used for chronic low-back pain?
A: We aren’t prespecifying which chronic low-back pain definition to use. You need to provide references and make justifications for the definition that you choose to use.
Q: How might Medicare’s decisions in October 2019 play into plans?
The timeline for Medicare to develop a national coverage determination (NCD) through its national coverage analysis process will occur after applications for this RFA are due. We recognize the difference in the timelines. The next time you will hear from CMS will be in July, when CMS posts its proposed NCD. A proposed decision is a complete policy, so come July (not October), you will see where Medicare intends to go for coverage of acupuncture for chronic low-back pain.
Based on the decision that Medicare makes (final decision in October 2019 and informed by the proposed NCD in July), the funded investigators will work with NIH during the planning phase to make necessary adjustments before moving into the implementation phase. We will work with whoever gets funded to adjust to the real-world changes that happen
Q: How should we budget for acupuncture service?
A: The RFA is for pragmatic research studies, meaning that the acupuncture service should be integrated into health care delivery and not set up as an independent set of research study visits to deliver the acupuncture. We also want the data to help inform us about the sustainability of the delivery of acupuncture within health care systems. In terms of the rules about what is allowed and not allowed in the budget and what the allowable costs are for research / patient care costs in an application, we refer you to your institution’s office of sponsored programs or grants to look at the NIH Grants Policy. This policy will be your guide for deciding what you budget for research costs as opposed to usual patient care costs in terms of what NIH does and does not cover. The answer to this question is intentionally vague so that you can follow the policy rules. If we need to make adaptations once awards are made, we will work with the funded investigators to do so.
Q: Should pragmatic clinical trials enroll patients at more than one institution or center?
A: The intention is to have an adequately powered study that can assess effectiveness. If you are conducting the research in one clinic or one region, the likelihood that the outcomes will be generalizable will be low. We encourage you to have multiple HCS partners with a study that is adequately powered at sites that are representative across the United States.
Q: Why is acupuncture not on the list of approved providers? What would be the process to change that?
A: Medicare is a statutory program. The skeleton of Medicare rules is within the Social Security Act. Modifications to most of the rules would require an Act of Congress to make changes to the Social Security Act. In other words, for many items, law is required to make such changes.
The list of whom Medicare can directly pay is not something that changes frequently; it’s a relatively static list. Paying acupuncturists directly is not something that CMS, as an agency, has direct control over or is able to change.
Medicare, however, recognizes that there are services that are reasonable and necessary to be furnished to patients but are not necessarily furnished directly by one of the listed practitioner types. For example, the NCD for supervised exercise therapy, which came out in 2017, shows how a setup could be structured in which a service is reasonable and necessary for an auxiliary person to furnish with direct supervision and billing by someone else. Should Medicare determine that coverage for acupuncture for low-back pain is reasonable and necessary for beneficiaries, Medicare will explain the details for this service.
Q: Is it necessary to include a study record for a clinical trial with an application?
A: Yes, a separate study record is necessary for the trial planned in the UH3 phase. If a pilot study in the UG3 phase qualifies as a clinical trial as defined by NIH, it also requires a separate study record.
Q: The RFA indicates that 12 weeks of acupuncture are required. Is it up to the PI to determine the frequency within that 12-week period? Are there any specifications for frequency during the 12 weeks?
A: We don’t have any specifications. We recommend that you rely on the scientific literature to justify how frequently the intervention is provided during the 12-week period. (The acupuncture intervention can be provided beyond 12 weeks, too.) We have also asked for a follow-up period with measures at 6 and 12 months. It is up to you whether you want to add acupuncture interventions to that period, and your design choice should be justified as well.
Q: Do different state licensing regulations have an impact when the intervention is being done across different states?
A: Whoever is providing care to patients needs to have the required state licensure to be doing so and must be practicing within their scope.
Q: Can a licensed acupuncturist be the one to provide care?
A: Yes. As long as the individual has a license in the state to provide the service, that would meet our requirements for who provides acupuncture in the study. Some supplemental insurance programs for individuals 65 years and older already provide acupuncture services in a variety of different ways. These programs could act as models in terms of licensing/credentialing and how they determine someone to be a qualified individual to provide the service.
Q: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is one of the cosponsors. What is the particular interest for NIAAA to sign onto this RFA?
A: NIAAA is interested in the common co-occurrence of alcohol use with chronic pain. NIAAA is likely to be particularly interested in studies that track that outcome and a secondary outcome. There is no requirement to include this as a secondary outcome at this time.
Q: What is the particular interest of the National Institute on Aging (NIA)?
A: NIA is interested in the special issues and challenges that older adults face. For instance, NIA is particularly interested in recruitment. There’s a tendency to recruit in ways that are feasible and easiest, and that tends to involve younger adults or older adults who are healthy or functionally intact. NIA is interested in seeing a broad range of ages among the older adults recruited in these trials and a broad range of health status—physical, cognitive, and functional.
NIA is also interested in looking at outcomes relevant to older adults—to the extent that it’s feasible within the setting of a pragmatic trial—such as functional outcomes, changes in medication, other issues related to polypharmacy, changes in comorbid conditions, indicators of the presence or status of severity of comorbid conditions, and patterns of health care utilization.
Q: The RFA asks for pragmatic trials—looking for broad generalizability, minimal patient contact, minimal research study visits, and recruitment through everyday clinical practice flow—but also for the rigor that’s expected of a potentially randomized controlled trial design. Do you have any suggestions on how to balance that?
A: We are looking for pragmatic trials that are introduced through the health care systems. We are not looking for a trial in which you are looking for very specific indications. People come into the clinic in a random way, and you’re searching for people. We are looking for the pragmatic approach: someone comes into the clinic, they have chronic low-back pain, there’s a method by which they’re brought through the system, and this is the intervention versus usual care or whatever the comparative arm is.
We often refer to the PRECIS tool, which is a way of evaluating where a study design element, such as recruitment, patient followup, or outcome collection, falls on the continuum from very pragmatic to very exploratory. We don’t expect you to be at the extreme of pragmatic for all of the elements. In your application, you’ll need to justify what makes the most sense for each spoke along the wheel of the trial that you’re designing. And you’ll need to make the case and convince reviewers in terms of where you are being more or less pragmatic, with the overall gestalt falling on the side of a pragmatic trial. One example to note: knowing that acupuncture service was actually delivered is probably something that we want you to confirm, as opposed to just indicating that an order was made for acupuncture services.
The rethinkingclinicaltrials.org website (http://www.rethinkingclinicaltrials.org/) has a useful source called The Living Textbook. It defines pragmatic trials and pragmatic research, includes other definitions, shows how the PRECIS tool works, and includes a set of chapters on the design of pragmatic trials within health care systems.
Q: Medicare also covers some populations under the age of 65. Is it expected to include such people as eligible participants? Or are older adults the sole interest?
A: We are specifically interested in older adults. There have been a number of large acupuncture studies on chronic low-back pain, but for the most part those studies have excluded individuals over the age of 65.
Q: Are all applications assigned to NCCIH or do they get assigned to other institutes or centers (ICs)?
A: Because NCCIH is conducting the review for these applications, all applications will initially be assigned to NCCIH. This will be indicated by the “AT” application number, which stands for NCCIH. However, having said that, there are multiple ICs participating in this funding opportunity announcement (FOA). So it is a good idea to point out in your cover letter whether you are interested in other ICs. After review, for those applications that are under funding consideration, we will then send the application to the IC that is interested in potentially funding it.
Q: What personnel should and should not be listed in the application?
A: In general, all personnel who are involved in a significant manner in the design and execution of the project should be listed. From the review perspective, we prefer that the application not list people who are on advisory committees. If you list them, then they are in conflict and can no longer review. You can list the type of expertise that is on your advisory committee but not exactly who will be sitting on it.
Q: One of the webinar slides mentions barriers to research. Does this also mean that sites need to identify barriers to care access (as this may vary depending on state) and how the trial design might address those barriers to access acupuncture care?
A: In your application and in your planning phase, you might want to include information about what barriers you anticipate and how you intend to overcome them. If the barriers will be different by location, which they are often are, it’s beneficial to have a variety of different strategies to overcome those barriers. As part of implementing the actual trial and overcoming challenges, some pragmatic trials incorporate implementation science methodology to track and identify challenges coming up within the health care system.
It’s important to be thoughtful in identifying obvious barriers. You need to propose something that can be tested and will have an answer. It isn’t going to be valuable to identify the barrier of not having enough acupuncturists and then test that. It’s important to select health care systems and regions where there are people with the skillset to deliver acupuncture. And the more you can think through what will be the limitations and how you plan to handle them, the stronger the application will be.
Q: Is there any limitation on what settings the patients are recruited from, such as emergency room, inpatient, outpatient?
A: We don’t have a prespecified setting in which patients need to be located.
Additional detailed questions will be answered in direct responses to the individuals who submitted them.
Dr. Weber: If you have additional questions, you can email us, and we will respond to you. There are many other HEAL Initiative FOAs. You can find those by using any search engine and doing a search for “NIH HEAL Initiative.” You’ll find a list of FOAs through a link on that website. Many of the individual ICs, including NCCIH, have pages on their own websites about their roles in the HEAL Initiative, and we encourage you to look at those.
Dr. Boineau: If you have any questions, please don’t hesitate to send us an email so that we can clarify any areas of concern.
Ms. Baldwin: Having CMS at the table can be helpful in many respects but also can cause some confusion at times. But as we move forward through our process with this NCD, we’ll have a lot more information, and we’ll be able to provide more clarifying information. If you’re able to visit the tracking sheet (the link on one of the slides), you’ll find some additional information and a way to contact CMS with specific questions about the national coverage analysis.
Dr. Schmidt: We are looking forward to receiving complete, compliant, and responsive applications. If you have any review-related questions, please feel free to reach out to us.
Dr. Eldadah: We are very happy to be involved in this initiative. It’s an important question for older adults. We’re looking forward to seeing the studies come in and fill a really important and unmet evidence need.
Scientitic Contact: Dr. Robin Boineau
RFA-AT-19-005: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)