Notice Number: NOT-AT-19-005
Key Dates
Release Date:November 02, 2018Estimated Publication Date of Funding Opportunity Announcement: December 08, 2018
First Estimated Application Due Date: February 15, 2019
Earliest Estimated Award Date: September 01, 2019
Earliest Estimated Start Date: September 20, 2019
Related Announcements
NOT-AT-19-004
Issued by
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Aging (NIA)
Purpose
The National Center for Complementary and Integrative Health (NCCIH), along with partnering Institutes/Centers/Offices, intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on an efficient, large-scale pragmatic trial to evaluate the impact of, and strategies to best implement acupuncture treatment of older adults (65 years and older) with chronic low back pain.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This Notice encourages investigators with expertise and insights into this area of evidence-based pain management to begin to consider applying for this new FOA. In addition, collaborative investigations combining expertise in acupuncture, pain management, and pragmatic clinical trials will be encouraged, and these investigators should also begin considering applying for this application.
The FOA is expected to be published in the Fall of Fiscal Year (FY) 2019 with an expected application due date in the Winter of FY 2019.
This FOA will utilize the UG3/UH3 activity code. Details of the planned FOA are provided below.
This study is part of the of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
Research Initiative Details
This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct an efficient, large-scale pragmatic trial to evaluate the impact of, and strategies to best implement, acupuncture treatment of older adults (65 years and older) with chronic low back pain (CLBP). This FOA requires that the intervention under study be embedded into health care delivery system, real world settings. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3) of up to three years. UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. Trials must be conducted across two or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory).
Background
Low back pain is an important US public health concern. It is associated with high levels of disability and is a common reason for primary care visits. The prognosis for acute back pain is generally favorable, with many patients improving after one to three months. The predominant population effected by low back pain is the group with CLBP and have pain that lasts 3 months or longer. As the prevalence of chronic conditions increases with age, older adults 65 years and older (65=/+) with CLBP will likely have comorbid conditions and require more healthcare services, adverse drug reactions, declining functional status and mortality.
In response to the U.S. opioid crisis, HHS is focused on preventing opioid addiction and providing more nonpharmacologic treatment options for chronic pain. AHRQ, CMS and NIH are collaborating in this effort. The Agency for Healthcare Research and Quality published a systematic review of noninvasive, nonpharmacological treatment for chronic pain in June 2018. https://effectivehealthcare.ahrq.gov/sites/default/files/cer-209-evidence-summary-non-pharma-chronic-pain.pdf This review noted that acupuncture improved function and/or pain for at least one month after treatment ended for chronic low back pain. Acupuncture efficacy trials data included in the review reported durable slight to moderate improvements in function and pain for CLBP patients that were <60 years of age. However, similar compelling data on the improvements in meaningful health outcomes of acupuncture for CLBP in older adults (65 or more years) are currently lacking. Such studies are critically important for expanding non-opioid pain management options for older adults. For health care policy makers or payers, such as the Center for Medicare & Medicaid Services (CMS), this evidence gap must be addressed to inform coverage determinations for acupuncture in older adults with CLBP. CMS is interested in generating evidence on promising items and services for Medicare patients and has several mechanisms to cover and pay for items and services in the context of a clinical study, including coverage with evidence development (CED) through a national coverage determination (NCD). CMS has published a guidance document for the Public, Industry and CMS staff, to help understand CMS implementation of CED through the NCD process (https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27 ). Section VI of this guidance document, entitled Requirements for CED under Section 1862(a)(1)(e), provides a list of general requirements for clinical studies that must be included (with occasional minor modifications) in the coverage determination. The guidance document relates that CMS would not anticipate approving a study that does not meet the listed requirements.
By addressing gaps in the literature on the benefits and harms of acupuncture in individuals 65=/+, it is anticipated that evidence on improvements in health outcomes derived from this initiative would assist CMS in determining Medicare coverage for acupuncture in CLBP. To this end, applicants may wish to consider how their model would translate into the Medicare Fee for Service model of coverage and payment (e.g., sites where acupuncture is furnished, types of practitioners that can bill Medicare).
Research Goals
This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct an efficient, large-scale pragmatic trial or implementation science study to evaluate the impact of acupuncture treatment in people 65+/+ with CLBP in a way that is integrated into health care delivery.
For the purpose of this FOA, embedded pragmatic clinical trials are studies that are conducted within the health care delivery setting and are primarily designed to determine the effects of an intervention under the usual conditions in which it will be applied , which is in contrast with explanatory trials that are primarily designed to determine the effects of an intervention under ideal circumstances http://www.bmj.com/content/350/bmj.h2147).
This UG3/UH3 will fund a one-year, milestone driven, start-up phase in preparation for a three-year randomized pragmatic clinical trial embedded delivery in two or more health care systems to assess the effectiveness of a minimum of 12 weeks of acupuncture treatment for addressing clinical significant changes in pain intensity, pain interference and/ or function in older Americans 65=/+ with CLBP. Subject selection must be based on definition of chronic low back pain that will be consistent with definitions in guidelines and be sufficient to be amenable to improvement with an effective intervention. Acupuncture treatment should be compared to usual care or another known effective intervention for treatment of CLBP.
The proposed projects must address the following criteria:
Research studies must include the following:
(1) Must be done in a CLBP population that is 65=/+ who meet guideline definition of CLBP. The project must enroll patients based on broad eligibility criteria to maximize diversity, and minimize intentional or unintentional exclusions based on risk, multi-morbidity, age, health literacy, demographics, or expected adherence.
(2) Must provide a minimum 12-week acupuncture intervention versus usual care or other intervention for chronic low back pain.
(3) Primary endpoint must be measured at 12 weeks, 6 months, and 12 months after randomization to treatment. The study must be powered for primary endpoint assessment at 6 months. Important health outcomes to CLBP patients include improvements in pain and function, as noted in the systematic review.
(4) The project must leverage opportunities made available through integrated health care systems and use of outcomes that can be captured by passive follow-up by electronic health records, and with minimal need for adjudication. Augmentation of the electronic health record is allowable for patient reported data and outcomes, although this should be streamlined and collected only at necessary time points.
(5) Proposed analytic plans for projects that propose cluster-randomized trials must address adequacy of sample size and study power and employ analytic strategies relevant for such pragmatic trial designs.
(6) The project design must incorporate rigorous controls, prospectively identified, preferably by randomization.
(7) Project must be done within at least two health care systems.
Research studies may include but are not limited to the following:
(1) Randomizing participants in the acupuncture arm to a maintenance phase for acupuncture versus no maintenance phase between 12 weeks and 24 weeks.
(2) Randomizing participants in the comparator arm to a maintenance phase or no maintenance.
(3) Collecting information from subjects on preference of interventions prior to, during and at end of study.
(4) Implementing cost-effective delivery methods for acupuncture such as group interventions with single provider versus other strategies.
(6) Including a cost-effectiveness evaluation.
(7) Evaluating different methods of implementing acupuncture into health care delivery to identify which is most efficient, cost-effective, and minimizes barriers.
During the UG3 or planning phase activities will generally include, but are not limited to:
- Assess adequacy and finalize clinically relevant outcome measures with other Collaboratory investigators. It is anticipated that successful applicants will work with other Collaboratory investigators and NIH to identify and harmonize common outcome measures (pain severity, pain interference, and pain functioning, as well as others).
- Refine estimates of requirements with guidance from NIH and the CCC, for sample size, numbers of sites, site to site heterogeneity, and implementation timetable.
- All studies must use at least two HCS for implementation.
- Develop detailed plans for site implementation, including site staff, method of identification, randomization (as applicable) and participant recruitment and acquisition and administration/implementation of the intervention if applicable.
- Finalize detailed plans for data coordination and quality control for the UH3 phase. It is not anticipated that the CCC will provide these functions for the acupuncture study. Data coordinating activities for individual Projects must be separately budgeted as part of the UH3 budget.
Project Implementation Phase (UH3): The objective of the up to three-year UH3 implementation phase is to conduct the Project in accordance with activities planned in the UG3 phase. The project is expected to implement all aspects of the proposed pragmatic trial.
Utilization of milestones is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Projects should include well-defined milestones for the planning phase (UG3) and annual milestones for the implementation phase (UH3).
Clinical Trials Not Supported by this FOA
The following types of clinical trials are not intended to be supported by this FOA and applications proposing such activities will be deemed non-responsive and returned without review:
- Phase I (first-in-human) trials
- Single site trials
- Studies to understand the mechanism of the intervention
- Studies to assess initial feasibility of an intervention
- Drug or device safety trials
- Studies that propose to conduct studies in animals or in vitro studies
- Studies that do not propose a trial of acupuncture in humans
- Studies that proposes a sham or time and attention control
Funding Information
Estimated Total Funding $1,250,000 in FY2019
Expected Number of Awards 2
Estimated Award Ceiling $750,000 in direct costs
Primary CFDA Numbers 93.213, 93.866
Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
NCCIH HEAL Initiatives
National Center for Complementary and Integrative Health (NCCIH)
Email: [email protected]
and Human Services (HHS)
