Key Dates

None

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

The National Institutes of Health (NIH) HEAL (Helping to End Addiction Long-term^SM) Initiative intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) soliciting applications for UG3/UH3 phased cooperative research to accelerate implementation of effective, non-opioid interventions for chronic pain management in rural and remote populations. Interventions addressing acute pain in rural and remote populations are also responsive if the acute pain requires the intervention of a health care provider for management, such as acute dental pain or acute low back pain and are likely to recur, become chronic, or escalate to a more serious complication if not managed appropriately. Projects include pragmatic, implementation or hybrid effectiveness-implementation trials to improve pain management and reduce the unnecessary use of opioid medications. Awards made under this FOA will initially support a milestone-driven, planning phase (UG3) of 1 to 2 years, with possible transition to a study conduct phase (UH3) of up to 3-4 years duration (5 years total for the two phases). Only UG3 projects with a planned pilot may request 2 years for the planning phase with up to 3 years for the UH3 implementation phase.in the community. All other projects may request 1 year for the UG3 phase with up to 4 years for the UH3 phase. UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase.

The purpose of this Notice is to allow potential applicants sufficient time to develop meaningful collaborations among investigators with expertise in rural health care delivery, health disparities, chronic pain management, pragmatic clinical trials, implementation trials, and/or methods to improve adherence to evidence-based guidelines. It will also allow potential applicants sufficient time to develop partnerships with health care systems or organizations and to develop responsive projects.

The FOA is expected to be published in Fall 2022, with an expected application due date in Winter 2022.

The overall goal of this initiative is to support the implementation of effective clinical practices and procedures that may lead to prevention or improved management of chronic pain in rural and/or remote populations, along with a reduction in unnecessary opioid prescribing and/or use. Results from the trials supported by this initiative should inform policy makers, payers, community stakeholders, health care providers and patients in the primary care, emergency department, hospital, home health, or dental setting. This initiative requires that the patients receiving services must reside in rural and/or remote areas and the intervention under study be integrated into a health care delivery system.

The initiative will require that the investigators partner with one or more rural healthcare system(s) or organization(s) to plan and implement the intervention. In addition, in the planning phase, investigators must develop one or more community-based partnership(s). Studies may propose to integrate multi-component or multiple interventions that have demonstrated efficacy. Trials will become part of and work with the HEAL Pragmatic and Implementation Studies to Improve the Management of Pain and Reduce Opioid Prescribing (PRISM) Program, which has leveraged the infrastructure of the NIH Pragmatic Trials Collaboratory (previously known as the NIH Health Care Systems (HCS) Research Collaboratory. (See https://rethinkingclinicaltrials.org/). The PRISM Program has established a Coordinating Center (CC) that is providing national leadership and technical expertise in all aspects of research conducted within the Health Care Systems (HCS). Awarded applicants will work with the CC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) to facilitate further planning and refinement of the proposed study in partnership with health care delivery systems.

For this initiative, patients receiving services must reside in rural and/or remote areas. Rural is defined according to Health Resources & Services Administration (HRSA) definition: All non-metro counties, all metro census tracts with Rural-Urban Commuting Area (RUCA) codes 4-10, and Large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with RUCA codes 2-3, outlying metro counties without an Urbanized Area (UA). For more detail on the addition of outlying metro counties, read the Federal Register Notice, Revised Geographic Eligibility for Federal Office of Rural Health Policy Grants. The HRSA Rural Health Grants Eligibility Analyzer can be used to determine rurality. Remote areas, defined by USDA Frontier and Remote (FAR) Area Code 4, are considered rural, therefore the definition of rural above will be used for eligibility. Rural and remote areas may include American Indian/Alaska Native (AI/AN) populations.

Investigators should consider subpopulation analysis to determine which interventions work best for specific population and cultural groups (e.g. American Indians/Alaska Natives, Hispanics or Latinos, Pacific Islanders, Veterans, occupations such as mining, agriculture, forestry, etc.) including medically underserved, un- and under-insured, Medicare or Medicaid eligible populations, and under-represented groups, with the intent to focus on reduction of health disparities.

Details of the planned FOA are provided below.

This effort is part of the NIH HEAL (Helping to End Addiction Long-term^SM) Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative^SM will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. More information and periodic updates about the Initiative are available at: https://heal.nih.gov/

Rural communities have been particularly hard hit by the opioid epidemic and are disproportionately impacted by prescription opioid-related overdose. However, patients with chronic pain are present across all geographic areas, and recent evidence indicates that the percentage of adults with chronic pain increases as the place of residence became more rural. Furthermore, many patients with chronic pain have comorbidities, including mental health conditions and opioid and/or alcohol use that complicate appropriate pain management. There are known disparities in management of pain in rural areas, with rural residents having a greater likelihood of being prescribed opioid analgesics than those in non-rural areas. Despite evidence for effective non-opioid interventions, these are not optimally implemented in rural areas. For example, rural residents are less likely to use self-management interventions for pain than those in non-rural areas.

Pain is shaped by biological, psychological, and social determinants of health. To fully address the factors affecting quality pain management, the interrelationships between health policy, healthcare services, biology and genetics, individual behaviors and social factors must be examined. Development and implementation of sustainable, effective non-opioid chronic pain management in rural and remote areas requires attention to the social determinants of health that affect overall health.

In rural settings, primary care practitioners, including physicians, nurse practitioners and physician assistants are responsible for addressing patients needs for pain management while reducing opioid use. Limited community resources and/or long distances to reach specialists such as behavioral health, pain specialists, and physical therapists, increase the challenges of chronic pain management in rural communities. While there have been some promising studies integrating effective, evidence-based pain management in rural settings, there is still a need for a coordinated approach to identify and reduce barriers and accelerate the implementation of high-quality chronic pain care to optimize health, address disparities, and advance health equity.

This initiative will support trials testing methods for management of chronic pain and acute pain, if the acute pain requires the intervention of a health care provider for management, such as acute dental pain or acute low back pain and are likely to recur, become chronic, or escalate to a more serious complication if not managed appropriately.

Pragmatic, implementation, and hybrid effectiveness-implementation trials are needed because policies, clinical practice guidelines, and tools and interventions have not been readily adopted or adapted and implemented in rural and remote settings. Research is needed to study strategies to equitably and efficiently implement effective interventions and evidence-based pain management guidelines in these settings.

For the purpose of this initiative, we define "embedded pragmatic clinical trials" and "implementation research", as follows:

Embedded pragmatic clinical trials are conducted within a health care delivery system that will oversee delivery of care (which may be provided in traditional or non-traditional health care settings including, but not limited to clinics, hospitals, mobile care units, community centers, etc.), and are primarily designed to determine the effects of an intervention under the usual conditions in which it will be applied . This is in contrast to explanatory trials that are primarily designed to determine the effects of an intervention under ideal circumstances . "There are three key attributes of pragmatic clinical trials (PCTs): (1) an intent to inform decision-makers (patients, clinicians, administrators, and policy-makers), as opposed to elucidating a biological or social mechanism; (2) an intent to enroll a population relevant to the decision in practice and representative of the patients or populations and clinical settings for whom the decision is relevant; and (3) either an intent to (a) streamline procedures and data collection so that the trial can focus on adequate power for informing the clinical and policy decisions targeted by the trial or (b) measure a broad range of outcomes (http://rethinkingclinicaltrials.org/chapters/pragmatic-clinical-trial/what-is-a-pragmatic-clinical-trial-2/)."

Implementation research seeks to understand the behavior of practitioners and support staff, organizations, community and family members, and policymakers in context as key influences on the adoption, implementation and sustainability of evidence-based health interventions and guidelines (e.g., Community Guide to Preventive Services, U.S. Preventive Services Task Force, and clinical and professional societies' recommendations and guidelines). Implementation research studies should not assume that effective interventions can be integrated into any service setting and for consumer groups and populations without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change.

The awards supported by this initiative will utilize the existing coordinating center of the PRISM Program, which leverages the infrastructure of the NIH Health Care Systems (HCS) Research Collaboratory, now known as the Pragmatic Trials Collaboratory. The overall goal of the Collaboratory program is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care providers and delivery organizations and patients as research partners. The NIH HCS Research Collaboratory Program established a Coordinating Center (CC) led by Duke University in 2012 (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) that is providing national leadership and technical expertise. In 2019, the HEAL Initiative supported the PRISM Program, which expands the activities of the CC to support the PRISM awards. Awardees from this planned FOA will work with the NIH and CC for both the planning and implementation of their pragmatic clinical trial or implementation study.

Applications must specify one or more health care system or organizational partner(s) that will oversee delivery of care. The design of the proposed project should maximize external validity of the study, by testing generalizability, feasibility and sustainability of findings across rural and/or remote health care settings, and diverse staff and patient populations. Applications proposing effectiveness outcome should include a sufficient number of participating HCS or sites to allow for enrollment of participants for a fully powered assessment of effectiveness. Special research designs and methods of analysis are needed when participants are assigned to study arms in groups or clusters and when individuals are assigned to interventions which are delivered in a group format or via a shared health facilitator or provider https://researchmethodsresources.nih.gov/). Letters of support will be expected from each of the HCS and/or organizational partners named in the application, that relates their commitment to the proposed research and outlines how the project fits with organizational priorities, and the commitment of their staff to the project. The letter must provide a description of how the project would directly impact the quality of care within their organization and indicate level of intention to sustain the intervention(s) after the study period, based upon results.

These projects will be funded as phased awards with a one- or two-year planning phase (UG3) and a two-to-four-year implementation phase (UH3) (no more than 5 years total). Activities in both phases will depend on the specific study (e.g., disease domains, type of interventions, experimental design, randomization strategy and proposed outcome measures).

In the UG3 planning phase, one or more additional community-based partners must be identified. The second partner might be a primary health care provider (including physician, doctor of osteopathy, nurse practitioner, physicians assistant, nurse-midwife, nurse anesthetist, clinical nurse specialist, emergency medical service providers, etc.), community organization, faith-based organization, community health worker, library, school, etc. In the UG3 phase, barriers to implementation and patient/provider/community preferences for implementation must be identified and detailed plans to address these barriers and preferences developed with participation of the community partner(s).

TBD

Applications are not being solicited at this time.

Please direct all inquiries to:

Karen A. Kehl, PhD, RN
National Institute for Nursing Research (NINR)
Phone: 301-594-8010
karen.kehl@nih.gov

Beda Jean-Francois, PhD
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: beda.jean-francois@nih.gov

Alexis Bakos, PhD, MPH, RN
National Cancer Institute (NCI)
Phone: 301-921-5970
Email: alexis.bakos@nih.gov

Susan Shero, RN, BSN, MS
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-496-1051
Email: sheros@nih.gov

Basil Eldadah, MD, Ph.D.
National Institute on Aging (NIA)
Phone: 301-496-6761
Email: eldadahb@nia.nih.gov

Shelley Su
National Institute on Drug Abuse (NIDA)
Phone: 301-402-3869
Email: shelley.su@nih.gov

Dena Fischer, DDS, MSD, MS
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-4876
Email: dena.fischer@nih.gov

Priscah Mujuru, DrPH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-9765
Email: mujurup@mail.nih.gov

Cheryse A. Sankar, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-318-2889
Email: cheryse.sankar@nih.gov