The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications to conduct multisite embedded pragmatic or implementation trials to inform the uptake of pharmacologic, nonpharmacologic, and/or multicomponent approaches for acute and/or chronic sickle cell disease (SCD) pain management in health care systems that serve the SCD population. Trials may include or allow continuation of opioid medication as needed; however opioid medication use alone should not be the only intervention studied. Trials supported under this initiative could also address social and structural barriers such as stigma and racial bias to SCD pain management care.
The overall goal of this initiative is to support the “real world” assessment of pain management interventions and/or health care strategies to enhance adherence to pain management guidelines in health care systems that may lead to improved SCD pain management, allowing access to opioid pain management when needed. This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings, and it is expected that most data will be obtained through the electronic records of the health care system. Trials should be conducted across three or more health care systems (HCS) that provide care to SCD patient populations. Clinical trials will be conducted within the infrastructure of the HEAL Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Program Coordinating Center, which has dedicated pain, implementation science, and pragmatic clinical trial design. Awarded applicants will work with the Health Care Systems Research Collaboratory Coordinating Center (HCS CCC) (https://rethinkingclinicaltrials.org/) to facilitate further planning and refinement of the proposed study in partnerships with health care delivery systems.
Awards made under this FOA will support a milestone-driven planning phase (UG3) for 1 year, with possible transition to a clinical trial implementation phase (UH3) of up to an additional four years. Only UG3 projects that meet the scientific milestones and feasibility requirements will transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.
This study is part 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 bolsters 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://heal.nih.gov/.
Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, affecting up to 100,000 Americans, predominantly individuals of African descent and those who self-identify as Black (i.e., 1 in 365 African American children born with SCD) and individuals of Hispanic ethnicity (1 in 16,300). The most common complication of SCD is pain, including severe acute pain episodes primarily from vaso-occlusive crises and chronic persistent pain, including nociceptive and neuropathic. SCD pain symptoms span from childhood through adulthood and contribute to high rates of hospitalizations, emergency room visits, poor functional and psychosocial outcomes, and an increased rate of mortality. Management of acute and chronic pain among individuals with SCD is complex and often includes treatment such as opioid-based therapies which do not always address other co-occurring symptoms that may exacerbate pain, such as sleep disturbances, stress, anxiety, and depression. Even after curative SCD therapy, severe chronic pain continues for a significant proportion of individuals.
Further, the SCD population primarily comprises racial and ethnic minorities who experience disparities in receiving quality comprehensive care for SCD, including pain management. These disparities have been linked to the stigma associated with this disease as well as social factors such as racism and socioeconomic status. In turn this stigma associated with SCD impacts health outcomes, health seeking behavior, and patient-provider interactions. Indeed, recent reports from the National Academy of Sciences (https://www.nationalacademies.org/our-work/addressing-sickle-cell-disease-a-strategic-plan-and-blueprint-for-action#sectionPublications) and the Pain Management Best Practices Inter-Agency Task Force (https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html) highlight the need for a paradigm shift to provide comprehensive care delivery models for managing pain and improving the overall well-being and quality of life of individuals with SCD associated pain. To address these combined challenges, a biopsychosocial approach to pain management that includes a multidisciplinary approach that addresses biological, psychological, and social influences on pain provides an opportunity to treat the whole person, improve overall health status, and possibly mitigate some of the factors leading to the stigma associated with SCD.
While opioid therapy remains vital for the current management of acute SCD pain, non-opioid pharmacologic and nonpharmacologic approaches for pain management have been deemed feasible and of interest to individuals with SCD. Research is needed to enhance the evidence base regarding the real-world effectiveness of multicomponent non-opioid pharmacologic and nonpharmacologic approaches for acute and chronic SCD pain management approaches to reduce different SCD pain types, improve related psychological and functional outcomes, and reduce reliance solely on opioid-based treatments. Trials are needed to build an evidence base for how to implement effective pain management approaches into health care delivery for patients with SCD (https://www.nationalacademies.org/our-work/addressing-sickle-cell-disease-a-strategic-plan-and-blueprint-for-action#sectionPublications), as well as how to implement and increase adherence to pain management guidelines for patients with SCD (https://ashpublications.org/bloodadvances/article/4/12/2656/460974/American-Society-of-Hematology-2020-guidelines-for). To design and deliver effective approaches aimed at reducing stigma, reducing pain, and improving health outcomes, additional research is needed to determine effective implementation strategies to reduce stigma and address pain management health inequities for patients with sickle cell disease.
In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH’s Interest in Diversity (NOT-OD-20-031) for more details.
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