HEAL Initiative: Pragmatic and Implementation Studies for the Management of Sickle Cell Disease Pain (UG3/UH3, Clinical Trials Optional)

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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.

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