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 may propose methods to implement, improve adherence, or evaluate the effectiveness of guidelines for pain management in patients with SCD in various health care settings. 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 expertise in pain, implementation science, and pragmatic clinical trial design. Awarded applicants will work with the PRISM/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 or 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to an additional four years. Total duration of the award will be a maximum of 5 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.

Compantion FOA:   Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network (SCD-ERN, RFA-AT-23-002 )

Deadlines:

• Letter of Intent Due Date(s): Oct. 21, 2022

• Application Due Date: Nov. 15, 2022

RFA-AT-23-001 Expiration Date November 22, 2022