Pilot Studies Core

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PROJECT SUMMARY The lack of research testing interventions targeting patients with dementia (PWD) and their caregivers in real- world settings hinders the ability of health care systems (HCS) to adequately care for this rapidly expanding and highly vulnerable population. Pragmatic clinical trials that are embedded in HCS (ePCTs) can address this shortcoming. However, ePCTs are complex, require specific methodologies, skilled investigators, close partnerships with HCS, robust data infrastructures, and special regulatory and ethical considerations. Over the past several years, individual teams of investigators have begun to acquire experience conducting ePCTs among PWD and their caregivers. Their experience has reinforced how indispensable a pilot phase is to inform the successful conduct of the full ePCT. The Pilot Core of the National Institute on Aging (NIA) AD/ADRD HCS Research Collaboratory will therefore solicit, and fund over 30 pilot ePCTs and then guide all aspects of these studies throughout their lifecycles. The Core will 1) create a robust and transparent review process, 2) provide active technical assistance to increase the success of funded pilots, 3) promote the development of investigator expertise and leverage experiences across projects through structured trainings, and 4) facilitate the adaptation of pilot tested interventions into well-designed ePCTs. Ultimately, this will lead to full-scale ePCTs, and simultaneously build investigator capacity to conduct ePCTs. The Pilot Core will be led by Dr. Abraham Brody, PhD, RN, FAAN, Associate Professor of Nursing and Medicine at New York University, a nurse researcher with significant experience in dementia and ePCTs, who will work with a highly skilled, interdisciplinary, Executive Committee. The Pilot Core will leverage the overall infrastructure of the NIA AD/ADRD HCS Collaboratory to achieve: Aim 1: Solicit, rigorously review, select, and fund projects that will lead to future full-scale ePCTs focused on PWD and their caregivers; Aim 2: Provide the monitoring, mentorship, and resources to ensure rigorous, timely completion of pilot milestones, and effective sharing of pilot data and results; Aim 3: Promote the expertise of pilot project investigators in conducting ePCTs with PWD and their caregivers by: 1. Integrating them into the activities of the AD/ADRD Collaboratory and Working Group Cores, 2. Providing access to structured training opportunities led by the Training Core, and 3. Holding an annual Scientific Conference in Years 3-5 to present and share research and experiences; Aim 4: Assist pilot projects to transform completed pilot projects into successfully funded full-scale ePCTs in PWD and/or their caregivers. IMPACT: The NIA AD/ADRD Collaboratory Pilot Core will assist researchers to investigate practical interventions that can be implemented in HCS that serve over 5 million PWD and their caregivers. These pilots will seed multiple full-scale ePCTs aimed at improving the quality of life and health outcomes of this vulnerable population. It will also foster the expertise and career growth of pilot project leaders, enhancing the nation’s capacity to conduct ePCTs among PWD with HCS well into the future.