Pilot/Experimental Studies Core (PESC)

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Project Summary The program project grant’s (PPG’s) broad focus is to examine how healthcare policies impact the care of people with Alzheimer’s disease and related dementias (ADRD). Interventions to help providers deliver high-quality ADRD care in response to these emerging policies are critically needed. Pragmatic cluster randomized, controlled trials (RCTs), where the unit of randomization is the system or facility, are ideally suited to rigorously evaluate such interventions in the real-world conditions in which they are routinely implemented. Over the past five years, our group acquired expertise conducting cluster RCTs in a variety of healthcare settings that serve older adults. These trials are facilitated by the unique infrastructure of administrative and national databases that are the cornerstone of this PPG (e.g., linked mandatory clinical assessments and Medicare claims). Leveraging this foundation, the over-riding objective of the Pilot/Experimental Studies Core (PESC) is to provide catalytic support for innovative pilot research projects that will generate the feasibility data needed to conduct cluster RCTs of interventions aimed at improving care for people with ADRD and their families. The Aims are to: Aim 1: Solicit, select, and fund the preliminary work needed to support the future funding and conduct of cluster RCTs that evaluate interventions to improve care of ADRD patients. Aim 2: Integrate the PESC studies and investigators into the PPG infrastructure of data, research networks, and researchers. Aim 3: Provide the monitoring, mentorship, and resources to transform PESC-funded studies into successful, independently-funded cluster RCTs. The PESC will be co-directed by Susan Mitchell, MD, MPH (Principal Investigator) and Rosa Baier, MPH. Dr. Mitchell has a strong track record of mentoring, independent funding, and conducting cluster RCTs with people with ADRD. Ms. Baier leads a broader initiative at Brown conducting pragmatic research in older adults. Two new pilot studies will be funded in each of years 1-4 of the PPG. Applications will be solicited from the PGG’s senior investigators’ academic institutions. Rigorous procedures will be followed for PES selection, monitoring, and development into independently-funded research awards. For the first year of the PPG, we received four applications and, after formal review, selected two for inclusion in this application. Dr. Kira Ryskina (University of Pennsylvania) will develop and pilot test a social comparison feedback intervention to reduce physician prescribing of potentially-harmful medications among hospitalized ADRD patients. Dr. Sarah Berry (Harvard Medical School) will conduct a pilot project to assess the feasibility of an intervention to optimize medication prescription to reduce injurious falls in nursing home residents with ADRD. IMPACT: The research and intellectual resources within this PPG are uniquely suited as a platform to support pilot work to enable future pragmatic RCTs among people with ADRD. In this way, this proposed PESC has the potential to improve the quality of care provided to this rapidly growing and vulnerable population.