PREVENTABLE Clinical Sites Core

NIH RePORTER · NIH · U19 · $10,980,790 · view on reporter.nih.gov ↗

Abstract

The clinical sites core is a partnership between the National Patient-Centered Research Network (PCORnet) and the VA network (MAVERIC) combining approximately 35 health care systems and 60 VA hospitals with an eligible participant base of over 1.5 million older adults without dementia (including Alzheimer’s disease) or CVD. The clinical sites will randomize 20,000 diverse older US participants to determine the role of a moderate-intensity statin in preventing dementia, including Alzheimer’s disease, and prolonging disability-free survival in patients 75 years and older without clinically evident coronary heart disease, including those with frailty, impaired physical function, mild cognitive impairment, polypharmacy, and multi-morbidity. Sites will have a richly diverse US demographic including rural and urban areas (including Puerto Rico), some with over 50% minority participants. Start-up will be rapid, requiring engagement before randomization. Therefore, the pre-existing partnership and extant infrastructure between will position us well. The PCORnet and VA network/MAVERIC have a common data model against which electronic health record (EHR) data have been standardized, and have already provide data on eligible using the PREVENTABLE computable phenotype. PCORnet sites have negotiated terms for data sharing and other agreements, and have all executed single (SMART) IRB agreements and the VA network will use the VA IRB (NIH policy based exception). The clinical sites core will be under the leadership of Dr. Adrian Hernandez, PI of the PCORnet coordinating center and the NIH’s Health System Collaboratory and Dr. Jacob Joseph, PI of the MAVERIC research infrastructure. PCORnet and VA leaders have identified qualified and experienced potential site PIs and vetted proposed site payment and enrollment targets. During the protocol development year, ‘trailblazer’ sites, those with the largest pool of eligible participants and best performance in pragmatic trials, will set the stage for other sites. Performance during start-up, enrollment, data collection, and close-out will be monitored in real-time, and transparently shared across the study sites in the spirit of continuous quality improvement. Sites that do not meet pre-established performance metrics will be supported by local network leads and Steering Committee representatives, as well as from the Recruitment Core. The clinical site core specific aims are: AIM 1. Select and activate high-performing sites across 40 PCORnet health care systems and 60 hospitals in the VA Network/MAVERIC to randomize 20,000 diverse older US participants through an established partnership with proven success in pragmatic trial conduct. AIM 2. Socialize a broad group of health care systems in support of the trial hypothesis, and incentivize engagement by ensuring adequate funding, rewarding academic contributions, engaging local research structures (OAIC/Pepper Centers, GRECC, CTSA), and limiting site burden to sustain ...

Key facts

NIH application ID
10021555
Project number
5U19AG065188-02
Recipient
DUKE UNIVERSITY
Principal Investigator
Adrian Hernandez
Activity code
U19
Funding institute
NIH
Fiscal year
2020
Award amount
$10,980,790
Award type
5
Project period
2019-09-30 → 2027-08-31