The Protocol Implementation phase is critical to establish the infrastructure needed to ensure the successful recruitment and retention of participants, delivery of the study intervention, and ascertainment of the primary and secondary outcomes. This will be crucial to set the tone and confirm programmatic success of the study that will determine the role of a moderate-intensity statin in preventing dementia, including Alzheimer?s disease and Alzheimer?s disease-related dementias, 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. We will partner with the NIH to outline study expectations, finalize the overarching trial framework and communications strategies, as well as committee SOPs, guidelines, tools, templates, and resources. We will engage and solidify our partnership with PREVENTABLE Health Care Systems (within the PCORnet and VA network) and other PREVENTABLE collaborators by providing a single point-of-contact, the project manager, who will provide a framework for active continual engagement to ensure that potential problems are proactively identified and solutions efficiently crafted to help constituents meet aggressive project milestones. We will design the trial to maximize the study?s impact, address study-specific barriers, and create the correct framework to leverage expertise of key thought leaders and operational experts during protocol development. Further, close partnership and communication with enrolling sites will help project leaders identify barriers and develop targeted solutions for individual sites. We will continuously communicate study goals, initiatives, and ancillary study opportunities with the research community and broader public; we will also communicate effective strategies, processes, tools, and methods across PREVENTABLE HCSs. We will share successful (and communicate unsuccessful) processes, tools, and methods and discuss possible improvements, as well as how strategies might be adapted to suit particular PREVENTABLE sites and populations. The Protocol Refinement phase has the following specific aims:
AIM 1. Refine the protocol based on broad input from stakeholders and thought leaders to maximize opportunities for innovation in trial operations.
AIM 2. Assemble and staff operational and scientific subcommittees to solicit and implement rigorous feedback on proposed trial strategies, including site start up, recruitment, participant engagement, safety, geriatric assessments, CV assessments, quality control, and optimizing data integrations for trial outcome ascertainment.
AIM 3. Initiate and complete study start up inclusive of all study documents, regulatory approvals, contracts and activation of clinical sites, and recruitment approaches for patients.
