Over the past four decades, a host of non-pharmacologic interventions tested in trials (NIA Stage I, II, or III) have demonstrated significant clinical benefits for people living with Alzheimer's disease (AD) or an AD-related dementia (AD/ADRD;PWD) and family caregivers. Yet, with few exceptions, proven interventions have neither been tested in health care settings (HCS) using embedded pragmatic trial (ePCTs) designs nor widely disseminated. The lack of pragmatic testing in HCS impedes the adoption of such interventions into practice, with families and health providers continuing to have limited knowledge of and access to evidence-based care. To address this critical gap, the Dissemination and Implementation Core (D&I) of the NIA AD/ADRD HCS Collaboratory (Collaboratory) will assist investigators, and stakeholders (HCS, PWD, caregivers, providers, payers) when implementing and disseminating their dementia care interventions in the context of ePCTs. This Core is based on a fundamental scientific assumption: D&I considerations are critical to address throughout a project?s life-cycle (from idea conception, protocol development and testing to wide scale implementation via the NIA Stage Model) to optimize an intervention?s potentiality for integration into HCS. A major contribution of the D&I Core will be to advance and evaluate the utility of a novel framework to ascertain level of ?readiness? of an intervention to proceed to ePCTs. The D&I Core will be co-led by Drs. Laura N. Gitlin and Joseph Gaugler and include an Executive Committee (EC) of five internationally recognized experts in dementia implementation research. The D&I Core?s activities will be closely integrated with and informed by the AD/ADRD Collaboratory?s Stakeholder Engagement and Diversity/Inclusion Teams, HCS Leadership Council, and the Pilot, Training, Design/Statistics and Regulation/Ethics Cores.
The Specific Aims are:
Aim 1. Conduct, regularly update, and disseminate syntheses of the scientific literature regarding implementation of non-pharmacologic interventions for PWD and/or caregivers;
Aim 2 : Advance a framework for identifying stage of development of pilot studies and their readiness for conducting ePCT;
and Aim 3 : Provide ongoing technical assistance tailored to study needs of AD/ADRD Collaboratory-funded pilot project leaders and Career Development Awardees, and other NIA-funded investigators doing ePCTs from the outset of project development to enable them to advance their implementation and dissemination plans. IMPACT: The persistent failure of widespread implementation of proven interventions in HCS for PWD and caregivers is due in large part to inattention to D&I science from the inception of an intervention?s development. Conducting ePCTs will require systematic attention to evidentiary practices for implementing studies in complex, variegated HCS. The D&I Core is essential to assure implementation success of pilot studies, CDAs and ePCTs in order to enhance clinical relevance and change dementia care.
