Abstract
CONTEXT: Minoritized populations experience higher rates of dementia and worse health outcomes than non-Hispanic white people, but they are vastly underrepresented in pragmatic clinical trials embedded in health care systems (ePCTs). Little guidance is available to consider health equity-relevant issues in ePCTs. OBJECTIVE: This report describes the development, structure, and content of a guidance document developed by the National Institute on Aging Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory to help investigators systematically assess the integration of health equity into all aspects of ePCT design. DESIGN: Led by a task force of IMPACT investigators, a literature review of existing frameworks for health equity considerations in clinical trials was conducted. Next, priority health equity-relevant recommendations in the domains of ePCT design were solicited from Collaboratory experts. The 50 submitted recommendations were reduced to 36 nonoverlapping best practices and categorized into 6 domains, as follows: Getting Started, Community Stakeholder Engagement, Design and Analysis, Intervention Design and Implementation, Health Care System and Participant Selection, and Selecting Outcomes. Each domain had 6 best practice recommendations consisting of a succinctly worded main sentence, with 1 to 2 explanatory sentences. The content was finalized through an iterative process of editing and revision. CONCLUSIONS: Although specifically focused on ePCTs involving dementia care, the best practices are applicable to any ePCT and can be useful to advance health equity in traditional clinical trials. This guidance document provides a first step toward promoting holistic, structured integration of health equity into the design and conduct of ePCTs as a matter of good science.