Achieving Chronic Care Equity by Leveraging the Telehealth Ecosystem (ACCTIVATE): A Multilevel Randomized Controlled Trial Protocol.

Abstract

Background: Racial/ethnic and socioeconomic disparities in diabetes and hypertension outcomes persist in the United States (U.S.), and worsened during the COVID-19 pandemic. This was in part due to suboptimal implementation of telehealth in U.S. safety-net settings alongside the pre-existing "digital divide" - structural determinants that limit access to digital tools by marginalized communities. To improve health equity, it is critical that health systems in the U.S. integrate principles of digital and health literacy for more equitable chronic disease care.

Methods: We are conducting a 2x2 factorial randomized controlled trial, in partnership with a Community Advisory Board, assessing a multi-level intervention addressing barriers that affect the equitable use of telehealth amongst low-income patients in San Francisco County. Patient-level support is provided through the evidence-based strategies of health coaching and digital navigation ("digital coaching"); clinic-level support includes equity dashboards, patient advisory councils, and practice facilitation. We are randomizing 600 low-income, racially/ethnically diverse English and Spanish-speaking patients with uncontrolled diabetes to receive digital coaching (n=200) vs. usual care (n=400) for 3 months; and 11 public health primary care clinics to clinic support vs. usual care for 24 months. We aim to evaluate the impact of patient and clinic level interventions to determine individual effectiveness and potential synergistic impact on clinical and process measures related to diabetes and telehealth outcomes.

Results: The study's primary clinical outcome is change in patient-level Hemoglobin A1C (A1c); the primary process outcome is patient portal usage. Secondary clinical outcomes include changes in patient-level systolic blood pressure (SBP) and microalbuminuria (UACR), and changes in clinic-level A1c, SBP, and UACR. Secondary process outcomes assess patient-level changes in digital literacy, medication adherence, patient activation, and visit show rates, and clinic-level measures of telehealth adoption.

Discussion: The ACCTiVATE trial tests a multi-level intervention developed through a stakeholder-engaged research approach and user-centered design to be feasible and acceptable for impacted communities. If efficacious, ACCTiVATE may provide a scalable model to improve chronic health outcomes and telehealth equity among marginalized racial/ethnic populations experiencing structural and interpersonal access barriers.

Trial registration: ClinicalTrials.gov identifier NCT06598436. Registered 15 September 2024.