Omomukuyo Adenike, Ramirez Andy, Davis Aliyah, Velasquez Alexandra, Najmabadi Adriana L, Kong Marianna, Willard-Grace Rachel, Brown William, Broderick Andrew, Suomala Karla, McCulloch Charles E, Franco Nora, Sarkar Urmimala, Lyles Courtney, Tran Amber S, Sharma Anjana E, Tuot Delphine S
Department of Medicine, Division of Nephrology, Zuckerberg San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, United States.
Department of Family & Community Medicine, University of California, San Francisco, School of Medicine, San Francisco, CA, United States.
Med Res Arch. 2024 Nov;12(11). doi: 10.18103/mra.v12i11.6087.
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.
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.
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.
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.
ClinicalTrials.gov identifier NCT06598436. Registered 15 September 2024.
在美国，糖尿病和高血压治疗结果方面的种族/族裔及社会经济差异持续存在，且在新冠疫情期间有所恶化。部分原因是美国安全网环境中远程医疗的实施效果欠佳，同时存在既有的“数字鸿沟”，即限制边缘化社区获取数字工具的结构性因素。为改善健康公平性，美国的医疗系统将数字素养和健康素养原则融入慢性病护理以实现更公平的护理至关重要。
我们正在与一个社区咨询委员会合作开展一项2×2析因随机对照试验，评估一项针对影响旧金山县低收入患者公平使用远程医疗的障碍的多层次干预措施。通过健康指导和数字导航（“数字指导”）的循证策略提供患者层面的支持；诊所层面的支持包括公平仪表盘、患者咨询委员会和实践促进。我们将600名患有未控制糖尿病的低收入、种族/族裔多样的英语和西班牙语患者随机分为接受3个月的数字指导（n = 200）与常规护理（n = 400）；并将11家公共卫生初级保健诊所随机分为接受24个月的诊所支持与常规护理。我们旨在评估患者和诊所层面干预措施的影响，以确定个体有效性以及对与糖尿病和远程医疗结果相关的临床和过程指标的潜在协同影响。
该研究的主要临床结局是患者层面糖化血红蛋白（A1c）的变化；主要过程结局是患者门户的使用情况。次要临床结局包括患者层面收缩压（SBP）和微量白蛋白尿（UACR）的变化，以及诊所层面A1c、SBP和UACR的变化。次要过程结局评估患者层面数字素养、药物依从性、患者激活和就诊显示率的变化，以及诊所层面远程医疗采用情况的指标。
ACCTiVATE试验测试了一种通过利益相关者参与的研究方法和以用户为中心的设计开发的多层次干预措施，对受影响社区来说是可行且可接受的。如果有效，ACCTiVATE可能提供一个可扩展的模式，以改善经历结构性和人际获取障碍的边缘化种族/族裔人群的慢性健康结局和远程医疗公平性。
ClinicalTrials.gov标识符NCT06598436。2024年9月15日注册。
