Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial

William Martinez, Amber J Hackstadt, Gerald B Hickson, S Trent Rosenbloom, Tom A Elasy, William Martinez, Amber J Hackstadt, Gerald B Hickson, S Trent Rosenbloom, Tom A Elasy

Abstract

Background: My Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds.

Objective: This study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy).

Methods: We are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians).

Results: This study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment.

Conclusions: This randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points.

Trial registration: ClinicalTrials.gov NCT03947333; https://ichgcp.net/clinical-trials-registry/NCT03947333.

International registered report identifier (irrid): DERR1-10.2196/25955.

Keywords: attitudes; diabetes mellitus; health knowledge; health literacy; mobile phone; patient activation; patient portals; practice; self-management; type 2.

Conflict of interest statement

Conflicts of Interest: None declared.

©William Martinez, Amber J Hackstadt, Gerald B Hickson, S Trent Rosenbloom, Tom A Elasy. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.05.2021.

Figures

Figure 1
Figure 1
The eHealth Enhanced Chronic Care Model with key aspects of My Diabetes Care shown in italics under the corresponding domain.
Figure 2
Figure 2
My Diabetes Care screenshot and features. Stars across the top fill in when the patient's glycated hemoglobin, blood pressure, cholesterol, or flu vaccine status are within goal range (ie, a value in the green zone on the infographic for each measure). Info icons provide a brief literacy-level appropriate description of each measure. Infographics display health data relative to a goal (green), caution (yellow), and warning (red) ranges. Patients Like Me indicates the average value of similar patients (ie, Vanderbilt patients with diabetes of the same gender, age group, and insulin-use status), and hovering over the icon reveals this description to the patient. Me indicates the patient's value, and hovering over the icon displays historical values. Literacy-level appropriate educational materials (hyperlinks) are paired with each measure. Message Your Doctor allows patients to send a secure message to members of their health care team. Online patient support community allows users to navigate directly to the American Diabetes Association (ADA) support community; a separate ADA account (username and password) is required. News Feeds provide newly published diabetes-related content, including recipes, discoveries, and new medications. FAQ provides answers to frequently asked questions regarding site features and navigation.
Figure 3
Figure 3
Recruitment and enrollment flowchart. MHAV: My Health At Vanderbilt; MRAV: My Research At Vanderbilt; T2DM: type 2 diabetes mellitus.

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