JMIR Publications

ABSTRACT

Background:

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

Objective:

Our study aims to evaluate the effects of MDC on patient activation among adult patients with type 2 diabetes mellitus (T2DM). In addition, we plan to assess secondary outcomes including system usage and usability and effects of MDC on cognitive and behavioral outcomes (e.g., self-care and self-efficacy).

Methods:

We are conducting a 6-month, 2-arm, parallel-design, pragmatic randomized controlled trial (RCT) of the effect of MDC on patient activation. Adult patients with T2DM are recruited from primary care clinics affiliated with VUMC. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, able to speak and read in English, age 21 or over, and have an existing MHAV account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long term care facilities, with known cognitive deficits or severe visual impairment, and currently participating in another diabetes related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data including the Patient Activation Measure® 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, such primary care physician.

Results:

The study is ongoing. Recruitment closed May 2020 and 270 patients were randomized. Of those randomized, the majority (80.1%, 214/267) are white non-Hispanic, 13.1% (35/267) are black non-Hispanic, 43.7% (118/270) reported being 65 or older, and 33.6% (90/268) reported limited health literacy. We have at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment.

Conclusions:

This RCT 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 health records, our intervention is directly integrated into routine care and is highly scalable and sustainable. Our findings and evolving patient portal functionality will inform the continued development of the intervention to best meet users’ needs as well as a larger trial focused on the impact of MDC on clinical endpoints. Clinical Trial: ClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333