JMIR Publications

ABSTRACT

Background:

Our research team recently utilized user-centered Design Sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (e.g., no diabetes eye exam in last 12 months).

Objective:

This study aims to evaluate the effect of our novel diabetes care gaps intervention (DCGI) on completion of selected evidence-based, diabetes monitoring and preventative services and secondary outcomes (e.g., diabetes self-efficacy).

Methods:

We are conducting a 12-month, 2-arm, pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if have type 1 or 2 DM, can read in English, are ages 18 to 75, have a current patient portal account and reliable access to a mobile device with iOS or android operating system with internet access. We exclude patients with a medical condition that prevents them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among four selected DM monitoring and preventative services (diabetes eye exam, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12-month post randomization. Secondary outcomes will include diabetes self-efficacy, attitudes toward managing diabetes in general, change in understanding of diabetes monitoring and preventative care, diabetes distress, satisfaction with MHAV, and patient-initiated orders at baseline, 3-months, 6-months, and 12-month post randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used.

Results:

This study is ongoing. Recruitment was closed in February 2022; 433 patients were randomized. Of those randomized, most (288/433, 66.5%) were non-Hispanic White, and 33.5% (145/433) were racial or ethnic minorities, 33.9% (147/433) reported being 65 or older, and 30.7% (133/433) indicated limited health literacy.

Conclusions:

The study directly tests the hypothesis that a patient portal intervention – alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care – will reduce diabetes care gaps compared to usual care. The insights gained from this study will have broad implications for designing and implementing interventions that address various care gaps, such as cancer screening and vaccinations, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention. Clinical Trial: NCT04894903