Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diabetes Mellitus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Masking Description: The PI will be blinded to randomization of primary care physicians and their associated patientsPrimary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Participants will be recruited from the patient panels of the 94 randomized primary care physicians (PCPs) on staff at all 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. PCPs will be randomized 1:1 to the intervention or usual care. Based on randomization of their ...

Participants will be recruited from the patient panels of the 94 randomized primary care physicians (PCPs) on staff at all 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. PCPs will be randomized 1:1 to the intervention or usual care. Based on randomization of their primary care physician, 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt without the intervention. Patients will be invited by mail (or email) to be screened for enrollment in the study. Eligible and interested patients will be offered a link to a secure study website where they will complete a web-based consent form. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, 9-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.

Tracking Information

NCT #
NCT04894903
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: William Martinez, MD, MS Vanderbilt University Medical Center