Clinical trial NCT04894903: Effects of a Patient Portal Intervention to Address Diabetes Care Gaps
Official title: Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Self-efficacy
Patient Web Portals
Health Information Technology
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-20
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring \& preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.

Detailed description: Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 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 to the currently available version of My Health at Vanderbilt without the study intervention. 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, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.

Eligibility criteria: Inclusion Criteria:

* Established patient with a participating primary care physician from a participating clinic
* Type 1 or 2 diabetes mellitus
* Able to read in English
* Age 18 to 75 years old
* Mobile device (smartphone or tablet) with internet access
* Active My Health at Vanderbilt (MHAV) account

Exclusion Criteria:

* A medical condition that prevents use of a mobile device
* Pregnant or planning to become pregnant during the study period
* Severe difficulty seeing
* On dialysis

Primary outcomes:
measure: Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Secondary outcomes:
measure: Patient Initiated Orders
timeFrame: 12-month follow-up
measure: Change in Understanding of Diabetes Monitoring and Preventative Care
timeFrame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
measure: Change in Confidence Toward Managing Diabetes in General
timeFrame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
measure: Change in Diabetes Distress
timeFrame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
measure: Satisfaction/Usability of My Health at Vanderbilt
timeFrame: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
measure: Change in Blood Glucose Control
timeFrame: Baseline to 12-month follow-up
measure: Treatment Intensification
timeFrame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
measure: Change in Diabetes Self-efficacy
timeFrame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
measure: Reported Services Completed Outside Vanderbilt System
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William Martinez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: