Clinical trial NCT04728620: Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps
Official title: A Patient Portal Intervention to Address Diabetes Care Gaps: A Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Medical Informatics
Preventative Care
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: 2021-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring \& preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).

Detailed description: Up to 60 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access to a new feature within the patient portal at Vanderbilt University Medical Center. The new feature will be available via the patient portal native app (i.e., My Health at Vanderbilt (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients to: (1) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (2) initiate an order for the care.

Study participants will complete questionnaires electronically via email at three time points: baseline (T0), immediately after first use of the intervention (T1), and three-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.

Eligibility criteria: Inclusion Criteria:

* Established patient at participating primary care clinic
* Type 1 or 2 diabetes mellitus
* Able to speak and read in English
* Age 18 to 75 years old
* Mobile device (smartphone or tablet) with internet access
* Active MHAV account and willing and able to use the MHAV native app on a mobile device
* Due (based on evidence-based guidelines) for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination.

Exclusion Criteria:

* Known cognitive deficits or functional impairment preventing the use of a mobile device
* Pregnant or planning to become pregnant during the study period
* Severe difficulty seeing
* Severe difficulty hearing
* Medical condition that make it hard for people to understand what they are saying

Primary outcomes:
measure: Usability
timeFrame: Immediately after first use T(1), at approximately 1 month
measure: User Experience
timeFrame: 3-month follow up (T2)
Secondary outcomes:
measure: Change in Attitudes Toward Managing Diabetes in General
timeFrame: Enrollment (T0) and 3-month follow up (T2)
measure: Change in Diabetes Distress
timeFrame: Enrollment (T0) and 3-month follow up (T2)
measure: Change in Understanding of Diabetes Monitoring and Preventative Care
timeFrame: Enrollment (T0) and 3-month follow up (T2)
measure: Patient Initiated Orders
timeFrame: 3-month follow up (T2)
measure: Order Completion
timeFrame: 3-month follow up (T2)
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: