Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps

NCT ID: NCT04728620

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-05-25

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps.

Group Type: EXPERIMENTAL

Diabetes Care Gaps Patient Portal Intervention

Intervention Type: OTHER

The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care.

Interventions

Diabetes Care Gaps Patient Portal Intervention

The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

William Martinez, MD, MS

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Martinez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R18DK123373-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202281

Identifier Type: -

Identifier Source: org_study_id