Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps

A Patient Portal Intervention to Address Diabetes Care Gaps: A Usability Study

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Diabetes Care Gaps Patient Portal Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Experience	User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications.	3-month follow up (T2)
Usability	The System Usability Scale (SUS) is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability.	Immediately after first use T(1), at approximately 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Distress	The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.	Enrollment (T0) and 3-month follow up (T2)
Change in Attitudes Toward Managing Diabetes in General	The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of self-efficacy (i.e., the confidence a person has in managing their own health and health care) and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the items. Higher scores indicate greater self-efficacy.	Enrollment (T0) and 3-month follow up (T2)
Change in Understanding of Diabetes Monitoring and Preventative Care	Unique study specific items to assess participants' understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants.	Enrollment (T0) and 3-month follow up (T2)
Patient Initiated Orders	The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., hemoglobin A1c). Participants with more than one diabetes care gap can initiated an order for more than one evidence-based diabetes monitoring and preventative service (e.g. hemoglobin A1c and diabetes eye exam).	3-month follow up (T2)
Order Completion	The investigators will collect data on the number of completed (i.e., care received) evidence-based diabetes monitoring and preventative services after a corresponding patient initiated order.	3-month follow up (T2)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Medical Informatics; Diabetes Mellitus; Preventative Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 202281; R18DK123373-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.
• IPD Sharing Time Frame: Deidentified individual participant data that underlie the results reported will be available after publication in a peer reviewed journal and posted on clinical trials and ending after 36 months after publication.
• IPD Sharing Access Criteria: Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No