Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps

NCT04728620 | Completed Results

• 2 other identifiers: 202281R18DK123373-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Medical Informatics; Preventative Care

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Secondary Outcomes (5)

• Change in Attitudes Toward Managing Diabetes in General

  Enrollment (T0) and 3-month follow up (T2)

• Change in Diabetes Distress

  Enrollment (T0) and 3-month follow up (T2)

• Change in Understanding of Diabetes Monitoring and Preventative Care

  Enrollment (T0) and 3-month follow up (T2)

• Patient Initiated Orders

  3-month follow up (T2)

• Order Completion

  3-month follow up (T2)

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Diabetes Care Gaps Patient Portal Intervention 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: William Martinez, MD
• Organization: Vanderbilt University Medical Center

william.martinez@vumc.org

(615) 936-1010

Study Officials

• William Martinez, MD, MS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: May 6, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)