Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps

July 11, 2023 updated by: William Martinez, MD, MS, Vanderbilt University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
User Experience
Time Frame: 3-month follow up (T2)
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
Time Frame: Immediately after first use T(1), at approximately 1 month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Diabetes Distress
Time Frame: Enrollment (T0) and 3-month follow up (T2)
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
Time Frame: Enrollment (T0) and 3-month follow up (T2)
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
Time Frame: Enrollment (T0) and 3-month follow up (T2)
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
Time Frame: 3-month follow up (T2)
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
Time Frame: 3-month follow up (T2)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Martinez, MD, MS, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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