Effects of a Patient Portal Intervention to Address Diabetes Care Gaps

Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial

The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.

Study Overview

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

Detailed Description

Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access to the currently available version of My Health at Vanderbilt without the study intervention. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.

• Study Type: Interventional
• Enrollment (Actual): 440
• 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 with a participating primary care physician from a participating clinic
• Type 1 or 2 diabetes mellitus
• Able to read in English
• Age 18 to 75 years old
• Mobile device (smartphone or tablet) with internet access
• Active My Health at Vanderbilt (MHAV) account

Exclusion Criteria:

• A medical condition that prevents use of a mobile device
• Pregnant or planning to become pregnant during the study period
• Severe difficulty seeing
• On dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. .	Other: Diabetes Care Gaps Patient Portal Intervention; The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
No Intervention: Usual Care; Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months	Number of diabetes care gaps per patient out of four possible: no diabetes eye exam in the last 12 months,; no hemoglobin A1C blood test in the last 6 months,; no urine microalbumin in the last 12 months, and; no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.	Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up

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. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Understanding of Diabetes Monitoring and Preventative Care	Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Satisfaction/Usability of My Health at Vanderbilt	The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale [0 (Strongly disagree) to 4 (strongly agree)] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).	Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Change in Diabetes Self-efficacy	The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Patient Initiated Orders	The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c).	12-month follow-up
Change in Confidence 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 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). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Blood Glucose Control	Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.	Baseline to 12-month follow-up
Treatment Intensification	The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Reported Services Completed Outside Vanderbilt System	The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention.	12-month follow-up

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): April 30, 2022
• Primary Completion (Actual): February 3, 2024
• Study Completion (Actual): March 2, 2024

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Self-efficacy; Health Information Technology; Patient Web Portals
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: 212257; R18DK123373 (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