Effects of a Patient Portal Intervention to Address Diabetes Care Gaps

NCT04894903 | Completed Results DMC

• 2 other identifiers: 212257R18DK123373
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Self-efficacy; Patient Web Portals; Health Information Technology

Outcome Measures

Primary Outcomes (1)

• 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: 1. no diabetes eye exam in the last 12 months, 2. no hemoglobin A1C blood test in the last 6 months, 3. no urine microalbumin in the last 12 months, and 4. 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 Outcomes (9)

• Patient Initiated Orders

  12-month follow-up

• Change in Understanding of Diabetes Monitoring and Preventative Care

  Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up

• Change in Confidence Toward 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 Diabetes Distress

  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

  Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).

Interventions

Diabetes Care Gaps Patient Portal Intervention OTHER

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.

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 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

You may not qualify if:

• 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

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

Related Publications (1)

• Hackstadt AJ, Elasy TA, Gangaputra S, Harper KJ, Mayberry LS, Nelson LA, Peterson NB, Rosenbloom ST, Yu Z, Martinez W. Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e56123. doi: 10.2196/56123.

  PMID: 38941148 DERIVED

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, MS
• 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: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 20, 2021
• Study Start: April 30, 2022
• Primary Completion: February 3, 2024
• Study Completion: March 2, 2024
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

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)