Digital Health Navigation for Latino Patients With Type II Diabetes

Digital Health Navigation for Latino Patients With Type II Diabetes: A Randomized Controlled Trial

The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Digital Navigation

Detailed Description

Latinos have the second-highest age-adjusted prevalence and among the highest incidence of diabetes. Latinos also experience worse glycemic control and diabetes-related complications, including diabetic retinopathy and chronic renal disease. These findings are concerning since Latinos are the largest minority group in the U.S and will account for 25% of the population by 2045.

Digital tools, like patient portals and telemedicine, offer an opportunity to address some of the challenges that lead to these disparities, especially during care transitions. However, Latinos, especially those who are Spanish-speaking are less likely to use digital health tools. Findings from previous health information technology work have highlighted barriers, including 1) digital access and literacy, 2) interface usability, 3) privacy, and 4) patient preference. One promising intervention to address digital literacy gaps is the use digital navigators.

This study aims are to assess a digital health navigation intervention focused on increasing patient portal use after discharge among Latino patients with type II diabetes admitted to the general medicine inpatient floor.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge A Rodriguez, MD; Phone Number: 617-732-7063; Email: bwhtelediabetes@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Jorge A Rodriguez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-identified Latino adult patients with type II diabetes
• Admitted to general medicine floors at Brigham and Women's Hospital
• Preferred language: English or Spanish

Exclusion Criteria:

• Critical illness
• dementia, delirium, or other condition that limits ability to participate in education and consent process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Navigation; Patients in this arm will receive 1:1 digital navigation support which will teach them about the functions of the patient portal and telehealth.	Other: Digital Navigation; 1:1 educational support at the bedside about the functions of the patient portal and telehealth that can help with care transitions.
No Intervention: Standard of Care; Patients in this arm will receive the standard of care which will be an educational sheet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Login to the Portal	Number of participants with at least 1 login to the portal in the 30 days after discharge	30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants that Perform Distinct Portal Functions	Proportion of participants that perform distinct portal functions (sending messages, requesting refill)	30 days post-discharge
Proportion of participants that complete a telehealth	Proportion of participants that complete a telehealth visit during post-discharge period	30 days post-discharge
Proportion of participants that are re-admitted	Proportion of participants that are re-admitted within 30 days after discharge	30 days post-discharge

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Publications and helpful links

General Publications

• Rodriguez JA, Charles JP, Bates DW, Lyles C, Southworth B, Samal L. Digital healthcare equity in primary care: implementing an integrated digital health navigator. J Am Med Inform Assoc. 2023 Apr 19;30(5):965-970. doi: 10.1093/jamia/ocad015.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Latinos
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2024p000095; K23MD016439 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is no current plan to share data with other researchers.

Drug and device information, study documents

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