Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening

Not Applicable

• Conditions: Pre Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT05730582
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The study team's central hypothesis is that the Parkland Diabetes Detection Program (PDDP) screening invitations targeted by race/ethnicity with culturally concordant messaging and tailored by glycemic risk (known PDM vs. unknown glycemic state) plus phone-based navigation of non-responders will be more effective at closing screening gaps than PDDP generic screening invitations and usual care, opportunistic screening alone.

Detailed Description

The research team will conduct a pragmatic, split cluster randomized controlled trial (clinic=cluster; patient randomization) in 12 community-based primary care clinics in an integrated safety net health system serving a high-risk, racially/ethnically diverse population.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-16
• Study Start: 2024-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-12-01
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500000

Inclusion Criteria

• Patient is alive at time of data extraction
• Age >= 18 at time of data extraction and <76
• Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit
• Patient NOT included in Parkland Diabetes Registry
• Preferred language is Spanish or English
• Ethnicity is Hispanic or Non-Hispanic
• Race is White or Black
• Patient is not pregnant in last 12 months

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group

• Last A1C value <5.7 (normal)
• Last A1C value >6.4 (diabetes)
• Last A1C value = blank (unchecked)
• Last A1C date occurred within last 12 months from date of export

Exclusion Criteria for Study Population 2: Score-Based Glycemic Risk Group

• Risk score <9
• Last A1C date occurred in last 30 months from date of export
• Last A1C value was >5.7 (PDM/DM)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Program effectiveness	12 months	Program effectiveness will be assessed by comparing the proportion of patients completing HgA1c or Fasting Blood Glucose screening tests at Day 365 across intervention and control arms.
Cost effectiveness as measured by costs per patient screened	12 months	Cost effectiveness will be assessed by comparing the costs per patient screened across study arms
Cost effectiveness as measured by cost per case found	12 months	Cost effectiveness will be assessed by comparing the costs per case found across study arms
Invitation efficacy	60 days	Invitation efficacy will be assessed by comparing the proportion of patients completing HgA1c or Fasting Blood Glucose screening tests at Day 60 in the targeted-tailored invitation intervention compared to the generic invitation intervention.
Direct costs	12 months	Direct costs of diabetes screening compared across study arms

Trial Locations

Locations (1)

Parkland Health; 🇺🇸 Dallas, Texas, United States