Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05730582

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pre Diabetes

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Parkland Diabetes Detection Program (PDDP) Screening Invitation

Behavioral

The PDDP is designed to supplement and close screening gaps that persist despite opportunistic screening. Program staff order diabetes screening tests for randomized patients, then mail screening invitation letters to inform patients that they are at risk for diabetes. The letter informs them that a screening test has been ordered, and requests that they complete testing at their clinic lab. Patients who were mailed the letter but have not completed screening after 30 days are tracked and are send a second "reminder" invitation. Patients randomized to the targeted-tailored intervention study arm receive an additional phone call after 30 days.

Primary outcomes

  1. Invitation efficacy

    Time frame: 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.

  2. Program effectiveness

    Time frame: 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.

  3. Direct costs

    Time frame: 12 months

    Direct costs of diabetes screening compared across study arms

  4. Cost effectiveness as measured by costs per patient screened

    Time frame: 12 months

    Cost effectiveness will be assessed by comparing the costs per patient screened across study arms

  5. Cost effectiveness as measured by cost per case found

    Time frame: 12 months

    Cost effectiveness will be assessed by comparing the costs per case found across study arms

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 16, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.