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

NCT05730582 | Enrolling By Invitation

• 2 other identifiers: STU 2022-0996R01MD016101
• Study Type: interventional
• Target: 500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Pre Diabetes

Keywords

Diagnostic Screening Program; Health System Intervention

Outcome Measures

Primary Outcomes (5)

• Invitation efficacy

  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.

  60 days

• Program effectiveness

  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.

  12 months

• Direct costs

  Direct costs of diabetes screening compared across study arms

  12 months

• Cost effectiveness as measured by costs per patient screened

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

  12 months

• Cost effectiveness as measured by cost per case found

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

  12 months

Study Arms (3)

Generic Screening Invitation

ACTIVE COMPARATOR

Patients randomized to this study arm will receive the generic letter to inform them that they are at risk for T2D and that they are not up to date on screening. The letter also informs them that a screening test has been ordered, and requests that they complete testing at their clinic lab. The letter is signed by the patient's primary care provider and sent in both English and Spanish. This letter was previously developed and has been in use by the Parkland Diabetes Detection Program.

Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation

Targeted-Tailored Screening Invitation

EXPERIMENTAL

Patients randomized to this study arm will receive the tailored letter, which uses messaging developed collaboratively by patients and clinical stakeholders under a prior NIH-funded research study (STU 2021-0743), in addition to available EHR data, to inform patients that they are at risk for Type 2 Diabetes based on specific clinical characteristics and that they are not up to date on screening. The letter also informs them that a screening test has been ordered, and requests that they fast and complete testing at their clinic lab within 60 days. Fasting instructions will specify nothing to eat or drink except water for at least 8 hours. The letter will be signed electronically by the patient's primary care provider and sent in both English and Spanish.

Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation

Standard of Care

NO INTERVENTION

Patients randomized to this study arm will receive opportunistic screening based on routine clinical activities. Patients will be assigned a study number for tracking purposes, but no intervention activities via the Parkland Dysglycemia Detection Program will occur for this study arm.

Interventions

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.

Generic Screening Invitation; Targeted-Tailored Screening Invitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Parkland Health

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Michael Bowen, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine and Pediatrics

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 16, 2023
• Study Start: March 5, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)