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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2; Pre Diabetes
• Intervention / Treatment: Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation

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 Type: Interventional
• Enrollment (Estimated): 500000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Generic Screening Invitation; 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; 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.
Experimental: Targeted-Tailored Screening Invitation; 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; 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.
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Michael Bowen, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diagnostic Screening Program; Health System Intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: STU 2022-0996; R01MD016101 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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