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

NCT ID: NCT05730582

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 500000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2028-12-30

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.

Conditions

Diabetes Mellitus, Type 2; Pre Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Parkland Diabetes Detection Program (PDDP) Screening Invitation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Parkland Diabetes Detection Program (PDDP) Screening Invitation

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Edward Bowen

Associate Professor of Internal Medicine and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Bowen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Parkland Health

Dallas, Texas, United States

Countries

United States

Other Identifiers

R01MD016101

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 2022-0996

Identifier Type: -

Identifier Source: org_study_id