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

The University of Texas System (UT)

Status: Invitation-only

Conditions: Pre Diabetes; Diabetes Mellitus, Type 2

Treatments: Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05730582

STU 2022-0996

R01MD016101 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500,000 participants in 3 patient groups

Generic Screening Invitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation

Targeted-Tailored Screening Invitation

Experimental group

Description:

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.

Treatment:

Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation

Standard of Care

No Intervention group

Description:

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.