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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05730582
• Other study ID #: STU 2022-0996
• Secondary ID: R01MD016101
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: December 30, 2028

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500000
• Est. completion date: December 30, 2028
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pre Diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Parkland Health	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Direct costs	Direct costs of diabetes screening compared across study arms	12 months
Primary	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
Primary	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