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Enrolling by invitation NCT05730582

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

No phase Interventional Diabetes Mellitus, Type 2 Pre Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parkland Diabetes Detection Program (PDDP) Screening Invitation.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Pre Diabetes. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 se

Primary outcome measures

  • Invitation efficacy [Time frame: 60 days]
  • Program effectiveness [Time frame: 12 months]
  • Direct costs [Time frame: 12 months]
  • Cost effectiveness as measured by costs per patient screened [Time frame: 12 months]
  • Cost effectiveness as measured by cost per case found [Time frame: 12 months]

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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Parkland Health — Dallas

Identifiers

NCT: NCT05730582 · STU 2022-0996 · R01MD016101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗