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

N/AEnrolling By InvitationNCT05730582

University of Texas Southwestern Medical Center500,000 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

500,000

Conditions

Diabetes Mellitus, Type 2 Pre Diabetes

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Direct costs

Direct costs of diabetes screening compared across study arms

Time frame: 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

Time frame: 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

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes