Diabetes Mellitus, Type 2, Pre Diabetes
Conditions
Keywords
Diagnostic Screening Program, Health System Intervention
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.
Interventions
BEHAVIORALParkland 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.
Sponsors
University of Texas Southwestern Medical Center
National Institute on Minority Health and Health Disparities (NIMHD)
Parkland Health and Hospital System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invitation efficacy | 60 days | 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. |
| Program effectiveness | 12 months | 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. |
| Direct costs | 12 months | Direct costs of diabetes screening compared across study arms |
| Cost effectiveness as measured by costs per patient screened | 12 months | Cost effectiveness will be assessed by comparing the costs per patient screened across study arms |
| Cost effectiveness as measured by cost per case found | 12 months | Cost effectiveness will be assessed by comparing the costs per case found across study arms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Bowen, MD
University of Texas Southwestern Medical Center
Outcome results
None listed