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

Study Overview
=================
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.

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

Conditions
-----------------
Pre Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Generic Screening Invitation<br>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. | Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation<br>* 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.<br>|
| Experimental: Targeted-Tailored Screening Invitation<br>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. | Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation<br>* 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.<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Direct costs | Direct costs of diabetes screening compared across study arms | 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 | 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 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Screening Program, Health System Intervention