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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Parkland Diabetes Detection Program (PDDP) Screening Invitation

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type 2 focused on measuring Diagnostic Screening Program, Health System Intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Generic Screening Invitation

Targeted-Tailored Screening Invitation

Standard of Care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Direct costs

Direct costs of diabetes screening compared across study arms

Cost effectiveness as measured by costs per patient screened

Cost effectiveness will be assessed by comparing the costs per patient screened across study arms

Cost effectiveness as measured by cost per case found

Cost effectiveness will be assessed by comparing the costs per case found across study arms

Secondary Outcome Measures

Full Information

NCT ID

NCT05730582

First Posted

January 11, 2023

Last Updated

February 16, 2023

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT05730582

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

August 1, 2026 (Anticipated)

Study Completion Date

December 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Pre Diabetes

Keywords

Diagnostic Screening Program, Health System Intervention

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Generic Screening Invitation

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Targeted-Tailored Screening Invitation

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Parkland Diabetes Detection Program (PDDP) Screening Invitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Invitation efficacy

Description

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

Title

Program effectiveness

Description

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

Title

Direct costs

Description

Direct costs of diabetes screening compared across study arms

Time Frame

12 months

Title

Cost effectiveness as measured by costs per patient screened

Description

Cost effectiveness will be assessed by comparing the costs per patient screened across study arms

Time Frame

12 months

Title

Cost effectiveness as measured by cost per case found

Description

Cost effectiveness will be assessed by comparing the costs per case found across study arms

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Molly McGuire, MPH

Phone

214-648-8487

Email

molly.mcguire@utsouthwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Bowen, MD

Organizational Affiliation

University of Texas Southwestern Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

No

Diabetes Mellitus, Type 2, Pre Diabetes

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial