SMART Pilot Trial of Glycemic Screening Outreach

University of California, Los Angeles (UCLA)

Status: Invitation-only

Conditions: Obesity; Overweight (BMI > 25)

Treatments: Behavioral: Mailed letter; Behavioral: Text message; Behavioral: Patient portal message

Study type: Interventional

Funder types: Other

Identifiers

NCT06915194

IRB-24-6330

Details and patient eligibility

About

Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.

Enrollment: 105 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight or obese

Exclusion criteria

• Existing type 2 diabetes, A1c drawn within past 3 years

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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105 participants in 5 patient groups

Initial text, follow-up text, letter

Experimental group

Description:

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Treatment:

Behavioral: Text message

Behavioral: Mailed letter

Initial portal, follow-up portal, letter

Experimental group

Description:

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Treatment:

Behavioral: Patient portal message

Behavioral: Mailed letter

Initial text, follow-up portal, letter

Experimental group

Description:

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Treatment:

Behavioral: Patient portal message

Behavioral: Text message

Behavioral: Mailed letter

Initial portal, follow-up text, letter

Experimental group

Description:

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Treatment:

Behavioral: Patient portal message

Behavioral: Text message

Behavioral: Mailed letter

Usual care

No Intervention group

Description:

Patients do not receive any glycemic screening invitations