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Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP) by promoting: 1. counseling and referral to primary care, during OB visits, via electronic health record (EHR)-based clinical decision support (CDS) 2. dysglycemia testing for women with prior GDM, prompted via CDS during both OB and primary care visits 3. dissemination of understandable information on future risk and the need for ongoing evaluation generated automatically via the EHR and printed for patients with after-visit summaries (AVS) 4. motivational messaging and reminders supporting transitions of care delivered directly to patients via short message service (SMS) text messages 5. individualized outreach and support for those who need additional help arranging a primary care visit We will utilize a stepped wedge design to achieve the study's specific aims, which are to: Aim 1 Test the effectiveness of STEP-UP, compared with usual care, to improve patient: 1) knowledge of reproductive risks associated with T2DM and recommended self-care activities; 2) engage in self-care behaviors, including diet, physical activity, adherence to diabetes medications, and use of folic acid and most or moderately effective contraception, when indicated; and 3) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol. Aim 2 Investigate the heterogeneity of STEP-UP intervention effects by patients' race, ethnicity, and language. Aim 3 Assess the reach, adoption, implementation, maintenance and costs of STEP-UP components.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Cook County Health
Chicago, Illinois, United States
AllianceChicago
Chicago, Illinois, United States
Start Date
November 1, 2023
Primary Completion Date
September 1, 2025
Completion Date
January 31, 2026
Last Updated
August 13, 2025
1,500
ESTIMATED participants
OB Provider Clinical Decision Support (CDS)
BEHAVIORAL
Patient Education (OB Visit)
BEHAVIORAL
Text messaging
BEHAVIORAL
Patient Outreach
BEHAVIORAL
Primary Care Provider Clinical Decision Support (CDS)
BEHAVIORAL
Patient Education (Primary Care Visit)
BEHAVIORAL
Lead Sponsor
Northwestern University
Collaborators
NCT06648174
NCT06948825
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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