Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)

NCT05852054 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: STU00217979
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Gestational Diabetes Mellitus; Hypertension in Pregnancy; Dysglycemia

Outcome Measures

Primary Outcomes (1)

• Primary care visit (PCV) completion

  Assess completion of a primary care visit (yes/no) within 6 months of delivery. Using procedures from a pilot study, the investigator will consider an encounter a PCV if it occurred by 6 months after the delivery date; had an assigned provider type of "nurse practitioner," "physician," "internal medicine," "family medicine," and/or "physician assistant;" and did not have an assigned provider type of "OB/GYN" and/or "certified nurse midwife." The PCV rate across STEP-UP vs. UC will be calculated by dividing eligible patients with greater than or equal to 1 PCV (numerator) by the denominator of all eligible patients.

  6 months

Secondary Outcomes (3)

• Completion of dysglycemia testing

  6 months

• Orders for dysglycemia testing

  6 months

• Dysglycemia and hypertension cases detected

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

Patients will receive the usual standard of care

STEP-UP

ACTIVE COMPARATOR

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP

Behavioral: 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)

Interventions

OB Provider Clinical Decision Support (CDS) BEHAVIORAL

When an eligible patients' chart is opened by a provider, the provider will be alerted to counsel patients about future risk for T2D and hypertension and the need to establish a primary care medical home. The alert will include a 'referral' to primary care and a brief guide with 'key points for counseling'. For patients with prior GDM, this will also include an option to order guideline-recommended oral glucose tolerance test (OGTT) with a single click.

STEP-UP

Patient Education (OB Visit) BEHAVIORAL

A 1-page document will be printed or delivered electronically for eligible patients after every postpartum OB visit during the STEP-UP condition. The document will encourage patients to know the risk and will describe the importance of routine primary care and chronic disease evaluation and management. It will also provide tips for lowering risk through lifestyle changes. Patient materials will be delivered in English or Spanish based on the structured EHR variable for preferred language.

STEP-UP

Text messaging BEHAVIORAL

At 3 months postpartum, all eligible patients who have not scheduled a primary care visit will receive a motivational text to prompt scheduling; a second text will be sent for those who still have not made an appointment. Among those who schedule a visit, a reminder text will be sent before the visit. Texts will be in English or Spanish based on patients' preferred language field in the EHR and written at a \<5th grade reading level.

STEP-UP

Patient Outreach BEHAVIORAL

Patients who have not scheduled a primary care visit by 4 months postpartum will receive outreach from a trained coordinator who will assist with scheduling and help patients troubleshoot common barriers, such as concerns about transportation or cost.

STEP-UP

Primary Care Provider Clinical Decision Support (CDS) BEHAVIORAL

The CDS will notify the provider that the patient had a recent high-risk pregnancy and signal the need to counsel the individual about their future risk for T2D and/or hypertension and the need for ongoing care. A brief guide with 'key points for counseling' described in plain language will be provided. For patients with prior GDM, the CDS will also include an easy to access 'smartset' to order appropriate testing (A1c, FG, or OGTT) based on time since delivery and provider discussions with the patient.

STEP-UP

Patient Education (Primary Care Visit) BEHAVIORAL

A 1-page material will again be automatically printed or delivered electronically for eligible patients after their first primary care visit; it will replicate content from prior material provided after the OB visit.

STEP-UP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All trial participants will be women with gestational diabetes and/or hypertensive disorders of pregnancy; they will be accrued into the study upon delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Delivered during an accrual period,
• Had a chart diagnosis during their index pregnancy of GDM and/or HDP,
• Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery,
• Speak English or Spanish,
• Age 18 or older

Sponsors & Collaborators

• Northwestern University: lead
• AllianceChicago: collaborator
• Cook County Health: collaborator

Study Sites (2)

Cook County Health

Chicago, Illinois, 60612, United States

Location

AllianceChicago

Chicago, Illinois, 60654, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Stacy Bailey, PhD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a stepped wedge, pragmatic design. Study sites deliver usual care until they are randomized to provide the STEP-UP intervention.

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: November 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: January 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)