Clinical trial NCT05852054: Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
Official title: Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gestational Diabetes Mellitus
Hypertension in Pregnancy
Dysglycemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: AllianceChicago
name: Cook County Health
First posted: 2023-05-10
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a stepped wedge, pragmatic design. Study sites deliver usual care until they are randomized to provide the STEP-UP intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Primary care visit (PCV) completion
timeFrame: 6 months
Secondary outcomes:
measure: Completion of dysglycemia testing
timeFrame: 6 months
measure: Orders for dysglycemia testing
timeFrame: 6 months
measure: Dysglycemia and hypertension cases detected
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Chicago
country: United States
facility: AllianceChicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stacy Bailey, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: