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

Northwestern University

Status and phase: Active, not recruiting; Phase 3

Conditions: Gestational Diabetes Mellitus; Dysglycemia; Hypertension in Pregnancy

Treatments: 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: OB Provider Clinical Decision Support (CDS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05852054

STU00217979

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients will receive the usual standard of care

STEP-UP

Active Comparator group

Description:

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

Treatment:

Behavioral: Patient Education (Primary Care Visit)

Behavioral: OB Provider Clinical Decision Support (CDS)

Behavioral: Primary Care Provider Clinical Decision Support (CDS)

Behavioral: Patient Outreach

Behavioral: Text messaging

Behavioral: Patient Education (OB Visit)