Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
- Conditions
- Hypertension in PregnancyDysglycemiaGestational Diabetes Mellitus
- Interventions
- Behavioral: OB Provider Clinical Decision Support (CDS)Behavioral: Patient Education (OB Visit)Behavioral: Text messagingBehavioral: Patient OutreachBehavioral: Primary Care Provider Clinical Decision Support (CDS)Behavioral: Patient Education (Primary Care Visit)
- Registration Number
- NCT05852054
- Lead Sponsor
- Northwestern University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1500
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description STEP-UP Patient Education (OB Visit) STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP STEP-UP Patient Outreach STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP STEP-UP Text messaging STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP STEP-UP OB Provider Clinical Decision Support (CDS) STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP STEP-UP Primary Care Provider Clinical Decision Support (CDS) STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP STEP-UP Patient Education (Primary Care Visit) STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
- Primary Outcome Measures
Name Time Method Primary care visit (PCV) completion 6 months 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.
- Secondary Outcome Measures
Name Time Method Orders for dysglycemia testing 6 months Assess whether eligible patients have an order for any dysglycemia test (e.g. A1c, fasting glucose, oral glucose tolerance test) at any time during the 6-month follow-up period. This dichotomous outcome largely assesses the effectiveness of the provider-facing STEP-UP components. The investigator ascertain orders in this same way across STEP-UP and UC conditions. As an exploratory outcome, the investigator will examine the proportion of total tests ordered through the CDS versus the routine lab order entry mechanism. The investigator will also examine the association of orders with patient characteristics (e.g. age, BMI, race, ethnicity, language) and provider characteristics available in the EHR (i.e. physician vs. advanced practice provider, patient panel size).
Completion of dysglycemia testing 6 months Assess rates of testing for dysglycemia among eligible women who had a diagnosis of GDM in their index pregnancy. This binary outcome (yes/no) will be ascertained by the presence of a value from any dysglycemia test (e.g. A1c, fasting glucose, oral glucose tolerance test) at any time within the 6-month follow-up period. The testing rate across STEP-UP vs. UC will be calculated by dividing this numerator by the denominator of all eligible patients with GDM in their index pregnancy.
Dysglycemia and hypertension cases detected 6 months Assess the rate of dysglycemia and hypertension cases detected among eligible patients. Rate of detection for dysglycemia will be determined by the proportion of eligible patients with a prior diagnosis of GDM (i.e. denominator) who have a test value indicating dysglycemia according to ADA guidelines during follow-up (i.e. numerator). The rate of dysglycemia cases detected will be compared between STEP-UP and UC conditions. The investigator will run similar analyses for hypertension, using 2017 American College of Cardiology/American Heart Association criteria (hypertension: systolic blood pressure (SBP) greater than or equal to 130 mmHg or diastolic blood pressure (DBP)greater than or equal to 80 mmHg; stage 2 hypertension defined as SBP greater than or equal to 140 mmHg or DBP greater than or equal to 90 mmHg).
Trial Locations
- Locations (2)
Cook County Health
🇺🇸Chicago, Illinois, United States
AllianceChicago
🇺🇸Chicago, Illinois, United States