Supporting Transitions to Primary Care Among Under-resourced, Postpartum

Status Recruiting

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05852054
Study type	Interventional
Source	Northwestern University
Contact	Stacy Bailey, PhD MPH
Phone	312-503-5595
Email	stacy-bailey@northwestern.edu
Status	Recruiting
Phase	Phase 3
Start date	November 1, 2023
Completion date	May 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06099574` - A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
Completed	`NCT02890693` - Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring	N/A
Completed	`NCT02744300` - Balance After Baby Intervention for Women With Recent Gestational Diabetes	N/A
Completed	`NCT02384226` - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Completed	`NCT02436551` - Gestational Diabetes in Central Asia: Prevalence and Management
Recruiting	`NCT02275845` - Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus	Phase 3
Recruiting	`NCT04621396` - The Next Generation Longitudinal Birth Cohort Diabetes Study
Completed	`NCT01931280` - A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring	N/A
Completed	`NCT01916694` - Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus	N/A
Not yet recruiting	`NCT01637727` - Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women	N/A
Completed	`NCT01565564` - Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes	N/A
Recruiting	`NCT00550979` - Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk	N/A
Completed	`NCT00460018` - Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)	Phase 2
Not yet recruiting	`NCT04915716` - Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus
Completed	`NCT04422821` - Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial	N/A
Recruiting	`NCT04369313` - Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers	N/A
Recruiting	`NCT05348863` - SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes	N/A
Recruiting	`NCT04272840` - The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus	N/A
Completed	`NCT02588729` - A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT	N/A
Completed	`NCT01922791` - Nutrition and Pregnancy Intervention Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms