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STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy

Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04527926
Acronym
STEPuP
Enrollment
1022
Registered
2020-08-27
Start date
2020-09-30
Completion date
2026-04-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder, Pregnancy Related

Keywords

Opioid-use Disorder, Medication-assisted Treatment, Pregnancy

Brief summary

This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Findings from this research will provide high quality evidence about how to increase evidence-based treatment for pregnant women with OUD and subsequent maternal-child health outcomes.

Detailed description

The prevalence of opioid use disorder (OUD) during pregnancy has quadrupled over the past decade, as have maternal and neonatal morbidity and mortality related to substance use. Medication assisted treatment (MAT) use during pregnancy reduces adverse outcomes and is the recommended, evidence-based practice (EBP) for OUD treatment during pregnancy. Despite this, 40% of pregnant women with OUD do not receive MAT. Currently, there are no effective strategies to expand MAT access and availability for pregnant women, especially in rural, low-resource settings where maternal opioid use is disproportionately high. As an initial step to address this gap, the investigators engaged key stakeholders across a large health system in Pennsylvania to determine barriers and facilitators to expanding treatment services in high need, low-resource obstetric settings. The stakeholders identified a critical need for a women-centered, low resource, sustainable, provider-level intervention to facilitate the adoption of MAT in obstetric settings. Therefore, the investigators objective is to test the effectiveness of a prenatal provider education and training program designed to facilitate the adoption of EBP for OUD during pregnancy called Project STEPuP (Substance abuse Treatment and Education during pregnancy and Postpartum). Project STEPuP, grounded in preliminary and pilot work conducted by the research team, has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke," remotely supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs. To achieve this objective, the research team will conduct a cluster-randomized clinical trial across 12 obstetric sites in Pennsylvania and New York. Outcomes among 870 patients will be assessed during pregnancy, at delivery and through 1 year postpartum. The investigators central hypothesis is that Project STEPuP will facilitate EBP adoption, increase MAT utilization and improve health outcomes among pregnant and postpartum women with OUD and their children. Specifically, the investigators aim to: 1) Create organizational readiness to facilitate Project STEPuP implementation; 2) Assess the effect of Project STEPuP on provider adoption of EBP for OUD during pregnancy; and 3) Evaluate the effect of provider adoption of EBP on maternal and child health outcomes. The investigators research is significant by addressing the substantial knowledge gap of how to increase MAT use in pregnancy and innovative by examining the role that prenatal providers can play in expanding treatment access. Study outcome measures refined in January 2024 to align with grant proposal and increase readability.

Interventions

BEHAVIORALSTEPuP Intervention

Project STEPup has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke" remotely-supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs.

BEHAVIORALUsual Care

Standard of Care

Sponsors

University of Pittsburgh
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Providers: 1. provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites, 2. provides care to pregnant women with OUD 3. English speaking Patient: Maternal and child outcome data will be collected from the Electronic Health Record (EHR) and individual patients will not be recruited to participate in the randomized controlled trial (RCT). Inclusion criteria for a small subset of pregnant women will be recruited for a one-time qualitative interview (n=50): 1. meet The Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for OUD 2. received care at participating sites while pregnant during the study time period and 3. speak English

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Patient Medication-assisted treatment (MAT) utilizationup to 1 year post deliveryAs measured by total count of weeks in pregnancy with any Medications for Opioid Use Disorder (MOUD) either buprenorphine or methadone, use during pregnancy
Provider Provision of Buprenorphineup to 1 year post deliveryAs measured by total number of patients within a prenatal practice with opioid use disorder that receive MOUD treatment (either buprenorphine or methadone)

Secondary

MeasureTime frameDescription
Hepatitis C Virus (HCV) Screening Rateduring pregnancy (up to 40 weeks)Number of participants screened for Hepatitis C Virus (HCV) as measured by related laboratory testing
Human Immunodeficiency Virus (HIV) Screening Rateduring pregnancy (up to 40 weeks)Number of participants screened for Human Immunodeficiency Virus (HIV) as measured by related laboratory testing
Mental Health Screening Rateduring pregnancy (up to 40 weeks)Number of participants who received a mental health screening test, Patient Health Questionaire-2 or Patient Health Questionaire-9 (PHQ-2 or PHQ-9)
Contraceptive Utilization Ratedelivery up to 1 year post deliveryNumber of participants utilizing postpartum contraceptive as measured by contraception prescription
Breastfeeding Ratedelivery up to 1 year post deliveryNumber of participants breastfeeding as measured by feeding records from infant charts (yes/no)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElizabeth Krans, MD

UPMC Magee-Womens Hospital

PRINCIPAL_INVESTIGATORMarian Jarlenski, PhD

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026