NCT04527926

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

5.6 years

First QC Date

August 18, 2020

Last Update Submit

September 30, 2025

Conditions

Opioid-use DisorderPregnancy Related

Keywords

Opioid-use DisorderMedication-assisted TreatmentPregnancy

Outcome Measures

Primary Outcomes (2)

  • Patient Medication-assisted treatment (MAT) utilization

    As measured by total count of weeks in pregnancy with any Medications for Opioid Use Disorder (MOUD) either buprenorphine or methadone, use during pregnancy

    up to 1 year post delivery

  • Provider Provision of Buprenorphine

    As measured by total number of patients within a prenatal practice with opioid use disorder that receive MOUD treatment (either buprenorphine or methadone)

    up to 1 year post delivery

Secondary Outcomes (5)

  • Hepatitis C Virus (HCV) Screening Rate

    during pregnancy (up to 40 weeks)

  • Human Immunodeficiency Virus (HIV) Screening Rate

    during pregnancy (up to 40 weeks)

  • Mental Health Screening Rate

    during pregnancy (up to 40 weeks)

  • Contraceptive Utilization Rate

    delivery up to 1 year post delivery

  • Breastfeeding Rate

    delivery up to 1 year post delivery

Study Arms (2)

STEPuP Intervention

EXPERIMENTAL

STEPuP interventions

Behavioral: STEPuP Intervention

Usual Care

ACTIVE COMPARATOR

Standard of Care

Behavioral: Usual Care

Interventions

STEPuP InterventionBEHAVIORAL

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.

Also known as: Project STEPuP(Substance abuse Treatment and Education during Pregnancy and Postpartum)
STEPuP Intervention
Usual CareBEHAVIORAL

Standard of Care

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Providers:
  • provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites,
  • provides care to pregnant women with OUD
  • 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).
  • meet The Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for OUD
  • received care at participating sites while pregnant during the study time period and
  • speak English

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Postpartum Period

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Elizabeth Krans, MD

    UPMC Magee-Womens Hospital

    PRINCIPAL INVESTIGATOR

  • Marian Jarlenski, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 27, 2020

Study Start

September 30, 2020

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)