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

January 25, 2024 updated by: Elizabeth Krans, MD, University of Pittsburgh

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

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.

Study Overview

Status

Enrolling by invitation

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STEPuP Intervention
STEPuP interventions
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.
Other Names:
  • Project STEPuP(Substance abuse Treatment and Education during Pregnancy and Postpartum)
Active Comparator: Usual Care
Standard of Care
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Medication-assisted treatment (MAT) utilization
Time Frame: up to 1 year post delivery
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
Time Frame: up to 1 year post delivery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C Virus (HCV) Screening Rate
Time Frame: during pregnancy (up to 40 weeks)
Number of participants screened for Hepatitis C Virus (HCV) as measured by related laboratory testing
during pregnancy (up to 40 weeks)
Human Immunodeficiency Virus (HIV) Screening Rate
Time Frame: during pregnancy (up to 40 weeks)
Number of participants screened for Human Immunodeficiency Virus (HIV) as measured by related laboratory testing
during pregnancy (up to 40 weeks)
Mental Health Screening Rate
Time Frame: during 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)
during pregnancy (up to 40 weeks)
Contraceptive Utilization Rate
Time Frame: delivery up to 1 year post delivery
Number of participants utilizing postpartum contraceptive as measured by contraception prescription
delivery up to 1 year post delivery
Breastfeeding Rate
Time Frame: delivery up to 1 year post delivery
Number of participants breastfeeding as measured by feeding records from infant charts (yes/no)
delivery up to 1 year post delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth Krans, MD, UPMC Magee-Womens Hospital
  • Principal Investigator: Marian Jarlenski, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY19070128
  • 1R01DA049759-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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