- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527926
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy (STEPuP)
Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Magee Womens Hospital of UPMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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).
Inclusion criteria for a small subset of pregnant women will be recruited for a one-time qualitative interview (n=50):
- 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
Exclusion Criteria:
- None
Study Plan
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:
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Krans, MD, UPMC Magee-Womens Hospital
- Principal Investigator: Marian Jarlenski, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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