Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04527926 |
| Other study ID # |
STUDY19070128 |
| Secondary ID |
1R01DA049759-01 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2020 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
