Clinical trial NCT04527926: STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
Official title: Project STEPuP: a Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Opioid-use Disorder
Pregnancy Related
Keywords: Opioid-use Disorder
Medication-assisted Treatment
Pregnancy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Medication-assisted treatment (MAT) utilization
timeFrame: up to 1 year post delivery
measure: Provider Provision of Buprenorphine
timeFrame: up to 1 year post delivery
Secondary outcomes:
measure: Hepatitis C Virus (HCV) Screening Rate
timeFrame: during pregnancy (up to 40 weeks)
measure: Human Immunodeficiency Virus (HIV) Screening Rate
timeFrame: during pregnancy (up to 40 weeks)
measure: Mental Health Screening Rate
timeFrame: during pregnancy (up to 40 weeks)
measure: Contraceptive Utilization Rate
timeFrame: delivery up to 1 year post delivery
measure: Breastfeeding Rate
timeFrame: delivery up to 1 year post delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: UPMC Magee-Womens Hospital
name: Elizabeth Krans, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Marian Jarlenski, PhD
role: PRINCIPAL_INVESTIGATOR
References: