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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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
STEPuP Intervention
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.
Usual Care
Standard of Care

Locations

Country Name City State
United States Magee Womens Hospital of UPMC Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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