Provider Education Program for Opioid Use Disorder in Pregnant Women

(STEPuP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the STEPuP Intervention treatment for opioid use disorder in pregnant women?

Research shows that patient navigation and women-centered treatment programs can improve treatment engagement and outcomes for pregnant women with opioid use disorder, suggesting that similar approaches like the STEPuP Intervention may also be effective. ^{1 2 3 4 5}

How is the STEPuP Intervention treatment different from other treatments for opioid use disorder in pregnant women?

The STEPuP Intervention is unique because it focuses on educating healthcare providers to improve the care of pregnant women with opioid use disorder, addressing a gap in treatment access and quality that is not typically covered by standard medical treatments. ^{1 2 3 4 6}

Research Team

Elizabeth Krans, MD

Principal Investigator

UPMC Magee-Womens Hospital

Marian Jarlenski, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for prenatal care providers who treat pregnant women with opioid use disorder (OUD). Providers must be English-speaking and work at obstetric sites. While patient data will be used, only a small group of English-speaking pregnant women meeting OUD criteria will be directly involved in interviews.

Inclusion Criteria

I speak English and can participate in a one-time interview.

I'm sorry, I need more information to understand the criterion. Can you please provide me with more context or the full criterion?

You are someone who takes care of pregnant women with opioid use disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 40 weeks

Intervention

Implementation of the STEPuP program, including provider education, addiction teleconsultation, case management, and telepsychiatry support

up to 40 weeks

Follow-up

Participants are monitored for MAT utilization and health outcomes postpartum

up to 1 year post delivery

Treatment Details

Interventions

• STEPuP Intervention
• Usual Care

Trial Overview The STEPuP intervention is being tested against usual care to see if it improves the adoption of evidence-based treatments for OUD during pregnancy by prenatal providers. The goal is to enhance maternal-child health outcomes through better provider practices.

Participant Groups

Group I: STEPuP Intervention Experimental Treatment 1 Intervention

STEPuP interventions

Group II: Usual Care Active Control 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Patient navigation (PN) significantly improved treatment adherence and engagement in opioid use disorder (OUD) among pregnant individuals, with better outcomes in medication use and substance use disorder treatment attendance compared to usual care (UC).

The pilot study, involving 102 pregnant participants, demonstrated that those receiving PN had fewer reported overdoses at 2 and 6 months postpartum, suggesting that PN may enhance safety and effectiveness in managing OUD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Cochran, G., Smid, MC., Krans, EE., et al.[2023]

Pregnant women with opioid use disorder (OUD) who received women-centered treatment through the Pregnancy Recovery Program (PRC) were more likely to start buprenorphine during pregnancy and had higher doses at delivery compared to those in non-PRC programs.

Women in the PRC group showed better engagement in postpartum care, with higher attendance rates for follow-up visits and increased use of long-acting reversible contraception, as well as a smaller decrease in breastfeeding rates during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pregnancy Recovery Center: A women-centered treatment program for pregnant and postpartum women with opioid use disorder. Krans, EE., Bobby, S., England, M., et al.[2019]

Among 42,239 treatment episodes for opioid use disorder (OUD) in pregnant women from 2013 to 2017, only 47.4% received medications like methadone or buprenorphine, indicating a significant gap in treatment adherence to guidelines.

While the administration of medications for OUD increased from 41.0% to 52.0% over the study period, retention in treatment actually declined from 39.0% to 33.0%, suggesting that simply providing medication is not enough to ensure long-term treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Initiation of Medication for Opioid Use Disorder and Retention in Treatment Among U.S. Pregnant Women, 2013-2017. Nguemeni Tiako, MJ., Friedman, A., Culhane, J., et al.[2021]

From 1996 to 2014, the number of pregnant women entering treatment for opioid use disorder (OUD) increased significantly, yet the percentage receiving pharmacotherapy remained stable at around 50%, indicating a gap in treatment access.

Pharmacotherapy recipients were typically older, more likely to be white, and had different substance use patterns compared to non-recipients, with notable regional disparities in pharmacotherapy utilization, particularly in the South where fewer women received such treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and disparities in receipt of pharmacotherapy among pregnant women in publically funded treatment programs for opioid use disorder in the United States. Short, VL., Hand, DJ., MacAfee, L., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The Pregnancy Recovery Center: A women-centered treatment program for pregnant and postpartum women with opioid use disorder. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of Initiation of Medication for Opioid Use Disorder and Retention in Treatment Among U.S. Pregnant Women, 2013-2017. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Trends and disparities in receipt of pharmacotherapy among pregnant women in publically funded treatment programs for opioid use disorder in the United States. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Medication-Assisted Treatment Use Among Pregnant Women With Opioid Use Disorder. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Beyond the Treatment Box: Perspectives on the Federal Response to Opioid Use, Pregnancy, and Neonatal Abstinence Syndrome. [2018]