Treatment of Pregnant Women With OUD

NCT04240392 | Completed Results DMC

• 2 other identifiers: 2000027031MAT-2018C2-12891
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 11

Brief Summary

The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)

Conditions

Opioid-use Disorder

Keywords

opioid; pregnant

Outcome Measures

Primary Outcomes (3)

• Treatment Engagement

  Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD

  30 days from baseline

• Treatment Retention

  Dichotomous- A participant is considered to have been successfully retained in the study if the participant remained in treatment with no stoppage of greater than 1 month. The numbers reported below for 3 months postpartum differ from those in the Participant Flow, as the numbers in the Participant Flow represent only completed REDCap survey assessments. For the retention outcome, we could utilize additional sources of data collection, such as medical records, site reports, and treatment utilization forms (which were done more frequently than survey assessments), thus resulting in a higher N for this outcome.

  delivery and three-month post-partum

• Patient Activation Measure (PAM)

  The PAM is a patient-centered questionnaire that measures health care knowledge, beliefs, skills and confidence in managing illnesses. The PAM has 13 items with a 5-point Likert response scale. The raw scores are summed and transformed to 0-100 metric (0 = lowest activation level, 100 = highest). The Week 26 numbers below are lower than those in the Participant Flow because participants were allowed to enter the study after 26 weeks of pregnancy and did not have a separate baseline and Week 26 PAM assessment; instead, it was counted as their baseline PAM assessment only. However, other study assessments were unique to week 26 and were completed concurrently with baseline assessments, which were counted separately, accounting for the higher N for Week 26 in the Participant Flow. The postpartum ECHO sample size is 85 rather than 86 because one participant skipped the PAM questions during their 3-month postpartum assessment.

  baseline, week 26, week 36 and 3-monhts post-partum

Study Arms (2)

Collaborative Care (CC)

EXPERIMENTAL

The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation the care manager will ask participants to complete an assessment battery of self-reported measures.

Behavioral: Collaborative Care (CC)

Extension for Community Healthcare Outcomes (ECHO)

ACTIVE COMPARATOR

ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.

Behavioral: Extension for Community Healthcare Outcomes (ECHO)

Interventions

Collaborative Care (CC) BEHAVIORAL

The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.

Collaborative Care (CC)

Extension for Community Healthcare Outcomes (ECHO) BEHAVIORAL

The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.

Extension for Community Healthcare Outcomes (ECHO)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women with opioid use disorder
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Females age 18 or older
• Documented pregnancy in the medical record at less than 34 weeks gestation
• Delivery date no later than July 1, 2024
• Willingness to adhere to the study schedule
• Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire
• Ability to communicate in English
• No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks

You may not qualify if:

• Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent
• Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible
• Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)

Sponsors & Collaborators

• Yale University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (11)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Hospital of Central CT

New Britain, Connecticut, 06052, United States

Location

Yale New Haven Hospital Maternal Fetal Medicine Unit

New Haven, Connecticut, 06511, United States

Location

Yale New Haven Hospital Women's Center/Hill Health Center

New Haven, Connecticut, 06511, United States

Location

Coastal ObGyn & Midwifery

New London, Connecticut, 06320, United States

Location

OB Gyn Services PC

Norwich, Connecticut, 06360, United States

Location

Essex County ObGyn

Beverly, Massachusetts, 01915, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

AFA Obstetrics & Gynecology

Concord, Massachusetts, 01742, United States

Location

Women's Health, Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Wesson's Women's Clinic UMASS Baystate

Springfield, Massachusetts, 01199, United States

Location

Related Publications (2)

• Kaufman JS, Yonkers KA, Maltz C, Friedhoff CM, Londono Tobon A, Mele A, Tessier-Kay M, Grechukhina O, Lipkind H, Byatt N, Forray A. Reporting Perinatal Substance Use to Child Protective Services: Obstetric Provider Perspectives on the Impact on Care. J Womens Health (Larchmt). 2024 Nov;33(11):1501-1508. doi: 10.1089/jwh.2023.0822. Epub 2024 May 21.

  PMID: 38770764 DERIVED

• Forray A, Mele A, Byatt N, Londono Tobon A, Gilstad-Hayden K, Hunkle K, Hong S, Lipkind H, Fiellin DA, Callaghan K, Yonkers KA. Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics. PLoS One. 2022 Jan 13;17(1):e0261751. doi: 10.1371/journal.pone.0261751. eCollection 2022.

  PMID: 35025898 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Ariadna Forray, MD
• Organization: Yale School of Medicine

ariadna.forray@yale.edu

203-785-2618

Study Officials

• Ariadna Forray, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a matched-pair cluster randomized trail design. The investigators will match clinical centers in pairs. The participants in each pair will be randomly assigned to either CC or ECHO using computer generated random numbers.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: January 27, 2020
• Study Start: June 18, 2020
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years after the end of the study
• Access Criteria: we will ask people to complete a request form

Locations

US (11)