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Treatment of Pregnant Women With OUD

Treatment of Pregnant Women With OUD

Recruiting
18 years and older
Female
Phase N/A

Overview

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

Description

The investigators are proposing a cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with an OUD: 1) a collaborative care (CC) approach based upon the Massachusetts Office-Based-Opioid Treatment (OBOT) Model that would provide onsite training, and support to providers and participants through the use of care managers (CMs) vs 2) a telesupport approach modeled on the Project Extension for Community Healthcare Outcomes (ECHO), a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing.

Eligibility

Inclusion Criteria:

  • 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 December 15, 2022
  • 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

Exclusion Criteria:

  • 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)

Study details
    Opioid-use Disorder

NCT04240392

Yale University

16 February 2024

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