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Completed

NCT Number: NCT04240392

Treatment of Pregnant Women With OUD

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

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital, Hartford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Treatment Engagement

    Time frame: 30 days from baseline

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

  2. Treatment Retention

    Time frame: delivery and three-month post-partum

    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.

  3. Patient Activation Measure (PAM)

    Time frame: baseline, week 26, week 36 and 3-monhts post-partum

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women

Acronym: SMART

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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