Treatment of Pregnant Women With OUD (SMART)

Yale University

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Behavioral: Collaborative Care (CC); Behavioral: Extension for Community Healthcare Outcomes (ECHO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04240392

MAT-2018C2-12891 (Other Grant/Funding Number)

2000027031

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Collaborative Care (CC)

Experimental group

Description:

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.

Treatment:

Behavioral: Collaborative Care (CC)

Extension for Community Healthcare Outcomes (ECHO)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Extension for Community Healthcare Outcomes (ECHO)