Treatment of Pregnant Women With OUD (SMART)
Opioid-use Disorder
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid, pregnant
Eligibility Criteria
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)
Sites / Locations
- Hartford HospitalRecruiting
- Hospital of Central CTRecruiting
- Yale New Haven Hospital Maternal Fetal Medicine UnitRecruiting
- Yale New Haven Hospital Women's Center/Hill Health CenterRecruiting
- Coastal ObGyn & MidwiferyRecruiting
- OB Gyn Services PCRecruiting
- Essex County ObGynRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- AFA Obstetrics & GynecologyRecruiting
- Women's Health, Lowell General HospitalRecruiting
- Wesson's Women's Clinic UMASS BaystateRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Collaborative Care (CC)
Extension for Community Healthcare Outcomes (ECHO)
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.
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.