Treatment of Pregnant Women With OUD

Not Applicable

Active, not recruiting

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

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

Detailed 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.

Recruitment & 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 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)

Arm && Interventions

Group	Intervention	Description
Collaborative Care (CC)	Collaborative Care (CC)	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.
Extension for Community Healthcare Outcomes (ECHO)	Extension for Community Healthcare Outcomes (ECHO)	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.

Primary Outcome Measures

Name	Time	Method
Treatment Engagement	30 days from baseline	Dichotomous- A participant completes engagement if the baseline assessment is completed and the participant has greater than 2 visits for treatment of OUD
Treatment Retention	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
Patient Activation Measure (PAM)	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).

Secondary Outcome Measures

Name	Time	Method

Locations (11): Hospital of Central CT
🇺🇸
New Britain, Connecticut, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Hartford Hospital
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Hartford, Connecticut, United States
Yale New Haven Hospital Maternal Fetal Medicine Unit
🇺🇸
New Haven, Connecticut, United States
Yale New Haven Hospital Women's Center/Hill Health Center
🇺🇸
New Haven, Connecticut, United States
Wesson's Women's Clinic UMASS Baystate
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Springfield, Massachusetts, United States
Coastal ObGyn & Midwifery
🇺🇸
New London, Connecticut, United States
OB Gyn Services PC
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Norwich, Connecticut, United States
Essex County ObGyn
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Beverly, Massachusetts, United States
AFA Obstetrics & Gynecology
🇺🇸
Concord, Massachusetts, United States
Women's Health, Lowell General Hospital
🇺🇸
Lowell, Massachusetts, United States