Treatment of Pregnant Women With OUD

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

Detailed Description
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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.

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

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Collaborative Care (CC)
* Behavioral: Extension for Community Healthcare Outcomes (ECHO)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will use a matched-pair cluster randomized trail design. The investigators will match clinical centers in pairs. The participants in each pair will be randomly assigned to either CC or ECHO using computer generated random numbers.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care (CC)<br>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. | Behavioral: Collaborative Care (CC)<br>* 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.<br>|
| Active Comparator: Extension for Community Healthcare Outcomes (ECHO)<br>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. | Behavioral: Extension for Community Healthcare Outcomes (ECHO)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Engagement | Dichotomous- A participant completes engagement if the baseline assessment is completed and the participant has greater than 2 visits for treatment of OUD | 12 months | 
| Treatment Retention | 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 2 months | 12 months | 
| Patient Activation Measure (PAM) | Operationalized as assigning participants to one of four PAM levels based upon scores | 24 weeks | 
| Patient Activation Measure (PAM) | Operationalized as assigning participants to one of four PAM levels based upon scores | 36 weeks | 
| Patient Activation Measure (PAM) | Operationalized as assigning participants to one of four PAM levels based upon scores | 3 months post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, pregnant