Study Results
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View full resultsBasic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2020-06-18
2024-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Collaborative Care (CC)
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)
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.
Extension for Community Healthcare Outcomes (ECHO)
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.
Interventions
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Collaborative Care (CC)
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Ariadna Forray, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Hospital of Central CT
New Britain, 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
Coastal ObGyn & Midwifery
New London, Connecticut, United States
OB Gyn Services PC
Norwich, Connecticut, United States
Essex County ObGyn
Beverly, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
AFA Obstetrics & Gynecology
Concord, Massachusetts, United States
Women's Health, Lowell General Hospital
Lowell, Massachusetts, United States
Wesson's Women's Clinic UMASS Baystate
Springfield, Massachusetts, United States
Countries
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References
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Kaufman JS, Yonkers KA, Maltz C, Friedhoff CM, Londono Tobon A, Mele A, Tessier-Kay M, Grechukhina O, Lipkind H, Byatt N, Forray A. Reporting Perinatal Substance Use to Child Protective Services: Obstetric Provider Perspectives on the Impact on Care. J Womens Health (Larchmt). 2024 Nov;33(11):1501-1508. doi: 10.1089/jwh.2023.0822. Epub 2024 May 21.
Forray A, Mele A, Byatt N, Londono Tobon A, Gilstad-Hayden K, Hunkle K, Hong S, Lipkind H, Fiellin DA, Callaghan K, Yonkers KA. Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics. PLoS One. 2022 Jan 13;17(1):e0261751. doi: 10.1371/journal.pone.0261751. eCollection 2022.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MAT-2018C2-12891
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2000027031
Identifier Type: -
Identifier Source: org_study_id
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