Treatment of Pregnant Women With OUD (SMART)
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| ClinicalTrials.gov Identifier: NCT04240392 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2020
Last Update Posted : December 21, 2020
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Sponsor:
Yale University
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Yale University
- Study Details
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Brief Summary:
The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opioid-use Disorder | Behavioral: Collaborative Care (CC) Behavioral: Extension for Community Healthcare Outcomes (ECHO) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 480 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women |
| Actual Study Start Date : | June 18, 2020 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | July 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: 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. |
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Active Comparator: 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.
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Behavioral: 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. |
Primary Outcome Measures :
- Treatment Engagement [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]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
- Patient Activation Measure (PAM) [ Time Frame: 24 weeks ]Operationalized as assigning participants to one of four PAM levels based upon scores
- Patient Activation Measure (PAM) [ Time Frame: 36 weeks ]Operationalized as assigning participants to one of four PAM levels based upon scores
- Patient Activation Measure (PAM) [ Time Frame: 3 months post delivery ]Operationalized as assigning participants to one of four PAM levels based upon scores
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Pregnant women with opioid use disorder |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240392
Contacts
| Contact: Karen A Hunkele, BA | 203-764-8124 | karen.hunkele@yale.edu | |
| Contact: Kathryn Gilstad-Hayden, MS | 203-764-7210 | kathryn.gilstad-hayden@yale.edu |
Locations
| United States, Connecticut | |
| Bridgeport Hospital | Recruiting |
| Bridgeport, Connecticut, United States, 06610 | |
| Contact: Crina Boeras, MD Crina.boeras@bpthosp.org | |
| Hospital of Central Connecticut | Not yet recruiting |
| New Britain, Connecticut, United States, 06052 | |
| Contact: Shannon Shiel, MD shannon.shiel@hhchealth.org | |
| Contact: Karen Haverly, MD karen.haverly@hhchealth.org | |
| Principal Investigator: Shannon Shiel, MD | |
| Principal Investigator: Karen Haverly, MD | |
| Yale New Haven Hospital Maternal Fetal Medicine Unit | Recruiting |
| New Haven, Connecticut, United States, 06511 | |
| Contact: Heather Lipkind, MD heather.lipkind@yale.edu | |
| Yale New Haven Hospital Women's Center/Hill Health Center | Recruiting |
| New Haven, Connecticut, United States, 06511 | |
| Contact: Shefali Pathy, MD shefali.pathy@yale.edu | |
| Coastal ObGyn & Midwifery | Recruiting |
| New London, Connecticut, United States, 06320 | |
| Contact: Amy Snyder, MD Amy.l.snyder@gmail.com | |
| OB Gyn Services PC | Recruiting |
| Norwich, Connecticut, United States, 06360 | |
| Contact: David Kalla, MD david.kalla@hhchealth.org | |
| Stamford Hospital | Recruiting |
| Stamford, Connecticut, United States, 06902 | |
| Contact: Scott Chudnoff, MD Schudnoff@stamhealth.org | |
| Waterbury Hospital | Not yet recruiting |
| Waterbury, Connecticut, United States, 06708 | |
| Contact: Maria Munoz, MD mafermu7@gmail.com | |
| United States, Massachusetts | |
| Essex County ObGyn | Recruiting |
| Beverly, Massachusetts, United States, 01915 | |
| Contact: Melissa Sherman, MD melissa.sherman@lahey.org | |
| Beth Israel Deaconess Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Leanna Sudhoff, MD lsudhoff@bidmc.harvard.edu | |
| Women's Health, Lowell General Hospital | Recruiting |
| Lowell, Massachusetts, United States, 01854 | |
| Contact: Kristin D'Orsi, MD kristin.DOrsi@lowellgeneral.org | |
| Wesson's Women's Clinic UMASS Baystate | Not yet recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| Contact: Megan Miller, MD megan.millerMD@baystatehealth.org | |
Sponsors and Collaborators
Yale University
Patient-Centered Outcomes Research Institute
Investigators
| Principal Investigator: | Ariadna Forray, MD | Yale University |
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT04240392 |
| Other Study ID Numbers: |
2000027031 MAT-2018C2-12891 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) ) |
| First Posted: | January 27, 2020 Key Record Dates |
| Last Update Posted: | December 21, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-Identified data will be made available to other researchers upon request. Please contact Dr. Yonkers. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | 2 years after the end of the study |
| Access Criteria: | we will ask people to complete a request form |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Yale University:
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opioid pregnant |
Additional relevant MeSH terms:
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Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |