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Treatment of Pregnant Women With OUD (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240392
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 5, 2019
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE June 18, 2020
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • Treatment Engagement [ Time Frame: 12 months ]
    Dichotomous- A participant completes engagement if the baseline assessment is completed and the participant has at least 1 visit per month for 3 months 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Pregnant Women With OUD
Official Title  ICMJE Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Collaborative Care (CC)
  • 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.
    Intervention: Behavioral: Extension for Community Healthcare Outcomes (ECHO)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women with opioid use disorder
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04240392
Other Study ID Numbers  ICMJE 2000027031
MAT-2018C2-12891 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Ariadna Forray, MD Yale University
PRS Account Yale University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP