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Treatment of Pregnant Women With OUD (SMART)

Primary Purpose

Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care (CC)
Extension for Community Healthcare Outcomes (ECHO)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid, pregnant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hartford HospitalRecruiting
  • Hospital of Central CTRecruiting
  • Yale New Haven Hospital Maternal Fetal Medicine UnitRecruiting
  • Yale New Haven Hospital Women's Center/Hill Health CenterRecruiting
  • Coastal ObGyn & MidwiferyRecruiting
  • OB Gyn Services PCRecruiting
  • Essex County ObGynRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • AFA Obstetrics & GynecologyRecruiting
  • Women's Health, Lowell General HospitalRecruiting
  • Wesson's Women's Clinic UMASS BaystateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collaborative Care (CC)

Extension for Community Healthcare Outcomes (ECHO)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
Patient Activation Measure (PAM)
Operationalized as assigning participants to one of four PAM levels based upon scores
Patient Activation Measure (PAM)
Operationalized as assigning participants to one of four PAM levels based upon scores
Patient Activation Measure (PAM)
Operationalized as assigning participants to one of four PAM levels based upon scores

Secondary Outcome Measures

Full Information

First Posted
September 5, 2019
Last Updated
October 4, 2023
Sponsor
Yale University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04240392
Brief Title
Treatment of Pregnant Women With OUD
Acronym
SMART
Official Title
Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
November 14, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
opioid, pregnant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care (CC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Extension for Community Healthcare Outcomes (ECHO)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Collaborative Care (CC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Extension for Community Healthcare Outcomes (ECHO)
Intervention Description
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 Measure Information:
Title
Treatment Engagement
Description
Dichotomous- A participant completes engagement if the baseline assessment is completed and the participant has greater than 2 visits for treatment of OUD
Time Frame
12 months
Title
Treatment Retention
Description
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
Time Frame
12 months
Title
Patient Activation Measure (PAM)
Description
Operationalized as assigning participants to one of four PAM levels based upon scores
Time Frame
24 weeks
Title
Patient Activation Measure (PAM)
Description
Operationalized as assigning participants to one of four PAM levels based upon scores
Time Frame
36 weeks
Title
Patient Activation Measure (PAM)
Description
Operationalized as assigning participants to one of four PAM levels based upon scores
Time Frame
3 months post delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women with opioid use disorder
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen A Hunkele, BA
Phone
203-764-8124
Email
karen.hunkele@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Gilstad-Hayden, MS
Phone
203-764-7210
Email
kathryn.gilstad-hayden@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariadna Forray, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Bakaysa, MD
Email
stephanie.bakaysa@hhchealth.org
Facility Name
Hospital of Central CT
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen OCCFB Haverly, MD
Email
karen.haverly@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Karen Haverly, MD
First Name & Middle Initial & Last Name & Degree
Karen Haverly, MD
Facility Name
Yale New Haven Hospital Maternal Fetal Medicine Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Grechukhina, MD
Email
olga.grechukhina@yale.edu
Facility Name
Yale New Haven Hospital Women's Center/Hill Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shefali Pathy, MD
Email
shefali.pathy@yale.edu
Facility Name
Coastal ObGyn & Midwifery
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sage Macleod, CNM
Email
sagecnm@gmail.com
Facility Name
OB Gyn Services PC
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kalla, MD
Email
david.kalla@hhchealth.org
Facility Name
Essex County ObGyn
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Sherman, MD
Email
melissa.sherman@lahey.org
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hacker, ScD
Email
mhacker@bidmc.harvard.edu
Facility Name
AFA Obstetrics & Gynecology
City
Concord
State/Province
Massachusetts
ZIP/Postal Code
01742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherriann Perivolotis, CNM
Phone
978-371-1396
Facility Name
Women's Health, Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin D'Orsi, MD
Email
kristin.DOrsi@lowellgeneral.org
Facility Name
Wesson's Women's Clinic UMASS Baystate
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Miller, MD
Email
megan.millerMD@baystatehealth.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-Identified data will be made available to other researchers upon request. Please contact Dr. Yonkers.
IPD Sharing Time Frame
2 years after the end of the study
IPD Sharing Access Criteria
we will ask people to complete a request form
Citations:
PubMed Identifier
35025898
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Pregnant Women With OUD

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