Treatment of Pregnant Women With OUD

Opioid-use Disorder Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04240392
• Other study ID #: 2000027031
• Secondary ID: MAT-2018C2-12891
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: November 14, 2024

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: November 14, 2024
• Est. primary completion date: November 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
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	Hartford Hospital	Hartford	Connecticut
United States	Women's Health, Lowell General Hospital	Lowell	Massachusetts
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	Wesson's Women's Clinic UMASS Baystate	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days from baseline
Primary	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 1 month	delivery and three-month post-partum
Primary	Patient Activation Measure (PAM)	The PAM is a patient-centered questionnaire that measures health care knowledge, beliefs, skills and confidence in managing illnesses. The PAM has 13 items with a 5-point Likert response scale. The raw scores are summed and transformed to 0-100 metric (0 = lowest activation level, 100 = highest).	baseline, week 26, week 36 and 3-monhts post-partum