Clinical trial NCT04240392: Treatment of Pregnant Women With OUD
Official title: Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: opioid
pregnant
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-01-27
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Treatment Engagement
timeFrame: 30 days from baseline
measure: Treatment Retention
timeFrame: delivery and three-month post-partum
measure: Patient Activation Measure (PAM)
timeFrame: baseline, week 26, week 36 and 3-monhts post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Britain
country: United States
facility: Hospital of Central CT
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital Maternal Fetal Medicine Unit
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital Women's Center/Hill Health Center
state: Connecticut
city: New London
country: United States
facility: Coastal ObGyn & Midwifery
state: Connecticut
city: Norwich
country: United States
facility: OB Gyn Services PC
state: Connecticut
city: Beverly
country: United States
facility: Essex County ObGyn
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Concord
country: United States
facility: AFA Obstetrics & Gynecology
state: Massachusetts
city: Lowell
country: United States
facility: Women's Health, Lowell General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Wesson's Women's Clinic UMASS Baystate
state: Massachusetts
Study officials:
affiliation: Yale University
name: Ariadna Forray, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.