Treatment of Pregnant Women With OUD

Not Applicable

Completed

Conditions: Opioid-use Disorder

Registration Number: NCT04240392

Lead Sponsor: Yale University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 230

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Engagement	30 days from baseline	Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD
Treatment Retention	delivery and three-month post-partum	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. The numbers reported below for 3 months postpartum differ from those in the Participant Flow, as the numbers in the Participant Flow represent only completed REDCap survey assessments. For the retention outcome, we could utilize additional sources of data collection, such as medical records, site reports, and treatment utilization forms (which were done more frequently than survey assessments), thus resulting in a higher N for this outcome.
Patient Activation Measure (PAM)	baseline, week 26, week 36 and 3-monhts post-partum	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). The Week 26 numbers below are lower than those in the Participant Flow because participants were allowed to enter the study after 26 weeks of pregnancy and did not have a separate baseline and Week 26 PAM assessment; instead, it was counted as their baseline PAM assessment only. However, other study assessments were unique to week 26 and were completed concurrently with baseline assessments, which were counted separately, accounting for the higher N for Week 26 in the Participant Flow. The postpartum ECHO sample size is 85 rather than 86 because one participant skipped the PAM questions during their 3-month postpartum assessment.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (11): Hartford Hospital
🇺🇸
Hartford, Connecticut, 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
Essex County ObGyn
🇺🇸
Beverly, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
AFA Obstetrics & Gynecology
🇺🇸
Concord, Massachusetts, United States
Women's Health, Lowell General Hospital
🇺🇸
Lowell, Massachusetts, United States
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Hartford Hospital
🇺🇸Hartford, Connecticut, United States