Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 22
- 主要终点
- Treatment Engagement
研究概览
简要总结
The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Collaborative Care (CC) (Behavioral)
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.
干预措施: Extension for Community Healthcare Outcomes (ECHO) (Behavioral)
结局指标
主要结局
Treatment Engagement
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点