Substance Use in Pregnancy- Optimizing Retention in Treatment by Maximizing Opportunities for Management
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Number of participants with no unplanned 60-day gap in clinical care
研究概览
简要总结
Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.
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
- •Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver
- •Diagnosis of SUD as defined by DSM-5 and/or as documented in the clinical record
- •18 years of age or older
- •Two or more positive domains in first screening for social drivers of health
- •Receiving ongoing care at participating study site
排除标准
- •Declining follow-up care at participating study site
- •Participated in R61 pilot study for CM
- •Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach
- •Unable to participate in English
研究组 & 干预措施
Contingency Management
Receiving social drivers screening, all standard clinical care, and contingency management
干预措施: Contingency Management (Behavioral)
Contingency Management
Receiving social drivers screening, all standard clinical care, and contingency management
干预措施: Social Drivers of Health Screening (Other)
Usual Care
Receiving social drivers screening and all standard clinical care
干预措施: Social Drivers of Health Screening (Other)
结局指标
主要结局
Number of participants with no unplanned 60-day gap in clinical care
时间窗: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Median number of days until time to loss to follow-up
时间窗: From date of randomization until 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Median number of days until loss to follow-up defined as unplanned 60-day gap in clinical care
Number of Urine Drug Screen (UDS) positive for prescribed Medication for Opioid Use Disorder (MOUD)
时间窗: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks
次要结局
- Number of urine drug screen (UDS) negative for non prescribed substances(Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks)
- Number of patients randomized pregnant that have preterm birth(After randomization, at delivery)
- Number of liveborn opioid exposed infants receiving pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome(After randomization and delivery, during delivery admission, up to 1 month after delivery)
- Number of infants admitted to NICU(After randomization and delivery, during delivery admission)
- Median number of days of NICU Length of Stay(After randomization and delivery, during delivery admission, until delivery admission discharge, an average of two weeks)
- Median number of maternal hospital admissinons to inpatient service(Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks)
- Number of participants with overdose(Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks)
- Number of maternal deaths(Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks)
- Number of participants with custody of infant at hospital discharge(At infant discharge from delivery admission, an average of two weeks)
- Count of participants reporting each child custody scenario(6 months post randomization)