Randomized Trial: Optimizing Pregnancy and Treatment Interventions for Moms (OPTI-Mom) 3.0
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 429
- 试验地点
- 1
- 主要终点
- Change in illicit opioid use
研究概览
简要总结
We want to learn if Patient Navigation helps pregnant Medicaid members with opioid use disorder, with or without stimulant use disorder, stay in care, use medications for opioid use disorder, reduce substance use, and connect with services, compared to usual care.
Enrolled participants will be randomly assigned (by chance, like flipping a coin) to one of two groups: Usual Care or Patient Navigation.
Participate will last up to 14 months and participants randomized to Patient Navigation may have about 14 sessions/calls with a Patient Navigator (30-45 minutes each) and complete 3 surveys (30-60 minutes each). All visits can be by phone or video.
详细描述
Pregnant and postpartum individuals with opioid use disorder (OUD) experience a disproportionate burden of morbidity, mortality, and overdose risk in the United States. Increasingly, this population is affected by co-occurring stimulant use disorder (StUD), which further complicates treatment engagement and outcomes. Although many individuals attempt to discontinue substance use during pregnancy, withdrawal symptoms, psychosocial stressors, stigma, and unmet health-related social needs frequently contribute to return to use. Return to use is strongly associated with treatment disengagement, adverse maternal and neonatal outcomes, and increased risk of overdose.
Medication for opioid use disorder (MOUD), including buprenorphine and methadone, is the standard of care during pregnancy and is associated with reduced overdose risk and improved outcomes. However, MOUD alone is often insufficient to address complex behavioral, social, and structural barriers to sustained recovery. In addition, there are no FDA-approved medications for stimulant use disorder, and optimal behavioral strategies to address co-occurring OUD and StUD and improve treatment retention remain unclear.
Existing integrated and comprehensive care models have shown benefits but are often resource-intensive, difficult to scale, and may inadequately address social determinants of health and patient self-management. Patient Navigation (PN) is a patient-centered, scalable model designed to reduce barriers to care, improve coordination across fragmented health and social service systems, and provide individualized motivational support. PN has demonstrated effectiveness across chronic health conditions and shows promise for improving outcomes among pregnant persons with OUD.
This study evaluates an enhanced PN intervention for pregnant persons with OUD with or without co-occurring StUD (OUD±StUD). The intervention integrates strengths-based case management, motivational interviewing, and contingency management (CM), an evidence-based behavioral approach that reinforces treatment engagement and behavior change through incentives and is among the most effective interventions for stimulant use.
This mixed-methods, type 2 hybrid effectiveness-implementation study includes three components:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Adult (≥18 years)
- •Opioid use disorder
- •≥7 weeks gestation
- •Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD)
- •Provide permission to access administrative claims and medical records of their care and those of their neonate
- •Speak English
排除标准
- •Plan to terminate pregnancy
- •Had a psychotic and/or manic episode in the last 30 days
- •Cannot provide contact information for themselves and 2 collateral contacts
- •Do not possess a reliable phone
- •Plan to move from the area ≤6 months of delivery
- •>32 weeks gestation
研究组 & 干预措施
Usual Care
This arm includes brief case management and referral.
Patient Navigation
The intervention portion consists of sessions delivered in both the participant's prenatal and postnatal period.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Change in illicit opioid use
时间窗: 36 months
14-panel urine toxicology Timeline Follow Back (TLFB)
次要结局
未报告次要终点
研究者
Jerry Cochran
Professor
University of Utah