The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 2
- 主要终点
- Receipt of Perinatal Care Components
研究概览
简要总结
This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care.
详细描述
African American women and their infants experience profound perinatal health disparities. The purpose of this study is to develop and evaluate the OPTIMIZE intervention, which is an integrated and comprehensive perinatal care checklist with patient navigation support, using a Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial among 600 African American women (15-45 years of age and 1st-2nd trimester of pregnancy) recruited from approximately 20 clinics affiliated with two Chicago area community health center networks that are the largest providers of perinatal care for low-income African American women in Chicago. Clinic sites will be randomized 1:1 to standard perinatal care (control arm) or standard perinatal care plus the OPTIMIZE checklist with Patient Navigation support starting from the initial prenatal visit and up through 12-weeks postpartum (intervention arm).
The study will test the central hypothesis that African American women in the OPTIMIZE intervention group will have received a greater proportion of recommended perinatal care components (prenatal care content, postpartum care content, and social determinants of health content) consistent with American College of Obstetricians and Gynecologists guidelines than African American women in the standard care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 15 to 45 years
- •Self-identified as Black/African American
- •Pregnant or recently gave birth (less than 6 months post-delivery)
- •English speaking
排除标准
- •Cognitive impairment
- •Incarceration
- •Adults unable to consent
研究组 & 干预措施
Standard Care
This arm includes provision of standard perinatal care.
OPTIMIZE
This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support.
干预措施: OPTIMIZE (Behavioral)
结局指标
主要结局
Receipt of Perinatal Care Components
时间窗: Baseline through 6 months postpartum
The primary outcome will be a composite proportion of perinatal care components across three domains, including prenatal care, postpartum care, and social determinants of health content compared between the intervention and control arms.
次要结局
- Rate of human papillomavirus vaccine(Up to 6 months postpartum)
- Rate of influenza vaccine uptake(Up to 6 months postpartum)
- Rate of breastfeeding(6 weeks, 3 months, and 6 months postpartum)
- Rate of depressive symptoms(Baseline through 6 months postpartum)
- Rate of postpartum contraception uptake and adherence(Up to 6 months postpartum)
- Rate of Tetanus, Diphtheria, Pertussis vaccine uptake(Up to 6 months postpartum)
研究者
Melissa Simon
Vice Chair of Clinical Research
Northwestern University