The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pregnancy Related
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic TrialMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 15 years and 45 years
- Gender
- Only males
Description
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 ...
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.
Tracking Information
- NCT #
- NCT04261894
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Melissa A Simon, MD Northwestern University