Recruitment

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