The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

Phase 3

Recruiting

• Conditions: Pregnancy Related
• Interventions: Behavioral: OPTIMIZE

• Registration Number: NCT04261894
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Study Start: 2021-06-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Age 15 to 45 years
• Self-identified as Black/African American
• Pregnant or recently gave birth (less than 6 months post-delivery)
• English speaking

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Exclusion Criteria

• Cognitive impairment
• Incarceration
• Adults unable to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTIMIZE	OPTIMIZE	This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support.

Primary Outcome Measures

Name	Time	Method
Receipt of Perinatal Care Components	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.

Secondary Outcome Measures

Name	Time	Method
Rate of human papillomavirus vaccine	Up to 6 months postpartum	Proportion of women receiving human papillomavirus vaccine
Rate of influenza vaccine uptake	Up to 6 months postpartum	Proportion of women receiving influenza vaccine
Rate of breastfeeding	6 weeks, 3 months, and 6 months postpartum	Measured by patient report of feedings per day and week
Rate of depressive symptoms	Baseline through 6 months postpartum	Proportion of women with postpartum depression as measured by Patient Health Questionnaire-9
Rate of postpartum contraception uptake and adherence	Up to 6 months postpartum	Proportion of women receiving and maintaining contraception
Rate of Tetanus, Diphtheria, Pertussis vaccine uptake	Up to 6 months postpartum	Proportion of women receiving Tetanus, Diphtheria, Pertussis vaccine

Trial Locations

Locations (1)

ACCESS Community Health Network; 🇺🇸 Chicago, Illinois, United States