The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

Conditions
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Pregnancy Related

Intervention / Treatment
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* Behavioral: OPTIMIZE


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Cognitive impairment Incarceration Adults unable to consent

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTIMIZE<br>This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support. | Behavioral: OPTIMIZE<br>* The study intervention is implementation of the OPTIMIZE perinatal care checklist with patient navigation support. The checklist will contain perinatal care components to be assessed for each participant. Specifically, the checklist will be built into the electronic health record as a secure digital record of: (1) the participant's adherence to the recommended prenatal and postpartum visit schedule, (2) the completion of procedures and processes in a participant's prenatal and postpartum standard care plan, and (3) the completion of processes to address social determinants of health, along with completion of referrals to appropriate support resources. The OPTIMIZE checklist will also include records of patient navigation review, engagement, and tracking of barrier status and resolution<br>|
| No Intervention: Standard Care<br>This arm includes provision of standard perinatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of Perinatal Care Components | 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. | Baseline through 6 months postpartum | 

Secondary Outcome Measures

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