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Completed

NCT Number: NCT04261894

The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

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.

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Key information

Conditions

Pregnancy Related

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ACCESS Community Health Network

Chicago, Illinois, 60609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPTIMIZE

Behavioral

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

Primary outcomes

  1. Receipt of Perinatal Care Components

    Time frame: 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 outcomes

  1. Rate of breastfeeding

    Time frame: 6 weeks, 3 months, and 6 months postpartum

    Measured by patient report of feedings per day and week

  2. Rate of depressive symptoms

    Time frame: Baseline through 6 months postpartum

    Proportion of women with postpartum depression as measured by Patient Health Questionnaire-9

  3. Rate of postpartum contraception uptake and adherence

    Time frame: Up to 6 months postpartum

    Proportion of women receiving and maintaining contraception

  4. Rate of influenza vaccine uptake

    Time frame: Up to 6 months postpartum

    Proportion of women receiving influenza vaccine

  5. Rate of Tetanus, Diphtheria, Pertussis vaccine uptake

    Time frame: Up to 6 months postpartum

    Proportion of women receiving Tetanus, Diphtheria, Pertussis vaccine

  6. Rate of human papillomavirus vaccine

    Time frame: Up to 6 months postpartum

    Proportion of women receiving human papillomavirus vaccine

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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