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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: OPTIMIZE

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anastasia Harris, MPH, CHES; Phone Number: (774) 361-3215; Email: OPTIMIZEstudy@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60609
      • Recruiting
      • Access Community Health Network
      • Contact: Danielle Lazar
      • Principal Investigator: Danielle Lazar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPTIMIZE; This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support.	Behavioral: OPTIMIZE; 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
No Intervention: Standard Care; This arm includes provision of standard perinatal care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Melissa A Simon, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SP0052930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No