The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

NCT04261894 | Completed DMC

• 1 other identifier: SP0052930
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of breastfeeding

  6 weeks, 3 months, and 6 months postpartum

• Rate of depressive symptoms

  Baseline through 6 months postpartum

• Rate of postpartum contraception uptake and adherence

  Up to 6 months postpartum

• Rate of influenza vaccine uptake

  Up to 6 months postpartum

• Rate of Tetanus, Diphtheria, Pertussis vaccine uptake

  Up to 6 months postpartum

Study Arms (2)

OPTIMIZE

EXPERIMENTAL

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

Behavioral: OPTIMIZE

Standard Care

NO INTERVENTION

This arm includes provision of standard perinatal care.

Interventions

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

OPTIMIZE

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment
• Incarceration
• Adults unable to consent

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

ACCESS Community Health Network

Chicago, Illinois, 60609, United States

Location

Study Officials

• Melissa A Simon, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Clinical Research

Model Details: Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: June 23, 2021
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)