The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

Pregnancy Related Clinical Trial

Official title:

The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261894
• Other study ID #: SP0052930
• Status: Recruiting
• Phase: Phase 3
• Start date: June 23, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Anastasia Harris, MPH, CHES
• Phone: (774) 361-3215
• Email: OPTIMIZEstudy[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
United States	ACCESS Community Health Network	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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