Clinical trial NCT04261894: The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
Official title: The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 548
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of Perinatal Care Components
timeFrame: Baseline through 6 months postpartum
Secondary outcomes:
measure: Rate of breastfeeding
timeFrame: 6 weeks, 3 months, and 6 months postpartum
measure: Rate of depressive symptoms
timeFrame: Baseline through 6 months postpartum
measure: Rate of postpartum contraception uptake and adherence
timeFrame: Up to 6 months postpartum
measure: Rate of influenza vaccine uptake
timeFrame: Up to 6 months postpartum
measure: Rate of Tetanus, Diphtheria, Pertussis vaccine uptake
timeFrame: Up to 6 months postpartum
measure: Rate of human papillomavirus vaccine
timeFrame: Up to 6 months postpartum
Other outcomes:
Locations:
city: Chicago
country: United States
facility: ACCESS Community Health Network
state: Illinois
Study officials:
affiliation: Northwestern University
name: Melissa A Simon, MD
role: PRINCIPAL_INVESTIGATOR
References: