Clinical trial NCT05588245: Trial of Community-based Patient Navigation
Official title: A Pragmatic Trial of Integrating Community-based Patient Navigation Into the Continuum of Maternal Care for Black Women in a Safety-Net Health System: Effects on Maternal Health, Health Care, Morbidity, and Mortality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-10-20
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.

Detailed description: Severe maternal morbidities (SMM) are outcomes of labor and delivery that result in serious effects on short- or long-term health. Many SMM represent "near miss" events for maternal deaths. In Georgia, Black women experience SMM at a rate far higher than women of other races and ethnicities. Equity-centered models of care - such as embedding patient navigators into the maternity care continuum - offer promise for improving maternal health through meeting the social needs, lowering stress, and promoting access to and utilization of care for those giving birth. To date, however, research about maternity care navigation's effectiveness and needed inputs for its adoption into clinical care are lacking. To fill this research gap, the investigators propose to complete a pragmatic randomized controlled trial (RCT) of integrating community-based patient navigators into maternal care of Black women being cared for through Grady Health System (a safety net health system in Atlanta). The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. The first arm (the comparison group) will receive the standard of care. The second arm (the intervention group) will receive a community-based patient navigator with 3 prenatal contacts and 5 postpartum contacts; during each contact, the community-based patient navigator will offer health assessment and education, along with group education and social support. For participants in both arms, the researchers will collect data on patient-level measures upon enrollment (\<20 weeks' of pregnancy), at 6-8 weeks postpartum, and at 12 months postpartum; data collection will involve questionnaires, review of case logs and review of medical records. Measures of effectiveness will include the number of SMM and maternal death events per woman (primary outcome). To evaluate how the intervention might reduce primary outcomes, questionnaires will also assess measures of unmet need, stress and depressive symptoms, attendance of prenatal and postpartum care. Embedded process evaluation will assess the number and content of navigation encounters in which the woman participates and the acceptability of the intervention from patient and provider perspectives.

Written informed consent will be obtained as a criterion for participation. All participants will be compensated for their time. Confidentiality will be maintained on several levels including training of investigators and staff, restrictions on data access, and use of HIPPA-compliant data storage procedures. Data will be stripped of identifiers before analysis and destroyed when no longer needed.

This study will be among the first to test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.

Eligibility criteria: Inclusion Criteria:

* A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),
* ≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record),
* covered by Medicaid
* for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs
* expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment.

Exclusion Criteria:

* The intent to transfer care to a health system outside of metro Atlanta
* incarceration, which would interfere with intervention provision and outcome ascertainment
* adults unable to give consent
* individuals who are not yet adults
* prisoners
* cognitively impaired individuals with impaired decision-making capacity
* individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)

Primary outcomes:
measure: Change in number of SMM and maternal death events
timeFrame: Baseline, 12 months postpartum
Secondary outcomes:
measure: Change in number of post-delivery maternal morbidity (non-SMM) events
timeFrame: Baseline, 12 months postpartum
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Anne L Dunlop, MD
role: PRINCIPAL_INVESTIGATOR
References: