Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05588245 |
| Other study ID # |
STUDY00004987 |
| Secondary ID |
R01NR020756-02 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 25, 2024 |
| Est. completion date |
June 2027 |
Study information
| Verified date |
May 2024 |
| Source |
Emory University |
| Contact |
Anne L Dunlop, MD |
| Phone |
678-480-5285 |
| Email |
amlang[@]emory.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
