Trial of Community-based Patient Navigation (NCT05588245) | Clinical Trial Compass
RecruitingNot Applicable
Trial of Community-based Patient Navigation
United States540 participantsStarted 2024-01-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.