RECRUITING

Trial of Community-based Patient Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-01-25
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05588245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),
  2. * ≥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),
  3. * covered by Medicaid
  4. * for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs
  5. * 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.
  1. * The intent to transfer care to a health system outside of metro Atlanta
  2. * incarceration, which would interfere with intervention provision and outcome ascertainment
  3. * adults unable to give consent
  4. * individuals who are not yet adults
  5. * prisoners
  6. * cognitively impaired individuals with impaired decision-making capacity
  7. * individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)

Contacts and Locations

Study Contact

Anne L Dunlop, MD
CONTACT
678-480-5285
amlang@emory.edu

Principal Investigator

Anne L Dunlop, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady Memorial Hospital
Atlanta, Georgia, 30303
United States

Collaborators and Investigators

Sponsor: Emory University

  • Anne L Dunlop, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-25
Study Completion Date2027-06

Study Record Updates

Study Start Date2024-01-25
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related