Trial of Community-based Patient Navigation

NCT05588245 | Recruiting DMC

• 2 other identifiers: STUDY00004987R01NR020756-02
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Change in number of SMM and maternal death events

  This is a count measure that reflects the total number of SMM and/or death events during the delivery admission through 12-months of delivery according to the presence/absence of the 21 SMM indicator diagnosis codes (as published by the Centers for Disease Control and Prevention) and/or a death event documented in the EPIC electronic medical record.

  Baseline, 12 months postpartum

Secondary Outcomes (1)

• Change in number of post-delivery maternal morbidity (non-SMM) events

  Baseline, 12 months postpartum

Study Arms (2)

Comparison Group (Standard of Care)

ACTIVE COMPARATOR

Participants will receive the standard of care.

Behavioral: Standard of Care

Intervention Group

EXPERIMENTAL

Participants 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.

Behavioral: Community-based prenatal/perinatal/postpartum patient navigator

Interventions

Standard of Care BEHAVIORAL

Participants will undergo the same SDoH screener (AHC-Health Related Social Needs Tool) as full intervention participants, which will serve as the basis for a one-time brief session with the clinical research coordinator that will involve review of a 'Resource Guide' that provides a listing of available community resources to meet common social needs. Participants in this arm will also complete other prenatal and postpartum data collection items over the course of the study (with the exception of qualitative interviews).

Comparison Group (Standard of Care)

Community-based prenatal/perinatal/postpartum patient navigator BEHAVIORAL

Uses Freeman's principles of navigation to enhance patient access to care (e.g., help patients manage appointments), promote patient self-efficacy (e.g., connect patients to community housing, food, transportation resources), and sustain engagement with the healthcare system (e.g., bridge perinatal and primary care).

Also known as: PPP-PN

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anne L Dunlop, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne L Dunlop, MD

CONTACT

678-480-5285; amlang@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: January 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available in the final year of the study (Year 5, anticipated starting September 2026) when all data collection is complete and will be available thereafter.
• Access Criteria: Consistent with the NIH Data Sharing Policy, the investigators will make the de-identified data and associated documentation available to users under a data-sharing agreement. To gain access to study data, anyone not part of the original research protocol will submit a Data Analysis Request Form, which requires elucidation of the specific data requested along with a statement that the investigator must provide: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)