NCT07869212

Brief Summary

Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to prenatal and postpartum services, and downstream clinical outcomes related to maternal morbidity and mortality.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
50mo left

Started Apr 2027

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2031

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3 years

First QC Date

September 30, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Community Care HubsCommunity Health WorkerPrenatal CarePostpartum CareIntegrated Data SystemsResiliency Skill BuildingLearning Collaboratives

Outcome Measures

Primary Outcomes (1)

  • Timely prenatal and postpartum care connection

    Prenatal care initiation and postpartum care attendance

    Prenatal care visit within first trimester AND postpartum care visit within 7-84 days after delivery

Secondary Outcomes (9)

  • Screening completion rates

    First trimester of pregnancy

  • Brief Resiliency Scale

    Annually during the trial

  • Self-efficacy for CHWs

    Annually during the trial

  • turnover intention

    Annually during the trial

  • Patient engagement

    Postpartum (7-84 days after delivery)

  • +4 more secondary outcomes

Study Arms (4)

Arm 1: Integrated Data Systems

OTHER

Community Care Hub infrastructure enhanced with Integrated Data Systems support.

Other: Integrated Data Systems

Arm 2: Integrated Data Systems + Learning Collaborative

OTHER

Community Care Hub infrastructure enhanced with Integrated Data Systems and Learning Collaborative support.

Other: Integrated Data SystemsOther: Learning Collaborative

Arm 3: Integrated Data Systems + Resiliency Skill Building

OTHER

Community Care Hub infrastructure enhanced with Integrated Data Systems and Resiliency Skill Building support.

Other: Integrated Data SystemsOther: Resiliency Skill Building

Arm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building

OTHER

Community Care Hub infrastructure enhanced with Integrated Data Systems, Learning Collaborative and Resiliency Skill Building support.

Other: Integrated Data SystemsOther: Learning CollaborativeOther: Resiliency Skill Building

Interventions

Integrated Data Systems support intervention includes standardized social needs screening, improved data sharing and care coordination and health information exchange integration.

Arm 1: Integrated Data SystemsArm 2: Integrated Data Systems + Learning CollaborativeArm 3: Integrated Data Systems + Resiliency Skill BuildingArm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building

Learning Collaborative intervention includes specialized perinatal training for CHWs, peer learning and expert-led education, and trauma-informed and evidence-based care practices.

Arm 2: Integrated Data Systems + Learning CollaborativeArm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building

Resiliency Skill Building intervention includes Community Resiliency Model training, burnout prevention and workforce well-being support and ongoing coaching for CHWs and supervisors.

Arm 3: Integrated Data Systems + Resiliency Skill BuildingArm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
The trial includes 8 Pathways Community Hubs located throughout Ohio. Hubs are randomly assigned to study conditions rather than individual participants.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Officials

  • Daniel Walker, PhD, MPH

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Binkley, PhD, MSc, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: This study is an experimental, cluster-randomized trial using a 2×2 factorial design. The research evaluates hub-level system-level and workforce-level interventions implemented within Pathways Community Hubs that serve pregnant and postpartum individuals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair of Research and Associate Professor

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 9, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

April 30, 2031

Last Updated

October 9, 2026

Record last verified: 2026-10