Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care

Summary

The overarching goal of Thriving Hearts is to implement a multi-level program through Local Health Departments (LHDs) that cultivates conditions for mothers and birthing people to not only survive pregnancy, but to thrive. Thriving Hearts is a collaboration among LHDs in ten North Carolina counties, designed to reduce incidence of Hypertensive Disorders of Pregnancy (HDP) and their complications through support and connection at the individual, healthcare provider, and community level. The investigators will conduct a pragmatic, stepped-wedge, cluster randomized study. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in clusters in a randomly assigned sequence at 9-month intervals.

Conditions

• Hypertensive Disorder of Pregnancy

Interventions

OTHER

Usual Care

Prior to implementation of the Thriving Hearts package of services, people living in participating counties will receive usual care for pregnancy, birth, and postpartum services. The study team will quantify existing services using a study-developed usual care assessment instrument.

BEHAVIORAL

Thriving Hearts

Thriving Hearts is a collaboration among LHDs in ten North Carolina counties. At the individual level, pregnant individuals will self-screen for HDP risk during prenatal visits, and those at risk will be provided a Mama Hearts Care Kit, including a home blood pressure monitor, low dose aspirin, and culturally tailored educational materials. At the healthcare provider level, burnout and compassion fatigue will be addressed through skill-building activities, including training in the Community Resilience and Mindfulness-Based Stress Reduction. At the community level, Loving Connection will provide proactive material and social support through Community Health Workers, text messaging-based communication, a medical legal partnership, and capacity-building support for community-based organizations.

Sponsors & Collaborators

• Orange County Health Department

  collaborator UNKNOWN

• Duke University

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• The North Carolina Alliance of Public Health Agencies, Inc.

  collaborator UNKNOWN

• Jacaranda Health

  collaborator OTHER

• Piedmont Health Services, Inc.

  collaborator UNKNOWN

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Alison M Stuebe, MD, MSc · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• United States

Study Locations