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

NCT06744231 | Enrolling By Invitation

• 1 other identifier: 24-2138
• Study Type: interventional
• Target: 17,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Community health workers; Medical Legal Partnership; Home blood pressure monitoring; Low dose aspirin; Community Resilience Model; Trauma-informed care; Healing Centered Engagement; Sense of community; Person-centered maternity care

Outcome Measures

Primary Outcomes (1)

• Hypertensive Disorder of Pregnancy

  Population-level incidence of hypertensive disorders of pregnancy. The primary outcome population consist of all births to residents of the 10 Thriving Hearts counties between January 1, 2025 and June 30, 2029. The outcome is ascertained using secondary data from birth certificates, electronic health records, and claims data. Informed consent is not obtained from individuals for this secondary data-based ascertainment.

  Between admission for delivery and 4 weeks postpartum for births occurring between January 1, 2025 and June 30, 2029, as determined from EMR, claims, and administrative data.

Secondary Outcomes (5)

• Change in Brief Professional Quality of Life Score among people who serve pregnant women in Thriving Hearts Counties

  Cross-sectional survey of individuals who serve pregnant women in Thriving Hearts counties, repeated during each of the six study time periods, at months 6, 15, 24, 33, 42, and 51.

• Change in World Health Organization (WHO)-5 Wellbeing Index among people who serve pregnant women in Thriving Hearts Counties

  Cross-sectional survey of individuals who serve pregnant women in Thriving Hearts counties, repeated during each of the six study time periods, at months 6, 15, 24, 33, 42, and 51.

• Person-Centered Maternity Care Scale Score, postpartum survey

  Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth

• Brief Sense of Community Scale, postpartum survey

  Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth

• World Health Organization (WHO)-5 Wellbeing Index, postpartum survey

  Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth

Study Arms (2)

Pre-intervention

PLACEBO COMPARATOR

In the pre-intervention sequence(s), pregnant and parenting people in participating counties will experience treatment-as-usual.

Other: Usual Care

Post-intervention

ACTIVE COMPARATOR

In the post-intervention sequence(s), pregnant and parenting people in participating counties will experience care enhanced with Thriving Hearts components, including point-of-care HDP prevention, health care providers equipped with resources for coping with secondary trauma, and proactive provision of social and material support.

Behavioral: Thriving Hearts

Interventions

Usual Care OTHER

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.

Pre-intervention

Thriving Hearts BEHAVIORAL

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.

Post-intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥15 and ≤55
• Had a live birth at \>=24 weeks in the past 6 months
• Listed the birthing parent's residential address on the birth certificate as within a Thriving Hearts county ( Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
• Are able to communicate in English or Spanish

You may not qualify if:

• \< 15 or \> 55 years of age
• Did not have a live birth at \>= 24 weeks in the past 6 months
• Residential address not listed on birth certificate as one of the study counties
• Not able to communicate in either English
• Cross-sectional survey of people who serve perinatal patients
• To assess the effectiveness of the Healing Centered Engagement program, the team will conduct cross-sectional surveys of people who serve perinatal patients in Thriving Hearts counties, repeated during each of the six study time periods
• Age ≥ 18
• Provides services for perinatal patients in a Thriving Hearts county (Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
• Are able to communicate in English
• Age \< 18
• Does not provide services for perinatal patients in a Thriving Hearts county (Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
• Are unable to communicate in English

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Orange County Health Department: collaborator
• Duke University: collaborator
• Wake Forest University Health Sciences: collaborator
• The North Carolina Alliance of Public Health Agencies, Inc.: collaborator
• Jacaranda Health: collaborator
• Piedmont Health Services, Inc.: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• PCORI: Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care
• Thriving Hearts project web site

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Alison M Stuebe, MD, MSc

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators plan a multisite step-wedge cluster randomized trial to test the extent to which the a Local Health Department led population health program reduces rates of hypertensive disorders of pregnancy (HDP, primary outcome), patient experience measures (secondary outcomes) and maternity health worker quality of life (secondary outcome). The Thriving Hearts program will be implemented in a stepped-wedge design with six nine-month time periods, 3 sequences, and 3 or 4 counties in each sequence, with 10 counties in total.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 to 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)