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

NCT ID: NCT06744231

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2029-12-31

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.

Detailed Description

Birthing people in the United States experience unacceptable rates of severe maternal morbidity (SMM) and maternal mortality (MM). Hypertensive disorders of pregnancy (HDP) are a major contributor: among individuals who died during the birth hospitalization, one in three had an HDP diagnosis. Populations that have experienced structural racism are disproportionately affected. Compared with white birthing people, Black birthing people with HDP are more likely to experience severe morbidity, and they are 3.7 times more likely to die from HDP complications. To address the root causes of these disparities, multicomponent strategies are urgently needed. The overarching goal of Thriving Hearts is to implement such a multi-level intervention through Local Health Departments (LHDs), cultivating 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 HDP and its complications through support and connection at the individual, healthcare provider, and community level. At the individual level, Mama Hearts maternity care will provide evidence-based, culturally tailored, holistic preventative care for pregnant people at risk for HDP. At the healthcare provider level, the project will address burnout and compassion fatigue among LHD staff and community healthcare providers through healing-centered, trauma-informed care. At the community level, Loving Connection will deploy community health workers and an integrated medical-legal partnership to provide proactive support through universal, strength-based assistance in a mutual aid context, building awareness of local resources and cultivating spaces for community support, connection, and joy.

The Thriving Hearts study uses a hybrid type 1 effectiveness-implementation design. To quantify effectiveness, the team will conduct a pragmatic, stepped-wedge, cluster randomized trial, implementing the intervention through LHDs. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in pairs in a randomly assigned sequence, at 9-month intervals. The team will systematically document usual care in each county. To inform future scale-up and dissemination, the team will conduct a mixed methods implementation evaluation.

The team will use this approach to accomplish the following specific aims: 1) Quantify the extent to which Thriving Hearts reduces incidence of HDP and associated complications and increases uptake of support resources among birthing people in the ten Thriving Hearts counties, using PCORnet, Carolina Cost and Quality Initiative Claims, Birth Certificate, and State Hospital Discharge data. 2) Quantify the extent to which Thriving Hearts improves patient-reported experiences and outcomes, measured through cross-sectional surveys of a subset of postpartum people in each county. 3) Quantify the extent to which healing-centered, trauma-informed care improves health team effectiveness and well-being, measured using cross-sectional surveys of professional quality of life and wellbeing. 4) Identify factors that affect implementation of the Thriving Hearts program at health department- and community-levels using the Consolidated Framework for Implementation Research 2.0.

The study population will include all individuals who give birth in the 10 Thriving Hearts counties, including Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person Counties. In 2021, there were 26,900 births in these counties, of whom 29% were non-Hispanic Black, 19% were Hispanic, and 43% were non-Hispanic white. Over the five-year comparative effectiveness study, the team anticipates that there will be ~140,000 births in the participating counties, providing ample power to assess outcomes in the full sample and to perform stratified analyses to test the extent to which Thriving Hearts reduces disparities in processes, experiences, and outcomes.

The study's primary outcome is the incidence of HDP during pregnancy, birth, or within 28 days postpartum, indexed by clinical data (PCORnet), diagnosis codes, and documentation on the birth certificate. Among Thriving Hearts county residents who birthed at UNC-affiliated hospitals from January 2019 through March 2023, 20.4% of Black patients and 17.4% of white patients had a diagnosis of HDP. The team hypothesizes that Thriving Hearts will reduce HDP incidence by 20%, consistent with effect sizes reported for several subcomponents of the multilevel intervention.

Secondary outcomes include clinical processes (first-trimester enrollment Medicaid and WIC, postpartum visit attendance, acute care utilization) and outcomes (HDP morbidity, severe maternal morbidity); patient-reported experiences (person-centered maternity care, autonomy, respectful care) and outcomes (wellbeing, mental health, social support, maternal function); and health care team-reported experience (addressing health-related social needs) and outcomes (wellbeing, professional quality of life, secondary trauma symptoms).

Conditions

Hypertensive Disorder of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pre-intervention

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

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: 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.

Post-intervention

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.

Group Type: ACTIVE_COMPARATOR

Thriving Hearts

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• < 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
• 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orange County Health Department

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

The North Carolina Alliance of Public Health Agencies, Inc.

UNKNOWN

Sponsor Role: collaborator

Jacaranda Health

OTHER

Sponsor Role: collaborator

Piedmont Health Services, Inc.

UNKNOWN

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison M Stuebe, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Central Contacts

Alison M Stuebe, MD, MSc

Role: CONTACT

astuebe@med.unc.edu

919-966-1601

Quintana Stewart, MPA

Role: CONTACT

qstewart@orangecountync.gov

919-245-2412

Related Links

https://www.pcori.org/research-results/2023/thriving-hearts-healing-centered-integrated-community-maternity-care

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

Other Identifiers

24-2138

Identifier Type: -

Identifier Source: org_study_id