Clinical trial NCT06744231: Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care
Official title: Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Orange County Health Department
name: Duke University
name: Wake Forest University Health Sciences
name: The North Carolina Alliance of Public Health Agencies, Inc.
name: Jacaranda Health
name: Piedmont Health Services, Inc.
name: Patient-Centered Outcomes Research Institute
First posted: 2024-12-20
Enrollment: 17500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

Eligibility criteria: Any individual who is pregnant or \<4 months postpartum and resides in county where Thriving Hearts is active can engage with Thriving Hearts-supported programs and services.

Cross-sectional survey of postpartum people

For participation in the population-based survey of postpartum parents, the following criteria are required:

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

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

Inclusion criteria:

* 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:

* 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

Primary outcomes:
measure: Hypertensive Disorder of Pregnancy
timeFrame: Between admission for delivery and 4 weeks postpartum
Secondary outcomes:
measure: Change in Brief Professional Quality of Life Score among people who serve pregnant women in Thriving Hearts Counties
timeFrame: 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.
measure: Change in World Health Organization (WHO)-5 Wellbeing Index among people who serve pregnant women in Thriving Hearts Counties
timeFrame: 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.
measure: Person-Centered Maternity Care Scale Score, postpartum survey
timeFrame: Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth
measure: Brief Sense of Community Scale, postpartum survey
timeFrame: Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth
measure: World Health Organization (WHO)-5 Wellbeing Index, postpartum survey
timeFrame: Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Alison M Stuebe, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: