Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care
- Conditions
- Hypertensive Disorder of Pregnancy
- Registration Number
- NCT06744231
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 17500
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hypertensive Disorder of Pregnancy Between admission for delivery and 4 weeks postpartum Population-level incidence of hypertensive disorders of pregnancy.
- Secondary Outcome Measures
Name Time Method 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. The Brief Professional Quality of Life scale is a measure of compassion satisfaction, burnout, and secondary traumatic stress. assessed using a 5-point Likert scale: 1 = Never (0 days), 2 = Rarely (1 day), 3 = Sometimes (2-3 days), 4 = Often (4-5 days), 5 = Always (6-7 days). Scores range from 12-60 with higher scores associated with worse professional quality of life.
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. The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive statements rated using Likert questions ranging from 5 (all the time) to 0 (never), which tap into the subjective well-being of the respondents. Scores range from 0-100 (raw score is multiplied by 4). Higher scores = higher wellbeing.
Person-Centered Maternity Care Scale Score, postpartum survey Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth The Person-Centered Maternity Care Scale is a validated tool that can be used to measure person-centered prenatal care that reflects the experiences of people of color consisting of 26 items. Scores range from a minimum of 16 to a maximum of 78 with higher scores indicate more person-centered care.
Brief Sense of Community Scale, postpartum survey Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth The BSCS was designed to assess the dimensions of needs fulfillment, group membership, influence, and emotional connection with 8 questions rated using a 5-point, Likert-type response option format ranging from strongly agree to strongly disagree. Scores range from 8-40 wtih higher scores indicating a stronger sense of community.
World Health Organization (WHO)-5 Wellbeing Index, postpartum survey Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive statements rated using Likert questions ranging from 5 (all the time) to 0 (never), which tap into the subjective well-being of the respondents. Scores range from 0-100 (raw score is multiplied by 4). Higher scores = higher wellbeing.
Trial Locations
- Locations (1)
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States