跳至主要内容
临床试验/NCT06744231
NCT06744231Enrolling By Invitation不适用

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

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 17,500 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
17,500
试验地点
2
主要终点
Hypertensive Disorder of Pregnancy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • < 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:
  • 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

研究组 & 干预措施

Pre-intervention

Placebo Comparator

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

干预措施: Usual Care (Other)

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.

干预措施: Thriving Hearts (Behavioral)

结局指标

主要结局

Hypertensive Disorder of Pregnancy

时间窗: Between admission for delivery and 4 weeks postpartum

Population-level incidence of hypertensive disorders of pregnancy.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验