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强化家庭访视护理与儿童早期结局:一项随机临床试验

Intensive Nurse Home Visiting and Early Childhood Outcomes: A Randomized Clinical Trial.

作者信息

Swanson Katarina, Ayers Sam, Oviedo Dea, Zhou R Annetta, Bates Mary Ann, Baicker Katherine, Chien Alyna T, McConnell Margaret

机构信息

Harvard PhD Program in Health Policy, Harvard University, Cambridge, Massachusetts.

Berkeley PhD Program in Public Policy, University of California, Berkeley.

出版信息

JAMA Pediatr. 2025 Jun 16. doi: 10.1001/jamapediatrics.2025.1600.

Abstract

IMPORTANCE

Programs that provide home visiting in early life have been proposed as a way to reduce early childhood adversity and improve child health outcomes. More evidence is needed to understand these programs' impact when delivered at scale.

OBJECTIVE

To evaluate how receiving home visits through the Nurse-Family Partnership (NFP), a program designed to support young and low-income families, impacted children's utilization and health outcomes in the 2 years after birth.

DESIGN, SETTING, AND PARTICIPANTS: The NFP is a home visiting program designed with the aim of reducing the incidence of adverse health outcomes in early childhood. In this study, we used data from a randomized clinical trial that enrolled 5670 Medicaid-eligible pregnant people in South Carolina who were randomly assigned at a 2:1 ratio to the NFP treatment (n = 3806) or usual care (n = 1864) between 2016 and 2020. The trial was conducted in 9 NFP-implementing authorities. Participants were eligible if they were fewer than 28 weeks pregnant with their first child, aged 15 years or older, and income eligible for Medicaid (income <200% of the federal poverty level). Data analysis was performed from June 2023 to July 2024.

INTERVENTION

The treatment group was offered NFP home visits during pregnancy and 2 years postpartum, while the control group received usual care.

MAIN OUTCOMES AND MEASURES

The primary outcome was a composite measure that included child mortality and claims related to major injury or concern for abuse or neglect within the first 2 years of life. Secondary outcomes included emergency department utilization and preventive health care measures, such as well-child visits and their components, including screenings for cognitive development, blood lead levels, fluoride varnish application, and dental health. We used an intent-to-treat approach with a linear regression model to estimate the treatment effect of NFP on early childhood outcomes by comparing participants assigned to the control and treatment group, regardless of whether they used NFP services.

RESULTS

Among enrolled participants, 4932 individuals were tracked to a live birth (3295 in the intervention group and 1637 in the control group) and were analyzed for child health and utilization outcomes once their child turned 2 years old. Mean (SD) participant age was 22.5 (4.7) years. The incidence of the composite adverse outcome was 27.3% and 26.8% in the intervention and control groups, respectively (adjusted between-group difference, 0.4 percentage points; 95% CI, -2.3 to 3.0), with no statistically significant differences between elements of the composite primary outcome. Among participants assigned to receive NFP, their children were less likely to use the emergency department by 2.9 percentage points (95% CI, -5.5 to -0.3), a 4% reduction relative to the rate of 72.8% in the control group. Once we adjusted for multiple hypothesis testing, this outcome was no longer statistically significant. Assignment to NFP did not significantly impact the likelihood of receiving the guideline number of well-child visits or preventive services.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, assignment to intensive nurse home visiting services did not reduce the likelihood of adverse outcomes in early childhood measured through administrative data. More evidence is needed to understand whether delivering intensive home visiting services at scale to a Medicaid population influences other child outcomes, including longer-term developmental outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03360539.

摘要

重要性

已提出在生命早期提供家访服务的项目,作为减少幼儿期逆境并改善儿童健康结局的一种方式。需要更多证据来了解这些项目大规模实施时的影响。

目的

评估通过护士-家庭伙伴关系(NFP)接受家访服务(该项目旨在支持年轻的低收入家庭)对儿童出生后2年内的医疗服务利用情况和健康结局的影响。

设计、设置和参与者:NFP是一个家访项目,旨在降低幼儿期不良健康结局的发生率。在本研究中,我们使用了一项随机临床试验的数据,该试验纳入了南卡罗来纳州5670名符合医疗补助条件的孕妇,她们在2016年至2020年间以2:1的比例被随机分配到NFP治疗组(n = 3806)或常规护理组(n = 1864)。该试验在9个实施NFP的机构进行。参与者纳入标准为:怀有第一个孩子且孕周小于28周、年龄15岁及以上、收入符合医疗补助条件(收入<联邦贫困线的200%)。数据分析于2023年6月至2024年7月进行。

干预措施

治疗组在孕期和产后2年接受NFP家访服务,而对照组接受常规护理。

主要结局和测量指标

主要结局是一项综合指标,包括儿童死亡率以及与出生后前2年内重大伤害或虐待或忽视相关的索赔。次要结局包括急诊科就诊情况和预防性医疗保健措施,如儿童健康检查及其组成部分,包括认知发育筛查、血铅水平检测、氟化物涂漆和口腔健康检查。我们采用意向性分析方法,使用线性回归模型,通过比较分配到对照组和治疗组的参与者来估计NFP对幼儿结局的治疗效果,无论他们是否使用了NFP服务。

结果

在纳入的参与者中,4932人追踪到活产(干预组3295人,对照组1637人),其孩子满2岁时对儿童健康和医疗服务利用结局进行了分析。参与者的平均(标准差)年龄为22.5(4.7)岁。干预组和对照组综合不良结局的发生率分别为27.3%和26.8%(调整后的组间差异为0.4个百分点;95%置信区间为-2.3至3.0),综合主要结局各要素之间无统计学显著差异。在被分配接受NFP服务的参与者中,其孩子使用急诊科的可能性降低了2.9个百分点(95%置信区间为-5.5至-0.3),相对于对照组72.8%的使用率降低了4%。在我们对多重假设检验进行调整后,这一结局不再具有统计学显著性。分配到NFP组对接受儿童健康检查或预防性服务的指南规定次数的可能性没有显著影响。

结论和相关性

在这项随机临床试验中,分配接受强化护士家访服务并未降低通过行政数据衡量的幼儿期不良结局的可能性。需要更多证据来了解对符合医疗补助条件的人群大规模提供强化家访服务是否会影响其他儿童结局,包括长期发育结局。

试验注册

ClinicalTrials.gov标识符:NCT03360539。

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