MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-21 DOI:10.1016/j.cct.2025.107850

Stephanie L. Fitzpatrick , Jennifer Polo , Patti Ephraim , Elizabeth Vrany , Codruta Chiuzan , Melissa Basile , Ciaran P. Friel , Khatiya Chelidze Moon , Emily Silvia , Hallie Bleau , Wanda Nicholson , Dawnette Lewis

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引用次数: 0

Abstract

Background

Black birthing people are disproportionately affected by severe maternal morbidity (SMM). The MOMs Chat & Care Study (R01NR021134) is a pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model to facilitate timely, appropriate care for high-risk Black birthing people and reduce the risk for SMM.

Methods

We will recruit 674 adult, English and Spanish-speaking Black birthing people who are less than 17 weeks gestational age, considered high risk based on the Obstetrics-Comorbidity Index and/or history of preeclampsia, and receive care at a Northwell Health obstetric practice. Participants will be randomized to either MOMs High Touch or Low Touch. In both intervention arms participants will receive close monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods, Fitbit to track physical activity, and bi-weekly postpartum telehealth visits up to 6-weeks postpartum. MOMs High Touch will also receive 12 bi-weekly self-management support telehealth visits during pregnancy and a home blood pressure monitor. The two arms will be compared on incidence of SMM at labor and delivery (Aim 1), SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and treatment (Aim 2), perceived social support (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will be used to examine facilitators and barriers to intervention implementation (Aim 5).

Conclusion

Findings from this study will inform how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.

Registration of Clinical Trials: This trial is registered on www.ClinicalTrials.gov (NCT06335381).

Protocol version: 07/22/2024, 24–0131-NH.

查看原文本刊更多论文

产妇聊天与护理研究：预防黑人产妇严重发病的实用随机临床试验的原理和设计。

背景：黑人分娩的人不成比例地受到严重孕产妇发病率（SMM）的影响。妈妈聊天与护理研究（R01NR021134）是一项实用的随机临床试验，旨在测试综合护理模式的有效性，以促进对高危黑人分娩人群的及时，适当的护理，并降低SMM的风险。方法：我们将招募674名成年、说英语和西班牙语的黑人孕妇，她们的胎龄小于17 周，根据产科合并症指数和/或先兆子痫史被认为是高危人群，并在Northwell Health产科诊所接受护理。参与者将被随机分配到妈妈的高触碰或低触碰。在这两个干预组中，参与者将通过聊天机器人技术接受密切监控，并在产前和产后期间由妈妈团队及时提供护理和服务，Fitbit跟踪身体活动，并在产后6周内每两周进行一次产后远程医疗访问。“妈妈的高触控”还将在怀孕期间接受12次两周一次的自我管理支持远程医疗访问和家庭血压监测仪。将比较两组在分娩和分娩时SMM的发生率（目的1）、产后1个月和1年的SMM相关住院情况（目的1a）、到子痫前期诊断和治疗的时间（目的2）、感知到的社会支持（目的3）和身体活动轨迹（探索性目的4）。混合方法将用于检查干预实施的促进因素和障碍（目的5）。本研究的结果将告知如何可行地实施有效和可持续的综合护理方法来解决SMM差异。临床试验注册：该试验已在www.Clinicaltrials: gov （NCT06335381）上注册。协议版本：07/22/2024,24-0131-NH。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.