Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Kaitlyn K. Stanhope , Taé Stallworth , Alexandra D. Forest , Danielle Vuncannon , Gabriela Juarez , Sheree L. Boulet , Franklyn Geary , Anne L. Dunlop , Sarah C. Blake , Victoria L. Green , Denise J. Jamieson
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引用次数: 0

Abstract

Background

Black and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI > 30)] to promote postpartum visit attendance.

Methods

To address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4–12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care).

Discussion

Through engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings.

Trial registration

This trial was registered on ClinicalTrials.gov (NCT05430815) on June 23, 2022.

为被遗忘的怀孕四个月做好规划:平行分组随机对照试验,测试产后规划干预与标准产前护理的对比。
背景:黑人和棕色人种的孕产妇在不良健康后果方面一直存在差异,部分原因是围产期护理不足。本研究的目标是为具有一种或多种导致严重孕产妇发病的心脏代谢风险因素[妊娠糖尿病、糖尿病、妊娠高血压疾病(慢性高血压、子痫前期、子痫或妊娠高血压)或孕前肥胖(体重指数大于 30)]的产科病人设计并评估一种以患者为中心的干预措施,以促进产后就诊率:为了满足已确定的未满足的产后支持需求和产后护理障碍,我们开发了 20 个专题产后规划模块,每个模块都有相应的患者教育材料、社区资源、护理协调协议和临床医生支持工具(决策辅助工具、电子病历提示和字段)。在产前护理过程中,由一名研究协调员提供教育内容(英语或西班牙语),促进参与者的规划和共同决策,为参与者提供资源,并将决策记录在电子病历中。我们将按照 1:1 的比例随机抽取 320 名符合条件的患者接受干预或标准产前护理,并评估其对产后 4-12 周就诊率和次要结果(产后心理健康、感知到的未来孕产风险和心脏代谢风险、避孕药具使用率、初级保健使用率、再入院率和患者对护理的满意度)的影响:通过与患者和社区利益相关者的合作,我们开发了一种基于指南、适合当地情况的干预措施,以解决高危产科患者参与产后护理的驱动因素。如果证明有效,这些教育材料和基于电子病历的工具可适用于其他环境:该试验于2022年6月23日在ClinicalTrials.gov(NCT05430815)上注册。
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
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.
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