Linking inter-professional newborn and contraception care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine well-baby visits

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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引用次数: 0

Abstract

Background

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes. Despite this, nearly one third of U.S. women experience a short IPI.

Objective

To address the gap in the current model of postpartum (PP) contraception care by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care to improve access to timely PP contraception.

Methods

The LINCC Trial will take place in seven clinical locations across five community health centers within the U.S. PP patients (planned n = 3150) who are attending a Well-Baby Visit between 0 and 6 months will be enrolled. The LINCC Trial aims to leverage the Electronic Health Record to prompt providers to ask PP patients attending a Well-Baby Visit about their PP contraception needs and facilitate co-scheduling of PP contraception care with routine newborn care visits. The study includes a cluster randomized, cross-sectional stepped wedge design to roll out the intervention across the seven sites. The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies. Implementation outcomes will be assessed at baseline and 6 months after site enters intervention period.

Conclusions

The LINCC Trial seeks to evaluate the effectiveness and feasibility of a linked care model in comparison to usual care.

新生儿和避孕护理专业间联系试验(LINCC):将产后避孕护理与常规婴儿健康检查联系起来的阶梯式楔形分组随机试验方案。
背景:在前次分娩后 18 个月内怀孕(称为短孕间隔期 [IPI])的母亲和婴儿面临不良健康后果的高风险。尽管如此,仍有近三分之一的美国妇女经历过短孕间间隔:目的:通过开发和实施一种新方法,将产后避孕护理与新生儿健康护理联系起来(共同安排),以改善及时获得产后避孕护理的机会,从而弥补当前产后避孕护理模式的不足:LINCC 试验将在美国 5 个社区卫生中心的 7 个临床地点进行。PP 患者(计划人数 = 3150)在 0 至 6 个月期间接受婴儿健康检查时将被纳入试验。LINCC 试验旨在利用电子健康记录提示医疗服务提供者向接受婴儿健康访视的 PP 患者询问其 PP 避孕需求,并促进 PP 避孕护理与常规新生儿护理访视的共同安排。该研究采用分组随机、横断面阶梯式楔形设计,在七个地点推广干预措施。研究结果包括在 PP 满两个月和六个月时接受最有效或中等有效的避孕方法;以及短 IPI 怀孕率。实施结果将在基线和站点进入干预期后 6 个月进行评估:LINCC 试验旨在评估联动护理模式与常规护理相比的有效性和可行性。
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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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