随机混合1型试点试验评估急诊护理行动计划(ECAP)在农村卫生网络中的初步有效性和实施:一项研究方案。

IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Abigail Palaza, Peter Callas, Peter S Dayan, Dennis Z Kuo, Lauren Riney, Sandra P Spencer, Renee Stapleton, Martha Stevens, Christian R Studts, Christian D Pulcini
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引用次数: 0

摘要

导语:患有医疗复杂性(CMC)的儿童是有特殊医疗需求的儿童的一个子集,定义为高医疗利用率,严重的单系统或多系统器官功能障碍,在许多情况下,依赖医疗技术。在紧急护理环境中,这一人群面临的已知挑战包括护理质量差、可避免的入院以及护理人员和提供者的高负担。虽然专家和专业协会建议使用应急护理规划工具来解决这些问题,但缺乏证据支持这些工具的有效性和实施。通过以人为本的设计方法,我们最近与主要合作伙伴合作,为医疗复杂的婴儿制定和优化紧急护理行动计划(ECAP)。在这里,我们描述了一项针对医疗复杂性婴儿的1型混合有效性-实施随机对照试验(RCT)的试验方案,旨在评估ECAP的有效性和实施。方法与分析:在1型混合疗效-实施随机对照试验中,具有医疗复杂性的婴儿及其护理人员将被随机分配到干预组(ECAP)或对照组(标准护理)。主要结果是婴儿参与者的住院天数。其他有效性结果包括感知避免急诊(ED)访问,医疗保健费用,照顾者压力和自我效能。初步实施结果包括可接受性、可行性、适当性和可用性,以及达成、采用和实施的环境障碍和促进因素。关键合作伙伴,包括CMC的护理人员和医疗保健提供者,将参与整个ECAP的实施和试验的执行。伦理与传播:本研究已获得佛蒙特大学机构审查委员会(STUDY00002937)的批准。研究结果将通过同行评议的出版物、会议报告、焦点小组和对主要利益相关者的访谈等方式传播。试验注册号:NCT06444282。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical complexity within a rural health network: a study protocol.

Introduction: Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.

Methods and analysis: Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.

Ethics and dissemination: This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.

Trial registration number: NCT06444282.

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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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