增加家庭气管造口护理资源 (BREATHE)
增加家庭气管切开护理的资源和护理人员的能力：一项务实的随机试验
The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:
- What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
- How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?
Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.
研究概览
详细说明
The study is focused on a rare and medically complex population of children with tracheostomies. The study is a Type I hybrid effectiveness-implementation study using a pragmatic randomized trial at six participating sites. The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main question[s] it aims to answer are:
- What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
- How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?
Caregiver participants will randomly assigned to the Comparator arm (gold standard discharge program) or to the Intervention arm (gold standard program with other components). Caregiver participants will complete three surveys over the course of 6 months. The investigators will test two main hypotheses: the Intervention arm will have (1) significantly lower caregiver burden at 4 weeks post discharge (primary outcome) and (2) significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm.
The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
La Jolla、California、美国、92093
- University of San Diego Rady Children's Hospital
-
-
Maryland
-
Silver Spring、Maryland、美国、20910
- Children's National Medical Center, Children's Research Institute
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55404
- Children's Hospitals and Clinics of Minnesota
-
-
Ohio
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Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital Medical Center
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19146
- Children's Hospital of Philadelphia
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Lead or primary adult caregiver (18 or older) of infants or children (0-17 years old) with tracheostomy who are planning for discharge to home, including children who are dependent on ventilator
Exclusion Criteria:
- Patients transferred to other hospital or facility (and/or not discharged to home during study period)
- Primary caregiver unable to read or write in English, Spanish, Mandarin, or Arabic
- Not residing in the U.S. for at least 12 months after discharge
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Active Comparator Caregivers
TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers |
The Trach Me Home discharge program includes caregiver education, skills training and case management. |
|
实验性的：Intervention Caregivers
Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers. |
The Trach Me Home discharge program includes caregiver education, skills training and case management. The Trach Plus program includes education, social support, and outreach to outpatient care team. |
|
有源比较器：Active Comparator Physicians
Primary care physicians' of the enrolled participant's child receiving discharge communication |
The Trach Me Home discharge program includes caregiver education, skills training and case management. |
|
实验性的：Intervention Physicians
Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge |
The Trach Me Home discharge program includes caregiver education, skills training and case management. The Trach Plus program includes education, social support, and outreach to outpatient care team. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Caregiver Burden
大体时间：4 weeks post-discharge
|
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. |
4 weeks post-discharge
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medical Complications Associated with Tracheostomy
大体时间：6 months post-discharge
|
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse. |
6 months post-discharge
|
|
6-month Readmission Rate
大体时间：6 months post-discharge
|
Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge. |
6 months post-discharge
|
|
Frequency of pediatrician communication
大体时间：6 months post-discharge
|
Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report. |
6 months post-discharge
|
|
Primary care pediatrician satisfaction
大体时间：6 months post-discharge
|
Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication. |
6 months post-discharge
|
|
Medical Complications Associated with Tracheostomy
大体时间：4 weeks post-discharge
|
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse. |
4 weeks post-discharge
|
|
Caregiver Burden
大体时间：6 months post-discharge
|
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. |
6 months post-discharge
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of readmissions
大体时间：6 months post discharge
|
The total number of electronic health record documented emergency room visits and hospital admissions will be collected, with higher numbers being worse (indicating more readmissions). |
6 months post discharge
|
合作者和调查者
合作者
调查人员
- 首席研究员：Karen Sepucha, PhD、Massachusetts General Hospital
- 首席研究员：Christopher Hartnick, MD、Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2023P001695
- IHS-2022C1-26100 (其他赠款/资助编号：Patient Centered Outcomes Research Institute (PCORI))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers.
The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
IPD 共享时间框架
After study results have been published, about 1 year after the end of the funded grant period, the study materials and de-identified data will be placed on an open access service such as ICPSR where they will be available indefinitely.
IPD 共享访问标准
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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