Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 480
- 试验地点
- 12
- 主要终点
- Caregiver Burden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study.
The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Caregiver Burden
时间窗: 4 weeks post-discharge
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
次要结局
- 6-month Readmission Rate(6 months post-discharge)
- Frequency of pediatrician communication(6 months post-discharge)
- Primary care pediatrician satisfaction(6 months post-discharge)
- Caregiver Burden(6 months post-discharge)
- Medical Complications Associated with Tracheostomy(4 weeks post-discharge)
研究者
Karen Sepucha
Associate Professor
Massachusetts General Hospital