Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Perceptions about barriers and facilitators for implementation of the bundle
研究概览
简要总结
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest. Advancements in the care provided in Pediatric Intensive Care Units (PICUs) have led to fewer deaths in children. These improvements are unfortunately countered by the emergence of side effects of critical illness, known as PICU-acquired complications (PACs). Delirium, muscle weakness, drug dependency and withdrawal are increasingly common. PACs occur because children are often over-sedated and experience long periods of immobilization. PACs delay recovery, increase disability and worsen long-term function and quality-of-life. Although they are preventable, PACs are very common and frequently overlooked by clinicians. This study aims to "liberate"children from critical illness and improve their recovery and functioning after discharge, through an innovative rehabilitation bundle of 8 complementary steps (PICU Liber8) to reduce sedation, allow children to awaken and breathe comfortably, encourage early mobilization, and engage families in their child's care.
详细描述
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle.
The objectives are:
- Primary - Implementation Objectives: to determine the feasibility and resources required to implement PICU Liber8 in 2 PICUs, evaluate strategies for successful bundle adoption. Co-Primary - Process Objectives: to determine the impact of PICU Liber8 on the process of care.
- Secondary Efficacy: impact on PACs and patient reported outcomes The methods consist of a PICU Liber8 Bundle Implementation Plan (Pronovost's 4 E's Framework), and measurement of the impact of Implementation through Orchestrated Testing (OT).
For successful adoption of the PICU Liber8 bundle, the following are necessary:
- A context appropriate implementation framework.
- An implementation team leader.
- Inter-professional team engagement (i.e. RN, RT, MD, pharmacy, allied health and family).
- Ability to customize PICU Liber8 to the needs of each site. We will use the Pronovost's implementation framework, which has been shown to facilitate successful bundle adoption and improve the quality of patient care in adult and pediatric ICUs.17-19 This framework has 4 phases: Engage, Educate, Execute and Evaluate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Perceptions about barriers and facilitators for implementation of the bundle
时间窗: 18 months
Qualitative (i.e., narrative) assessment, description, and comparison of the perceptions from key stakeholders (i.e., family members, patients, clinicians, administrative personnel, nurse team, etc.) between groups about perceived barriers and facilitators for the adequate bundle's implementation. This belongs to the acceptability outcome.
Completion rate of daily goals (compliance)
时间窗: 18 months
The total number and percentage of daily goals completed from a pre-established daily goals checklist that assess compliance with the bundle. This is considered part of the feasibility outcomes group.
Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups.
时间窗: 18 months
Evaluation of performance as narrative description and comparison between periods of study, about the impact of the bundle on the process of quality of care. This also is part of the feasibility outcomes group.
次要结局
- Length of stay(1 month)
- Ventilator-free days at 30 days(1 month)
- Incidence of morbidities(18 months)
- 30-day mortality(18 months)
- Risk measurement of psychological sequelae.(18 months)
- Economic analysis(18 months)
- Health related quality of life(18 months)
- Parental stress(18 months)
- Functionality(18 months)
研究者
Karen Choong
Professor
McMaster University