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Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A pragmatic, stepped-wedge trial

“PICU Up!”的临床效果

基本信息

批准号：
10634659
负责人：
SAPNA R KUDCHADKAR
金额：
$ 61.51万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-08 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10634659
关键词：
2 year old Absence of pain sensation Admission activity Adoption Adult Affect Bed rest Biometry Breathing Caring Child Childhood Clinical Clinical Trials Clinical effectiveness Cognitive Communities Community Hospitals Critical Care Critical Illness Critically ill children Data Delirium Elements Engineering Exercise Family Focus Groups Goals Health system Home Hospitals Human Iatrogenesis Immobilization Impairment Intensive Care Units Interdisciplinary Study Intervention Investments Lead Leadership Mechanical ventilation Medical Methods Morbidity - disease rate Muscle Weakness Occupational Therapist Occupational Therapy Outcome Pain management Patient Admission Patient-Focused Outcomes Patients Pediatric Intensive Care Units Phase Physical therapy Pilot Projects Prevalence Study Prevention Public Health Qualitative Research Randomized Randomized, Controlled Trials Rehabilitation therapy Research Risk Safety Sedation procedure Site Sleep Sleep disturbances Surveys Survivors System Technology Testing United States Work clinical practice contextual factors critical developmental period effectiveness evaluation experience functional decline functional improvement functional status hazard high risk hospital readmission implementation strategy improved improved outcome intervention delivery mortality novel physical therapist pilot trial prevent primary outcome process evaluation psychologic randomized trial safety and feasibility safety testing therapy design treatment as usual

项目摘要

PROJECT SUMMARY While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. Our prior studies revealed that <10% of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, we developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. We have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of our research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. We propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States (1,440 patients), with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.

项目摘要虽然美国儿科重症监护病房（PICU）的死亡率正在改善，但存活的儿童经常出现持续的身体、认知和心理障碍。超过一半的重症儿童经历潜在的可预防的PICU获得性疾病，机械通气儿童处于最大的风险在重症成年人中，随机试验表明，渐进性活动能力很早就开始了（在开始机械通气的3天内），减少肌肉无力和持续时间机械通气然而，尚未在PICU中进行类似的随机研究。我们事先研究表明，<10%的功能下降风险最高的危重儿童通过在PICU入院前3天内接受物理或职业治疗。考虑到镇静剂和精神错乱的相互作用 PICU中的睡眠和不动，单组分干预，如镇静协议，一致显示出减少机械通气持续时间的益处。因此，我们开发了第一个儿科专业干预（PICU Up！）将目标导向的镇静、谵妄预防，促进睡眠，和家庭参与日常PICU护理，以促进早期和渐进的流动性。我们已经证明了这一务实、多方面战略的安全性和可行性在单中心和多中心试点研究中。因此，我们研究的下一阶段是评估 PICU的临床有效性和交付起来！对一系列PICU患者和健康状况的干预系统. 我们提出了一个务实的，阶梯楔形，集群随机对照试验，将包括10个学术和美国社区医院（1，440例患者），目的如下：1）评估 PICU起来！在真实世界条件下进行的干预减少了机械通气持续时间（主要结局），并改善谵妄和功能状态相比，常规护理重症儿童; 2）进行多方利益相关者、混合方法的过程评估，以确定关键的背景因素与PICU Up的交付相关！如果证明有效，PICU起来！干预有可能深刻改变医疗保健， PICU通过改善越来越多的儿童的结局，危重病的儿科幸存者