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

• 批准号: 10097465
• 负责人: SAPNA R KUDCHADKAR
• 金额: $ 70.74万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 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/10097465
• 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; Evaluation; Exercise; Family; Focus Groups; Goals; Health system; Home; Hospitals; Human; Iatrogenesis; Impairment; Intensive Care Units; Interdisciplinary Study; Intervention; Lead; Leadership; Mechanical ventilation; Medical; Methods; Morbidity - disease rate; Muscle Weakness; Occupational Therapist; Occupational Therapy; Outcome; Pain management; Patient-Focused Outcomes; Patients; Pediatric Intensive Care Units; Phase; Physical therapy; Pilot Projects; Plant Roots; Prevalence Study; Prevention; Process; Protocols documentation; 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; base; clinical practice; contextual factors; critical developmental period; effectiveness evaluation; experience; functional decline; functional status; hazard; high risk; hospital readmission; implementation strategy; improved; improved functioning; improved outcome; mortality; novel; physical therapist; pilot trial; prevent; primary outcome; psychologic; randomized trial; safety and feasibility; safety testing; therapy design; treatment as usual

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.

项目总结