Paediatric Early Rehabilitation/Mobilisation During InTensive Care: An Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of early rehabilitation and/or mobilisation (ERM) delivered on Day 3 post PICU admission
研究概览
简要总结
In the UK, critical illness or injury affects about 19,000 Children and Young Persons (CYP) every year who are admitted to the paediatric intensive care unit (PICU) to receive life-sustaining treatments. Although survival rates from PICU are at an all-time high (>96%), low levels of mortality have been offset by an increase in morbidity. The impact of being critically ill and exposed to the PICU is multiple. Weakness, cognitive impairment, organ dysfunction, and psychological problems have been reported to emanate from deconditioning. Subsequently, post-PICU many CYP experience significant and residual physical, cognitive, and psychosocial morbidities that impact on their quality of life. The contemporary focus has turned to the development, testing, and implementation of interventions to minimize the harmful effects of critical care and maximize patient outcomes.
Early rehabilitation and/or mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health professionals from multiple disciplines and care-givers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive).
Rehabilitation has been shown to improve quality of life and patient outcomes; reduce health inequalities, and make significant savings to the health care system. Benefits have been demonstrated in the use of ERM in adult ICU populations in relation to patient outcomes as well as healthcare utilization. Studies also indicate that the intervention is safe and feasible, reduces delirium and increases ventilator-free days, improves day-to-day functioning and reduces hospital readmissions. However, in the United Kingdom (UK), the understanding of current ERM practices (including content, barriers, facilitators, feasibility, and safety) and their impact on the outcomes of pediatric ICU patients is limited. This has stifled an evidence-based approach to ERM which has resulted in disparity in the adoption and utilization of ERM interventions in PICUs across the UK.
To address this critical gap, the first phase of a four-phase program of the PERMIT study will generate evidence of current PICU ERM practices by conducting a survey and an observational study.
The second phase of the study will involve conducting qualitative workshops to develop a prototype ERM program. Qualitative workshops will also be conducted among key stakeholders (clinicians, parents, CYP) to inform the design of an ERM intervention.
The third phase will investigate this ERM program in a pilot study in UK PICUs and finally, the efficacy of the intervention will be tested using a large scale, definitive randomized controlled trial (RCT).
详细描述
The PERMIT study aims to ascertain current ERM practices within PICU settings and barriers/facilitators to ERM delivery.
The investigators plan to directly observe current ERM practices within UK PICUs, identify patients who do and do not receive ERM, describe the variation between PICUs and factors associated with ERM practices.
Inclusion Criteria:
- All Children and Young Persons (CYP) (0-<16 years)
- Admitted to PICU
- Remain within PICU on day 3 post-admission
The broad inclusion criteria will allow for the observation of all types of patients admitted for PICU care (acute and elective e.g. post-surgical recovery) and all age ranges.
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
- 38 Weeks 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Children and Young Persons (CYP) (0-<16 years)
- •Admitted to PICU
- •Remain within PICU on day 3 post-admission
排除标准
- •Local decision by PI or treating clinical team not to include patient
- •Parent or guardian choose to opt out.
结局指标
主要结局
Number of early rehabilitation and/or mobilisation (ERM) delivered on Day 3 post PICU admission
时间窗: 3 weeks
The prevalence and scope of ERM will be described as the proportion of patients with any 'active interaction' delivered on Day 3 post-admission.
次要结局
- The cumulative prevalence of ERM for each day in PICU after Day 3 up to Day 10 post-admission(3 weeks)
- Dose of ERM per day of PICU admission(3 weeks)
- Incidence rates and ratios of the number of ERM interventions from Day 3 to Day 10 post PICU admission(3 weeks)
- Factors associated with variability of early rehabilitation and/or mobilisation (ERM) delivery(3 weeks)
- To evaluate predictors of ERM provided on Day 3 post-PICU-admission(3 weeks)
