Feasibility of Implementing the Paediatric Early Rehabilitation & Mobilisation During InTensive Care (PERMIT) Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of PICUs implementing PERMIT intervention
研究概览
简要总结
19,000 children and young people (CYP)/year are admitted to Paediatric Intensive Care Unit (PICU). The investgators want to see if patients recover quicker if rehabilitation starts early and they are encouraged to get moving whilst still in PICU. This is known as 'early rehabilitation and mobilisation' (ERM).
PERMIT is an National Institute of Health research/Health Technology Assessment funded programme with four stages:
- The investgators undertook a national survey of perceptions, a systematic review of the literature and an observational study of ERM over 2 weeks across 14 United Kingdom PICUs
- The investgators worked with professionals and families to develop an ERM manual appropriate for the age and acuity level of the child.
- In the current phase the investgators will try out the ERM manual in 3 PICUs to see if they are useful and then
- Make suggestions about further research.
This protocol outlines the third stage, exploring feasibility and acceptability of implementing the PERMIT intervention in the following Steps:
Step 1: Implementing the PERMIT intervention within 3 PICUs Step 2: Enrolling and delivering PERMIT intervention to CYP in PICU Step 3: Measuring outcomes and assessing impact of PERMIT intervention on CYP and parents.
Over 5 months, the investgatorswill share the ERM manual with 6-15 key staff on 3 PICUs so that they can consider implementation; they will be interviewed weekly. 90 staff will be eligible to complete 3 online questionnaires. If implementation is feasible, the investgators will recruit up 30 children aged 0-16 years in 3 PICUs if parents consent. On ward rounds the PICU team will use the ERM manual to assess acuity and prescribe ERM. the investgators will collect routine data and observe whether prescribed ERM is delivered. After further consent, up to 30 parents can complete questionnaires at PICU discharge and interviews (n=12-15 consenting, approx 3 declining Step 2) within 30 days. 12-15 staff will be interviewed.
详细描述
Purpose and design To design clinical trials to investigate the potential benefits of ERM in critically ill children, it is crucial to understand the feasibility of implementation and opinions of families.
The Stage 3 feasibility study aims to assess the feasibility of the following Steps:
Step 1:
(i) Prepare PICUs to implement the PERMIT intervention. (ii) Assess barriers & facilitators to implementation.
Step 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Steps 1-3:
- •The PERMIT champions: health care professionals (HCP) and managers from each PICU who will lead the implementation of the PERMIT intervention. The PERMIT champions could be the PI, the PIC manager, a consultant lead, a physio lead and a senior nurse but this is decided locally.
- •HCP: Health care professionals who work within the PICU and could be /are involved in delivering the PERMIT intervention to CYP (i.e. doctors, nurses, allied health professionals, play therapists, psychologists etc.).
- •Steps 2-3:
- •Admitted to a participating PICU. Age 0 to <16 years at time of admission. Likely to remain within PICU on day 3 post admission. Consent by parent/legal guardian.
- •Parents/legal guardians of CYP fulfilling criteria above.
排除标准
- •Steps 1-3:
- •PERMIT champions who decline to participate in the debrief.
- •Steps 2-3:
- •Local decision by PICU health care professionals not to include CYP.
结局指标
主要结局
Number of PICUs implementing PERMIT intervention
时间窗: 4 weeks
The prevalence and scope of ERM will be described as the proportion of PICUs progressing from step 1 (PICU preparation) to step 2 (patient delivery). Assessment of implementation progress within PICUs (e.g. barriers and facilitators to implementation) PICUs using the weekly debrief with PERMIT champions, the three brief online surveys of PICU health care professionals and the interviews with PICU health care professionals.
Proportion of eligible CYP recruited to receive the PERMIT intervention
时间窗: 4 weeks
The proportion of eligible CYP recruited to receive the PEMRIT intervention will be calculated as the number of eligible CYP recruited divided by the total number of eligible CYP at each site.
Proportion of completed outcome assessment tools of eligible CYP
时间窗: 4 weeks
Proportion of CYP with 100% completed outcome measurement tools and \>50% completed will be recorded at each PICU site.
次要结局
- Acceptability of all data collection forms, outcome measurement tools and the PERMIT intervention as a whole(4 weeks)
- Number of ERM activities prescribed per CYP following patient acuity screening(4 weeks)
- Number of ERM activities delivered per CYP(4 weeks)