Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Feasibility - resources
研究概览
简要总结
An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay.
The investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) in the ICU
- •Anticipated length of stay ≥48 hours for whom a request for physiotherapy has been placed by the treating physician
- •Appropriateness for physiotherapy confirmed by the unit's physiotherapist.
- •Families will be eligible if they are able to be present in ICU during physiotherapist or research team work hours until they are cleared to deliver activities independently, then at least three times weekly thereafter.
排除标准
- •Patients who are receiving end of life care
- •Patients who have high risk injuries including spinal cord injury or spinal fractures, post-operative from spinal surgery, and untreated hip or long bone fractures
- •Patients at risk of raised intracranial pressure (ICP) (e.g. Malignant middle cerebral artery stroke, large subarachnoid hemorrhage), admitted post trauma activation, post-operative from brain surgery or with external ventricular drain (EVD) in situ.
- •Patients who are bed-bound or require mechanical lift at baseline who would not otherwise be offered physiotherapy services.
- •Exclusion criteria for families include any major barriers to participation, i.e., physical, cognitive, emotional or capacity to understand and communicate with the team.
结局指标
主要结局
Feasibility - resources
时间窗: Study duration - up to one year
Physiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay.
Feasibility - recruitment rate
时间窗: Study duration - up to one year
We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
Feasibility - protocol adherence
时间窗: During ICU stay, censored at 1 month
We define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions
Feasibility - consent rate
时间窗: Study duration - up to one year
We define a successful consent rate as \> 70% of SDMs or patients approached to consent, agreeing to take part in the study
次要结局
- Patient & Family PTSD symptoms(1 & 3 months)
- Adverse Events(During ICU stay, censored at 1 month)
- Family satisfaction(1 & 3 months)
- Patient Delirium(During ICU stay, censored at 1 month)
研究者
Kimberley Lewis
Assistant Professor, Intensivist
St. Joseph's Healthcare Hamilton