Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Delirium Prevalence and Duration
研究概览
简要总结
Title: Guided Occupational Therapist (OT) Cognitive Interventions for Critically Ill Patients
Short Title: GOTCI
Methodology: Randomized Control Trial
Study Duration: 12-15 months
Study Centre: Single Center - South Health Campus, ICU, Calgary, Alberta, Canada
Objectives: The aim for this study is to evaluate the effect of specific OT guided cognitive interventions on delirium in adult critically ill patients.
Number of Subjects: 112
Primary Outcome: Delirium Prevalence and Duration
Secondary Outcomes: Cognitive function, physical function, quality of life, ICU length of stay, hospital length of stay and days of mechanical ventilation.
Inclusion Criteria: Adult Critically Ill Patients admitted to South Health Campus ICU, Calgary, Alberta
Type of Intervention: OT guided cognitive intervention based on RASS score
Dose: One on one therapeutic sessions with an OT. Five days a week, Monday to Friday, between 0800-1600. There will be twice daily sessions for 20 minutes each.
Duration of administration: Cognitive Therapy to be initiated Monday to Friday, for the duration of participant ICU admission.
Reference therapy: Standard of care within the Department of Critical Care Medicine in Calgary is delirium prevention strategies using the ABCDEF bundled approach.
Statistical Methodology: Descriptive statistics (mean, median, proportion) will be employed to describe the study population. The primary outcome of delirium prevalence will be explored using multivariable logistic regression, which will provide an estimate of the odds ratio and accompanying 95% confidence intervals. Both per protocol and intent to treat analyses will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
All investigators, with the exception of the occupational therapist, will be blinded to participant randomization.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult medical/surgical critically ill patients admitted to the South Health Campus ICU in Calgary, Alberta during designated 6-month study period.
排除标准
- •as follows:
- •Primary Direct Brain Injury
- •Prior diagnosis of dementia-related illness
- •Prior diagnosis of developmental disability
- •Pre-existing cognitive impairment
- •Requiring palliative care
- •In ICU for less than 48 hours
- •Non-English speaking
- •Severe communication disorders
- •Non-critically ill Plasma Exchange Therapy patients
- •Severe hearing or visual impairment
- •ICU to ICU transfers
- •COVID-19 positive patients
结局指标
主要结局
Delirium Prevalence and Duration
时间窗: From date of patient enrolment to ICU discharge, an average of 6.7 days.
Ever Delirium: Measured using the Intensive Care Delirium Screening Checklist (ICDSC). If the patient has a positive score in the ICDSC at any point during the patient's ICU stay then the patient is considered to have delirium and qualifies for Ever Delirium. Delirium Duration: Number of days the patient has a positive score on the ICDSC. This does not have to be consecutive days.
次要结局
- ICU length of stay(ICU admission date to ICU discharge date is the time the patient will be given the treatment which is an average of 6.7 days.)
- Quality of Life using the EQ5D-5L (EuroQual 5 Dimensions-5 Levels). This is a health quality of life measure assessing five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression.(Measured after the treatment period is completed (within 24 hours of discharge) which is an average of 6.7 days.)
- Cognitive Function(Measured within 24 hours of patient ICU admission and again after the treatment period is completed which is an average of 6.7 days.)
- Physical Function(Measured within 48 hours of ICU admission and again after the treatment period is completed which is an average of 6.7 days.)
- Days of Mechanical Ventilation(Measured on day 1 of mechanical ventilation through to day of extubation (cessation of mechanical ventilation), an average of 4 days.)
- Length of Hospital Stay(Up to 6 months)
研究者
Kirsten Deemer, NP
Critical Care Nurse Practitioner
Alberta Health Services, Calgary