Prediction of Functional Outcomes From Chronic Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 6
- 主要终点
- Proportion of Patients who Survive with Severe Cognitive Disability
研究概览
简要总结
The purpose of the study is to establish clinical determinants of poor cognitive and physical functional outcome of CCI patients so that the investigators may develop and validate a multi-dimensional clinical prediction model to more effectively inform decision making earlier in the course of the ICU care. The investigators hypothesize that multiple premorbid and acute factors measured early in the course of CCI will have strong independent associations with functional recovery. The investigators further hypothesize that social and economic factors are associated with long-term functional outcomes independent of the acute clinical problems.
详细描述
A substantial number of critically ill patients experience persistent organ failure leading to chronic critical illness (CCI). The majority of these patients die within a year, and many survivors must cope with long-term physical and cognitive limitations that are often severe. Survival with severe physical and cognitive dysfunction is a significant clinical, emotional, and economic burden in this population, but little is known about which patients are at highest risk for physical and cognitive dysfunction. Moreover, although long-term mortality in CCI can be reliably estimated with a validated mortality prediction model, there is currently no validated method to predict long-term functional disability for purposes of shared decision-making and resource planning. In order to address these gaps in knowledge, the investigators will conduct a multi-center prospective cohort study that measures clinical and premorbid risk factors for long-term physical and cognitive dysfunction in CCI. Using these risk factors, the investigators will construct a multi-outcome prognostic model for survival with severe physical or cognitive dysfunction to facilitate shared decision-making and resource planning. Additionally, the investigators will identify independent social and economic variables that are risk factors for long-term survival and functional disability.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of Patients who Survive with Severe Cognitive Disability
时间窗: 12 months
Severe Cognitive Disability defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of greater than 3.44 (range 0-5, 5 being worse) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of less than 17 (Range 0-22, 0 being worse). Severity of Cognitive Delay will be confirmed with a Functional Activities Questionnaire (FAQ) score of greater than 8 (Range 0-30, 30 being worst).
Proportion of patients who die within one year
时间窗: 12 months
Confirmed dead at 1-year follow up.
Proportion of Patients who Survive with Severe Physical and Cognitive Disability
时间窗: 12 months
Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs). Severe Cognitive Disability defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of greater than 3.44 (range 0-5, 5 being worse) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of less than 17 (Range 0-22, 0 being worse). Severity of Cognitive Delay will be confirmed with a Functional Activities Questionnaire (FAQ) score of greater than 8 (Range 0-30, 30 being worst).
Proportion of Patients who Survive with Severe Physical Disability
时间窗: 12 months
Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs).
Proportion of Patients who Survive with No Severe Functional Disability
时间窗: 12 months
No severe physical disability is indicated by requiring assistance with 3 or fewer Activities of Daily Living (ADLs). No Severe Cognitive Disability is defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of less than 3.44 (range 0-5) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of greater than 17 (Range 0-22).
次要结局
- Proportion of Patients who Survive with No Severe Functional Disability(6 months)
- Caregiver Burden Score: BSFC(6 and 12 months)
- Proportion of Patients who Survive with Severe Physical and Cognitive Disability(6 months)
- Caregiver Anxiety and Depression Score: HADS(12 months)
- Proportion of Patients who Survive with Severe Physical Disability(6 months)
- Proportion of Patients who Survive with Severe Cognitive Disability(6 months)
- Proportion of patients who die within 6 months.(6 months)
- Caregiver Quality of Life Score: EQ-5D(6 and 12 months)
- Caregiver PTSD Score: IES-R(12 months)
- Patient Quality of Life Score: NeuroQOL(6 and 12 months.)
- Patient Quality of Life Score: EQ-5D(6 and 12 months.)