Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 3
- 主要终点
- 90 day Barthel Index (hierarchical testing)
研究概览
简要总结
The primary aim of the study is to assess the mobility dose in neurocritical care patients with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and patient outcomes. The investigators hypothesize that patients' mobilization dose in the intensive care unit (ICU) predicts discharge disposition, 90 day Barthel Index and other outcomes like muscle wasting (expressed as decrease in rectus femoris cross sectional area (RF-CSA) in the paretic and non-paretic limb measured by bedside ultrasound), and ICU length of stay (LOS).
详细描述
The investigators have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of surgical intensive care unit patients (NCT01363102). In addition, the investigators have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).
This is a prospective, observational study to observe the relation between mobility dose, muscle wasting and patient outcomes in critically ill stroke patients.
Patients will be enrolled within 48 hours of ICU admission. The investigators will measure the dose of activity, that is duration and intensity of mobilization in critically ill patients with ischemic stroke and intracerebral hemorrhage. By mobility "dose" the investigators are referring to all provider-directed activities (by nursing, and physical therapists) meant to enhance the patient's mobility level. The investigators take into account mobility "dose", defined as a function of both the mobility level (e.g., sitting at the edge of the bed, ambulating) as well as its duration. Of note, there is so far no published data available that describes patients' mobility "dose" in such an integrative, semi-quantitative fashion.
The investigators use the existing mobility intensity quantification tool (MQS) (NCT03196960) and test the hypotheses that mobilization dose predicts muscle wasting in critically ill stroke patients, adverse hospital discharge disposition as well as 90 day Barthel Index. The investigators will apply hierarchical testing to evaluate the association between mobilization dose and discharge disposition as well as 90-day Barthel Index.
The Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score (SOMS), a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit depending on mobilization level).
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
- •Aged 18 years and older
- •Admitted to the neurological intensive care service within the past 48 hours
- •an expected ICU length of stay of at least 48h
- •New onset ischemic stroke or non-traumatic intracerebral hemorrhage
- •Baseline functional independence: Barthel-Index of 70 or above 2 weeks before admission (obtained retrospectively from patient or proxy)
排除标准
- •Transfers from other institutions (hospitals, long-term rehabilitation facilities, skilled nursing facilities) with a stay >48h at the outside institution
- •absence of lower extremities
- •not committed to full support
- •exclusive or clinically predominant posterior circulation ischemic stroke
- •subarachnoid hemorrhage, subdural and epidural hemorrhage
结局指标
主要结局
90 day Barthel Index (hierarchical testing)
时间窗: 90 days post discharge from hospital (collected through follow up phone call)
The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.
Adverse Hospital Discharge Disposition
时间窗: patient will be followed until hospital discharge; assessed at hospital discharge; expected between study day 3 and 30
Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.
次要结局
- Neurological ICU length of stay(admission until discharge from neurological ICU; an expected 3 to 20 days)
- FIM Score at ICU discharge(assessed at discharge from neurological ICU; expected between study day 3 and 20)
- Days on sedation(during hospital stay; an expected 0 to 30 days)
- 30-day hospital readmission(30 days after discharge from hospital, obtained through follow up phone call)
- Delirium-free days(CAM-ICU will be evaluated daily during hospital stay; an expected 0 to 30 days)
- 30 day Barthel Index(30 days post discharge from hospital (collected through follow up phone call))
- mortality(during ICU stay, hospital stay or within the 30day or 90day follow up period (follow up data collected through phone call)
- ICU readmission(during hospital stay; expected to be assessed between study day 3 and 30)
- Falls(during hospital stay; expected to be assessed between study day 3 and 30)
- Neurological ICU length of stay until discharge readiness(admission until discharge readiness from neurological ICU; an expected 3 to 20 days)
- 90-day GOS-E (Extended Glasgow Outcomes Scale)(obtained 90 days after discharge from hospital through follow up phone call)
- Total costs of care(during hospital stay)
- Rectus Femoris Muscle Cross Sectional Area Rectus Femoris Muscle Cross Sectional Area(will be measured at least twice (on day of enrollement and before discharge); if stay longer than one week, ultrasound will be performed weekly (every 7 days); expected total time period of 3 to 30 days)
- hospital length of stay(admission until discharge from hospital: patient will be followed until discharge from hospital; an expected 3 to 30 days)
研究者
Balachundhar Subramaniam
Professor of Anesthesia
Beth Israel Deaconess Medical Center