Does Perioperative Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium in Older, Frail Patients Undergoing Elective Inpatient Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients of postoperative delirium (POD) as measured by confusion assessment measure (CAM)
研究概览
简要总结
The purpose of this research is to find out the best way to reduce delirium in frail, older patients undergoing planned surgery. Delirium is a state of confusion and difficulty concentrating that is temporary. Delirium may make the person anxious, angry, sleepy, not think clearly, or hallucinate. Being frail in medicine means that the body may not easily recover from a stressor, such as surgery. This study will determine if a detailed on-going evaluation by a Geriatrician, doctor who specializes in the care of older adults, after surgery is better at decreasing the risk of delirium than simply highlighting the patient's frailty in the electronic medical record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frailty as measured by the 5-modified frailty index (5-mFI) during the anesthesia preoperative assessment. The 5-mFI consists of 5 elements: 1-dependency for activities of daily living, 2-congestive heart failure within 30 days, 3-chronic obstructive pulmonary disease or pneumonia currently treated with antibiotics, 4-diabetes, and 5-hypertension. The diagnosis of frailty by the 5-mFI is based upon the presence of 2 or more of the elements.
- •Elective inpatient surgery with an expected LOS > 1 day;
- •Receiving general anesthesia
- •Adults who are unable to consent if they have a designated proxy able to consent
排除标准
- •Absence or withdrawal of informed consent,
- •Presence of current delirium
研究组 & 干预措施
CGA group
Participants will receive the CGA intervention for up to 2 weeks
干预措施: CGA (Behavioral)
Control Group
Participants will receive standard of care treatment for up to 2 weeks
干预措施: control (Other)
结局指标
主要结局
Proportion of patients of postoperative delirium (POD) as measured by confusion assessment measure (CAM)
时间窗: up to 7 days
The CAM score ranges from 1-4. Each score means the following: 1. \- acute onset or fluctuating course, 2. \- inattention, 3. \- altered mental status 4. \- disorganized thinking. The diagnosis of delirium by the CAM is based on the presence of features 1 and 2 and either 3 or 4.
次要结局
- home delirium measured by CAM(up to 18 days)
- The proportion of patients who had a non-escalation of discharge level of care(1 day (at the end of the intervention))
- length of stay (LOS)(1 day (at the end of the intervention))
- prolonged length of stay (LOS)(1 day (at the end of the intervention))
- home delirium measured by CAM(up to 18 days)
研究者
Elizabeth Mahanna Gabrielli
Associate Professor of Clinical Anesthesiology
University of Miami