Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility as measured by number of CAM assessment days
研究概览
简要总结
There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
- •Age >= 65
排除标准
- •Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department
- •Admitted as "observation" (i.e., expected length of stay < 2 nights)
- •Admitted > 24 hours prior to time of enrollment
- •Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)
- •Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included
- •Patients lacking decision-making capacity for whom no Legally Authorized Representative (LAR) is available
- •Primary reason for admission "altered mental status", drug withdrawal, stroke, or seizure
- •Patients for whom a withdrawal pathway has been preemptively initiated based on their substance use history (e.g., the alcohol withdrawal pathway order set or other as needed ("PRN") orders for the indication of withdrawal)
- •Delirium present at time of enrollment
- •Glasgow Coma Scale (GCS) < 10 at time of enrollment
- •Enrolled in this trial during a previous admission (i.e., we will not resample)
- •Enrolled in a separate trial this admission
- •Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety concern)
- •Significant fall risk per nursing assessment
结局指标
主要结局
Feasibility as measured by number of CAM assessment days
时间窗: 5 days
Feasibility as measured by number of patients screened
时间窗: 5 days
Feasibility as measured by number of patients who dropped out of the study
时间窗: 5 days
Feasibility as measured by number of patients who wore the earplugs
时间窗: 5 days
Incidence of delirium
时间窗: The first 5 days of patients' hospitalization
Will be assessed using the CAM
Feasibility as measured by number of patients ineligible
时间窗: 5 days
Feasibility as measured by number of patients who decline to participate
时间窗: 5 days
Feasibility as measured by number of patients who wore the eye masks
时间窗: 5 days
Feasibility as measured by number of patients who successfully completed the study
时间窗: 5 days
次要结局
未报告次要终点