Evaluation of the Quality Management Project 'Prevention of Post-operative Delirium in the Care of Older Patients' at the University Medical Centre Hamburg
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 720
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium is a common complication in older adults undergoing surgery. It is characterized by an acute and fluctuating disturbance of attention, awareness, and thinking. Delirium may be associated with prolonged hospital stay, loss of independence, cognitive decline, complications, and increased need for care.
The University Medical Center Hamburg-Eppendorf has introduced a multicomponent care program to prevent postoperative delirium in patients aged 65 years and older. The program includes preoperative assessment of risk factors such as frailty, cognitive impairment, and malnutrition, as well as information for patients and relatives. Depending on the individual risk profile, preventive measures may include support with orientation, adequate hydration and nutrition, early mobilization, preservation of the sleep-wake cycle, use of glasses and hearing aids, avoidance of unnecessary room changes, and reduction of medications that may contribute to delirium. A specialized delirium team supports patients and clinical staff during the hospital stay.
EvaDel is a prospective study evaluating how patient care and clinical outcomes change while this delirium prevention program is gradually implemented in routine clinical practice. Participants will be followed from before surgery until three months after the operation. The study will assess the occurrence of postoperative delirium, cognitive function, independence in everyday activities, postoperative complications, and the extent to which the preventive measures were successfully implemented.
The study hypothesis is that a higher degree of implementation of the delirium prevention program will be associated with a lower rate of postoperative delirium and with better cognitive, functional, and clinical outcomes after surgery.
详细描述
EvaDel is a prospective, single-center, longitudinal implementation study evaluating a multicomponent program for the prevention of postoperative delirium in patients aged 65 years and older undergoing inpatient surgery at the University Medical Center Hamburg-Eppendorf.
The program includes preoperative assessment of delirium-related risk factors, including cognitive impairment, frailty, and malnutrition. Patients are assigned to a low-, intermediate-, or high-risk category. Depending on the individual risk profile, preventive measures may include patient and family education, support with orientation, adequate hydration and nutrition, early mobilization, preservation of the sleep-wake cycle, use of glasses and hearing aids, avoidance of unnecessary room transfers, and reduction of potentially deliriogenic medication. A specialized delirium team supports patients and clinical staff.
All participants receive care according to the prevention processes established at the time of treatment. No separate control group is planned. As the program is implemented gradually in routine clinical practice, outcomes will be analyzed in relation to time since implementation began and to the documented degree of implementation.
Data are collected from medical records and standardized assessments before surgery, during the postoperative hospital stay, at discharge, and during follow-up up to three months after surgery. Assessments include postoperative delirium, cognitive function, frailty, nutritional status, functional independence, complications, and patient experience.
The primary analysis will examine whether postoperative delirium decreases with increasing implementation of the prevention program. Secondary analyses will evaluate cognitive, functional, and clinical outcomes, feasibility, and adherence to the individual prevention measures. Regression models will account for relevant baseline and perioperative risk factors. Exploratory analyses will also be performed within the predefined delirium risk groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Age ≥65 years
- •Scheduled for or undergoing inpatient surgery at the study site
- •Able to provide written informed consent
- •Sufficient language proficiency to understand the study information and complete the study assessments
排除标准
- •Current schizophrenia
- •Active alcohol dependence or harmful alcohol use
- •Current drug abuse
- •severe intellectual disability
- •Preoperative delirium
- •Inability to understand the nature, significance, and implications of study participation or to provide informed consent
结局指标
主要结局
Incidence of postoperative delirium
时间窗: postoperative days 1-5
Proportion of participants with at least one positive delirium assessment using the Nursing Delirium Screening Scale (NuDESC) or the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM).
次要结局
- Functional independence(3 months postoperative)
- Cognitive function(3 months postoperative)
- Postoperative complications(30 days postoperative)