跳至主要内容
临床试验/NCT01952899
NCT01952899Unknown不适用

Improvement of Care for ICU Patients With Delirium by Early Screening and Treatment

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
Delirium guideline adherence

研究概览

简要总结

Objective: Delirium is an important and frequently occurring complication in intensive care patients. However, screening and treatment of delirium is not in accordance with current national and international guidelines. The first objective of this prospective study is to describe the barriers and facilitators for guideline adherence. Second, investigators will develop a tailored implementation strategy. Finally, investigators will describe the effects of the tailored implementation on the adherence of the guideline in a pilot study. Design: Current practices, attitudes and deviations from a national (Dutch) delirium guideline will be assessed in a prospective before-measurement. Barriers and facilitators will be identified with surveys and focus group interviews. Adherence to the guideline will be studied in a before-after study in 7 ICUs in the Southwest of the Netherlands. Further, the effect of a multifaceted implementation strategy-guided implementation will be assessed with regard to important clinical outcomes, such as mortality and delirium incidence. Population: Professionals (Physicians/intensivists, nurses' and psychiatrists) and ICU patients. Intervention: The delirium guideline of the Netherlands Society of Intensive Care (NVIC) is implemented in this study. Implementation strategies: Barriers and facilitators will be determined in focus group interviews (n=7) with health care professionals resulting in a tailored guideline implementation strategy. In the development of the strategies specific attention will be paid to sustaining the guideline adherence. Main outcome: 1. Current practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation strategy; 4. Percentage of adherence to the guideline (early screening, prevention and treatment of delirium); 5. Effects of implementation on outcomes (economic, mortality, delirium incidence). Data analysis / power: The main effects, guideline adherence, will be evaluated by comparing the before and after measurements. Calculating from 90% power,2-sided alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of 85%. Economic evaluation: The economic analysis will be performed from a health care perspective. Investigator will calculate and compare the direct medical costs of usual care (before) and care after implementation of the guideline. Additionally, the cost of the tailored guideline implementation process will be calculated. The economic analysis will be a cost-minimalization analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Screening delirium by all patients
  • Measuring of guide line adherence for all professionals working on the ICU
  • Implementation guideline: all professionals

排除标准

  • 未提供

结局指标

主要结局

Delirium guideline adherence

时间窗: 36 monts

1. Current practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation strategy; 4. Percentage of adherence to the guideline (early screening, prevention and treatment of delirium); 5. process evaluation in terms of relevant clinical outcomes, economic assessment, delirium incidence. 6. Re-validation of delirium screening tools (CAM-ICU and ICDSC)

次要结局

  • Economic evaluation(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Z. Trogrlic

MSc / PhD-Student

Erasmus Medical Center

研究点 (1)

Loading locations...

相似试验