Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial
研究概览
详细说明
This is a single-centre randomized controlled clinical trial to assess the effectiveness of discharge coordinator intervention compared to care as usual in patients with COPD.
The study is being conducted at University Clinic of Pulmonary and Allergic Diseases Golnik, Slovenia. Patients with suspicion of acute exacerbation of COPD will be screened at admission when they will be informed about study details. After explanations of concerns and questions that they might have, a signed informed consent will be collected. During 48 hours, patients will be included according to their eligibility. Main inclusion criteria are COPD stage II-IV according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, ability to perform phone contacts and availability for home visits. Patients will be excluded if in unstable or terminal stage of disease other than COPD, if they will die during hospitalization, or if unable to follow the study protocol.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Golnik、斯洛文尼亚、SI-4204
- University Clinic Golnik
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age >35 years
- acute exacerbation of COPD stage II-IV
- residence in the geographical area linked to the study hospital
- ability to communicate
- give written informed consent
Exclusion Criteria:
- diagnosis of cognitive impairment
- unstable or terminal disease other than COPD
- withdrawal of written informed consent before discharge
- inability of phone contact
- death during hospitalisation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Coordinated discharge
Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
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In intervention group, a discharge coordinator contacts hospitalized patients the day after randomization.
During hospitalization, discharge coordinator visits are scheduled according to patients' problems and home-care needs.
At 48 hours after hospital discharge, a discharge coordinator calls patients by phone to check the process of adjustment to home environment and to inquire about additional needs patients might have.
Thereafter, phone contacts are scheduled according to the patients' needs and 7-10 days after the hospital discharge a home visit is performed by discharge coordinator, respectively.
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安慰剂比较：Control
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
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Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of patients hospitalized due to COPD worsening
大体时间：180 days
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A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD.
Endpoint will be adjudicated by Endpoint committee.
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180 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All-cause mortality
大体时间：180 days
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Mortality will be ascertained at the Central Population Registry.
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180 days
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Acute exacerbations of COPD
大体时间：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Time to hospitalization due to COPD worsening
大体时间：180 days
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A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD.
Endpoint will be adjudicated by Endpoint committee.
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180 days
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Days alive and out of hospital
大体时间：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Health-related quality of life
大体时间：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Health care costs
大体时间：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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合作者和调查者
调查人员
- 首席研究员：Jerneja Farkas, MD, PhD、University of Ljubljana
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Golnik-COPD-DC-1
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