Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Number of patients hospitalized due to COPD worsening
研究概览
简要总结
This is a single-centre randomized controlled clinical trial which will enroll COPD patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention group, which will have care organized by discharge coordinator, and control group which will receive care as usual. The primary endpoint of this study is time to hospitalization due to COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and at following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90 days, and 180 days.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of patients hospitalized due to COPD worsening
时间窗: 180 days
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.
次要结局
- All-cause mortality(180 days)
- Health care costs(180 days)
- Time to hospitalization due to COPD worsening(180 days)
- Days alive and out of hospital(180 days)
- Health-related quality of life(180 days)
- Acute exacerbations of COPD(180 days)
研究者
Mitja Lainščak
Professor
The University Clinic of Pulmonary and Allergic Diseases Golnik