Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Control; Other: Coordinated discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT01225627

Golnik-COPD-DC-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 253 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

253 participants in 2 patient groups, including a placebo group

Coordinated discharge

Experimental group

Description:

Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.

Treatment:

Other: Coordinated discharge

Control

Placebo Comparator group

Description:

Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.

Treatment:

Other: Control