Clinical trial NCT01225627: Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic disease management
Chronic obstructive pulmonary disease
Discharge planning
Discharge coordinator
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 253
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients hospitalized due to COPD worsening
timeFrame: 180 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 180 days
measure: Acute exacerbations of COPD
timeFrame: 180 days
measure: Time to hospitalization due to COPD worsening
timeFrame: 180 days
measure: Days alive and out of hospital
timeFrame: 180 days
measure: Health-related quality of life
timeFrame: 180 days
measure: Health care costs
timeFrame: 180 days
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic Golnik
Study officials:
affiliation: University Clinic Golnik
name: Mitja Lainscak, MD, PhD
role: STUDY_CHAIR
affiliation: University of Ljubljana
name: Jerneja Farkas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farkas J, Kadivec S, Kosnik M, Lainscak M. Effectiveness of discharge-coordinator intervention in patients with chronic obstructive pulmonary disease: study protocol of a randomized controlled clinical trial. Respir Med. 2011 Oct;105 Suppl 1:S26-30. doi: 10.1016/S0954-6111(11)70007-5.