Clinical Trials Directory

Trials / Completed

CompletedNCT01225627

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
253 (actual)
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik · Academic / Other
Sex
All
Age
35 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2009-11-01
Primary completion
2011-12-01
Completion
2012-06-01
First posted
2010-10-21
Last updated
2013-04-09

Locations

1 site across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT01225627. Inclusion in this directory is not an endorsement.