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

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik (Other)

Overall Status

Completed

CT.gov ID

NCT01225627

Collaborator

(none)

253

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: Coordinated discharge Other: Control	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

253 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coordinated discharge Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.	Other: Coordinated discharge 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.
Placebo Comparator: Control Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.	Other: Control Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.

Arm

Intervention/Treatment

Experimental: Coordinated discharge

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

Other: Coordinated discharge

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.

Placebo Comparator: Control

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

Other: Control

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

Outcome Measures

Primary Outcome Measures

Number of patients hospitalized due to COPD worsening [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.

Secondary Outcome Measures

All-cause mortality [180 days]
Mortality will be ascertained at the Central Population Registry.
Acute exacerbations of COPD [180 days]
Endpoint will be adjudicated by Endpoint committee.
Time to hospitalization due to COPD worsening [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.
Days alive and out of hospital [180 days]
Endpoint will be adjudicated by Endpoint committee.
Health-related quality of life [180 days]
Endpoint will be adjudicated by Endpoint committee.
Health care costs [180 days]
Endpoint will be adjudicated by Endpoint committee.