Skip to main content
OpenTrials
Completed

NCT Number: NCT01225627

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Golnik

Golnik, SI-4204, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coordinated discharge

Other

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.

Control

Other

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

Primary outcomes

  1. Number of patients hospitalized due to COPD worsening

    Time frame: 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 outcomes

  1. All-cause mortality

    Time frame: 180 days

    Mortality will be ascertained at the Central Population Registry.

  2. Acute exacerbations of COPD

    Time frame: 180 days

    Endpoint will be adjudicated by Endpoint committee.

  3. Time to hospitalization due to COPD worsening

    Time frame: 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.

  4. Days alive and out of hospital

    Time frame: 180 days

    Endpoint will be adjudicated by Endpoint committee.

  5. Health-related quality of life

    Time frame: 180 days

    Endpoint will be adjudicated by Endpoint committee.

  6. Health care costs

    Time frame: 180 days

    Endpoint will be adjudicated by Endpoint committee.

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Registry information

Official study title

Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 21, 2010
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.