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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier:
NCT01225627
First received: October 18, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
 Other: Coordinated discharge
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:

Primary Outcome Measures:
  • Number of patients hospitalized due to COPD worsening [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Mortality will be ascertained at the Central Population Registry.

  • Acute exacerbations of COPD [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Endpoint will be adjudicated by Endpoint committee.

  • Time to hospitalization due to COPD worsening [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Endpoint will be adjudicated by Endpoint committee.

  • Health-related quality of life [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Endpoint will be adjudicated by Endpoint committee.

  • Health care costs [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Endpoint will be adjudicated by Endpoint committee.


Enrollment: 253
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225627

Locations
Slovenia
University Clinic Golnik
Golnik, Slovenia, SI-4204
Sponsors and Collaborators
The University Clinic of Pulmonary and Allergic Diseases Golnik
Investigators
Study Chair: Mitja Lainscak, MD, PhD University Clinic Golnik
Principal Investigator: Jerneja Farkas, MD, PhD University of Ljubljana
  More Information

Publications:

Responsible Party: Mitja Lainščak, Professor, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01225627     History of Changes
Other Study ID Numbers: Golnik-COPD-DC-1
Study First Received: October 18, 2010
Last Updated: April 8, 2013
Health Authority: Slovenia: Ethics Committee

Keywords provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:
Chronic disease management
Chronic obstructive pulmonary disease
Discharge planning
Discharge coordinator

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013