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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

October 18, 2010
April 8, 2013
November 2009
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01225627 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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.
  • Other: Control
    Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
  • Experimental: Coordinated discharge
    Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
    Intervention: Other: Coordinated discharge
  • 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.
    Intervention: Other: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT01225627
Golnik-COPD-DC-1
Yes
Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik
The University Clinic of Pulmonary and Allergic Diseases Golnik
Not Provided
Study Chair: Mitja Lainscak, MD, PhD University Clinic Golnik
Principal Investigator: Jerneja Farkas, MD, PhD University of Ljubljana
The University Clinic of Pulmonary and Allergic Diseases Golnik
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP