Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Coordinated discharge
Control
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic disease management, Chronic obstructive pulmonary disease, Discharge planning, Discharge coordinator
Eligibility 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
Sites / Locations
- University Clinic Golnik
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Coordinated discharge
Control
Arm Description
Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
Outcomes
Primary Outcome Measures
Number of patients hospitalized due to COPD worsening
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
Mortality will be ascertained at the Central Population Registry.
Acute exacerbations of COPD
Endpoint will be adjudicated by Endpoint committee.
Time to hospitalization due to COPD worsening
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
Endpoint will be adjudicated by Endpoint committee.
Health-related quality of life
Endpoint will be adjudicated by Endpoint committee.
Health care costs
Endpoint will be adjudicated by Endpoint committee.
Full Information
NCT ID
NCT01225627
First Posted
October 18, 2010
Last Updated
April 8, 2013
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
1. Study Identification
Unique Protocol Identification Number
NCT01225627
Brief Title
Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic disease management, Chronic obstructive pulmonary disease, Discharge planning, Discharge coordinator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coordinated discharge
Arm Type
Experimental
Arm Description
Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
Intervention Type
Other
Intervention Name(s)
Coordinated discharge
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
Primary Outcome Measure Information:
Title
Number of patients hospitalized due to COPD worsening
Description
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.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Mortality will be ascertained at the Central Population Registry.
Time Frame
180 days
Title
Acute exacerbations of COPD
Description
Endpoint will be adjudicated by Endpoint committee.
Time Frame
180 days
Title
Time to hospitalization due to COPD worsening
Description
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.
Time Frame
180 days
Title
Days alive and out of hospital
Description
Endpoint will be adjudicated by Endpoint committee.
Time Frame
180 days
Title
Health-related quality of life
Description
Endpoint will be adjudicated by Endpoint committee.
Time Frame
180 days
Title
Health care costs
Description
Endpoint will be adjudicated by Endpoint committee.
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, MD, PhD
Organizational Affiliation
University Clinic Golnik
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jerneja Farkas, MD, PhD
Organizational Affiliation
University of Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Golnik
City
Golnik
ZIP/Postal Code
SI-4204
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22015082
Citation
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.
Results Reference
background
Learn more about this trial
Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
We'll reach out to this number within 24 hrs