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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225627
• Other study ID #: Golnik-COPD-DC-1
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: April 8, 2013
• Start date: November 2009
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Slovenia	University Clinic Golnik	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	180 days	No
Secondary	All-cause mortality	Mortality will be ascertained at the Central Population Registry.	180 days	No
Secondary	Acute exacerbations of COPD	Endpoint will be adjudicated by Endpoint committee.	180 days	No
Secondary	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.	180 days	No
Secondary	Days alive and out of hospital	Endpoint will be adjudicated by Endpoint committee.	180 days	No
Secondary	Health-related quality of life	Endpoint will be adjudicated by Endpoint committee.	180 days	No
Secondary	Health care costs	Endpoint will be adjudicated by Endpoint committee.	180 days	No