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

NCT01225627 | Completed DMC

• 1 other identifier: Golnik-COPD-DC-1
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic disease management; Chronic obstructive pulmonary disease; Discharge planning; Discharge coordinator

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• All-cause mortality

  180 days

• Acute exacerbations of COPD

  180 days

• Time to hospitalization due to COPD worsening

  180 days

• Days alive and out of hospital

  180 days

• Health-related quality of life

  180 days

Study Arms (2)

Coordinated discharge

EXPERIMENTAL

Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.

Other: Coordinated discharge

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

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.

Coordinated discharge

Control OTHER

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

Control

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University Clinic of Pulmonary and Allergic Diseases Golnik: lead

Study Sites (1)

University Clinic Golnik

Golnik, SI-4204, Slovenia

Location

Related 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.

  PMID: 22015082 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Mitja Lainscak, MD, PhD

  University Clinic Golnik

  STUDY CHAIR

• Jerneja Farkas, MD, PhD

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 21, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

SL (1)