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

NCT ID: NCT01225627

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-06-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coordinated discharge

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

Group Type: EXPERIMENTAL

Coordinated discharge

Intervention Type: 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.

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role: lead

Responsible Party

Mitja Lainščak

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitja Lainscak, MD, PhD

Role: STUDY_CHAIR

University Clinic Golnik

Jerneja Farkas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ljubljana

Locations

University Clinic Golnik

Golnik, , Slovenia

Countries

Slovenia

References

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.

Reference Type: BACKGROUND

PMID: 22015082 (View on PubMed)

Other Identifiers

Golnik-COPD-DC-1

Identifier Type: -

Identifier Source: org_study_id