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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Coordinated discharge
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coordinated discharge<br>Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care. | Other: Coordinated discharge<br>* 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.<br>|
| Placebo Comparator: Control<br>Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice. | Other: Control<br>* Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Mortality will be ascertained at the Central Population Registry. | 180 days | 
| Acute exacerbations of COPD | Endpoint will be adjudicated by Endpoint committee. | 180 days | 
| 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 | 
| Days alive and out of hospital | Endpoint will be adjudicated by Endpoint committee. | 180 days | 
| Health-related quality of life | Endpoint will be adjudicated by Endpoint committee. | 180 days | 
| Health care costs | Endpoint will be adjudicated by Endpoint committee. | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic disease management, Chronic obstructive pulmonary disease, Discharge planning, Discharge coordinator