Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic disease management, Chronic obstructive pulmonary disease, Discharge planning, Discharge coordinator
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.
Interventions
OTHERCoordinated 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.
OTHERControl
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
Sponsors
The University Clinic of Pulmonary and Allergic Diseases Golnik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients hospitalized due to COPD worsening | 180 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute exacerbations of COPD | 180 days | Endpoint will be adjudicated by Endpoint committee. |
| Time to hospitalization due to COPD worsening | 180 days | 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. |
| All-cause mortality | 180 days | Mortality will be ascertained at the Central Population Registry. |
| Health-related quality of life | 180 days | Endpoint will be adjudicated by Endpoint committee. |
| Health care costs | 180 days | Endpoint will be adjudicated by Endpoint committee. |
| Days alive and out of hospital | 180 days | Endpoint will be adjudicated by Endpoint committee. |
Countries
Slovenia
Outcome results
None listed