Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Manisa Celal Bayar University | OTHER |
| Ege University | OTHER |
| Gazi University | OTHER |
| Duzce University |
Not provided
Not provided
Not provided
Not provided
Readmission to hospital is one of the most important problems in chronic obstructive pulmonary disease (COPD) patients who developed chronic respiratory failure. Patients receiving long-term oxygen therapy (LTOT) and noninvasive ventilation (NIV) constitute the most vulnerable group because of the need for comprehensive care. However, because of lack of health care support systems in Turkey, many advanced COPD patients are hospitalized due to preventable problems such as insufficient knowledge about the therapies, nonadherence to therapy and technical issues related to LTOT/NIV equipment. The aim of this multicenter randomized trial is to find out whether a structured discharge and follow-up protocol reduce the rate of unplanned, COPD-related hospital readmissions over 90 days in patients receiving LTOT or NIV.
The study is planned with Turkish Thoracic Society and Global Alliance Against Respiratory Disease-Turkey partnership and being carried out 10 centers throughout Turkey. COPD patients who are prescribed long-term oxygen therapy for hypoxemic respiratory failure and/or noninvasive ventilation for hypercapnic respiratory failure will be included in the study and will be randomized to either intervention or control arm. The intervention mainly consists of not only education about the disease and medications but also the education of the equipment and how to use it to have the best benefit. Control arm patients will receive usual care, which consists of basic education of the patient about the therapies. The primary outcome of the study is readmission in 90 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | The intervention mainly consists of a developed protocol for education about the disease and medications AND an education of the equipment and how to use it to have the best benefit. Actions in structured discharge and follow up protocol:
|
|
| Control | No Intervention | Control patients will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol for structured discharge and follow-up | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Readmission rate | The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge | 90days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first exacerbation | Time to first exacerbation after discharge | 90 days |
| Rate of exacerbation | Total COPD exacerbation rate within 90 days after discharge |
Not provided
Inclusion Criteria:
COPD patients who developed chronic respiratory failure and are eligible for long-term oxygen therapy (LTOT) or noninvasive ventilation (NIV) according to Turkish National Social Security regulations
Definitions:
COPD: The diagnosis of COPD is made according to GOLD criteria Chronic respiratory failure: PaO2>60mmHg at room air and/or PaCO2> 45
Eligibility for LTOT:
Eligibility for NIV:
Exclusion Criteria:
1. Patients receiving LTOT or NIV for a different cause 2. Patients who do not give consent 3. Patients who are unable to be followed up regularly due to reasons such as living far from study center, lack of family support, unwillingness or inability to contact regularly.
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| BEGUM ERGAN, MD | Dokuz Eylul University | Study Director |
| TUGBA GOKTALAY, MD | Manisa Celal Bayar University | Study Director |
| PINAR ERGUN, MD | Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital | Principal Investigator |
| ALEV GURGUN, MD | Ege University | Principal Investigator |
| METIN AKGUN, MD | Ataturk University | Principal Investigator |
| NURDAN KOKTURK, MD | Gazi University | Principal Investigator |
| EZGI OZYILMAZ, MD | Cukurova University | Principal Investigator |
| ASLI DILEKTASLI, MD | Uludag University | Principal Investigator |
| BIRSEN OCAKLI, MD | Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital | Principal Investigator |
| ONER BALBAY, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylul University | Izmir | Narlıdere | 35340 | Turkey (Türkiye) | ||
| Cukurova University |
Not provided
| OTHER |
| Cukurova University | OTHER |
| Ataturk University | OTHER |
| Uludag University | OTHER |
| Atatürk Chest Diseases and Chest Surgery Training and Research Hospital | OTHER |
| Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital | OTHER |
| Ordu University | OTHER |
| Hacettepe University | OTHER |
| Turkish Directorate General of Public Health | UNKNOWN |
| Istanbul University - Cerrahpasa | OTHER |
| Diskapi Yildirim Beyazit Education and Research Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
| 90 days |
| Rate of hospitalization | Total hospitalization number due to COPD within 90 days after discharge | 90 days |
| Compliance to treatment | Compliance to LTOT and NIV therapies will be assessed by duration of use (number of hours per day and number of nights per week) within 90 days after discharge. | 90 days |
| Long term survival | One year survival after discharge | One year |
| Duzce University |
| Principal Investigator |
| Adana |
| Turkey (Türkiye) |
| Gazi University | Ankara | Turkey (Türkiye) |
| Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital | Ankara | Turkey (Türkiye) |
| Uludag University | Bursa | Turkey (Türkiye) |
| Duzce University | Düzce | Turkey (Türkiye) |
| Ataturk University | Erzurum | Turkey (Türkiye) |
| Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital | Istanbul | Turkey (Türkiye) |
| Ege University | Izmir | Turkey (Türkiye) |
| Celal Bayar University | Manisa | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided