COPD Exacerbation Clinical Trial
Official title:
The Effectiveness of Structured Discharge and Follow-up Protocol on Readmission Rate in COPD Patients Receiving LTOT and NIV: A Multicenter Randomized Trial
Verified date | July 2019 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
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: 1. PaO2 = 55 mmHg or SaO2 = 88% under room air 2. PaO2 value of 55-59 mmHg or SaO2 = 89% and cor pulmonale with hematocrit >55 or p pulmonale in ECG or congestive heart failure. Eligibility for NIV: 1. PaCO2=55 mmHg or 2. PaCO2 50 to 54 mmHg and nocturnal desaturation = %88 for 5 minutes under 2lt/min nasal O2 therapy 3. PaCO2 50 to 54 mmHg and >2 exacerbations within the last year 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. - |
Country | Name | City | State |
---|---|---|---|
Turkey | Cukurova University | Adana | |
Turkey | Gazi University | Ankara | |
Turkey | Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital | Ankara | |
Turkey | Uludag University | Bursa | |
Turkey | Duzce University | Düzce | |
Turkey | Ataturk University | Erzurum | |
Turkey | Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital | Istanbul | |
Turkey | Dokuz Eylul University | Izmir | Narlidere |
Turkey | Ege University | Izmir | |
Turkey | Celal Bayar University | Manisa |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University | Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Ataturk University, Celal Bayar University, Cukurova University, Duzce University, Ege University, Gazi University, Hacettepe University, Health Sciences University Diskapi Yildirim Beyazit Education and Research Hospital, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul University Cerrahpasa Faculty, T.C. ORDU ÜNIVERSITESI, Turkish Directorate General of Public Health, Uludag University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Readmission rate | The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge | 90days | |
Secondary | Time to first exacerbation | Time to first exacerbation after discharge | 90 days | |
Secondary | Rate of exacerbation | Total COPD exacerbation rate within 90 days after discharge | 90 days | |
Secondary | Rate of hospitalization | Total hospitalization number due to COPD within 90 days after discharge | 90 days | |
Secondary | 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 | |
Secondary | Long term survival | One year survival after discharge | One year |
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