Chronic Respiratory Failure, COPD Exacerbation, Long Term Oxygen Therapy, Noninvasive Ventilation
Conditions
Keywords
copd, exacerbation, structured discharge, readmission, chronic respiratory failure
Brief summary
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.
Detailed description
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.
Interventions
OTHERProtocol for structured discharge and follow-up
Sponsors
Celal Bayar University
Ege University
Gazi University
Duzce University
Cukurova University
Ataturk University
Uludag University
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
Ordu University
Hacettepe University
Turkish Directorate General of Public Health
Istanbul University - Cerrahpasa
Diskapi Yildirim Beyazit Education and Research Hospital
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readmission rate | 90days | The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first exacerbation | 90 days | Time to first exacerbation after discharge |
| Rate of exacerbation | 90 days | Total COPD exacerbation rate within 90 days after discharge |
| Rate of hospitalization | 90 days | Total hospitalization number due to COPD within 90 days after discharge |
| Compliance to treatment | 90 days | 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. |
| Long term survival | One year | One year survival after discharge |
Countries
Turkey (Türkiye)
Outcome results
None listed