An interventional study of Protocol for structured discharge and follow-up in COPD Exacerbation, Noninvasive Ventilation and Long Term Oxygen Therapy, sponsored by Dokuz Eylul University. Status unknown at 10 sites in Turkey. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Prevention
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.
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:
-
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: 1. Patient education for disease severity and medications 2. Education of family/relatives about medications and types of equipment 3. Detailed education for LTOT and/or NIV (how to use, duration of use, solutions for possible common problems) 4. Preparation of home environment for patients needs 5. Regular telephone visits on day 7 and day 14 after discharge and telephone visits in emergency situations and early referral to the hospital when needed 6. Outpatient control for the first month
Other: Protocol for structured discharge and follow-up
Control patients will receive usual care
Readmission rate
The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge
Time frame: 90days
Time to first exacerbation
Time to first exacerbation after discharge
Time frame: 90 days
Rate of exacerbation
Total COPD exacerbation rate within 90 days after discharge
Time frame: 90 days
Rate of hospitalization
Total hospitalization number due to COPD within 90 days after discharge
Time frame: 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.
Time frame: 90 days
Long term survival
One year survival after discharge
Time frame: One year
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Dokuz Eylul University