Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Structured Discharge and Follow-up Protocol on Readmission Rate in COPD Patients Receiving LTOT and NIV: A Multicenter Randomized Trial

Conditions
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COPD Exacerbation, Noninvasive Ventilation, Long Term Oxygen Therapy, Chronic Respiratory Failure

Intervention / Treatment
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* Other: Protocol for structured discharge and follow-up


Participation Criteria
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Eligibility Criteria
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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: PaO2 ≤ 55 mmHg or SaO2 ≤ 88% under room air 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: PaCO2≥55 mmHg or 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. -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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: Patient education for disease severity and medications Education of family/relatives about medications and types of equipment Detailed education for LTOT and/or NIV (how to use, duration of use, solutions for possible common problems) Preparation of home environment for patients needs 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 Outpatient control for the first month | Other: Protocol for structured discharge and follow-up<br> <br> |
| No Intervention: Control<br>Control patients will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate | The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge | 90days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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copd, exacerbation, structured discharge, readmission, chronic respiratory failure