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

Not Applicable

• Conditions: Noninvasive Ventilation; COPD Exacerbation; Chronic Respiratory Failure; Long Term Oxygen Therapy
• Interventions: Other: Protocol for structured discharge and follow-up

• Registration Number: NCT03499470
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2016-11-07
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Protocol for structured discharge and follow-up	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

Primary Outcome Measures

Name	Time	Method
Readmission rate	90days	The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge

Secondary Outcome Measures

Name	Time	Method
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
Long term survival	One year	One year survival 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.

Trial Locations

Locations (10)

Dokuz Eylul University; 🇹🇷 Izmir, Narlıdere, Turkey

Cukurova University; 🇹🇷 Adana, Turkey

Gazi University; 🇹🇷 Ankara, Turkey

Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital; 🇹🇷 Ankara, Turkey

Celal Bayar University; 🇹🇷 Manisa, Turkey

Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital; 🇹🇷 Istanbul, Turkey

Uludag University; 🇹🇷 Bursa, Turkey

Duzce University; 🇹🇷 Düzce, Turkey

Ataturk University; 🇹🇷 Erzurum, Turkey

Ege University; 🇹🇷 Izmir, Turkey