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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03499470
• Other study ID #: 20.478.486.359
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: July 2019
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

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Related Conditions & MeSH terms

• Chronic Respiratory Failure
• COPD Exacerbation
• Long Term Oxygen Therapy
• Noninvasive Ventilation
• Respiratory Insufficiency

Intervention

Other:
• Protocol for structured discharge and follow-up

Locations

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

Sponsors (15)

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

Country where clinical trial is conducted

Turkey, 

Outcome

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