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

Primary Purpose

COPD Exacerbation, Noninvasive Ventilation, Long Term Oxygen Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Protocol for structured discharge and follow-up
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COPD Exacerbation focused on measuring copd, exacerbation, structured discharge, readmission, chronic respiratory failure

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Dokuz Eylul University
  • Cukurova University
  • Gazi University
  • Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
  • Uludag University
  • Duzce University
  • Ataturk University
  • Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
  • Ege University
  • Celal Bayar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Control patients will receive usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first exacerbation
Time to first exacerbation after discharge
Rate of exacerbation
Total COPD exacerbation rate within 90 days after discharge
Rate of hospitalization
Total hospitalization number due to COPD within 90 days after discharge
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.
Long term survival
One year survival after discharge

Full Information

First Posted
April 2, 2018
Last Updated
July 16, 2019
Sponsor
Dokuz Eylul University
Collaborators
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, T.C. ORDU ÜNİVERSİTESİ, Hacettepe University, Turkish Directorate General of Public Health, Istanbul University - Cerrahpasa (IUC), Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03499470
Brief Title
Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
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, T.C. ORDU ÜNİVERSİTESİ, Hacettepe University, Turkish Directorate General of Public Health, Istanbul University - Cerrahpasa (IUC), Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, Noninvasive Ventilation, Long Term Oxygen Therapy, Chronic Respiratory Failure
Keywords
copd, exacerbation, structured discharge, readmission, chronic respiratory failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control patients will receive usual care
Intervention Type
Other
Intervention Name(s)
Protocol for structured discharge and follow-up
Primary Outcome Measure Information:
Title
Readmission rate
Description
The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge
Time Frame
90days
Secondary Outcome Measure Information:
Title
Time to first exacerbation
Description
Time to first exacerbation after discharge
Time Frame
90 days
Title
Rate of exacerbation
Description
Total COPD exacerbation rate within 90 days after discharge
Time Frame
90 days
Title
Rate of hospitalization
Description
Total hospitalization number due to COPD within 90 days after discharge
Time Frame
90 days
Title
Compliance to treatment
Description
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
Title
Long term survival
Description
One year survival after discharge
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BEGUM ERGAN, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
TUGBA GOKTALAY, MD
Organizational Affiliation
Celal Bayar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
PINAR ERGUN, MD
Organizational Affiliation
Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ALEV GURGUN, MD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
METIN AKGUN, MD
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NURDAN KOKTURK, MD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EZGI OZYILMAZ, MD
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ASLI DILEKTASLI, MD
Organizational Affiliation
Uludag University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BIRSEN OCAKLI, MD
Organizational Affiliation
Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ONER BALBAY, MD
Organizational Affiliation
Duzce University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
State/Province
Narlıdere
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Cukurova University
City
Adana
Country
Turkey
Facility Name
Gazi University
City
Ankara
Country
Turkey
Facility Name
Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
City
Ankara
Country
Turkey
Facility Name
Uludag University
City
Bursa
Country
Turkey
Facility Name
Duzce University
City
Düzce
Country
Turkey
Facility Name
Ataturk University
City
Erzurum
Country
Turkey
Facility Name
Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
City
Istanbul
Country
Turkey
Facility Name
Ege University
City
Izmir
Country
Turkey
Facility Name
Celal Bayar University
City
Manisa
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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