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

Sponsor

Dokuz Eylul University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03499470

Collaborator

Celal Bayar University (Other), Ege University (Other), Gazi University (Other), Duzce University (Other), Cukurova University (Other), Ataturk University (Other), Uludag University (Other), Atatürk Chest Diseases and Chest Surgery Training and Research Hospital (Other), Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital (Other), T.C. ORDU ÜNİVERSİTESİ (Other), Hacettepe University (Other), Turkish Directorate General of Public Health (Other), Istanbul University Cerrahpaşa Faculty (Other), Diskapi Yildirim Beyazit Education and Research Hospital (Other)

160

Enrollment

Locations

Arms

33.7

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation Noninvasive Ventilation Long Term Oxygen Therapy Chronic Respiratory Failure	Other: Protocol for structured discharge and follow-up	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 7, 2016

Anticipated Primary Completion Date :

Aug 31, 2019

Anticipated Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention 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
No Intervention: Control Control patients will receive usual care

Arm

Intervention/Treatment

Active Comparator: Intervention

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

No Intervention: Control

Control patients will receive usual care

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Long term survival [One year]
One year survival after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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:

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:

Patients receiving LTOT or NIV for a different cause 2. Patients who do not give consent
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dokuz Eylul University	Izmir	Narlıdere	Turkey	35340
2	Cukurova University	Adana		Turkey
3	Gazi University	Ankara		Turkey
4	Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital	Ankara		Turkey
5	Uludag University	Bursa		Turkey
6	Duzce University	Düzce		Turkey
7	Ataturk University	Erzurum		Turkey
8	Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital	Istanbul		Turkey
9	Ege University	Izmir		Turkey
10	Celal Bayar University	Manisa		Turkey

Sponsors and Collaborators

Dokuz Eylul University
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 Cerrahpaşa Faculty
Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

Study Director: BEGUM ERGAN, MD, Dokuz Eylul University
Study Director: TUGBA GOKTALAY, MD, Celal Bayar University
Principal Investigator: PINAR ERGUN, MD, Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
Principal Investigator: ALEV GURGUN, MD, Ege University
Principal Investigator: METIN AKGUN, MD, Ataturk University
Principal Investigator: NURDAN KOKTURK, MD, Gazi University
Principal Investigator: EZGI OZYILMAZ, MD, Cukurova University
Principal Investigator: ASLI DILEKTASLI, MD, Uludag University
Principal Investigator: BIRSEN OCAKLI, MD, Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
Principal Investigator: ONER BALBAY, MD, Duzce University