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

NCT ID: NCT03499470

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-07
• Study Completion Date: 2019-08-31

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.

Conditions

COPD Exacerbation; Noninvasive Ventilation; Long Term Oxygen Therapy; Chronic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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:

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

Group Type: ACTIVE_COMPARATOR

Protocol for structured discharge and follow-up

Intervention Type: OTHER

Control

Control patients will receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protocol for structured discharge and follow-up

Intervention Type: OTHER

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:

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.

-

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celal Bayar University

OTHER

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: collaborator

Gazi University

OTHER

Sponsor Role: collaborator

Duzce University

OTHER

Sponsor Role: collaborator

Cukurova University

OTHER

Sponsor Role: collaborator

Ataturk University

OTHER

Sponsor Role: collaborator

Uludag University

OTHER

Sponsor Role: collaborator

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: collaborator

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: collaborator

Ordu University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: collaborator

Turkish Directorate General of Public Health

UNKNOWN

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Begum Ergan

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

BEGUM ERGAN, MD

Role: STUDY_DIRECTOR

Dokuz Eylul University

TUGBA GOKTALAY, MD

Role: STUDY_DIRECTOR

Celal Bayar University

PINAR ERGUN, MD

Role: PRINCIPAL_INVESTIGATOR

Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital

ALEV GURGUN, MD

Role: PRINCIPAL_INVESTIGATOR

Ege University

METIN AKGUN, MD

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

NURDAN KOKTURK, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

EZGI OZYILMAZ, MD

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

ASLI DILEKTASLI, MD

Role: PRINCIPAL_INVESTIGATOR

Uludag University

BIRSEN OCAKLI, MD

Role: PRINCIPAL_INVESTIGATOR

Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital

ONER BALBAY, MD

Role: PRINCIPAL_INVESTIGATOR

Duzce University

Locations

Dokuz Eylul University

Izmir, Narlıdere, Turkey (Türkiye)

Cukurova University

Adana, , Turkey (Türkiye)

Gazi University

Ankara, , Turkey (Türkiye)

Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital

Ankara, , Turkey (Türkiye)

Uludag University

Bursa, , Turkey (Türkiye)

Duzce University

Düzce, , Turkey (Türkiye)

Ataturk University

Erzurum, , Turkey (Türkiye)

Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital

Istanbul, , Turkey (Türkiye)

Ege University

Izmir, , Turkey (Türkiye)

Celal Bayar University

Manisa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20.478.486.359

Identifier Type: -

Identifier Source: org_study_id