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

NCT03499470 | Unknown

• 1 other identifier: 20.478.486.359
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

copd; exacerbation; structured discharge; readmission; chronic respiratory failure

Outcome Measures

Primary Outcomes (1)

• Readmission rate

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

  90days

Secondary Outcomes (5)

• Time to first exacerbation

  90 days

• Rate of exacerbation

  90 days

• Rate of hospitalization

  90 days

• Compliance to treatment

  90 days

• Long term survival

  One year

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Other: Protocol for structured discharge and follow-up

Control

NO INTERVENTION

Control patients will receive usual care

Interventions

Protocol for structured discharge and follow-up OTHER

Intervention

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Celal Bayar University: collaborator
• Ege University: collaborator
• Gazi University: collaborator
• Duzce University: collaborator
• Cukurova University: collaborator
• Ataturk University: collaborator
• Uludag University: collaborator
• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: collaborator
• Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital: collaborator
• Ordu University: collaborator
• Hacettepe University: collaborator
• Turkish Directorate General of Public Health: collaborator
• Istanbul University - Cerrahpasa: collaborator
• Diskapi Yildirim Beyazit Education and Research Hospital: collaborator

Study Sites (10)

Dokuz Eylul University

Izmir, Narlıdere, 35340, Turkey (Türkiye)

Location

Cukurova University

Adana, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital

Ankara, Turkey (Türkiye)

Location

Uludag University

Bursa, Turkey (Türkiye)

Location

Duzce University

Düzce, Turkey (Türkiye)

Location

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital

Istanbul, Turkey (Türkiye)

Location

Ege University

Izmir, Turkey (Türkiye)

Location

Celal Bayar University

Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• BEGUM ERGAN, MD

  Dokuz Eylul University

  STUDY DIRECTOR

• TUGBA GOKTALAY, MD

  Celal Bayar University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 17, 2018
• Study Start: November 7, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

TU (10)