Clinical trial NCT03499470: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Noninvasive Ventilation
Long Term Oxygen Therapy
Chronic Respiratory Failure
Keywords: copd
exacerbation
structured discharge
readmission
chronic respiratory failure
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Celal Bayar University
name: Ege University
name: Gazi University
name: Duzce University
name: Cukurova University
name: Ataturk University
name: Uludag University
name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
name: T.C. ORDU ÜNİVERSİTESİ
name: Hacettepe University
name: Turkish Directorate General of Public Health
name: Istanbul University - Cerrahpasa
name: Diskapi Yildirim Beyazit Education and Research Hospital
First posted: 2018-04-17
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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Primary outcomes:
measure: Readmission rate
timeFrame: 90days
Secondary outcomes:
measure: Time to first exacerbation
timeFrame: 90 days
measure: Rate of exacerbation
timeFrame: 90 days
measure: Rate of hospitalization
timeFrame: 90 days
measure: Compliance to treatment
timeFrame: 90 days
measure: Long term survival
timeFrame: One year
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
state: Narlıdere
city: Adana
country: Turkey
facility: Cukurova University
city: Ankara
country: Turkey
facility: Gazi University
city: Ankara
country: Turkey
facility: Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
city: Bursa
country: Turkey
facility: Uludag University
city: Düzce
country: Turkey
facility: Duzce University
city: Erzurum
country: Turkey
facility: Ataturk University
city: Istanbul
country: Turkey
facility: Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
city: Izmir
country: Turkey
facility: Ege University
city: Manisa
country: Turkey
facility: Celal Bayar University
Study officials:
affiliation: Dokuz Eylul University
name: BEGUM ERGAN, MD
role: STUDY_DIRECTOR
affiliation: Celal Bayar University
name: TUGBA GOKTALAY, MD
role: STUDY_DIRECTOR
affiliation: Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
name: PINAR ERGUN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: ALEV GURGUN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: METIN AKGUN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: NURDAN KOKTURK, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University
name: EZGI OZYILMAZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uludag University
name: ASLI DILEKTASLI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
name: BIRSEN OCAKLI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duzce University
name: ONER BALBAY, MD
role: PRINCIPAL_INVESTIGATOR
References: