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

The Effectiveness of Structured Discharge and Follow-up Protocol on Readmission Rate in COPD Patients Receiving LTOT and NIV: A Multicenter Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: COPD Exacerbation; Chronic Respiratory Failure; Noninvasive Ventilation; Long Term Oxygen Therapy
• Intervention / Treatment: Other: Protocol for structured discharge and follow-up

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Çukurova University
  • Ankara, Turkey
    • Gazi University
  • Ankara, Turkey
    • Health Sciences University Ataturk Chest Diseases and Chest Surgery Hospital
  • Bursa, Turkey
    • Uludag University
  • Düzce, Turkey
    • Duzce University
  • Erzurum, Turkey
    • Ataturk University
  • Istanbul, Turkey
    • Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital
  • Izmir, Turkey
    • Ege University
  • Manisa, Turkey
    • Celal Bayar University
  • Narlıdere
    • Izmir, Narlıdere, Turkey, 35340
      • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rate	The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge	90days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Collaborators: Hacettepe University; Cukurova University; Gazi University; Ataturk University; Ege University; T.C. ORDU ÜNİVERSİTESİ; Atatürk Chest Diseases and Chest Surgery Training and Research Hospital; Duzce University; Uludag University; Celal Bayar University; Diskapi Yildirim Beyazit Education and Research Hospital; Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital; Istanbul University - Cerrahpasa (IUC); Turkish Directorate General of Public Health
• 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: EZGI OZYILMAZ, MD, Çukurova 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2016
• Primary Completion (ANTICIPATED): August 31, 2019
• Study Completion (ANTICIPATED): August 31, 2019

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (ACTUAL): April 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: exacerbation; readmission; copd; structured discharge; chronic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 20.478.486.359

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No