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

July 16, 2019 updated by: Begum Ergan, Dokuz Eylul University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  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
NO_INTERVENTION: Control
Control patients will receive usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Readmission rate
Time Frame: 90days
The rate of unplanned, COPD-related hospital readmissions over 90 days after discharge
90days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first exacerbation
Time Frame: 90 days
Time to first exacerbation after discharge
90 days
Rate of exacerbation
Time Frame: 90 days
Total COPD exacerbation rate within 90 days after discharge
90 days
Rate of hospitalization
Time Frame: 90 days
Total hospitalization number due to COPD within 90 days after discharge
90 days
Compliance to treatment
Time Frame: 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.
90 days
Long term survival
Time Frame: One year
One year survival after discharge
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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