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NCT Number: NCT02223780

Early Palliative Care for Patients With Severe and Very Severe COPD: a Randomised Study

Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment options, progressive lung disease. Patients with COPD often have only limited access to palliative care. The goal of this research project is to improve the quality of life of patients with COPD.

Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain and depression) are insufficiently alleviated. In addition, often in connection with an infection, patients frequently suffer from respiratory decompensation; this may lead to invasive interventions as well as the admission to the emergency room or an intensive care unit. It may ultimately lead to the death of the patient.

Aim This study aims to show that early palliative care can reduce the number of necessary invasive interventions and improve the quality of life of patients with COPD. For this purpose, a group of patients receiving early, standardized palliative care will be compared to a group of patients receiving customary treatment only, without systematic intervention by palliative care experts.

Significance The results of this study should make it possible to efficiently use the medical resources which are required for the appropriate care of patients with COPD. The goal is the best possible quality of life and better coordination of the measures taken, especially with regard to the area of acute care and the wishes of the patient.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Geneva

Geneva, Switzerland

About this study

The primary objective of the study is to assess the effectiveness of the introduction of early specialized palliative care on hospital, intensive care unit and emergency admissions of patients with severe and very severe COPD

Secondary objectives are:

The impact of early palliative care on the mood and anxiety of patients with severe and very severe COPD The impact of early palliative care on the health-related quality of life of patients with severe and very severe COPD.

The impact of early palliative care on the prescription of antibiotics during the last month of life of patients 4. The impact of early palliative care on advance care planning and end-of-life decision-making will be compared between the two groups Methodology Randomized study to one of the two groups in a ratio without stratification.

Study Duration 3 years Study Center(s) Single-center study Number of Subjects 180 patients Intervention Early specialized palliative care intervention Significance Given the trends toward aggressive and costly care near end-of-life among patients with COPD, a timely introduction of palliative care may limit unnecessary and burdensome personal and societal costs, and invasive approaches. The results of this study may provide some direction for future palliative care interventions in this particular population

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD defined according to GOLD criteria (FEV1/FVC < 70%) stage III or IV (FEV1 < 50% predicted)
  • and/or long term treatment with either domiciliary oxygen or home mechanical ventilation
  • and or one or more hospital admissions in the previous year for an acute exacerbation

Exclusion criteria

  • Moderate or severe cognitive impairment (MMSE<20)

Treatment and study plan

early palliative care

Other

the patients will benefit from an early palliative care consultation

Primary outcomes

  1. length of stay hospital, intensive care unit and emergency admissions

    Time frame: 1 year

    number of days

Secondary outcomes

  1. depression and anxiety

    Time frame: 1 year

    HADS

  2. Health related quality of life assessed by a generic questionnaire

    Time frame: 1 year

    SF-36

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

Can Early Introduction of Specialized Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients With Severe and Very Severe COPD? A Randomized Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2014
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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