Clinical trial NCT02223780: Early Palliative Care for Patients With Severe and Very Severe COPD: a Randomised Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
palliative care
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-08-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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)

Primary outcomes:
measure: length of stay hospital, intensive care unit and emergency admissions
timeFrame: 1 year
Secondary outcomes:
measure: depression and anxiety
timeFrame: 1 year
measure: Health related quality of life assessed by a generic questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Paul Janssens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber C, Stirnemann J, Herrmann FR, Pautex S, Janssens JP. 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. BMC Palliat Care. 2014 Oct 21;13:47. doi: 10.1186/1472-684X-13-47.