Clinical trial NCT03474575: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of COPD
Official title: EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: homecare, COPD, Exacerbation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: AGIR à Dom
First posted: 2018-03-22
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective and Biomedical Research excluding Health Product
Primary purpose: PREVENTION

Brief summary: The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized.

Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits.

Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.

Detailed description: Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS) , Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.

This program implements ambulatory care immediately after leaving the emergency department with a main goal of reducing hospital readmission during the first month. The home-based support includes daily visits at home conducted by the home care provider's nurses from day 1 to day 7, telephone calls at days 14 and 21 and a final home visit one month after discharge from the emergency department. Blood samples will be collected at inclusion, day 7 and one month during home visit and urine samples at inclusion, day 2, day 4 and one month during home visit .Telephone follow-up at 3, 6 months and one year.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 40 years
* Current or former smoker, with at least 10 pack-years
* previous history of COPD with concordant spirometry results
* Admission to the emergency department for an exacerbation defined as an acute event which is characterized by a degradation of respiratory symptoms greater than the usual daily variations and requiring a change in therapeutic management
* Patient with mild exacerbation characterized by a DECAF score at 0 or 1. (DECAF score: Dyspnea, Eosinopenia, Consolidation on chest x-ray, Acidaemia, and atrial Fibrillation. One point for each criterion. Mortality at one month is less than 3% if the DECAF score is 0 or 1).
* Residence within 30km of Grenoble Alps University Hospital
* Patient legally able to give consent
* Person affiliated to a medical insurance

Exclusion Criteria:

* Dementia or non-communicating patient in French language
* Patient unable to call the emergency department at any time in case of sudden worsening
* Pregnancy or breastfeeding woman
* patient under administrative or judicial supervision
* DECAF Score \> 1. Patient's with DECAF score \> 1 are considered at too high risk of mortality to be managed at home (they are usually hospitalized).

Primary outcomes:
measure: Rate of hospitalizations
timeFrame: 90 days
Secondary outcomes:
measure: Rate of all cause of hospitalizations
timeFrame: 6 months and one year
measure: hospitalization rate for COPD exacerbation aggravation
timeFrame: 3,6 and 12 months
measure: Hospitalization rate for worsening for cardio-respiratory symptoms
timeFrame: one year
measure: Mortality
timeFrame: 3, 6 and 12 months
measure: Determinants of hospitalization
timeFrame: 30 days
measure: Differential of biological and clinical markers
timeFrame: 30 days
measure: Differential of medical average cost per patient
timeFrame: 3 months
measure: Acceptance rate of early ambulatory care
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Emergency Department of University Hospital Grenoble
state: Auvergne Rhonalpes
Study officials:
References: