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Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of COPD

EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03474575
Acronym
EXADOM
Enrollment
84
Registered
2018-03-22
Start date
2017-05-19
Completion date
2023-12-19
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

homecare, COPD, Exacerbation

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.

Interventions

OTHERPrevention

The purpose is to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.

Sponsors

AGIR à Dom
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective and Biomedical Research excluding Health Product

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Rate of hospitalizations90 daysnumber of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay

Secondary

MeasureTime frameDescription
hospitalization rate for COPD exacerbation aggravation3,6 and 12 monthsnumber of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for COPD exacerbation aggravation
Hospitalization rate for worsening for cardio-respiratory symptomsone yearnumber of hospitalizations due to myocardial infarction, cardiac failure, stroke
Mortality3, 6 and 12 monthsnumber of death
Rate of all cause of hospitalizations6 months and one yearnumber of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for all cause
Differential of biological and clinical markers30 daysDifferential measurements of biological and clinical markers between day 30 and at inclusion
Differential of medical average cost per patient3 monthscomparaison between early discharge patient with ambulatory care group and patient with standard care (historical cohort)
Acceptance rate of early ambulatory care1 yearMeasured on the basis of a refusal register
Determinants of hospitalization30 daysmeasures of biological and clinical markers collected at baseline and at day 30

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026