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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

COPD

Treatments

Other: Prevention

Study type

Interventional

Funder types

Other

Identifiers

NCT03474575
38RC16.275

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

84 participants in 1 patient group

COPD patient
Other group
Description:
Prevention of re-hospitalization rate for Early supported discharge and enhanced homecare to patient admited for COPD exacerbation
Treatment:
Other: Prevention

Trial contacts and locations

1

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Central trial contact

Maxime MAIGNAN, PhD; Jean- Christian BOREL, PhD

Data sourced from clinicaltrials.gov

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