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Completed

NCT Number: NCT03474575

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department of University Hospital Grenoble

Grenoble, Auvergne Rhonalpes, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Prevention

Other

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

Primary outcomes

  1. Rate of hospitalizations

    Time frame: 90 days

    number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay

Secondary outcomes

  1. Rate of all cause of hospitalizations

    Time frame: 6 months and one year

    number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for all cause

  2. hospitalization rate for COPD exacerbation aggravation

    Time frame: 3,6 and 12 months

    number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for COPD exacerbation aggravation

  3. Hospitalization rate for worsening for cardio-respiratory symptoms

    Time frame: one year

    number of hospitalizations due to myocardial infarction, cardiac failure, stroke

  4. Mortality

    Time frame: 3, 6 and 12 months

    number of death

  5. Determinants of hospitalization

    Time frame: 30 days

    measures of biological and clinical markers collected at baseline and at day 30

  6. Differential of biological and clinical markers

    Time frame: 30 days

    Differential measurements of biological and clinical markers between day 30 and at inclusion

  7. Differential of medical average cost per patient

    Time frame: 3 months

    comparaison between early discharge patient with ambulatory care group and patient with standard care (historical cohort)

  8. Acceptance rate of early ambulatory care

    Time frame: 1 year

    Measured on the basis of a refusal register

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • AGIR à Dom

Registry information

Official study title

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

Acronym: EXADOM

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2018
Registry last updated
May 14, 2024

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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