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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Other: Prevention

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime MAIGNAN, PhD; Phone Number: 0033476766784; Email: mmaignan@chu-grenoble.fr
• Study Contact Backup: Name: Jean- Christian BOREL, PhD; Phone Number: 0033 762707821; Email: j.borel@agiradom.com

Study Locations

• France
  • Auvergne Rhonalpes
    • Grenoble, Auvergne Rhonalpes, France, 38043
      • Recruiting
      • Emergency Department of University Hospital Grenoble
      • Contact: Maxime MAIGNAN, PhD; Phone Number: 0033 476 76 67 84; Email: mmaignan@chu-grenoble.fr
      • Principal Investigator: Maxime MAIGNAN, PhD
      • Sub-Investigator: Damien VIGLINO, MD,Msc
      • Sub-Investigator: Christophe PISON, Pr MD PhD
      • Sub-Investigator: Jean-Louis PEPIN, Pr MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: COPD patient; Prevention of re-hospitalization rate for Early supported discharge and enhanced homecare to patient admited for COPD exacerbation	Other: Prevention; The purpose is to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of hospitalizations	number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all cause of hospitalizations	number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for all cause	6 months and one year
hospitalization rate for COPD exacerbation aggravation	number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for COPD exacerbation aggravation	3,6 and 12 months
Hospitalization rate for worsening for cardio-respiratory symptoms	number of hospitalizations due to myocardial infarction, cardiac failure, stroke	one year
Mortality	number of death	3, 6 and 12 months
Determinants of hospitalization	measures of biological and clinical markers collected at baseline and at day 30	30 days
Differential of biological and clinical markers	Differential measurements of biological and clinical markers between day 30 and at inclusion	30 days
Differential of medical average cost per patient	comparaison between early discharge patient with ambulatory care group and patient with standard care (historical cohort)	3 months
Acceptance rate of early ambulatory care	Measured on the basis of a refusal register	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: AGIR à Dom

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Estimated): October 28, 2023
• Study Completion (Estimated): December 19, 2023

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: homecare, COPD, Exacerbation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 38RC16.275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not provided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No