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

COPD Clinical Trial

— EXADOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474575
• Other study ID #: 38RC16.275
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: December 19, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 19, 2023
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COPD
• Emergencies

Intervention

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

Locations

Country	Name	City	State
France	Emergency Department of University Hospital Grenoble	Grenoble	Auvergne Rhonalpes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospitalizations	number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay	90 days
Secondary	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
Secondary	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
Secondary	Hospitalization rate for worsening for cardio-respiratory symptoms	number of hospitalizations due to myocardial infarction, cardiac failure, stroke	one year
Secondary	Mortality	number of death	3, 6 and 12 months
Secondary	Determinants of hospitalization	measures of biological and clinical markers collected at baseline and at day 30	30 days
Secondary	Differential of biological and clinical markers	Differential measurements of biological and clinical markers between day 30 and at inclusion	30 days
Secondary	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
Secondary	Acceptance rate of early ambulatory care	Measured on the basis of a refusal register	1 year