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

Primary Purpose

COPD

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Prevention

About this trial

This is an interventional prevention trial for COPD focused on measuring homecare, COPD, Exacerbation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Emergency Department of University Hospital GrenobleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COPD patient

Arm Description

Prevention of re-hospitalization rate for Early supported discharge and enhanced homecare to patient admited for COPD exacerbation

Outcomes

Primary Outcome Measures

Rate of hospitalizations

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

Secondary Outcome Measures

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

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

Hospitalization rate for worsening for cardio-respiratory symptoms

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

Mortality

number of death

Determinants of hospitalization

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

Differential of biological and clinical markers

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

Differential of medical average cost per patient

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

Acceptance rate of early ambulatory care

Measured on the basis of a refusal register

Full Information

NCT ID

NCT03474575

First Posted

February 9, 2018

Last Updated

July 4, 2023

Sponsor

University Hospital, Grenoble

Collaborators

AGIR à Dom

1. Study Identification

Unique Protocol Identification Number

NCT03474575

Brief Title

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

Acronym

EXADOM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 19, 2017 (Actual)

Primary Completion Date

October 28, 2023 (Anticipated)

Study Completion Date

December 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

AGIR à Dom

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

Keywords

homecare, COPD, Exacerbation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective and Biomedical Research excluding Health Product

Masking

None (Open Label)

Allocation

N/A

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD patient

Arm Type

Other

Arm Description

Prevention of re-hospitalization rate for Early supported discharge and enhanced homecare to patient admited for COPD exacerbation

Intervention Type

Other

Intervention Name(s)

Prevention

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of hospitalizations

Description

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

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Rate of all cause of hospitalizations

Description

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

Time Frame

6 months and one year

Title

hospitalization rate for COPD exacerbation aggravation

Description

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

Time Frame

3,6 and 12 months

Title

Hospitalization rate for worsening for cardio-respiratory symptoms

Description

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

Time Frame

one year

Title

Mortality

Description

number of death

Time Frame

3, 6 and 12 months

Title

Determinants of hospitalization

Description

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

Time Frame

30 days

Title

Differential of biological and clinical markers

Description

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

Time Frame

30 days

Title

Differential of medical average cost per patient

Description

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

Time Frame

3 months

Title

Acceptance rate of early ambulatory care

Description

Measured on the basis of a refusal register

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maxime MAIGNAN, PhD

Phone

0033476766784

mmaignan@chu-grenoble.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Jean- Christian BOREL, PhD

Phone

0033 762707821

j.borel@agiradom.com

Facility Information:

Facility Name

Emergency Department of University Hospital Grenoble

City

Grenoble

State/Province

Auvergne Rhonalpes

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact: