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

NCT03474575 | Completed DMC

• 1 other identifier: 38RC16.275
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

homecare, COPD, Exacerbation

Outcome Measures

Primary Outcomes (1)

• Rate of hospitalizations

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

  90 days

Secondary Outcomes (8)

• Rate of all cause of hospitalizations

  6 months and one year

• hospitalization rate for COPD exacerbation aggravation

  3,6 and 12 months

• Hospitalization rate for worsening for cardio-respiratory symptoms

  one year

• Mortality

  3, 6 and 12 months

• Determinants of hospitalization

  30 days

Study Arms (1)

COPD patient

OTHER

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

Other: Prevention

Interventions

Prevention OTHER

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

COPD patient

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• AGIR à Dom: collaborator

Study Sites (1)

Emergency Department of University Hospital Grenoble

Grenoble, Auvergne Rhonalpes, 38043, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective and Biomedical Research excluding Health Product

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 22, 2018
• Study Start: May 19, 2017
• Primary Completion: October 28, 2023
• Study Completion: December 19, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)