- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07782892
Impact of an Emergency Advanced Practice Nurse on Complications After Home Discharge of Oxygen-Dependent Patients Managed in the Emergency Department: A Quantitative and Qualitative Study (OXYURG-IPA)
Impact of the Advanced Practice Nurse (Emergency Care Specialty) on Complications Related to the Home Discharge of Patients on Oxygen Therapy After Management in the Emergency Department: A Quantitative and Qualitative Study
Since the COVID-19 pandemic, discharging patients home on low-flow oxygen therapy has proven to be a safe and effective alternative to hospitalization, helping to relieve overcrowded hospitals while ensuring continuity of care. At the investigating emergency department, a dedicated care pathway ("Oxy-Urg") already allows selected oxygen-dependent patients to return home with a home-care provider, regardless of the cause of their breathlessness, once their condition is stable.
This study evaluates whether managing these patients with a team combining an emergency advanced practice nurse (APN) and an emergency physician, rather than a physician alone, improves the organization of care and reduces complications after home discharge.
Adult oxygen-dependent patients eligible for the Oxy-Urg pathway are randomly assigned (1:1) to management by an APN-physician team (intervention group) or by a physician alone (control group). Both groups then receive the usual Oxy-Urg pathway (home oxygen therapy, provider tele-monitoring, community nurse and general practitioner follow-up).
The main goal is to compare the number of organizational adverse events occurring between inclusion and Day 28 between the two groups. The study also assesses clinical deterioration after discharge, the time professionals spend setting up the pathway, and, through interviews and a focus group, the experience of patients and professionals. The hypothesis is that the APN-physician team allows a more efficient organization and improves the patient experience, supporting the sustainability and wider use of this pathway.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aline CHENOU
- Phone Number: 0033369551460
- Email: aline.chenou@chru-strasbourg.fr
Study Locations
-
-
Grand Est
-
Strasbourg, Grand Est, France, 67000
- Hopitaux Universitaires de Strasbourg
-
Contact:
- Aline CHENOU
- Phone Number: 0033369551460
- Email: aline.chenou@chru-strasbourg.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patient (>= 18 years)
- Affiliated to a social health insurance scheme
- Able to understand the objectives and risks of the research and to give dated, signed informed consent
Oxygen-dependent patient eligible for the Oxy-Urg pathway, meeting all of the following:
- Stable for more than 12 hours on oxygen therapy in the emergency department
- Oxygen requirement <= 2 L/min (no upward change for 12 hours)
- Not socially isolated (relatives able to readily help the patient, living geographically close)
- Residing within the provider's geographical area (Bas-Rhin department)
- No known pregnancy at inclusion
Exclusion Criteria:
- Clinical condition requiring hospitalization (decided by the senior physician, per standard of care)
- Patient's refusal to enter the pathway
- Patient managed outside the emergency APN's working hours
- End-of-life patient
- Unable to give informed consent (including insufficient understanding of French)
- Subject in an exclusion period
- Subject under legal protection
- Subject under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Advanced practice nurse-physician team
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Organizational intervention: the emergency advanced practice nurse and the emergency physician jointly manage the inclusion of the patient in the Oxy-Urg pathway and the organization of the home discharge on oxygen.
|
|
Active Comparator: Emergency physician alone (usual care)
|
Usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with at least one organizational adverse event related to home discharge on oxygen
Time Frame: From inclusion (Day 0) to Day 28
|
At least one of the following organizational adverse events: (1) total pathway inclusion time greater than 20 minutes; (2) administrative error or omission regarding prescriptions, the liaison file or handover; (3) time to home oxygen availability exceeding the protocol target; (4) initial technical difficulty of the equipment requiring corrective action by the provider; (5) non-compliance with instructions given to home caregivers, evidenced by a documented non-conformity; (6) nurse visit not compliant with the prescription, observed and recorded.
|
From inclusion (Day 0) to Day 28
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC25_0056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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