NCT07782892

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Advanced practice nurseEmergency departmentHome oxygen therapyEarly supported dischargeCare pathwayOrganizational adverse eventsPatient experienceCare organization

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with at least one organizational adverse event related to home discharge on oxygen

    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

Study Arms (2)

Advanced practice nurse-physician team

EXPERIMENTAL
Other: APN-physician team management of the Oxy-Urg pathway

Emergency physician alone (usual care)

ACTIVE COMPARATOR
Other: Usual care: physician-alone management of the Oxy-Urg pathway

Interventions

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.

Advanced practice nurse-physician team

Usual care

Emergency physician alone (usual care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 under legal protection
  • Subject under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Grand Est, 67000, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations