- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aline CHENOU
- 전화번호: 0033369551460
- 이메일: aline.chenou@chru-strasbourg.fr
연구 장소
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Grand Est
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Strasbourg, Grand Est, 프랑스, 67000
- Hopitaux Universitaires de Strasbourg
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연락하다:
- Aline CHENOU
- 전화번호: 0033369551460
- 이메일: aline.chenou@chru-strasbourg.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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활성 비교기: Emergency physician alone (usual care)
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Usual care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of patients with at least one organizational adverse event related to home discharge on oxygen
기간: From inclusion (Day 0) to Day 28
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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.
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From inclusion (Day 0) to Day 28
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC25_0056
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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