- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Aline CHENOU
- Número de telefone: 0033369551460
- E-mail: aline.chenou@chru-strasbourg.fr
Locais de estudo
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Grand Est
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Strasbourg, Grand Est, França, 67000
- Hopitaux Universitaires de Strasbourg
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Contato:
- Aline CHENOU
- Número de telefone: 0033369551460
- E-mail: aline.chenou@chru-strasbourg.fr
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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Comparador Ativo: Emergency physician alone (usual care)
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Usual care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of patients with at least one organizational adverse event related to home discharge on oxygen
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RC25_0056
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