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Medical Triage in a Time of Scarce Resources. (XPHI-COVID-2)

8 de setembro de 2022 atualizado por: University Hospital, Caen

Medical Triage in a Time of Scarce Resources: a Randomized Controlled Study.

The XPHI-COVID-2 randomized study aims to investigate the moral choices in a context of scarce resources.

The participants are asked to complete the questionnaire of the Oxford Utilitarianism Scale and are exposed to medical triage dilemmas.

Participants are randomized between a group with reading of ethical guidelines and a group without reading of ethical guidelines, before they are asked to complete the questionnaire and being exposed to triage dilemmas.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

It is hypothesized that recalling ethical values before resolving dilemmas could modify the ability to adopt a utilitarian approach in resolving ethical dilemmas.

To verify this hypothesis, the score on the Impartial Harm subscale of the Oxford Utilitarianism Scale (IH-OUS) will be compared between a group with reading of ethical guidelines and a group without reading of ethical guidelines, before they are asked to complete the questionnaire and being exposed to triage dilemmas.

Number of subjects needed for the phase of study evaluating intensivists, anesthesiologists and emergency physicians : 580 - based on preliminary data, assuming 70% complete response rate of the survey and a standard deviation of 5

Secondary outcomes will be considered :

  • Beneficence Harm subscale of the Oxford Utilitarianism Scale (IB-OUS)
  • Values prioritized to resolve ethical dilemmas : impartial of benefits, prioritization of the young age, saving life years, saving most lives, equality of treatment, prioritization of the worst off, loyalty duty, principle of non-discrimination, prospective and retrospective instrumental value.

First phase of the study will aim to include first-line caregivers : intensivists, anesthesiologists, emergency physicians.

Other phases of the study will aim to include health care professionals from other categories and non health care professionals.

Subgroup analyses are planned :

  • Analysis according to the characteristics of the participant: gender, geographic location, diploma and type of exercise, category of institution to which the participant is attached.
  • Analysis according to the degree of knowledge in ethics, the degree of familiarity with ethical recommendations, the degree of familiarity with moral philosophy, the degree of religiosity, whether the participants declare to have taken knowledge or not of recommendations concerning medical triage in a situation of scarce resources.

It is also planned to carry out ancillary studies in parallel with the realization of the study presented here:

  • A study including non-physician participants aiming to identify the differences between non-physicians and physicians in terms of ethical values mobilized in medical triage.
  • A study including medical students aiming to identify an association between propensity to make utilitarian and choices of the medical specialty.
  • A study focused on the Oxford Utilitarianism Scale, integrating the results of the pilot study and the confirmatory study, aiming to identify predictors of responses to the dilemmas proposed within the scale.
  • A study evaluating the association between delay in ethical dilemmas resolution and utilitarian choices.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

500

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • França
    • Calvados
      • Caen, Calvados, França, 14000
        • Recrutamento
        • Caen University Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Caregivers
  • Noncaregivers from general population

Exclusion Criteria:

  • Withdrawal of agreement

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention
The participants have to read ethical guidelines before they are asked to complete the questionnaire of the Oxford Utilitarianism Scale and exposed to medical triage dilemmas.
Outro: Survey
Reading of ethical guidelines.
Sem intervenção: No intervention
The participants do not have to read ethical guidelines before they are asked to complete the questionnaire of the Oxford Utilitarianism Scale and exposed to medical triage dilemmas.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
IH-OUS score
Prazo: At the end of the inclusion period

Score on the Impartial Harm subscale of the Oxford Utilitarianism Scale (IH-OUS) : minimum value is 4 points and maximum value is 28 points.

The higher the value is, the more the participant's choices endorse the principle of causing harm to bring the greater good.
At the end of the inclusion period

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Utilitarian score
Prazo: At the end of the inclusion period
One point is given for each choice consistent with utilitarian principles when solving triage dilemmas, scaling this score from 0 to 14.
At the end of the inclusion period
IB-OUS score
Prazo: At the end of the inclusion period

Score on the Instrumental Beneficence subscale of the Oxford Utilitarianism Scale (IB-OUS) : minimum value is 5 points and maximum value is 35 points.

The higher the value is, the more the participant's choices endorse the impartial maximization of the greater good, even at the cost of personal self-sacrifice.
At the end of the inclusion period
Oxford utilitarianism scale
Prazo: At the end of the inclusion period

Bi-dimensional scale of utilitarian thinking associating the impartial harm and the beneficence subscale. The minimum value is 9 points and the maximum value is 63 points.

This scale aims to assess the utilitarian tendencies in people who are not philosophy professionals.
At the end of the inclusion period
Impartial of benefits
Prazo: At the end of the inclusion period

Principle of impartial assignment of resources used in resolving ethical dilemmas.

The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Prioritization of the young age
Prazo: At the end of the inclusion period
Propensity to prioritize the youngest person in ethical dilemmas. The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Saving life years
Prazo: At the end of the inclusion period
Propensity to save the most life years in resolving ethical dilemmas. The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Saving most lives
Prazo: At the end of the inclusion period
Propensity to save most lives in resolving ethical dilemmas. The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Equality of treatment
Prazo: At the end of the inclusion period
Propensity to treat people equally in ethical dilemmas. The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Prioritization of the worst off
Prazo: At the end of the inclusion period
Propensity to prioritize the worst off in ethical dilemmas. The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Duty of loyalty
Prazo: At the end of the inclusion period
Propensity of the caregiver to feel obliged vis-a-vis the patient The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Principle of non-discrimination (based on age, disability, socio-economic characteristics, gender, etc.)
Prazo: At the end of the inclusion period

The non-discrimination principle requires the equal treatment of an individual or group irrespective of their particular characteristics.

The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Prospective instrumental value
Prazo: At the end of the inclusion period

Propensity to promote and reward prospective instrumental value, based on future facts.

The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period
Retrospective instrumental value
Prazo: At the end of the inclusion period

Propensity to promote and reward retrospective instrumental value, based on past facts.

The value will be considered as respected by the majority of participants if more than 50% of respondents make a choice of a patient in accordance with this value.
At the end of the inclusion period

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Caen

Colaboradores

University of Geneva, Switzerland

Investigadores

  • Investigador principal: Clément GAKUBA, MD PhD, University Hospital, Caen

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de novembro de 2021

Conclusão Primária (Antecipado)

1 de outubro de 2022

Conclusão do estudo (Antecipado)

1 de novembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de julho de 2021

Primeira postagem (Real)

29 de julho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de setembro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2022

Última verificação

1 de outubro de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 1475 (CSL Behring)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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