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

8. september 2022 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Calvados
      • Caen, Calvados, Frankrig, 14000
        • Rekruttering
        • Caen University hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Caregivers
  • Noncaregivers from general population

Exclusion Criteria:

  • Withdrawal of agreement

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Reading of ethical guidelines.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
IH-OUS score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Utilitarian score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Clément GAKUBA, MD PhD, University Hospital, Caen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2021

Primær færdiggørelse (Forventet)

1. oktober 2022

Studieafslutning (Forventet)

1. november 2022

Datoer for studieregistrering

Først indsendt

23. juli 2021

Først indsendt, der opfyldte QC-kriterier

28. juli 2021

Først opslået (Faktiske)

29. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2022

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1475 (CSL Behring)

Plan for individuelle deltagerdata (IPD)

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