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

8. september 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
    • Calvados
      • Caen, Calvados, Frankrike, 14000
        • Rekruttering
        • CAEN University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Caregivers
  • Noncaregivers from general population

Exclusion Criteria:

  • Withdrawal of agreement

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Survey
Reading of ethical guidelines.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Caen

Samarbeidspartnere

University of Geneva, Switzerland

Etterforskere

  • Hovedetterforsker: Clément GAKUBA, MD PhD, University Hospital, Caen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2021

Primær fullføring (Forventet)

1. oktober 2022

Studiet fullført (Forventet)

1. november 2022

Datoer for studieregistrering

Først innsendt

23. juli 2021

Først innsendt som oppfylte QC-kriteriene

28. juli 2021

Først lagt ut (Faktiske)

29. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. september 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2022

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1475 (CSL Behring)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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