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

8 settembre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Anticipato)

500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Calvados
      • Caen, Calvados, Francia, 14000
        • Reclutamento
        • Caen University hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Caregivers
  • Noncaregivers from general population

Exclusion Criteria:

  • Withdrawal of agreement

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
IH-OUS score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Utilitarian score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Clément GAKUBA, MD PhD, University Hospital, Caen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2021

Completamento primario (Anticipato)

1 ottobre 2022

Completamento dello studio (Anticipato)

1 novembre 2022

Date di iscrizione allo studio

Primo inviato

23 luglio 2021

Primo inviato che soddisfa i criteri di controllo qualità

28 luglio 2021

Primo Inserito (Effettivo)

29 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 settembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2022

Ultimo verificato

1 ottobre 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 1475 (CSL Behring)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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