Medical Triage in a Time of Scarce Resources. (XPHI-COVID-2)
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Clément GAKUBA, MD PhD
- Telefonní číslo: +33231064736
- E-mail: gakuba-c@chu-caen.fr
Studijní záloha kontaktů
- Jméno: Florian COVA, PhD
- E-mail: Florian.Cova@unige.ch
Studijní místa
-
-
Calvados
-
Caen, Calvados, Francie, 14000
- Nábor
- Caen University hospital
-
Kontakt:
- Clément GAKUBA, MD
- Telefonní číslo: +33231064736
- E-mail: gakuba-c@chu-caen.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Caregivers
- Noncaregivers from general population
Exclusion Criteria:
- Withdrawal of agreement
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Žádný zásah: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
IH-OUS score
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Utilitarian score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Clément GAKUBA, MD PhD, University Hospital, Caen
Publikace a užitečné odkazy
Obecné publikace
- Emanuel EJ, Persad G, Upshur R, Thome B, Parker M, Glickman A, Zhang C, Boyle C, Smith M, Phillips JP. Fair Allocation of Scarce Medical Resources in the Time of Covid-19. N Engl J Med. 2020 May 21;382(21):2049-2055. doi: 10.1056/NEJMsb2005114. Epub 2020 Mar 23. No abstract available.
- Kahane G, Everett JAC, Earp BD, Caviola L, Faber NS, Crockett MJ, Savulescu J. Beyond sacrificial harm: A two-dimensional model of utilitarian psychology. Psychol Rev. 2018 Mar;125(2):131-164. doi: 10.1037/rev0000093. Epub 2017 Dec 21. Erratum In: Psychol Rev. 2018 Mar;125(2):164.
- Capraro, V., Earp, B.D., & Everett, J.A.C. (2019). Priming intuition disfavors instrumental harm but not impartial beneficence. Journal of Experimental Social Psychology. 83, 142-149. DOI: 10.1016/j.jesp.2019.04.006.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 1475 (CSL Behring)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .