Clinical trial NCT04982770: Medical Triage in a Time of Scarce Resources.
Official title: Medical Triage in a Time of Scarce Resources: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morals
Covid19
Ethics, Narrative
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2021-07-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Caregivers
* Noncaregivers from general population

Exclusion Criteria:

* Withdrawal of agreement

Primary outcomes:
measure: IH-OUS score
timeFrame: At the end of the inclusion period
Secondary outcomes:
measure: Utilitarian score
timeFrame: At the end of the inclusion period
measure: IB-OUS score
timeFrame: At the end of the inclusion period
measure: Oxford utilitarianism scale
timeFrame: At the end of the inclusion period
measure: Impartial of benefits
timeFrame: At the end of the inclusion period
measure: Prioritization of the young age
timeFrame: At the end of the inclusion period
measure: Saving life years
timeFrame: At the end of the inclusion period
measure: Saving most lives
timeFrame: At the end of the inclusion period
measure: Equality of treatment
timeFrame: At the end of the inclusion period
measure: Prioritization of the worst off
timeFrame: At the end of the inclusion period
measure: Duty of loyalty
timeFrame: At the end of the inclusion period
measure: Principle of non-discrimination (based on age, disability, socio-economic characteristics, gender, etc.)
timeFrame: At the end of the inclusion period
measure: Prospective instrumental value
timeFrame: At the end of the inclusion period
measure: Retrospective instrumental value
timeFrame: At the end of the inclusion period
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
Study officials:
affiliation: University Hospital, Caen
name: Clément GAKUBA, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Everett JAC, Faber NS, Savulescu J, Crockett MJ. The costs of being consequentialist: Social inference from instrumental harm and impartial beneficence. J Exp Soc Psychol. 2018 Nov;79:200-216. doi: 10.1016/j.jesp.2018.07.004.
citation: 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.