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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Ethics, Narrative; Morals
• Intervention / Treatment: Other: Survey

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clément GAKUBA, MD PhD; Phone Number: +33231064736; Email: gakuba-c@chu-caen.fr
• Study Contact Backup: Name: Florian COVA, PhD; Email: Florian.Cova@unige.ch

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • Recruiting
      • CAEN University Hospital
      • Contact: Clément GAKUBA, MD; Phone Number: +33231064736; Email: gakuba-c@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Caregivers
• Noncaregivers from general population

Exclusion Criteria:

• Withdrawal of agreement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey; Reading of ethical guidelines.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IH-OUS score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilitarian score	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	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	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	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	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	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	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	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	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	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.)	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	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: University of Geneva, Switzerland
• Investigators: Principal Investigator: Clément GAKUBA, MD PhD, University Hospital, Caen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1475 (CSL Behring)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No