Medical Triage in a Time of Scarce Resources.

Covid19 Clinical Trial

— XPHI-COVID-2  

Official title:

Medical Triage in a Time of Scarce Resources: a Randomized Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982770
• Other study ID #: 1475
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Caen
• Contact: Clément GAKUBA, MD PhD
• Phone: +33231064736
• Email: gakuba-c[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Caregivers

• Noncaregivers from general population

Exclusion Criteria:

• Withdrawal of agreement

Related Conditions & MeSH terms

• Covid19
• Ethics, Narrative
• Morals

Intervention

Other:
• Survey
Reading of ethical guidelines.

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Calvados

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	University of Geneva, Switzerland

Country where clinical trial is conducted

France, 

References & Publications (3)

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.

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. — View 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. Review. Erratum in: Psychol Rev. 2018 Mar;125(2):164. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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