MoralsXPHI-COVID-2NCT04982770
Medical Triage in a Time of Scarce Resources.
A study testing Survey in people with Morals and Covid19, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morals, Covid19, Ethics, Narrative
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers
- Noncaregivers from general population
Who cannot join
- Withdrawal of agreement
Trial locations and contacts
1 site in 1 country.
Florian COVA, PhD contact
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, Calvados, 14000
Clément GAKUBA, MD, +33231064736, gakuba-c@chu-caen.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Morals, Covid19, Ethics, Narrative
- Being tested
- Survey
- Medical subject headings
- COVID-19, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Reading of ethical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Survey |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the inclusion period
Secondary outcomes (13)
Utilitarian score
One point is given for each choice consistent with utilitarian principles when solving triage dilemmas, scaling this score from 0 to 14.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Nov 2021
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MoralsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor
- Investigators
- Clément GAKUBA, MD PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982770
- Sponsor's protocol ID
- 1475
- Acronym
- XPHI-COVID-2
- Status last verified
- Oct 2021
- First submitted
- 23 Jul 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29265854Capraro, 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. No abstract available.
PubMed 32202722
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Triage in a Time of Scarce Resources: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04982770
- Acronym / sponsor ID
- XPHI-COVID-2 / 1475
- Conditions
- Morals, Covid19, Ethics, Narrative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: SurveyThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Caregivers
- Noncaregivers from general population
Key exclusion criteria (1 listed)
- Withdrawal of agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyReading of ethical guidelines. | Other | Intervention |
Primary outcome
IH-OUS score
Time frame: 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.
13 secondary outcomes
Utilitarian score
Time frame: At the end of the inclusion period
IB-OUS score
Time frame: At the end of the inclusion period
Oxford utilitarianism scale
Time frame: At the end of the inclusion period
Impartial of benefits
Time frame: At the end of the inclusion period
Prioritization of the young age
Time frame: At the end of the inclusion period
Saving life years
Time frame: At the end of the inclusion period
Saving most lives
Time frame: At the end of the inclusion period
Equality of treatment
Time frame: At the end of the inclusion period
Prioritization of the worst off
Time frame: At the end of the inclusion period
Duty of loyalty
Time frame: At the end of the inclusion period
Principle of non-discrimination (based on age, disability, socio-economic characteristics, gender, etc.)
Time frame: At the end of the inclusion period
Prospective instrumental value
Time frame: At the end of the inclusion period
Retrospective instrumental value
Time frame: At the end of the inclusion period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 29265854Kahane 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.
- BackgroundCapraro, 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.
- Background: PubMed 32202722Emanuel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian COVA, PhD contact
Clément GAKUBA, MD PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Morals and Covid19, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clément GAKUBA, MD PhD (+33231064736, gakuba-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IH-OUS score (time frame: At the end of the inclusion period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982770, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.