Physician-assisted Dying in Mentally Ill Patients - Which Criteria Are Decisive?

November 1, 2022 updated by: Prof. Dr. med. Christian G. Huber, Psychiatric Hospital of the University of Basel

Physician-assisted Dying in Mentally Ill Patients - Which Criteria Are Decisive? An Exploratory Study in the General Population and in the Medical Profession About Physician-assisted Dying in Somatic Versus Mental Illness in Switzerland

Physician-assisted dying (PAD) is currently a highly controversial topic in medical ethics and public debates worldwide. It poses a moral conflict between the ethical principle of respect for patient autonomy and the ethical principle of beneficence in the sense of preserving life. Switzerland gives higher weight to the former principle: Article 115 of the Swiss Penal Code (StGB) permits PAD, provided it is not performed for "selfish reasons", and thus, occupies a special role in international comparison. However, the Swiss federal law does not regulate who exactly is entitled to access PAD, and there is no universal agreement in the concerned professional societies. Additional uncertainty arises when not the wish for PAD of a somatically ill person but that of a mentally ill person is to be assessed. It is therefore important for Switzerland - but also internationally - to regulate PAD for the mentally ill. On the one hand, mentally ill persons must not be discriminated in their desire for PAD compared to somatically ill persons while at the same time, their vulnerability must be taken into account. On the other hand, treating physicians must be protected in their ethical integrity and need security when they have to decide on PAD-requests. With the present study, we aim at contributing to the discussion of PAD in mentally ill patients and, with the help of an online/telephone survey, provide insights of the current situation in Switzerland within the general population and in the medical profession. This study addresses the following research questions: What is the attitude of the general population towards the current Swiss Academy of Medical Sciences (SAMS) ethical guidelines? What is the attitude of medical professionals? To what extent does the public discussion reflect the current situation in clinical practice? Does the stigmatization of the mentally ill have an influence on the assessment of their wish to die, and if so, where do prejudices need to be reduced? The study thus aims to expand the scientific literature on this highly relevant, currently controversial topic.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Anticipated)

20000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For this study, a survey of two groups is planned: a group of 10,000 people from the general population including the three language regions (German, Italian, and French) as well as a group of 10'000 physicians practicing in the cantons of Basel-Stadt, Basel-Landschaft, Aargau, Lucerne, Graubünden, Ticino and Vaud. In total, the sample thus comprises 20'000 individuals.

Description

Inclusion Criteria:

  • The inclusion criteria for participants from the general population are: (1) between 18 and 65 years old, and (2) sufficient knowledge of German, Italian, or French. Medical professionals are included if they are registered in one of the cantons Basel-Stadt, Basel-Landschaft, Aargau, Lucerne, Graubünden, Ticino or Vaud. Physicians from all specialties are to be surveyed to be able to draw a comparison between the different medical professionals.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Swiss Physicians
A group of approximately 10'000 physicians practicing in the cantons of Basel-Stadt, Basel-Landschaft, Aargau, Lucerne, Graubünden, Ticino and Vaud.
General population of Switzerland
A group of 10,000 people from the general population including the three language regions (German, Italian, and French)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of consent to physician-assisted dying in somatic versus mental illness
Time Frame: during the procedure
The primary endpoint will be the degree of consent to physician-assisted dying depending on the type of illness (somatic vs. mental) as assessed on a 5-point Likert scale (1 = I disagree; 5 = I agree).
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of consent to physician-assisted dying as a function of other factors
Time Frame: during the procedure

Degree of consent to physician-assisted dying on a 5-point Likert scale (1 = I disagree; 5 = I agree) scale as a function of

  1. the intolerable suffering
  2. decision-making capacity
  3. the availability of therapeutic options
  4. the terminal nature of the illness
during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021.
Time Frame: during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021 as measured through spontaneously expressed opinions in an open answer format in the context of a qualitative evaluation.
during the procedure
Correlation between the positioning of the respondents on the SAMS criteria of 2004, 2018, and 2021 and the evaluation of the case vignettes
Time Frame: during the procedure
Positioning of the respondents on the SAMS criteria as well as the positioning on the case vignettes will be measured on a 5-point Likert scale (1 = I disagree; 5 = I agree). Correlations will be calculated using the participants' ratings on these scales.
during the procedure
Correlation between the degree of stigmatization and the assessment of physician-assisted dying.
Time Frame: during the procedure
The degree of stigmatization will be measured using the Bogardus scale (Bogardus, 1925) as well as the Staff Attitude to Coercion Scale (SACS). The Bogardus and SACS scores range from 1 to 4, with 1 representing low degree of consent and 4 a high degree of consent. The assessment of physician-assisted dying is measured on a 5-point Likert scale (1 = I disagree; 5 = I agree). Correlations will be calculated using the participants' scores on the three scales mentioned.
during the procedure
Comparison of the primary and secondary endpoints between the two groups.
Time Frame: during the procedure

The primary endpoint will be the degree of consent to physician-assisted dying depending on the type of illness (somatic vs. mental) as assessed on a 5-point Likert scale (1 = I disagree; 5 = I agree). The secondary endpoint are measured as mentioned in secondary outcome 2-5, and 7.

Using the participants' scores on the different scales as indicated, correlations between the different endpoints will calculated to compare the primary and secondary endpoints.

during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021.
Time Frame: during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021 as measured by the agreement or disagreement when presented SAMS criteria of 2004, 2018 and 2021 on a 5-point Likert scale (1 = I disagree; 5 = I agree)
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (ACTUAL)

August 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • KZS Seed Grant 11/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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