Physician-Assisted SuicideNCT05492461
Physician-assisted Dying in Mentally Ill Patients - Which Criteria Are Decisive?
An observational study of Physician-Assisted Suicide, run by Psychiatric Hospital of the University of Basel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physician-Assisted Suicide
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Dec 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
About this study
Official title: 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.
- Conditions
- Physician-Assisted Suicide
- Medical subject headings
- Suicide, Assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Degree of consent to physician-assisted dying in somatic versus mental illness
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).
Measured: during the procedure
Secondary outcomes (6)
Degree of consent to physician-assisted dying as a function of other factors
Degree of consent to physician-assisted dying on a 5-point Likert scale (1 = I disagree; 5 = I agree) scale as a function of
- the intolerable suffering
- decision-making capacity
- the availability of therapeutic options
- the terminal nature of the illness
Measured: during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021.
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.
Measured: 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
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.
Measured: during the procedure
Correlation between the degree of stigmatization and the assessment of physician-assisted dying.
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.
Measured: during the procedure
Comparison of the primary and secondary endpoints between the two groups.
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.
Measured: during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021.
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)
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study startFeb 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physician-Assisted SuicideStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of the University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Christian G. Huber, Psychiatric Hospital of the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492461
- Sponsor's protocol ID
- KZS Seed Grant 11/20
- Status last verified
- Nov 2022
- First submitted
- 5 Jul 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kowalinski E, Ziltener T, Staub S, Moeller J, Trachsel M, Schneeberger AR, Franke I, Lang UE, Huber CG. Physician assisted-dying in mentally and somatically ill individuals in Switzerland: Protocol for survey-based study. Front Psychiatry. 2022 Oct 28;13:987791. doi: 10.3389/fpsyt.2022.987791. eCollection 2022.
PubMed 36386979
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05492461
- Acronym / sponsor ID
- KZS Seed Grant 11/20
- Conditions
- Physician-Assisted Suicide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Psychiatric Hospital of the University of BaselUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Aug 2022 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Degree of consent to physician-assisted dying as a function of other factors
Time frame: during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021.
Time frame: 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
Correlation between the degree of stigmatization and the assessment of physician-assisted dying.
Time frame: during the procedure
Comparison of the primary and secondary endpoints between the two groups.
Time frame: during the procedure
Positioning of the respondents to the SAMS criteria of 2004, 2018 and 2021.
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 36386979Kowalinski E, Ziltener T, Staub S, Moeller J, Trachsel M, Schneeberger AR, Franke I, Lang UE, Huber CG. Physician assisted-dying in mentally and somatically ill individuals in Switzerland: Protocol for survey-based study. Front Psychiatry. 2022 Oct 28;13:987791. doi: 10.3389/fpsyt.2022.987791. eCollection 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Physician-Assisted Suicide, run by Psychiatric Hospital of the University of Basel.
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 1 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of consent to physician-assisted dying in somatic versus mental illness (time frame: during the procedure). 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 NCT05492461, which also lists 1 linked publication.
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 2 Nov 2022.