Ethics SupportEthics-comNCT05146102
Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study).
A study testing ethics communication in group, in line with "the one to five-step method" in people with Ethics Support, run by Umeå University at 2 sites in Sweden.
Trial summary
Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ethics Support
- What is being tested?
- ethics communication in group, in line with "the one to five-step method"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Nov 2021to 15 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthcare professionals working at included wards
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Margareta Brännström
Skellefteå, Umeå Universitet, 93135
Margareta Brännström, Professor, 0761111286, margareta.brannstrom@umu.se
Catharina Fischer Grönlund, PhD
- Recruiting
Umeå university
Umeå, Umeå Universitet, 93187
Margareta Brännström, PhD, 0761111286, margareta.brannstrom@umu.se
Catarina Fischer Grönlund, PhD, catarina.fischer.gronlund@umu.se
About this study
Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to improve the ethical climate and prevent moral distress. Our research group has developed the "one to five-step method" for interprofessional ethical communication in groups. The overall aim of this project: is to implement and evaluate a method for organized interprofessional communication about ethical issues in healthcare.
Read the detailed description
Ethically difficult situations are a part of the everyday clinical practice for health care professionals and concerns difficult judgements, prioritization and crucial decisions. Being unable or prevented to act according to one's moral conviction for what is good and right care may increase the risk for health care professionals to experience moral distress. Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to improve the ethical climate and prevent moral distress. Our research group has developed the "one to five-step method" for interprofessional ethical communication in groups. The method is a stepwise support for facilitating ethics communication in clinical practice when the situations occurs. The overall aim of this project: is to implement and evaluate a method for organized interprofessional communication about ethical issues in healthcare.
Significance: The study can generate knowledge about ethics communication in groups in line with the " one to five step method", reduce moral distress, create improved ethical climate for healthcare professionals and in turn open up prerequisites for good care.
- Conditions
- Ethics Support
- Being tested
- ethics communication in group, in line with "the one to five-step method"
- Keywords
- ethics support, ethical rounds, healthcare personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethics communication in group, in line with "the one to five-step method"Other
Healthcare professionals working as "ethical representatives" at the current ward (n=5) have recently gone through a basic ethics program. They will continue by going through an education program for facilitating ethics communication in group, in line with "the one to five-step method"
The education program has a theoretical and practical approach, which includes the theoretical base of the ethical communication in groups and practicing "the one to five method" Thereafter, each "ethical representative" will facilitate interprofessional sessions at a clinical ward, once a month, for six months at their workplace. Gathering meetings for feedback will be offered for the "ethical representatives" once a month.
| Study group | Role | What they receive |
|---|---|---|
| ethics communication in group, in line with "the one to five-step method" | Experimental | Healthcare professionals working as "ethical representatives" at the current ward (n=5) have recently gone through a basic ethics program. They will continue by going through an education program for facilitating ethics communication in group, in line with "the one to five-step method"
* The education program has a theoretical and practical approach, which includes the theoretical base of the ethical communication in groups and practicing "the one to five method"
* Thereafter, each "ethical representative" will facilitate interprofessional sessions at a clinical ward, once a month, for six months at their workplace. Gathering meetings for feedback will be offered for the "ethical representatives" once a month. Receives: Other: ethics communication in group, in line with "the one to five-step method" |
| No organized ethics communication in group | No intervention | Healthcare professionals working as "ethical representatives" at the current ward (n=5) have recently gone through a basic ethics program. They have not being educated in "the one to five-step method and organized interprofessional sessions are not planned at the wards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
moral distress meausered by using the Meausure of Moral Distress for Health care Professionals (MMD-HP) and the Moral Distress Thermometer
primary outcome
Measured: Change from Baseline moral distress at 6 months
Secondary outcomes (2)
ethical climate meausered by the Swedish ethical climate questionnaire (SwECQ)
secondary outcome
Measured: Change from Baseline ethical climate at 6 months
experiences
interviews of the interventiongroup
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Nov 2021
- Primary completion15 May 2022 (estimated)
- Study completion15 May 2022 (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 Ethics SupportStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Single group
- Model description
- The interventiongroup is offered organized interprofessional sessions, once a month, for six months at their workplace. In the the controlgroup, organized interprofessional sessions are not planned at the wards.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margareta Brännström, Umeå University
- Investigators
- Margareta Brännström, Principal investigator, Umea university, department of nursing, Umeå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146102
- Sponsor's protocol ID
- Ethics-com001
- Acronym
- Ethics-com
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Margareta B, Ulf I, C FG. Effects of ethics communication in health care: a cluster randomised controlled trial. BMC Med Ethics. 2025 Jul 26;26(1):106. doi: 10.1186/s12910-025-01270-w.
PubMed 40713613
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study).
- ClinicalTrials.gov ID
- NCT05146102
- Acronym / sponsor ID
- Ethics-com / Ethics-com001
- Conditions
- Ethics Support
- Keywords
- ethics support, ethical rounds, healthcare personnel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 6 Dec 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.
Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to improve the ethical climate and prevent moral distress. Our research group has developed the "one to five-step method" for interprofessional ethical communication in groups. The overall aim of this project: is to implement and evaluate a method for organized interprofessional communication about ethical issues in healthcare.
Detailed description
Ethically difficult situations are a part of the everyday clinical practice for health care professionals and concerns difficult judgements, prioritization and crucial decisions. Being unable or prevented to act according to one's moral conviction for what is good and right care may increase the risk for health care professionals to experience moral distress. Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to improve the ethical climate and prevent moral distress. Our research group has developed the "one to five-step method" for interprofessional ethical communication in groups. The method is a stepwise support for facilitating ethics communication in clinical practice when the situations occurs. The overall aim of this project: is to implement and evaluate a method for organized interprofessional communication about ethical issues in healthcare.
Significance: The study can generate knowledge about ethics communication in groups in line with the " one to five step method", reduce moral distress, create improved ethical climate for healthcare professionals and in turn open up prerequisites for good care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventiongroup is offered organized interprofessional sessions, once a month, for six months at their workplace. In the the controlgroup, organized interprofessional sessions are not planned at the wards.
| Arm | Type | Receives |
|---|---|---|
| ethics communication in group, in line with "the one to five-step method" | Experimental | Other: ethics communication in group, in line with "the one to five-step method"Healthcare professionals working as "ethical representatives" at the current ward (n=5) have recently gone through a basic ethics program. They will continue by going through an education program for facilitating ethics communication in group, in line with "the one to five-step method" * The education program has a theoretical and practical approach, which includes the theoretical base of the ethical communication in groups and practicing "the one to five method" * Thereafter, each "ethical representative" will facilitate interprofessional sessions at a clinical ward, once a month, for six months at their workplace. Gathering meetings for feedback will be offered for the "ethical representatives" once a month. |
| No organized ethics communication in group | No intervention | –Healthcare professionals working as "ethical representatives" at the current ward (n=5) have recently gone through a basic ethics program. They have not being educated in "the one to five-step method and organized interprofessional sessions are not planned at the wards. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthcare professionals working at included wards
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethics communication in group, in line with "the one to five-step method"Healthcare professionals working as "ethical representatives" at the current ward (n=5) have recently gone through a basic ethics program. They will continue by going through an education program for facilitating ethics communication in group, in line with "the one to five-step method" The education program has a theoretical and practical approach, which includes the theoretical base of the ethical communication in groups and practicing "the one to five method" Thereafter, each "ethical representative" will facilitate interprofessional sessions at a clinical ward, once a month, for six months at their workplace. Gathering meetings for feedback will be offered for the "ethical representatives" once a month. | Other | ethics communication in group, in line with "the one to five-step method" |
Primary outcome
moral distress meausered by using the Meausure of Moral Distress for Health care Professionals (MMD-HP) and the Moral Distress Thermometer
Time frame: Change from Baseline moral distress at 6 months
primary outcome
2 secondary outcomes
ethical climate meausered by the Swedish ethical climate questionnaire (SwECQ)
Time frame: Change from Baseline ethical climate at 6 months
experiences
Time frame: at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 40713613Margareta B, Ulf I, C FG. Effects of ethics communication in health care: a cluster randomised controlled trial. BMC Med Ethics. 2025 Jul 26;26(1):106. doi: 10.1186/s12910-025-01270-w.
Related trials for Ethics Support
Not yet recruiting
The Impact of Technology-supported Interactive Teaching in Ethics Education
Ethics, Ethical Dilemma
Active, not recruiting
Ethics Education to Support Nurse Leaders in HealthCare
Knowledge, Attitudes, Practice
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.
Margareta Brännström principal investigator
Umea university, department of nursing, Umeå, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ethics communication in group, in line with "the one to five-step method" in people with Ethics Support, run by Umeå University at 2 sites in Sweden.
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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 Margareta Brännström (0761111286, margareta.brannstrom@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
moral distress meausered by using the Meausure of Moral Distress for Health care Professionals (MMD-HP) and the Moral Distress Thermometer (time frame: Change from Baseline moral distress at 6 months). 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 NCT05146102, 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 6 Dec 2021.