- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05146102
Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study). (Ethics-com)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Margareta Brännström
- Phone Number: 0761111286
- Email: margareta.brannstrom@umu.se
Study Locations
-
-
Umeå Universitet
-
Skellefteå, Umeå Universitet, Sweden, 93135
- Recruiting
- Margareta Brännström
-
Contact:
- Margareta Brännström, Professor
- Phone Number: 0761111286
- Email: margareta.brannstrom@umu.se
-
Sub-Investigator:
- Catharina Fischer Grönlund, PhD
-
Umeå, Umeå Universitet, Sweden, 93187
- Recruiting
- Umea University
-
Contact:
- Margareta Brännström, PhD
- Phone Number: 0761111286
- Email: margareta.brannstrom@umu.se
-
Contact:
- Catarina Fischer Grönlund, PhD
- Email: catarina.fischer.gronlund@umu.se
-
Principal Investigator:
- Margareta Brännström, PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthcare professionals working at included wards
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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"
|
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 Intervention: No organized ethics communication in group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from Baseline moral distress at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ethical climate meausered by the Swedish ethical climate questionnaire (SwECQ)
Time Frame: Change from Baseline ethical climate at 6 months
|
secondary outcome
|
Change from Baseline ethical climate at 6 months
|
experiences
Time Frame: at 6 month
|
interviews of the interventiongroup
|
at 6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margareta Brännström, Umea university, department of nursing, Umeå, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Ethics-com001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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