Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05146102
Status:
UNKNOWN
Last Update Posted:
2021-12-06
First Post:
2021-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'moral distress meausered by using the Meausure of Moral Distress for Health care Professionals (MMD-HP) and the Moral Distress Thermometer', 'timeFrame': 'Change from Baseline moral distress at 6 months', 'description': 'primary outcome'}], 'secondaryOutcomes': [{'measure': 'ethical climate meausered by the Swedish ethical climate questionnaire (SwECQ)', 'timeFrame': 'Change from Baseline ethical climate at 6 months', 'description': 'secondary outcome'}, {'measure': 'experiences', 'timeFrame': 'at 6 month', 'description': 'interviews of the interventiongroup'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ethics support', 'ethical rounds', 'healthcare personnel'], 'conditions': ['Ethics Support']}, 'referencesModule': {'references': [{'pmid': '40713613', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSignificance: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthcare professionals working at included wards\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05146102', 'acronym': 'Ethics-com', 'briefTitle': 'Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study).', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study).', 'orgStudyIdInfo': {'id': 'Ethics-com001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ethics communication in group, in line with "the one to five-step method"', 'description': '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"\n\n* 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"\n* 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.', 'interventionNames': ['Other: ethics communication in group, in line with "the one to five-step method"']}, {'type': 'NO_INTERVENTION', 'label': 'No organized ethics communication in group', 'description': '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.'}], 'interventions': [{'name': 'ethics communication in group, in line with "the one to five-step method"', 'type': 'OTHER', 'description': '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"\n\nThe 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.', 'armGroupLabels': ['ethics communication in group, in line with "the one to five-step method"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93135', 'city': 'Skellefteå', 'state': 'Umeå Universitet', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Margareta Brännström, Professor', 'role': 'CONTACT', 'email': 'margareta.brannstrom@umu.se', 'phone': '0761111286'}, {'name': 'Catharina Fischer Grönlund, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Margareta Brännström', 'geoPoint': {'lat': 64.75067, 'lon': 20.95279}}, {'zip': '93187', 'city': 'Umeå', 'state': 'Umeå Universitet', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Margareta Brännström, PhD', 'role': 'CONTACT', 'email': 'margareta.brannstrom@umu.se', 'phone': '0761111286'}, {'name': 'Catarina Fischer Grönlund, PhD', 'role': 'CONTACT', 'email': 'catarina.fischer.gronlund@umu.se'}, {'name': 'Margareta Brännström, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Umeå university', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Margareta Brännström', 'role': 'CONTACT', 'email': 'margareta.brannstrom@umu.se', 'phone': '0761111286'}], 'overallOfficials': [{'name': 'Margareta Brännström', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umea university, department of nursing, Umeå, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Margareta Brännström', 'investigatorAffiliation': 'Umeå University'}}}}