Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:57 PM
Study NCT ID:
NCT07423468
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Competency Awareness and Clinical Coordination in a Neonatal Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned at the department level to either an intervention group or a comparison group. One neonatal unit receives the structured intervention, while a comparable neonatal unit continues usual practice during the study period. Outcomes are assessed in both groups before and after the intervention period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work-Related Burnout', 'timeFrame': 'Baseline and immediately after the intervention period.', 'description': 'Work-related burnout will be assessed using the Copenhagen Burnout Inventory (work-related burnout subscale). Items are rated on a 5-point Likert-type scale and scored according to the instrument guidelines, with higher scores indicating greater burnout. The outcome will be reported as the mean scale score.'}, {'measure': 'Psychological Safety', 'timeFrame': 'Baseline and immediately after the intervention period.', 'description': 'Psychological safety will be assessed using the Team Psychological Safety scale (Edmondson). The scale consists of 7 items rated on a 1-7 Likert scale, with higher scores indicating greater psychological safety. The outcome will be reported as the mean questionnaire score.'}], 'secondaryOutcomes': [{'measure': 'Themes From Semi-Structured Staff Interviews on Experiences With Intervention Implementation', 'timeFrame': 'During the intervention period and immediately after its completion.', 'description': 'Semi-structured interviews with clinical staff and clinical coordinators will assess experiences with implementation of the intervention in everyday clinical work. The outcome will be reported as qualitative themes describing staff engagement with intervention activities, integration into daily practice, and how participants experienced changes associated with the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal Care', 'Interprofessional Relations', 'Psychological Safety', 'Simulation-based training', 'Clinical competence', 'Team coordination', 'Burnout'], 'conditions': ['Neonatal Care', 'Burnout, Professional', 'Psychological Safety', 'Interprofessional Relations']}, 'descriptionModule': {'briefSummary': "In neonatal care, patient safety depends not only on individual clinical skills, but also on how teams recognize and use the competencies available during a shift. When staff are uncertain about who is able to perform specific tasks, coordination can become difficult, and responsibilities may be unevenly distributed.\n\nThis study examines a structured intervention in a neonatal unit aimed at supporting the development of clinical competencies and increasing staff awareness of each other's capabilities. The intervention combines competency mapping, facilitated reflection, simulation-based activities, and ongoing dialogue with clinical coordinators to support everyday coordination and task allocation.\n\nThe study uses a mixed-methods design, including questionnaires and qualitative data, to explore how the intervention is implemented in practice and whether it contributes to changes in staff experiences of competence, collaboration, and confidence in clinical work.", 'detailedDescription': "Background and Rationale\n\nSafe neonatal care depends on effective coordination among healthcare professionals working across shifts and roles. In daily clinical practice, decisions about task allocation rely on shared understanding of staff competencies. When such understanding is limited, staff may hesitate to act, rely on informal assumptions, or experience uncertainty about their own or others' roles.\n\nWhile educational and quality improvement initiatives are commonly used in clinical settings, less attention has been given to how competencies are made visible, shared, and actively used in everyday coordination. This study addresses that gap by introducing an intervention designed to support both the development of clinical competencies and awareness of available expertise within the neonatal unit.\n\nAim\n\nThe aim of the study is to examine how a structured intervention may support staff in a neonatal unit in developing clinical competencies while increasing awareness of each other's capabilities in everyday clinical work.\n\nStudy Design\n\nThe study is conducted as a mixed-methods intervention study combining quantitative and qualitative approaches. The design includes both impact-oriented evaluation and process-oriented inquiry to support understanding of how the intervention unfolds in practice.\n\nSetting and Participants\n\nThe study takes place in a neonatal unit. Participants include nursing staff and clinical coordinators involved in daily clinical care and shift coordination. Participation in questionnaires and interviews is voluntary.\n\nIntervention\n\nThe intervention will be implemented over a 12-month period. It is designed as a flexible and participatory initiative aimed at supporting clinical competence development and increasing awareness of staff capabilities.\n\nIntervention activities may include collaborative competency mapping, facilitated reflection on roles and responsibilities, and learning activities intended to support confidence, coordination, and task allocation. Simulation-based activities may be introduced as part of the intervention, with content adapted to the local clinical context.\n\nClinical coordinators and local staff will be involved in planning and adapting activities throughout the intervention period. The content, format, and frequency of activities may be adjusted over time based on feedback and practical experience within the unit.\n\nEvaluation Overview\n\nThe evaluation includes both process-oriented and impact-oriented components. Together, these approaches aim to support understanding of how the intervention is implemented and how potential changes in staff experiences and clinical coordination may emerge in practice.\n\nEthical Considerations\n\nThe study involves healthcare professionals only. Participation is voluntary, and data are handled confidentially in accordance with applicable regulations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employed in the included departments\n* Profession as nurse\n\nExclusion Criteria:\n\n* If participants are employed in both the intervention and control groups during the project period'}, 'identificationModule': {'nctId': 'NCT07423468', 'acronym': 'NeoSim', 'briefTitle': 'Developing Competency Awareness and Clinical Coordination in a Neonatal Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Developing Competencies and Increasing Awareness of Staff Capabilities in a Neonatal Unit: A Mixed-methods Intervention Project', 'orgStudyIdInfo': {'id': 'NeoSim'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Competency Awareness and Simulation-Based Intervention', 'description': "Participants are exposed to a structured, unit-based intervention aimed at supporting the development of clinical competencies and increasing awareness of colleagues' capabilities in everyday neonatal care.", 'interventionNames': ['Behavioral: Competency Awareness and Simulation-Based Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Practice', 'description': 'Participants continue usual clinical practice during the study period without exposure to the structured intervention.'}], 'interventions': [{'name': 'Competency Awareness and Simulation-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention is a structured, unit-based initiative aimed at supporting the development of clinical competencies and increasing staff awareness of available expertise in everyday neonatal care. It combines competency mapping, facilitated reflection on roles and responsibilities, and locally adapted learning activities. Simulation-based activities are included, with scenarios tailored to the local clinical context. The intervention is implemented over a 12-month period and allows adjustments based on local needs and ongoing feedback from staff and clinical coordinators.', 'armGroupLabels': ['Competency Awareness and Simulation-Based Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'MidtSim, Aarhus University', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}