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:
University of Aarhus
Organization:
Study Overview
Official Title:
Developing Competencies and Increasing Awareness of Staff Capabilities in a Neonatal Unit: A Mixed-methods Intervention Project
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoSim
Brief Summary:
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.
This 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.
The 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.
This 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.
The 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.
Detailed Description:
Background and Rationale
Safe 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.
While 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.
Aim
The 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.
Study Design
The 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.
Setting and Participants
The 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.
Intervention
The 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.
Intervention 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.
Clinical 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.
Evaluation Overview
The 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.
Ethical Considerations
The study involves healthcare professionals only. Participation is voluntary, and data are handled confidentially in accordance with applicable regulations.
Safe 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.
While 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.
Aim
The 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.
Study Design
The 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.
Setting and Participants
The 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.
Intervention
The 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.
Intervention 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.
Clinical 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.
Evaluation Overview
The 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.
Ethical Considerations
The study involves healthcare professionals only. Participation is voluntary, and data are handled confidentially in accordance with applicable regulations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: