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Developing Competency Awareness and Clinical Coordination in a Neonatal Unit

Developing Competencies and Increasing Awareness of Staff Capabilities in a Neonatal Unit: A Mixed-methods Intervention Project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07423468
Acronym
NeoSim
Enrollment
160
Registered
2026-02-20
Start date
2025-10-01
Completion date
2027-08-01
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burnout, Professional, Interprofessional Relations, Neonatal Care, Psychological Safety

Keywords

Neonatal Care, Interprofessional Relations, Psychological Safety, Simulation-based training, Clinical competence, Team coordination, Burnout

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.

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.

Interventions

BEHAVIORALCompetency Awareness and Simulation-Based Intervention

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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Employed in the included departments * Profession as nurse

Exclusion criteria

* If participants are employed in both the intervention and control groups during the project period

Design outcomes

Primary

MeasureTime frameDescription
Work-Related BurnoutBaseline and immediately after the intervention period.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.
Psychological SafetyBaseline and immediately after the intervention period.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.

Secondary

MeasureTime frameDescription
Themes From Semi-Structured Staff Interviews on Experiences With Intervention ImplementationDuring the intervention period and immediately after its completion.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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026