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Clinical Trials/NCT07423468
NCT07423468Active, not recruitingNot Applicable

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

University of Aarhus1 site in 1 country160 target enrollmentStarted: October 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
160
Locations
1
Primary Endpoint
Work-Related Burnout

Study Overview

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

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Sex
All
Accepts 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

Arms & Interventions

Competency Awareness and Simulation-Based Intervention

Experimental

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.

Intervention: Competency Awareness and Simulation-Based Intervention (Behavioral)

Usual Practice

No Intervention

Participants continue usual clinical practice during the study period without exposure to the structured intervention.

Outcomes

Primary Outcomes

Work-Related Burnout

Time Frame: Baseline 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 Safety

Time Frame: Baseline 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 Outcomes

  • Themes From Semi-Structured Staff Interviews on Experiences With Intervention Implementation(During the intervention period and immediately after its completion.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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