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NCT Number: NCT07423468

Developing Competency Awareness and Clinical Coordination in a Neonatal Unit

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neonatal Care Behavior Behavioral Symptoms Burnout, Professional Burnout, Psychological Interprofessional Relations Occupational Diseases Occupational Stress Psychological Safety Stress, Psychological

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MidtSim, Aarhus University

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Competency Awareness and Simulation-Based Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Themes From Semi-Structured Staff Interviews on Experiences With Intervention Implementation

    Time frame: During 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: NeoSim

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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