Developing Competency Awareness and Clinical Coordination in a Neonatal Unit (NeoSim)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Burnout, Professional; Interprofessional Relations; Neonatal Care; Psychological Safety
• Intervention / Treatment: Behavioral: Competency Awareness and Simulation-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • MidtSim, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Competency Awareness and Simulation-Based Intervention; 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.	Behavioral: Competency 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.
No Intervention: Usual Practice; Participants continue usual clinical practice during the study period without exposure to the structured intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work-Related Burnout	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.	Baseline and immediately after the intervention period.
Psychological Safety	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.	Baseline and immediately after the intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Themes From Semi-Structured Staff Interviews on Experiences With Intervention Implementation	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.	During the intervention period and immediately after its completion.

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Burnout; Simulation-based training; Interprofessional Relations; Psychological Safety; Neonatal Care; Clinical competence; Team coordination
• Additional Relevant MeSH Terms: Occupational Stress; Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Behavior; Burnout, Psychological; Burnout, Professional
• Other Study ID Numbers: NeoSim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No