Developing Competency Awareness and Clinical Coordination in a Neonatal Unit

NCT07423468 | Active Not Recruiting

• 1 other identifier: NeoSim
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  During the intervention period and immediately after its completion.

Study Arms (2)

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.

Behavioral: Competency Awareness and Simulation-Based Intervention

Usual Practice

NO INTERVENTION

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

Interventions

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.

Competency Awareness and Simulation-Based Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Employed in the included departments
• Profession as nurse

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

MidtSim, Aarhus University

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Burnout, Professional; Burnout, Psychological

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 20, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)