跳至主要内容
临床试验/NCT07423468
NCT07423468
进行中(未招募)
不适用

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

University of Aarhus1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年10月1日最近更新:

概览

阶段
不适用
状态
进行中(未招募)
入组人数
160
试验地点
1
主要终点
Work-Related Burnout

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Employed in the included departments
  • Profession as nurse

排除标准

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

研究组 & 干预措施

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.

干预措施: 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.

结局指标

主要结局

Work-Related Burnout

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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