Neonatal CareNeoSimNCT07423468
Developing Competency Awareness and Clinical Coordination in a Neonatal Unit
A study testing Competency Awareness and Simulation-Based Intervention in people with Neonatal Care and Burnout, Professional, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neonatal Care, Burnout, Professional, Psychological Safety
- What is being tested?
- Competency Awareness and Simulation-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employed in the included departments
- Profession as nurse
Who cannot join
- If participants are employed in both the intervention and control groups during the project period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Competency Awareness and Simulation-Based Intervention
- Keywords
- Neonatal Care, Interprofessional Relations, Psychological Safety, Simulation-based training, Clinical competence, Team coordination, Burnout
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competency Awareness and Simulation-Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after the intervention period.
Secondary outcomes (1)
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.
Measured: During the intervention period and immediately after its completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Oct 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423468
- Sponsor's protocol ID
- NeoSim
- Acronym
- NeoSim
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Competencies and Increasing Awareness of Staff Capabilities in a Neonatal Unit: A Mixed-methods Intervention Project
- ClinicalTrials.gov ID
- NCT07423468
- Acronym / sponsor ID
- NeoSim / NeoSim
- Keywords
- Neonatal Care, Interprofessional Relations, Psychological Safety, Simulation-based training, Clinical competence, Team coordination, Burnout
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Competency Awareness and Simulation-Based Intervention | Experimental | Behavioral: Competency Awareness and Simulation-Based InterventionParticipants 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. |
| Usual Practice | No intervention | –Participants continue usual clinical practice during the study period without exposure to the structured intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Employed in the included departments
- Profession as nurse
Key exclusion criteria (1 listed)
- If participants are employed in both the intervention and control groups during the project period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Competency Awareness and Simulation-Based InterventionThe 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. | Behavioural | Competency Awareness and Simulation-Based Intervention |
Primary outcome
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.
1 secondary outcome
Themes From Semi-Structured Staff Interviews on Experiences With Intervention Implementation
Time frame: During the intervention period and immediately after its completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Competency Awareness and Simulation-Based Intervention in people with Neonatal Care and Burnout, Professional, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work-Related Burnout (time frame: Baseline and immediately after the intervention period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.