Transition to First-Line Nurse Manager RoleCTPNCT07191210
Co-Designed Comprehensive Transition Programme for First-Line Nurse Managers
A study testing Comprehensive Transition Programme (CTP) in people with Transition to First-Line Nurse Manager Role, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
This study will pilot a Comprehensive Transition Programme (CTP) to support nurses who move into first-line nurse manager (FLNM) roles at Clínica Universidad de Navarra. The transition to frontline management can be challenging and is linked to uncertainty, workload stress, and role ambiguity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transition to First-Line Nurse Manager Role
- What is being tested?
- Comprehensive Transition Programme (CTP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2025to 19 Dec 2025
- 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
- Clinical nurses with responsibility roles at Clínica Universidad de Navarra (CUN) but not yet formally appointed as supervisors.
- First-Line Nurse Managers (FLNMs) with less than five years of managerial experience in the CUN.
- FLNMs with more than five years of managerial experience acquired mainly in other institutions but recently appointed as first-line managers at the CUN.
- Ability to understand and provide informed consent.
Who cannot join
- Nurses with more than five years of continuous experience as FLNMs at the CUN.
- Nurses in middle or executive management roles (e.g., area directors, chief nursing officers).
- Clinical nurses without any responsibility or leadership role.
- Inability or unwillingness to provide informed consent.
About this study
Official title: A Co-Produced Comprehensive Transition Programme Designed Using Experience-Based Co-Design to Support First-Line Nurse Managers
This study will pilot a Comprehensive Transition Programme (CTP) to support nurses who move into first-line nurse manager (FLNM) roles at Clínica Universidad de Navarra. The transition to frontline management can be challenging and is linked to uncertainty, workload stress, and role ambiguity. The CTP was co-designed with clinical nurses, FLNMs, nursing directors and chief nursing officers using experience-based co-design methods so that its content fits the organisation's practice model and priorities.
The programme combines classroom training, online learning, mentorship, and structured reflective practice. Participants complete brief assessments before and after the programme. The primary focus is to see whether leadership practices improve; we will also examine feasibility and acceptability to inform future refinement.
Read more
This pilot uses a simple pre-post design with data collected at baseline and immediately after the programme. Findings will be used to optimise the CTP and to guide broader implementation in the health system.
(Eligibility, outcomes, dates and intervention components are detailed in their specific sections of this record.)
Read the detailed description
Rationale and aim. The move from bedside nursing to first-line nurse management is a critical career transition that requires new leadership, managerial and relational capabilities. In response, a multicomponent Comprehensive Transition Programme (CTP) was co-designed with stakeholders across organisational levels using experience-based co-design. The aim of this pilot is to generate preliminary evidence on usefulness and feasibility and to explore changes in leadership practices among novice FLNMs.
Design overview. Single-group, pre-post mixed-methods pilot conducted at a tertiary university hospital. Data are collected at two timepoints: baseline (prior to programme start) and immediately post-intervention. The primary outcome is change in leadership practices; additional indicators include acceptability, fidelity and qualitative insights from reflective narratives.
(Primary/secondary outcome measures, time frames and sample size appear in the Outcomes and Enrollment fields.)
Participants. Eligible participants are nurses on the institutional pathway to frontline management, including (a) clinical nurses with responsibility roles not yet formally appointed as supervisors; (b) FLNMs with <5 years' experience at the institution; and (c) FLNMs with prior experience elsewhere recently appointed at the institution. Participation is voluntary with written informed consent.
(Full inclusion/exclusion criteria are provided in the Eligibility section.)
Intervention (overview). The CTP is delivered over approximately three months and integrates:
Structured training on leadership and team management, care quality and improvement, communication, quality standards, and human resources/finance;
Mentorship by experienced nurse managers;
Online learning to reinforce key skills;
Reflective practice through guided narrative work and peer discussion. Delivery follows a common syllabus and mentoring framework to support consistency across participants.
(Specific components and any materials/providers are listed under Arms/Interventions.)
Implementation and fidelity. Standardised session objectives, shared teaching materials, common mentoring guidelines, and written instructions for reflective activities are used to promote consistency. Attendance and completion of activities are monitored as feasibility/fidelity indicators.
Data collection and analysis. Quantitative data are analysed descriptively and for pre-post change in leadership practices. Qualitative reflective narratives are appraised with a structured rubric and thematically analysed to capture perceived learning, role adjustment and relational practice. Integration of quantitative and qualitative strands supports interpretation of preliminary efficacy and feasibility.
(Instruments and time frames are specified in Outcome Measures.)
Ethics and data protection. The study has prior approval from the institutional Research Ethics Committee. All participants provide informed consent. Procedures follow applicable regulations for confidentiality and data protection.
Expected contribution. Results will inform refinements to content, sequencing and delivery of the CTP and support planning for a larger-scale evaluation and potential scale-up across services.
- Being tested
- Comprehensive Transition Programme (CTP)
- Keywords
- Nursing leadership, First-line nurse managers, Nurse manager education, Mentorship, Leadership training, Co-Production
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Transition Programme (CTP)Behavioural
A co-designed, multicomponent educational programme delivered over three months to support nurses transitioning into first-line management roles. The programme integrates classroom training modules, online learning, mentorship by senior nurse managers, and structured reflective practice.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Transition Programme (CTP) | Experimental | Participants will receive the Comprehensive Transition Programme (CTP), a multicomponent intervention including face-to-face training modules, online learning, mentorship, and reflective practice over a 3-month period. Receives: Behavioral: Comprehensive Transition Programme (CTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leadership practices (Leadership Practices Inventory, LPI)
Leadership behaviours will be assessed using the Leadership Practices Inventory (LPI), a validated 30-item questionnaire covering five domains: Model the Way, Inspire a Shared Vision, Challenge the Process, Enable Others to Act, and Encourage the Heart. Scores range from 10 to 100 per domain, with higher scores indicating more frequent leadership behaviours. Mean change between baseline and post-intervention will be analysed.
Measured: Up to 12 months (Baseline, 3 months, 6 months, 12 months)
Secondary outcomes (1)
Quality of reflective narratives
Reflective narratives written by participants will be assessed using an evaluation tool adapted from the Nursing Professional Practice Model (NPPM-CUN). The tool evaluates three core managerial competencies-respect, intentional presence, and knowing the team-together with reflective capacity. Each item is rated on a 4-point scale (1 = not demonstrated, 4 = fully demonstrated). Mean scores and changes between baseline and post-intervention will be analysed, complemented with thematic analysis of narrative content.
Measured: Up to 12 months (Baseline, 3 months, 6 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start3 Oct 2025 (estimated)
- Primary completion19 Dec 2025 (estimated)
- Study completion19 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transition to First-Line Nurse Manager RoleStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the Comprehensive Transition Programme (CTP), a multicomponent intervention including training sessions, mentorship, online learning, and reflective practice. No control or comparison group is included.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idoia Pardavila, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191210
- Sponsor's protocol ID
- UNAV-CTP-2024
- Other IDs
- Chair of María Egea
- Acronym
- CTP
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Co-Produced Comprehensive Transition Programme Designed Using Experience-Based Co-Design to Support First-Line Nurse Managers
- ClinicalTrials.gov ID
- NCT07191210
- Acronym / sponsor ID
- CTP / UNAV-CTP-2024
- Keywords
- Nursing leadership, First-line nurse managers, Nurse manager education, Mentorship, Leadership training, Co-Production
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 3 Oct 2025 (estimated)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 19 Dec 2025 (estimated)
- First posted
- 24 Sep 2025 (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.
This study will pilot a Comprehensive Transition Programme (CTP) to support nurses who move into first-line nurse manager (FLNM) roles at Clínica Universidad de Navarra. The transition to frontline management can be challenging and is linked to uncertainty, workload stress, and role ambiguity. The CTP was co-designed with clinical nurses, FLNMs, nursing directors and chief nursing officers using experience-based co-design methods so that its content fits the organisation's practice model and priorities.
The programme combines classroom training, online learning, mentorship, and structured reflective practice. Participants complete brief assessments before and after the programme. The primary focus is to see whether leadership practices improve; we will also examine feasibility and acceptability to inform future refinement.
This pilot uses a simple pre-post design with data collected at baseline and immediately after the programme. Findings will be used to optimise the CTP and to guide broader implementation in the health system.
(Eligibility, outcomes, dates and intervention components are detailed in their specific sections of this record.)
Detailed description
Rationale and aim. The move from bedside nursing to first-line nurse management is a critical career transition that requires new leadership, managerial and relational capabilities. In response, a multicomponent Comprehensive Transition Programme (CTP) was co-designed with stakeholders across organisational levels using experience-based co-design. The aim of this pilot is to generate preliminary evidence on usefulness and feasibility and to explore changes in leadership practices among novice FLNMs.
Design overview. Single-group, pre-post mixed-methods pilot conducted at a tertiary university hospital. Data are collected at two timepoints: baseline (prior to programme start) and immediately post-intervention. The primary outcome is change in leadership practices; additional indicators include acceptability, fidelity and qualitative insights from reflective narratives.
(Primary/secondary outcome measures, time frames and sample size appear in the Outcomes and Enrollment fields.)
Participants. Eligible participants are nurses on the institutional pathway to frontline management, including (a) clinical nurses with responsibility roles not yet formally appointed as supervisors; (b) FLNMs with <5 years' experience at the institution; and (c) FLNMs with prior experience elsewhere recently appointed at the institution. Participation is voluntary with written informed consent.
(Full inclusion/exclusion criteria are provided in the Eligibility section.)
Intervention (overview). The CTP is delivered over approximately three months and integrates:
Structured training on leadership and team management, care quality and improvement, communication, quality standards, and human resources/finance;
Mentorship by experienced nurse managers;
Online learning to reinforce key skills;
Reflective practice through guided narrative work and peer discussion. Delivery follows a common syllabus and mentoring framework to support consistency across participants.
(Specific components and any materials/providers are listed under Arms/Interventions.)
Implementation and fidelity. Standardised session objectives, shared teaching materials, common mentoring guidelines, and written instructions for reflective activities are used to promote consistency. Attendance and completion of activities are monitored as feasibility/fidelity indicators.
Data collection and analysis. Quantitative data are analysed descriptively and for pre-post change in leadership practices. Qualitative reflective narratives are appraised with a structured rubric and thematically analysed to capture perceived learning, role adjustment and relational practice. Integration of quantitative and qualitative strands supports interpretation of preliminary efficacy and feasibility.
(Instruments and time frames are specified in Outcome Measures.)
Ethics and data protection. The study has prior approval from the institutional Research Ethics Committee. All participants provide informed consent. Procedures follow applicable regulations for confidentiality and data protection.
Expected contribution. Results will inform refinements to content, sequencing and delivery of the CTP and support planning for a larger-scale evaluation and potential scale-up across services.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the Comprehensive Transition Programme (CTP), a multicomponent intervention including training sessions, mentorship, online learning, and reflective practice. No control or comparison group is included.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Transition Programme (CTP) | Experimental | Behavioral: Comprehensive Transition Programme (CTP)Participants will receive the Comprehensive Transition Programme (CTP), a multicomponent intervention including face-to-face training modules, online learning, mentorship, and reflective practice over a 3-month period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical nurses with responsibility roles at Clínica Universidad de Navarra (CUN) but not yet formally appointed as supervisors.
- First-Line Nurse Managers (FLNMs) with less than five years of managerial experience in the CUN.
- FLNMs with more than five years of managerial experience acquired mainly in other institutions but recently appointed as first-line managers at the CUN.
- Ability to understand and provide informed consent.
Key exclusion criteria (4 listed)
- Nurses with more than five years of continuous experience as FLNMs at the CUN.
- Nurses in middle or executive management roles (e.g., area directors, chief nursing officers).
- Clinical nurses without any responsibility or leadership role.
- Inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| Comprehensive Transition Programme (CTP)A co-designed, multicomponent educational programme delivered over three months to support nurses transitioning into first-line management roles. The programme integrates classroom training modules, online learning, mentorship by senior nurse managers, and structured reflective practice. | Behavioural | Comprehensive Transition Programme (CTP) |
Primary outcome
Change in leadership practices (Leadership Practices Inventory, LPI)
Time frame: Up to 12 months (Baseline, 3 months, 6 months, 12 months)
Leadership behaviours will be assessed using the Leadership Practices Inventory (LPI), a validated 30-item questionnaire covering five domains: Model the Way, Inspire a Shared Vision, Challenge the Process, Enable Others to Act, and Encourage the Heart. Scores range from 10 to 100 per domain, with higher scores indicating more frequent leadership behaviours. Mean change between baseline and post-intervention will be analysed.
1 secondary outcome
Quality of reflective narratives
Time frame: Up to 12 months (Baseline, 3 months, 6 months, 12 months)
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 24 Sep 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Transition Programme (CTP) in people with Transition to First-Line Nurse Manager Role, run by Clinica Universidad de Navarra, Universidad de Navarra.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in leadership practices (Leadership Practices Inventory, LPI) (time frame: Up to 12 months (Baseline, 3 months, 6 months, 12 months)). 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 24 Sep 2025.