- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05244512
Evidence-based Leadership in Nurse Leaders-FI (EVILEAD-FI)
June 6, 2023 updated by: Maritta Välimäki, University of Turku
Online Training to Improve Evidence-based Leadership Competencies Among Nurse Leaders in Finland: Study Protocol for a Randomised Feasibility Trial (EVILED-FI)
This study protocol describes a randomised feasibility trial that will evaluate the feasibility and preliminary effectiveness of the training course to improve evidence-based leadership competencies among nurse leaders working in hospitals in Finland.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will include a 6-months training intervention for nurse leaders working in hospital settings in Finland.
About 140 nurse leaders fulfilling the eligibility criteria will be randomly allocated (1:1) to participate in the online training course about evidence-based leadership or conventional leadership training course (reading material only).
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Finland
-
Helsinki, South Finland, Finland, 20014
- Helsingin kaupunki, psykiatria
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Official managerial role in the study organisation (hospital, clinic, ward level), which give them an authority to act as a nurse leader and monitor, develop and evaluate the care
- Being in full time or part time position
- All sex
- Aged up to 65 years
- Working in the study sites at the time of the recruitment
- Ability to read and write Finnish language
- Willingness to join the study based on their own free will
- Informed consent obtained
Exclusion Criteria:
- Non-nursing professionals in leadership position (e.g. physician, psychologist, pharmacist, dietician/nutritionist, dentist, physiotherapist, radiation therapist, paramedic, occupational therapist, social worker, or disability worker)
- Speaking only other languages than Finnish (e.g. Swedish or English)
- Out of duty during the recruitment period for family leave, long term sick leave, study leave or any other reason
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Evidence-based leadership training
The training course will take 6 months.
It is divided into seven online modules.
Participants join the course based on pre-structured schedule.
The progress of the training course will follow specific steps to improve participants' evidence-based leadership competencies.
First, each participant identifies one leadership problem on daily practice.
Second, organisational data will be collected and analysed to increase the understanding of the key problem.
Third, scientific literature will be searched, identified and critically appraised to find solutions.
Fourth, the views of stakeholders (patients, clinicians, family members, etc.) are considered together with ethical implications.
And last, all sources of information are critically appraised, new solution will be designed and implemented into the practice, and evaluated in real world context.
Each module includes specific learning material.
Trained tutors are responsible for mentoring each module.
|
7-modules online training over six months mentored by tutors.
Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback.
|
|
Active Comparator: Conventional training
The participants will join a training course with the same structure, topics, and timing as the experimental group.
However, training in this group is based on independent learning methods.
The participants have access to the separate learning platform, which includes reading material to be read independently.
No group discussions with peers, self-reflection, assignments, or support from tutors will be offered.
|
7-modules online training over six months.
Independent reading only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: 6 months
|
The degree of execution (success and failure of execution) of the intervention protocol by calculating the number of logins for each module and all participants
|
6 months
|
|
Adherence in the course
Time Frame: 6 months
|
Adherence in the course by calculating the number of returned course tasks out of all possible tasks
|
6 months
|
|
Adherence in the course tasks
Time Frame: 6 months
|
Adherence in the course by calculating the number of returned course tasks by each participant
|
6 months
|
|
Drop-out rate
Time Frame: 6 months
|
The drop-out rate calculated by the number of participants who left the study early (no follow-up data)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability in recruitment
Time Frame: Baseline
|
The number of nurse leaders who accepted (or refused) the invitation to participate in the research study
|
Baseline
|
|
Feasibility of the eligibility criteria
Time Frame: Baseline
|
The number of nurse leaders who fulfilled eligibility criteria
|
Baseline
|
|
Feasibility of the outcome instruments for measuring the potential effectiveness of the online course
Time Frame: Baseline and 6 months
|
The number of missing variables of each returned instrument
|
Baseline and 6 months
|
|
Leadership skills (Multifactor Leadership Questionnaire [MLQ])
Time Frame: Baseline and 6 months
|
Multifactor Leadership Questionnaire (MLQ)
|
Baseline and 6 months
|
|
Evidence-based practice, knowledge, and attitudes (Evidence Based Practice Questionnaire [EBPQ])
Time Frame: Baseline and 6 months
|
Evidence-Based Practice Questionnaire (EBPQ)
|
Baseline and 6 months
|
|
Self-efficacy (General Self-Efficacy Scale [GSE])
Time Frame: Baseline and 6 months
|
General Self-Efficacy Scale (GSE)
|
Baseline and 6 months
|
|
Self-esteem (Rosenberg Self-Esteem Scale [RSE])
Time Frame: Baseline and 6 months
|
Rosenberg Self-Esteem Scale (RSE)
|
Baseline and 6 months
|
|
Intention to leave (questionnaire)
Time Frame: Baseline and 6 months
|
Three-item questionnaire
|
Baseline and 6 months
|
|
Course feedback
Time Frame: 6 months
|
Eight-item questionnaire
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maritta A Välimäki, University of Turku
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2022
Primary Completion (Actual)
May 30, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
February 7, 2022
First Submitted That Met QC Criteria
February 16, 2022
First Posted (Actual)
February 17, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- UTUEvidence
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
According to the ethical reasons
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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