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Evidence-Based PracticeEVILEADNCT06886581

Online Training Course to Improve Evidence-based Leadership

A study testing Evidence-based leadership training in people with Evidence-Based Practice and Leadership, run by University of Turku at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this cluster clinical trial is to evaluate the effectiveness of online training course, targeted to unit leaders to improve staff's evidence-based skills (individual outcomes), EBP implementation (team-based outcomes), and the quality of care (organisational outcomes). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Evidence-Based Practice, Leadership
What is being tested?
Evidence-based leadership training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFinland
Study dates
5 Jun 2025to 31 Dec 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • have shown their willingness to join the study,
  • unit leaders have an official managerial position at the study organisation,
  • unit have a leaders with a professional licence to work in health or social care sector,
  • unit leaders represent any gender,
  • are able to speak, read and write in Finnish, and
  • have given informed consent to join the study.

Who cannot join

  • Those staff members who are off duty during the recruitment period (family leave, long-term sick leave, study leave, or any other reason).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maritta A Välimäki, PhD contact

+358-40-5599235

maritta.valimaki@helsinki.fi

Maija Satamo, RN, MSc contact

+358-50-4766116

maijakatriina.satamo@utu.fi

Finland1 site, 1 recruiting
  • City of Helsinki

    Helsinki, South Finland, 20014

    Mari A Riila, MNSc, +358-09-310-46595, mari.riila@hel.fi

    Mari Riila, MNSc, +358-09-310-46595, mari.riila@hel.fi

    Recruiting

Other trials in Finland

About this study

Official title: Effectiveness of Online Training Course to Improve Evidence-based Leadership Practices: a Cluster Randomised Two-arm Controlled Trial

The goal of this cluster clinical trial is to evaluate the effectiveness of online training course, targeted to unit leaders to improve staff's evidence-based skills (individual outcomes), EBP implementation (team-based outcomes), and the quality of care (organisational outcomes). Feasibility and fidelity of the intervention will be assessed as well. The main questions it aims to answer are:

  1. Does online training course improve staff's evidence-based practice?
  2. Does online training course improve staff's self-esteem and self-efficacy?
  3. Does online training course improve leadership for EBP implementation on organisational level?
  4. Does online training course improve the quality of patient care?
  5. Does online training course reduce staff's absence (sick leaves, intention to leave the ward or hospital)?
Read more

Participants will:

  • Participants will join in a seven-months online training course in small group or practice as usual.
  • Seven course modules, read course material, prepare assignments, join in peer discussions.
  • Self-assessment, self-reflection and give course feedback.
Read the detailed description

This cluster randomisation study will evaluate the effectiveness of online training course, targeted to unit leaders. The intervention will be delivered at the level of the cluster, i.e. professionals within clusters (education of unit leaders). Cluster randomisation study fits our purposes because our intention is to enhance the application of evidence by entire unit teams; the whole groups of collections of individuals in ward units are randomly assigned to receive educational intervention in groups, referred to as clusters.

This cluster trial will be conducted in two Finnish Wellbeing Services counties in southern Finland. The target group of study are unit leaders working in social and health care sector in a managerial position.

The units will be randomised into two groups: evidence-based leadership training (experimental group) or passive control group. The participants in the experimental group will join a seven months online course aiming to improve the evidence-based leadership competences.

All eligible unit leaders who have shown their interest to participate the study will receive an invitation email from the contact person of the study (the Chief Executive Officer). The email will include a link to study information and electronic informed consent in the Research Electronic Data Capture tool (REDCap). After given an electronic informed consent, the REDCap will lead to a baseline survey (background information of the participants of the specific units, baseline data). Unit leaders will be allocated into the study group as their unit.

All staff members who are working in the same unit with the unit leaders will be invited to join the study. First, staff members will receive an invitation email (sent by a Contact person) to explain the purpose of the study and its practical arrangements. If the staff member is willing to join the study, she or he will give an electronic content (REDCap) and respond to electronic surveys - but they do not join online training. After filling electronic forms, each staff members will be allocated into the same study group as their unit.

The outcomes are targeted to evaluate the effectiveness of the evidence-based online course on individual, team, and organisational level. The data will be formed based on characteristics of the unit and its participants, outcome data, course feedback, and feasibility data of the online training course. The primary endpoint with respect to effectiveness of the training course are an improvement in EBP from baseline to follow-up (month 7), measured immediately after the intervention using electronic survey administered to the unit leaders and staff.

The analysis will be carried out on an intent-to-treat (ITT) basis. Assumptions of normality of the residuals will be investigated. The characteristics of the units and respondents (staff members) will be summarized with descriptive statistics for each group. All individuals within the cluster will be included in the trial. In the sample size calculation, a clustering effect was assumed and accounted as the ICC coefficient. For data analysis the mixed effects model or two-level multilevel models that take into account clustering effects will be used. In the model analysis, the variation in the outcomes among clusters will be estimated and tested for its significance. The intra-cluster coefficient (ICC) will be reported. The overall efficacy of the outcomes will be estimated after taking into account the clustering effects. A descriptive summary of the baseline information for both clusters and individuals will be presented first as tables of summary data. Sensitivity analyses will be conducted on units in which participation in online training was low to evaluate whether intervention fidelity has any effect to the results of the primary outcome. Results will be expressed using rate ratios, odds ratios, or least-squares mean differences with corresponding 95% CIs, depending on the type of outcome. The intracluster (or intraclass) correlation coefficient (ICC) will also be calculated.

Covariate analysis will be conducted to control for potential confounding factors in statistical modelling. Participants' age, gender, and the number of returned task (by each participant in intervention group) will be included in the analysis.

Being tested
Evidence-based leadership training
Keywords
cluster randomised trial, evidence-based, leadership

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evidence-based leadership trainingBehavioural

    The structure of the course will follow the steps of the evidence-based approach: (1) each participant will identify their specific unit problem to be solved together with the team and unit leader will work with this problem during the course; (2) organisational data will be collated and analysed to understand the key problem of the unit; (3) scientific literature will be searched for, and critically appraised; (4) the views of stakeholders (patients, family members, etc.) will be considered along with implications; and (5) all sources of information will be collated together and the solution will be implemented into practice; the real situation will be evaluated. Each module includes specific learning material (power points, scientific articles), peer-group discussions, clinical exercises, and self-assessment and self-reflection. The unit leaders will work together their unit members. The course will be run in small group (about 15/agroup) and supported by tutors.

Study groups in NCT06886581
Study groupRoleWhat they receive
Evidence-based leadership trainingExperimentalThe participants in the experimental group will join a seven months online course aiming to improve the evidence-based leadership competences.
Receives: Behavioral: Evidence-based leadership training
Passive control groupNo interventionA passive control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Evidence-based Practice Questionnaire (EBPQ)

    The Evidence-based Practice Questionnaire (EBPQ) assess the implementation of evidence-based practice (24 items, score 1-7, three sub-scales: 1) the knowledge/skills (14 items, score 1-7, 1=Poor-7=Best, the range 14-98, a higher score represents greater knowledge in EBP); 2) the attitudes (4 items, score 1-7, the range 4-28; a higher score represents more a positive attitude toward EBP; 3) an evidence-based practice (6 items, score 1-7, 1=Never, 7=Frequently, range 6-42); the higher score is better.

    Measured: From enrollment to the end of training at 7 months.

Secondary outcomes (11)
  1. Self-Esteem Scale (RSE)

    Self-Esteem Scale (RSE) evaluate individual self-esteem with a 10-item unidimensional scale by focusing on both positive and negative feelings about the self (4-point Likert scale, 1=strongly agree - 4=strongly disagree). The sum score varies between 10 to 40: the higher score is better and represent higher self-esteem.

    Measured: From enrollment to the end of training at 7 months.

  2. The General Self-Efficacy Scale (GSE)

    The General Self-Efficacy Scale (GSE) assess optimistic self-beliefs for coping with a variety of difficult demands in life with 10 items (a 4-point Likert scale, 1 = not at all true, 4 = exactly true). Summed score ranges 10 - 40: the higher score indicates better coping abilities.

    Measured: From enrollment to the end of training at 7 months.

  3. The Implementation Leadership Scale (ILS) - Staff version

    The Implementation Leadership Scale (ILS)- Staff version, is 12-item questionnaire measuring leadership for EBP implementation. It consists of four subscales: (1) proactive leadership, (2) knowledgeable leadership, (3) supportive leadership, and (4) perseverant leadership. It is scored from 0 (not at all) to 4 (to a very great extent); the higher total score represents stronger implementation of EBP.

    Measured: From enrollment to the end of training at 7 months.

  4. The Implementation Leadership Scale (ILS) - Supervisor version

    The Implementation Leadership Scale (ILS)- Supervisor versions is 12-item questionnaire measuring leadership for EBP implementation. It consists of four subscales: (1) proactive leadership, (2) knowledgeable leadership, (3) supportive leadership, and (4) perseverant leadership. It is scored from 0 (not at all) to 4 (to a very great extent); the higher total score represents stronger implementation of EBP.

    Measured: From enrollment to the end of training at 7 months.

  5. The quality of care: Number of Patient Deaths (Register Data)

    Number of patient deaths during a seven-month follow-up period reported in hospital registers; lower numbers overall are better.

    Measured: From enrollment to the end of training at 7 months.

  6. The quality of care: Number of Treatment Complaints (Register Data)

    Number of patient/family members' treatment complaints during a seven-month follow-up period reported in hospital registers; lower numbers overall are better.

    Measured: From enrollment to the end of training at 7 months.

  7. The quality of care: Number of Medication Errors (Register Data)

    A number of medication errors during a seven-month follow-up period reported in hospital registers; lower numbers overall are better.

    Measured: From enrollment to the end of training at 7 months.

  8. Work absence: Number of Staff Absence Days (Register Data)

    Number of staff's absence days during a seven-month follow-up period reported in hospital registers (e.g. sick leave); lower numbers overall are better.

    Measured: From enrollment to the end of training at 7 months.

  9. Intention to leave the ward - survey

    During the last six months, how often a respondent has planned to leave the ward using a five-point scale (0 = never; 1 = now and then; 2 = quite often; 3 = very often; 4 = all the time): lower score is better.

    Measured: From enrollment to the end of training at 7 months.

  10. Intention to leave hospital - survey

    During the last six months, how often a respondent has planned to leave the hospital using a five-point scale (0 = never; 1 = now and then; 2 = quite often; 3 = very often; 4 = all the time): lower score is better.

    Measured: From enrollment to the end of training at 7 months.

  11. Intention to leave profession - survey

    During the last six months, how often a respondent has planned to leave the profession using a five-point scale (0 = never; 1 = now and then; 2 = quite often; 3 = very often; 4 = all the time): lower score is better.

    Measured: From enrollment to the end of training at 7 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start5 Jun 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886581
Sponsor's protocol ID
Ethics Committee 1/2025
Other IDs
HU 73715712
Acronym
EVILEAD
Status last verified
Jun 2025
First submitted
14 Mar 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Research data will include personal information of the participants. Thereore, entire research data cannot be make publicly available as it is. Meta-data of the study will be published.

Publications

  • Hu S, Chen W, Satamo M, Loyttyniemi E, Yang M, Liu G, Chen J, Tang Y, Varpula J, Li X, Valimaki M. Online training to improve evidence-based leadership competencies among nurse leaders in China: a feasibility randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e088386. doi: 10.1136/bmjopen-2024-088386.

    PubMed 39510773
  • Valimaki MA, Kirsi H, Yang M, Lantta T, Varpula J, Liu G, Tang Y, Chen W, Hu S, Chen J, Loyttyniemi E, Li X. Online training to improve evidence-based leadership competencies among nurse leaders in Finland and China: study protocols for two randomised feasibility trials. BMJ Open. 2023 Aug 14;13(8):e067306. doi: 10.1136/bmjopen-2022-067306.

    PubMed 37580090
  • Valimaki M, Satamo M, Yang M. Effectiveness of an online training course to improve evidence-based leadership practices among unit leaders: study protocol for a cluster randomised two-arm controlled trial (EVILEAD). Trials. 2025 Nov 14;26(1):508. doi: 10.1186/s13063-025-09207-9.

    PubMed 41239490

Questions about this trial

What is this clinical trial studying?

A study testing Evidence-based leadership training in people with Evidence-Based Practice and Leadership, run by University of Turku at 1 site in Finland.

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 6 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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 Finland. 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?

Contact Maritta A Välimäki, PhD (+358-40-5599235, maritta.valimaki@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Evidence-based Practice Questionnaire (EBPQ) (time frame: From enrollment to the end of training at 7 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886581, which also lists 3 linked publications.

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 13 Jun 2025.

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