Online Training Course to Improve Evidence-based Leadership

NCT ID: NCT06886581

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2026-12-31

Brief Summary

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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)?

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.

Detailed Description

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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.

Conditions

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Evidence-Based Practice Leadership

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Evidence-based leadership training

The participants in the experimental group will join a seven months online course aiming to improve the evidence-based leadership competences.

Group Type EXPERIMENTAL

Evidence-based leadership training

Intervention Type BEHAVIORAL

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.

Passive control group

A passive control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Evidence-based leadership training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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City of Helsinki

OTHER

Sponsor Role collaborator

Hospital District of Helsinki and Uusimaa

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Maritta Välimäki

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maritta A Välimäki, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

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City of Helsinki

Helsinki, South Finland, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Maritta A Välimäki, PhD

Role: CONTACT

+358-40-5599235

Maija Satamo, RN, MSc

Role: CONTACT

+358-50-4766116

Facility Contacts

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Mari A Riila, MNSc

Role: primary

+358-09-310-46595

Mari Riila, MNSc

Role: backup

+358-09-310-46595

References

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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.

Reference Type BACKGROUND
PMID: 39510773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37580090 (View on PubMed)

Related Links

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Other Identifiers

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HU 73715712

Identifier Type: OTHER

Identifier Source: secondary_id

Ethics Committee 1/2025

Identifier Type: -

Identifier Source: org_study_id

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