Clinical trial NCT06886581: Online Training Course to Improve Evidence-based Leadership
Official title: Effectiveness of Online Training Course to Improve Evidence-based Leadership Practices: a Cluster Randomised Two-arm Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Evidence-Based Practice
Leadership
Keywords: cluster randomised trial
evidence-based
leadership
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: City of Helsinki
name: Hospital District of Helsinki and Uusimaa
First posted: 2025-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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). 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The Evidence-based Practice Questionnaire (EBPQ)
timeFrame: From enrollment to the end of training at 7 months.
Secondary outcomes:
measure: Self-Esteem Scale (RSE)
timeFrame: From enrollment to the end of training at 7 months.
measure: The General Self-Efficacy Scale (GSE)
timeFrame: From enrollment to the end of training at 7 months.
measure: The Implementation Leadership Scale (ILS) - Staff version
timeFrame: From enrollment to the end of training at 7 months.
measure: The Implementation Leadership Scale (ILS) - Supervisor version
timeFrame: From enrollment to the end of training at 7 months.
measure: The quality of care: Number of Patient Deaths (Register Data)
timeFrame: From enrollment to the end of training at 7 months.
measure: The quality of care: Number of Treatment Complaints (Register Data)
timeFrame: From enrollment to the end of training at 7 months.
measure: The quality of care: Number of Medication Errors (Register Data)
timeFrame: From enrollment to the end of training at 7 months.
measure: Work absence: Number of Staff Absence Days (Register Data)
timeFrame: From enrollment to the end of training at 7 months.
measure: Intention to leave the ward - survey
timeFrame: From enrollment to the end of training at 7 months.
measure: Intention to leave hospital - survey
timeFrame: From enrollment to the end of training at 7 months.
measure: Intention to leave profession - survey
timeFrame: From enrollment to the end of training at 7 months.
Other outcomes:
measure: Course feedback - survey
timeFrame: After the course, at month 7.
measure: Feasibility and fidelity: number of total loggs in each module (f)
timeFrame: After the course, at month 7.
measure: Feasibility and fidelity: number of participants who logged in each module (n)
timeFrame: After the course, at month 7.
measure: Feasibility and fidelity: adherence to the course (f)
timeFrame: After the course, at month 7.
measure: Feasibility and fidelity: adherence to the course tasks (n)
timeFrame: After the course, at month 7.
measure: Feasibility and fidelity: drop-out from intervention
timeFrame: After the course, at month 7.
measure: Feasibility and fidelity: drop-out rate of study
timeFrame: After the course, at month 7.
Locations:
city: Helsinki
country: Finland
facility: City of Helsinki
state: South Finland
Study officials:
affiliation: University of Helsinki
name: Maritta A Välimäki, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.