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Идёт набор NCT06886581

Online Training Course to Improve Evidence-based Leadership

Без фазы С лечением Evidence-Based Practice Leadership

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Evidence-based leadership training.
Кому может быть актуально
Состояния в реестре: Evidence-Based Practice, Leadership. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Финляндия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 alo

Первичные конечные точки

  • The Evidence-based Practice Questionnaire (EBPQ) [Срок оценки: From enrollment to the end of training at 7 months.]
Вторичные конечные точки (11)
  • Self-Esteem Scale (RSE) [Срок оценки: From enrollment to the end of training at 7 months.]
  • The General Self-Efficacy Scale (GSE) [Срок оценки: From enrollment to the end of training at 7 months.]
  • The Implementation Leadership Scale (ILS) - Staff version [Срок оценки: From enrollment to the end of training at 7 months.]
  • The Implementation Leadership Scale (ILS) - Supervisor version [Срок оценки: From enrollment to the end of training at 7 months.]
  • The quality of care: Number of Patient Deaths (Register Data) [Срок оценки: From enrollment to the end of training at 7 months.]
  • The quality of care: Number of Treatment Complaints (Register Data) [Срок оценки: From enrollment to the end of training at 7 months.]
  • The quality of care: Number of Medication Errors (Register Data) [Срок оценки: From enrollment to the end of training at 7 months.]
  • Work absence: Number of Staff Absence Days (Register Data) [Срок оценки: From enrollment to the end of training at 7 months.]
  • Intention to leave the ward - survey [Срок оценки: From enrollment to the end of training at 7 months.]
  • Intention to leave hospital - survey [Срок оценки: From enrollment to the end of training at 7 months.]
  • Intention to leave profession - survey [Срок оценки: From enrollment to the end of training at 7 months.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Финляндия · 1 центр
  • City of Helsinki — Helsinki

Публикации

  • 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. PMID 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. PMID 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. PMID 41239490

Идентификаторы

NCT: NCT06886581 · Ethics Committee 1/2025 · HU 73715712

Первоисточники (государственные реестры)

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