Evidence-based Leadership in Nurse Leaders-CH (EVILEAD-CH)

November 28, 2023 updated by: Maritta Välimäki, University of Turku

Online Training to Improve Evidence-based Leadership Competencies Among Nurse Leaders in China: Study Protocol for a Randomised Feasibility Trial (EVILEAD-CH)

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 China.

Study Overview

Detailed Description

This study will include a 6-months training intervention for nurse leaders working in hospital settings in China. About 150 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 (Actual)

119

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

    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Tumor Hospital
      • Changsha, Hunan, China, 410013
        • Xiangya Hospital

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 simple Chinese 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 simple Chinese
  • 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
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
Leadership skills (Multifactor Leadership Questionnaire [MLQ])
Time Frame: Baseline and 6 months
Multifactor Leadership Questionnaire (MLQ)leadership skills
Baseline and 6 months
Course feedback (questionnaire)
Time Frame: Baseline and 6 months
Eight-item questionnaire
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maritta A Välimäki, Prof, University of Turku, Finland, mava@utu.fi

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)

July 13, 2022

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 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)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CHEvidence

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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