- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07378696
Implementing Evidence-Based Nursing: Leadership and Organizational Change for Implementation (LOCI-FIN-P)
This study aims to find out whether a leadership and organizational development program called the LOCI (Leadership and Organizational Change for Implementation) strategy can help nurses and their managers use the best available research in everyday care. Using evidence-based practice.
Previous work in the region showed that nurses and their managers want to use evidence-based practices but face challenges, such as unclear processes, limited support, and differences in skills. The LOCI strategy has helped leaders in other countries improve how new practices are introduced and supported. This study will test a version of LOCI adapted for Finnish healthcare settings.
Nurse managers and staff from selected hospital and elder care units will:
Take part in leadership and training sessions. Receive individual and group mentoring. Work with their teams on plans that support introducing new, research-based ways of working.
Two evidence-based practices will be introduced:
In psychiatric units: A safety planning method to help prevent suicide among people receiving mental health care.
In elder care units: Better ways to identify and treat malnutrition among older adults.
The study involves:
Nurse managers Nursing staff Senior nurse leaders Specialist nurses who support the training
The study will run for one year. The LOCI program lasts nine months, followed by a three-month follow-up period.
Assessment:
How well the adapted LOCI strategy works in practice (for example, whether participants find it useful).
Whether leadership skills and workplace support for evidence-based practices improve.
Whether the new care practices (suicide safety planning and malnutrition prevention) are used more often and more effectively.
Participants will complete questionnaires, take part in interviews or group discussions, and researchers will review documentation and care records to understand how the changes progress.
The study may help improve leadership skills, strengthen support for evidence-based practice, and improve care for patients in both mental health and elder care settings. The results may also help other healthcare organizations adopt similar approaches.
The study follows strict ethical and data protection rules. Survey participation is voluntary, and all personal information will be handled securely and confidentially. The care practices being introduced are already recommended in Finland and are part of normal care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaakko Varpula, PhD
- Phone Number: +358442784794
- Email: jaheva@utu.fi
Study Contact Backup
- Name: Riitta Askola, PhD
- Phone Number: +358505715760
- Email: raasko@utu.fi
Study Locations
-
-
-
Turku, Finland
- Recruiting
- The Wellbeing Services Country of Southwest Finland
-
Contact:
- Tarja Heino-Tolonen, PhD
- Phone Number: +358505725257
- Email: tarja.heino-tolonen@varha.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nurse manager
- Registered nurse
- Practical nurse
- Nurse director
Exclusion Criteria:
• Other healtcare professionals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Leadership and Organizational Change for Implementation (LOCI)
LOCI (Leadership and Organizational Change for Implementation) is a structured leadership and organizational development strategy designed to help managers strengthen their skills in implementing evidence-based practices.
It combines leadership training, individualized mentoring, and organizational support to create a workplace climate that makes it easier to adopt and sustain new, research-based ways of working.
|
LOCI (Leadership and Organizational Change for Implementation) is a structured leadership and organizational development strategy designed to help managers strengthen their skills in implementing evidence-based practices.
It combines leadership training, individualized mentoring, and organizational support to create a workplace climate that makes it easier to adopt and sustain new, research-based ways of working.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 3months after start of intervention, 9 months (end of intervention)
|
Acceptability of Intervention Measure (AIM), 4-item, 5-point Likert Scale (1-5), Min score 5, Max score 20.
Higher scores indicate greater acceptability.
|
3months after start of intervention, 9 months (end of intervention)
|
|
Appropriateness
Time Frame: 3months after start of intervention, 9 months (end of intervention)
|
Intervention Appropriateness Measure (IAM), 4-item, 5-point Likert scale (1-5), Min score 5, Max score 20.
Higher scores indicate greater appropriateness.
|
3months after start of intervention, 9 months (end of intervention)
|
|
Feasibility of intervention
Time Frame: 3months after start of intervention, 9 months (end of intervention)
|
Feasibility of Intervention Measure (FIM), 4-item, 5-point Likert scale (1-5), Min score 5, Xax score 20.
Higher scores indicate greater feasibility.
|
3months after start of intervention, 9 months (end of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness to implementation leadership
Time Frame: Baseline, 3month, 8months, 3 month follow-up
|
Implementation leadership scale (ILS), 21-item, 5-point Likert scale (0-4).
Min 0 and Max score 84.
Higher scores indicate better implementation-supportive leadership.
|
Baseline, 3month, 8months, 3 month follow-up
|
|
Effectiveness to transformational leadership
Time Frame: Baseline, 3month, 8months, 3 month follow-up
|
Global Transformational Leadership Scale (GTL), 7-item, 5-point Likert Scale (1-5), Min 7, Max score 35, higher score indicate better outcome, more transformational leadership behaviours.
|
Baseline, 3month, 8months, 3 month follow-up
|
|
Effectiveness to implementation climate
Time Frame: Baseline, 3month, 8months, 3 month follow-up
|
Implementation Climate Scale (ICS), 27-item, 5-point Likert scale (0-4), Min 0, Max score 108, higher scores indicate better outcomes - stronger organizational climate supporting evidence-based practice implementation.
|
Baseline, 3month, 8months, 3 month follow-up
|
|
Effectiveness to evidence-based practice attitudes
Time Frame: Baseline, 3month, 8months, 3 month follow-up
|
The Evidence-based Practice Attitude Scale (EBPAS), 15-item, 5-point Likert Scale (0-4).
Min 0, Max score 60, higher scores indicate better outcome, more positive atittudes towards evidence-based practice.
|
Baseline, 3month, 8months, 3 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anna Axelin, Professor, University of Turku, Department of Nursing Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TY/1603/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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