An interventional study of Leadership and organizational change for implementation in Leadership, Self-Harm and Malnutrition Elderly, sponsored by Jaakko Varpula. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Jaakko Varpula · Not applicable, Interventional, and Health services research
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.
249 studies on the registry are indexed under Self-Injurious Behavior; 92 are open to participants now.
This study's planned enrollment of 300 is above the median of 66 across 212 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →This is the only study on the registry with Jaakko Varpula as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: Leadership and organizational change for implementation
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.
Acceptability
Acceptability of Intervention Measure (AIM), 4-item, 5-point Likert Scale (1-5), Min score 5, Max score 20. Higher scores indicate greater acceptability.
Time frame: 3months after start of intervention, 9 months (end of intervention)
Appropriateness
Intervention Appropriateness Measure (IAM), 4-item, 5-point Likert scale (1-5), Min score 5, Max score 20. Higher scores indicate greater appropriateness.
Time frame: 3months after start of intervention, 9 months (end of intervention)
Feasibility 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.
Time frame: 3months after start of intervention, 9 months (end of intervention)
Effectiveness to implementation leadership
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.
Time frame: Baseline, 3month, 8months, 3 month follow-up
Effectiveness to transformational leadership
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.
Time frame: Baseline, 3month, 8months, 3 month follow-up
Effectiveness to implementation climate
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.
Time frame: Baseline, 3month, 8months, 3 month follow-up
Effectiveness to evidence-based practice attitudes
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.
Time frame: Baseline, 3month, 8months, 3 month follow-up
Plan to share: Yes — De-identified instrument-level data derived from questionnaires (ILS, GTL, ICS, EBPAS, AIM, IAM, FIM) completed by staff participants will be shared. These datasets will include item-level responses but will exclude any direct identifiers or variables that could reasonably enable re-identification.
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