LeadershipLOCI-FIN-PNCT07378696
Implementing Evidence-Based Nursing: Leadership and Organizational Change for Implementation
A study testing Leadership and organizational change for implementation in people with Leadership and Self-Harm, run by Jaakko Varpula at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leadership, Self-Harm, Malnutrition Elderly
- What is being tested?
- Leadership and organizational change for implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurse manager
- Registered nurse
- Practical nurse
- Nurse director
Who cannot join
- Other healtcare professionals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
The Wellbeing Services Country of Southwest Finland
Turku
Tarja Heino-Tolonen, PhD, +358505725257, tarja.heino-tolonen@varha.fi
About this study
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.
Read more
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.
- Conditions
- Leadership, Self-Harm, Malnutrition Elderly
- Being tested
- Leadership and organizational change for implementation
- Keywords
- Implementation, Evidence-based practice, Nursing, Leadership
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadership and organizational change for implementationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Leadership and Organizational Change for Implementation (LOCI) | Experimental | 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. Receives: Behavioral: Leadership and organizational change for implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3months after start of intervention, 9 months (end of intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3month, 8months, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeadershipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaakko Varpula
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaakko Varpula, University of Turku
- Investigators
- Anna Axelin, Professor, Study director, University of Turku, Department of Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378696
- Sponsor's protocol ID
- TY/1603/2025
- Acronym
- LOCI-FIN-P
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Evidence-Based Nursing: Leadership and Organizational Change for Implementation
- ClinicalTrials.gov ID
- NCT07378696
- Acronym / sponsor ID
- LOCI-FIN-P / TY/1603/2025
- Conditions
- Leadership, Self-Harm, Malnutrition Elderly
- Keywords
- Implementation, Evidence-based practice, Nursing, Leadership
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jaakko VarpulaUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leadership and Organizational Change for Implementation (LOCI) | Experimental | Behavioral: Leadership and organizational change for implementationLOCI (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nurse manager
- Registered nurse
- Practical nurse
- Nurse director
Key exclusion criteria (1 listed)
- Other healtcare professionals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadership and organizational change for implementationLOCI (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. | Behavioural | Leadership and Organizational Change for Implementation (LOCI) |
Primary outcome
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.
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.
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.
4 secondary outcomes
Effectiveness to implementation leadership
Time frame: Baseline, 3month, 8months, 3 month follow-up
Effectiveness to transformational leadership
Time frame: Baseline, 3month, 8months, 3 month follow-up
Effectiveness to implementation climate
Time frame: Baseline, 3month, 8months, 3 month follow-up
Effectiveness to evidence-based practice attitudes
Time frame: Baseline, 3month, 8months, 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Axelin, Professor study director
University of Turku, Department of Nursing Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leadership and organizational change for implementation in people with Leadership and Self-Harm, run by Jaakko Varpula at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaakko Varpula, PhD (+358442784794, jaheva@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 3months after start of intervention, 9 months (end of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.