NCT07378696

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

January 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

January 14, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

ImplementationEvidence-based practiceNursingLeadership

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3months after start of intervention, 9 months (end of intervention)

Secondary Outcomes (4)

  • Effectiveness to implementation leadership

    Baseline, 3month, 8months, 3 month follow-up

  • Effectiveness to transformational leadership

    Baseline, 3month, 8months, 3 month follow-up

  • Effectiveness to implementation climate

    Baseline, 3month, 8months, 3 month follow-up

  • Effectiveness to evidence-based practice attitudes

    Baseline, 3month, 8months, 3 month follow-up

Study Arms (1)

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.

Behavioral: Leadership and organizational change for implementation

Interventions

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.

Leadership and Organizational Change for Implementation (LOCI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurse manager
  • Registered nurse
  • Practical nurse
  • Nurse director

You may not qualify if:

  • Other healtcare professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Wellbeing Services Country of Southwest Finland

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

LeadershipOrganizational Innovation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Personnel ManagementOrganization and AdministrationHealth Services Administration

Study Officials

  • Anna Axelin, Professor

    University of Turku, Department of Nursing Science

    STUDY DIRECTOR

Central Study Contacts

Jaakko Varpula, PhD

CONTACT

Riitta Askola, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral researcher

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 30, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Instrument-level IPD will be made available upon publication of the main study findings.
Access Criteria
Researchers may request access by contacting the principal investigators. Data will be shared through a secure repository after approval of a brief data-use proposal and signing a data-use agreement.

Locations