Exploring Effectiveness and Mechanism of Change of an Implementation Strategy on Guideline Implementation in Schools

NCT05019937 | Completed

• 1 other identifier: 2020-01214
• Study Type: interventional
• Target: 2,276
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a two-armed randomized-controlled trial exploring the effectiveness and mechanisms of change of two different implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace. The project will be conducted among public primary and secondary schools belonging to four municipalities in Sweden. Data will be collected with mixed-methods at baseline and different time-points of follow-up.

Conditions

Mental Disorder; Stress

Keywords

Guideline; Implementation; Implementation strategies; Mechanism of change; Workplaces; Organisational and social work environment; Schools

Outcome Measures

Primary Outcomes (1)

• Guideline adherence

  Change from baseline in adherence to the recommendations of the guideline during 12-, and 24-months follow-up. Guideline adherence will be assessed with a checklist and questionnaire developed for the purpose of the project.

  At baseline, 12- and 24 months follow-up

Secondary Outcomes (5)

• Self-perceived health

  At baseline, 12- and 24-months follow-up

• Self-reported stress

  At baseline, 12- and 24-months follow-up

• Psychosocial safety climate

  At baseline, 12- and 24-months follow-up

• Organisational readiness to implement

  At baseline, 12- and 24-months follow-up

• Implementation leadership

  At baseline, 12- and 24-months follow-up

Other Outcomes (11)

• Knowledge

  12-months

• Skills

  12-months

• Social/professional role and identity

  12-months

Study Arms (2)

Multifaceted implementation strategy

EXPERIMENTAL

Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components

Behavioral: Educational meeting; Behavioral: Implementation team; Behavioral: Workshops; Behavioral: Plan-Do-Study-Act improvement cycles; Behavioral: Internal facilitator

Single implementation strategy

ACTIVE COMPARATOR

Schools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component

Behavioral: Educational meeting

Interventions

Educational meeting BEHAVIORAL

The investigators will hold a full-day educational meeting. The meeting will include educating 4-5 representatives of each school, and school-district representatives about the guideline and the advantages of adhering to the guideline.

Also known as: Conduct an educational meeting (15) - ERIC cluster Train and educate stakeholders

Multifaceted implementation strategy; Single implementation strategy

Implementation team BEHAVIORAL

The school-principal forms an implementation team that is responsible for implementing the guideline within their school. The team members (n=4-5) reflect on the implementation progress, make, and refine plans according to Plan-Do-Study-Act, share lessons learned and support each other.

Also known as: Organize implementation teams (48) - ERIC cluster Develop stakeholder inter-relationships

Multifaceted implementation strategy

Workshops BEHAVIORAL

The investigators will hold 5 workshops. Workshops will include providing in-depth knowledge and skills on the guideline recommendations. During each workshop one of the guideline recommendations will be presented and discussed. Moreover, the concept of Plan-Do-Study-Act will be introduced and how it can be used to implement the guideline recommendation(s). During each workshop, the implementation team will share with the group their developed PLAN and barriers and facilitators that have influenced the execution of the PLAN.

Also known as: Conduct ongoing training (19) - ERIC cluster Train and educate stakeholders

Multifaceted implementation strategy

Plan-Do-Study-Act improvement cycles BEHAVIORAL

The implementation team will implement the guideline in a cyclical manner by using Plan-Do-Study-Act. First a Plan is specified during the workshop by using SMART-goals, next the change is carried out between workshops (Do), the implementation team analyses whether it went well and what needs to be improved (Study), changes are made (Act) and finally the next cycle is planned.

Also known as: Conduct cyclical small tests of change (14) - ERIC cluster Use evaluative and iterative strategies

Multifaceted implementation strategy

Internal facilitator BEHAVIORAL

Each municipality assigns one or more internal facilitators, for example HR-strategist. The internal facilitator will meet their local implementation teams during the educational meeting and workshops. Further meeting can be scheduled based on the needs of each implementation team. The internal facilitator will create a supportive environment within which knowledge is exchanged, barriers to implementation identified, and processes or solutions to overcome those barriers developed, applied, and refined. Moreover, the internal facilitator will establish ongoing audit and feedback processes.

Also known as: Implementation facilitation (10) - ERIC cluster Provide interactive assistance

Multifaceted implementation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All personnel employed by the school

You may not qualify if:

• Personnel not employed by the school (e.g. cleaning- and canteen-personnel)

Sponsors & Collaborators

• Lydia Kwak: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute

Stockholm, 171 77, Sweden

Location

Related Publications (1)

• Rodlund A, Toropova A, Lengnick-Hall R, Powell BJ, Schafer Elinder L, Bjorklund C, Kwak L. A cluster-randomized controlled trial assessing the effectiveness of a multifaceted versus a discrete implementation strategy on fidelity to an occupational guideline for the prevention of mental health problems at the workplace: a dual perspective from Swedish schools. Implement Sci Commun. 2025 Nov 21;6(1):127. doi: 10.1186/s43058-025-00821-x.

  PMID: 41272910 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Lydia Kwak, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor, lecturer

Model Details: Two-armed cluster-randomized controlled trail

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 25, 2021
• Study Start: September 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

SE (1)