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

NCT ID: NCT05019937

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-12-31

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.

Detailed Description

There is an urgent need for more knowledge on effective implementation strategies, as two-thirds of implementation efforts fail to achieve the intended change, and half have no effect on outcomes of interest. These implementation failures are partly due to the limited understanding of how implementation strategies work-the mechanisms of change through which implementation strategies affect implementation. This project will fill this research-gap by exploring mechanism of change during a cluster randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace in schools. Schools are chosen as the setting for implementation given the high prevalence of mental ill-health among teachers. Moreover, schools lack a structured approach to the prevention of mental ill-health. The aim of the project is to investigate how implementation strategies affect the defined mechanisms and guideline implementation. Mechanisms that will be tested include hypothesized mediators originating from the individual behavior change theory COM-B. The project will be conducted in public primary and secondary schools in four municipalities in Sweden. Data will be collected with mixed-methods from school-management and personnel at baseline, and different time-points during follow-up.

Conditions

Mental Disorder; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Multifaceted implementation strategy

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

Group Type: EXPERIMENTAL

Educational meeting

Intervention Type: 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.

Implementation team

Intervention Type: 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.

Workshops

Intervention Type: 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.

Plan-Do-Study-Act improvement cycles

Intervention Type: 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.

Internal facilitator

Intervention Type: 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.

Single implementation strategy

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

Group Type: ACTIVE_COMPARATOR

Educational meeting

Intervention Type: 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.

Interventions

Educational meeting

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.

Intervention Type: BEHAVIORAL

Implementation team

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.

Intervention Type: BEHAVIORAL

Workshops

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.

Intervention Type: BEHAVIORAL

Plan-Do-Study-Act improvement cycles

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.

Intervention Type: BEHAVIORAL

Internal facilitator

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Conduct an educational meeting (15) - ERIC cluster Train and educate stakeholders; Organize implementation teams (48) - ERIC cluster Develop stakeholder inter-relationships; Conduct ongoing training (19) - ERIC cluster Train and educate stakeholders; Conduct cyclical small tests of change (14) - ERIC cluster Use evaluative and iterative strategies; Implementation facilitation (10) - ERIC cluster Provide interactive assistance

Eligibility Criteria

Inclusion Criteria

• All personnel employed by the school

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role: collaborator

Lydia Kwak

OTHER

Sponsor Role: lead

Responsible Party

Lydia Kwak

Associate professor, lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lydia Kwak, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2020-01214

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2020-01214

Identifier Type: -

Identifier Source: org_study_id