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

Not Applicable

Completed

• Conditions: Mental Disorder; Stress
• Interventions: Behavioral: Educational meeting; Behavioral: Implementation team; Behavioral: Workshops; Behavioral: Plan-Do-Study-Act improvement cycles; Behavioral: Internal facilitator

• Registration Number: NCT05019937
• Lead Sponsor: Lydia Kwak

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.

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Study Start: 2021-09-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2276

Inclusion Criteria

• All personnel employed by the school

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifaceted implementation strategy	Educational meeting	Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
Multifaceted implementation strategy	Plan-Do-Study-Act improvement cycles	Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
Multifaceted implementation strategy	Workshops	Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
Multifaceted implementation strategy	Implementation team	Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
Multifaceted implementation strategy	Internal facilitator	Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
Single implementation strategy	Educational meeting	Schools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component

Primary Outcome Measures

Name	Time	Method
Guideline adherence	At baseline, 12- and 24 months follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Self-reported stress	At baseline, 12- and 24-months follow-up	Change from baseline in self-reported stress during 12-, and 24-months follow-up. Self-reported stress is assessed with a single item (Arapovic-Johansson, Wahlin, Kwak, Bjorklund, \& Jensen, 2017; Elo, Leppanen, \& Jahkola, 2003).
Organisational readiness to implement	At baseline, 12- and 24-months follow-up	Change from baseline in organisational readiness to implement the guideline during 12-, and 24-months follow-up. Organisational readiness to implement will be assessed with the Leader Readiness to Implement Tool (LRIT) developed and validated by Cook et al. manuscript submitted. With the tool a total readiness index will be calculated, but also a change efficacy score and a change commitment score indicating the confidence and commitment to implement the guideline within the organisation (school).
Implementation leadership	At baseline, 12- and 24-months follow-up	Change from baseline in implementation leadership during 12- and 24-months follow-up. Implementation leadership will be assessed with items from the S-ILS (Aarons, Ehrhart, \& Farahnak, 2014; Lyon et al., 2018). The S-ILS assesses the degree to which a leader is Proactive, Knowledgeable, Supportive, and Perseverant in implementing evidence-based practice (the guideline). Scores for the subscales will be calculated and a total score for the S-ILS is calculated by taking a mean of the scale scores.
Self-perceived health	At baseline, 12- and 24-months follow-up	Change from baseline in self-perceived health during 12-, and 24-months follow-up. Self-perceived health is assessed with a single question from the SF-12 Health Survey (Ware JE, Kosinski MA, \& DM, 2002)
Psychosocial safety climate	At baseline, 12- and 24-months follow-up	Change from baseline in psychosocial safety climate during 12-, and 24-months follow-up. Psychosocial safety climate is assessed with PSC-4, which is a short questionnaire with 4 items measuring the Psychosocial Safety Climate at work (Berthelsen \& Muhonen, 2017)

Trial Locations

Locations (1)

Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute; 🇸🇪 Stockholm, Sweden