Clinical trial NCT05019937: Exploring Effectiveness and Mechanism of Change of an Implementation Strategy on Guideline Implementation in Schools
Official title: A Randomized Controlled Trial in Schools Aimed at Testing the Effectiveness of Implementation Strategies, Including Mechanism of Change, on Adherence to the Guideline for the Prevention of Common Mental Disorders at the Workplace.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Stress
Keywords: Guideline
Implementation
Implementation strategies
Mechanism of change
Workplaces
Organisational and social work environment
Schools
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2021-08-25
Enrollment: 2276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed cluster-randomized controlled trail
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* All personnel employed by the school

Exclusion Criteria:

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

Primary outcomes:
measure: Guideline adherence
timeFrame: At baseline, 12- and 24 months follow-up
Secondary outcomes:
measure: Self-perceived health
timeFrame: At baseline, 12- and 24-months follow-up
measure: Self-reported stress
timeFrame: At baseline, 12- and 24-months follow-up
measure: Psychosocial safety climate
timeFrame: At baseline, 12- and 24-months follow-up
measure: Organisational readiness to implement
timeFrame: At baseline, 12- and 24-months follow-up
measure: Implementation leadership
timeFrame: At baseline, 12- and 24-months follow-up
Other outcomes:
measure: Knowledge
timeFrame: 12-months
measure: Skills
timeFrame: 12-months
measure: Social/professional role and identity
timeFrame: 12-months
measure: Beliefs about capabilities
timeFrame: 12-months
measure: Beliefs about consequences
timeFrame: 12-months
measure: Reinforcement
timeFrame: 12-months
measure: Intentions
timeFrame: 12-months
measure: Goals
timeFrame: 12-months
measure: Environmental context and resources
timeFrame: 12-months
measure: Social influences
timeFrame: 12-months
measure: Behavioral regulation
timeFrame: 12-months
Locations:
city: Stockholm
country: Sweden
facility: Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Lydia Kwak, PhD
role: PRINCIPAL_INVESTIGATOR
References: