Evaluating the Effectiveness of Multifaceted Implementation Strategies for Implementing a Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools
Implementing the Swedish Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools: Study Protocol of a Cluster Randomized Controlled Trial Using Multifaceted Implementation Strategies
1 other identifier
interventional
732
1 country
1
Brief Summary
Given today's high prevalence of common mental disorders and related sick leave among teachers an urgent need exists for a more sustainable working life for this professional group. One way of doing this is by improving schools' social and organizational risk management. Recent reports have shown that many schools in Sweden however lack a structured approach to the management of social and organizational risks. In 2015, we launched the first Swedish occupational health guideline to support a structured prevention of social and organizational risks at the workplace with the aim of preventing common mental disorders. The long-term goal of this study is to support the implementation of this guideline within schools in order to improve social and organizational risk management and in doing so reduce risk factors for mental ill-health and related sick days. The objective of the study is to fill the current research-to-practice gap by conducting a cluster-randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the guideline in schools. The strategies that will be compared are training (ARM 1) versus training in combination with implementation teams and workshops (ARM 2). Our hypothesis for the study is that schools that receive support in implementing the guideline through combined strategies are more responsive to working in a structured and systematic manner with the management of social and organizational risks than schools that only receive training. The trial will be conducted in 20 primary schools in two municipalities in Sweden. All schools have agreed to participate. The primary outcomes are adherence to the guideline (implementation effectiveness) and self-reported exhaustion among schools personnel (intervention effectiveness); the secondary outcomes are risk factors for mental ill-health and absenteeism. Data will be collected at baseline, 6, 12 and 24 months by mixed methods (i.e. survey, focus-group interviews, observation, and register-data).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
September 12, 2017
CompletedFirst Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 14, 2020
September 1, 2020
2.1 years
September 19, 2017
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Guideline adherence (implementation effectiveness)
Change from baseline in adherence to the recommendations of the guideline during 6, 12 and 24 months follow-up period. We will use a questionnaire directed at the school management and a questionnaire directed at the school personnel. The questionnaires contain statements related to the recommendations in the guideline, such as "at our school we have clear and practical policies for preventing mental ill-health among our employees".
At baseline and 6, 12 and 24 months after baseline
Exhaustion (intervention effectiveness)
Change from baseline in personnel's self-reported exhaustion during 6, 12 and 24 months follow. We hypothesize that adherence to the recommendations of the guideline will affect school personnel's self-reported exhaustion assessed with the Oldenburg Burnout Inventory (response format 1-4).
At baseline and 6, 12 and 24 months after baseline
Secondary Outcomes (30)
Psychosocial safety climate
At baseline and 6, 12 and 24 months after baseline
Job demands
At baseline and 6, 12 and 24 months after baseline
Influence at work
At baseline and 6, 12 and 24 months after baseline
Social support colleagues
At baseline and 6, 12 and 24 months after baseline
Possibilities for development
At baseline and 6, 12 and 24 months after baseline
- +25 more secondary outcomes
Study Arms (2)
Multifaceted implementation strategies
EXPERIMENTALThe school-management will participate in a one-day training. In addition each intervention school will form an implementation team that is responsible for the implementation of the guideline within their school. The implementation teams will participate in 4-5 workshops in order to support the implementation process.
Single implementation strategy
ACTIVE COMPARATORThe control-schools will only receive training to the school-management.
Interventions
The school-management will participate in a one-day training aimed at providing knowledge and skills related the recommendations of the guideline for the prevention of common mental disorders at the workplace.In addition every intervention school will form an implementation team that is responsible for the implementation of the guideline. The implementation team will comprise of approximately 3-5 individuals with experience in the field of social and organizational work environment, for example school-management and occupational health and safety representative. The implementation teams will participate in 4-5 workshops aimed at supporting the implementation process. Intervention schools within the same municipality will participate in the same workshop in order to promote peer-support.
The school-management will participate in a one-day training aimed at providing knowledge and skills related to the recommendations of the guideline for the prevention of common mental disorders at the workplace
Eligibility Criteria
You may qualify if:
- all individuals who are employed by the participating schools
You may not qualify if:
- individuals employed by the participating municipalities and not by the participating schools, for example cleaning personal. Individuals on sick-leave
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
Stockholm, 171 77, Sweden
Related Publications (1)
Kwak L, Lornudd C, Bjorklund C, Bergstrom G, Nybergh L, Elinder LS, Stigmar K, Wahlin C, Jensen I. Implementation of the Swedish Guideline for Prevention of Mental ill-health at the Workplace: study protocol of a cluster randomized controlled trial, using multifaceted implementation strategies in schools. BMC Public Health. 2019 Dec 11;19(1):1668. doi: 10.1186/s12889-019-7976-6.
PMID: 31829186DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Lydia Kwak, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 19, 2017
First Posted
October 26, 2017
Study Start
September 12, 2017
Primary Completion
October 30, 2019
Study Completion
December 31, 2019
Last Updated
September 14, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
The ethical approval does not allow data-sharing of individual participation data.