NCT03322839

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
732

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

September 19, 2017

Last Update Submit

September 10, 2020

Conditions

Keywords

Guideline-adherenceImplementationImplementation-strategiesRandomized-controlled-trialOrganisational risk-factorsSchoolsSocial risk-factors

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

EXPERIMENTAL

The 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.

Behavioral: Multifaceted implementation strategies

Single implementation strategy

ACTIVE COMPARATOR

The control-schools will only receive training to the school-management.

Behavioral: Single implementation strategy

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.

Multifaceted implementation strategies

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

Single implementation strategy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • Lydia Kwak, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

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.

Locations