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

Primary Purpose

Mental Disorder, Stress

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Educational meeting
Implementation team
Workshops
Plan-Do-Study-Act improvement cycles
Internal facilitator
Sponsored by
Lydia Kwak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Disorder focused on measuring Guideline, Implementation, Implementation strategies, Mechanism of change, Workplaces, Organisational and social work environment, Schools

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All personnel employed by the school

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multifaceted implementation strategy

Single implementation strategy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Guideline adherence
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

Self-perceived health
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)
Self-reported stress
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).
Psychosocial safety climate
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)
Organisational readiness to implement
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
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.

Full Information

First Posted
August 9, 2021
Last Updated
October 19, 2023
Sponsor
Lydia Kwak
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT05019937
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lydia Kwak
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Stress
Keywords
Guideline, Implementation, Implementation strategies, Mechanism of change, Workplaces, Organisational and social work environment, Schools

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-armed cluster-randomized controlled trail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted implementation strategy
Arm Type
Experimental
Arm Description
Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
Arm Title
Single implementation strategy
Arm Type
Active Comparator
Arm Description
Schools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component
Intervention Type
Behavioral
Intervention Name(s)
Educational meeting
Other Intervention Name(s)
Conduct an educational meeting (15) - ERIC cluster Train and educate stakeholders
Intervention Description
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
Intervention Name(s)
Implementation team
Other Intervention Name(s)
Organize implementation teams (48) - ERIC cluster Develop stakeholder inter-relationships
Intervention Description
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
Intervention Name(s)
Workshops
Other Intervention Name(s)
Conduct ongoing training (19) - ERIC cluster Train and educate stakeholders
Intervention Description
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
Intervention Name(s)
Plan-Do-Study-Act improvement cycles
Other Intervention Name(s)
Conduct cyclical small tests of change (14) - ERIC cluster Use evaluative and iterative strategies
Intervention Description
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
Intervention Name(s)
Internal facilitator
Other Intervention Name(s)
Implementation facilitation (10) - ERIC cluster Provide interactive assistance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Guideline adherence
Description
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.
Time Frame
At baseline, 12- and 24 months follow-up
Secondary Outcome Measure Information:
Title
Self-perceived health
Description
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)
Time Frame
At baseline, 12- and 24-months follow-up
Title
Self-reported stress
Description
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).
Time Frame
At baseline, 12- and 24-months follow-up
Title
Psychosocial safety climate
Description
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)
Time Frame
At baseline, 12- and 24-months follow-up
Title
Organisational readiness to implement
Description
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).
Time Frame
At baseline, 12- and 24-months follow-up
Title
Implementation leadership
Description
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.
Time Frame
At baseline, 12- and 24-months follow-up
Other Pre-specified Outcome Measures:
Title
Knowledge
Description
Change in knowledge during 12-months. Knowledge is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for knowledge.
Time Frame
12-months
Title
Skills
Description
Change in skills during 12-months. Skills is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for skills.
Time Frame
12-months
Title
Social/professional role and identity
Description
Change in social/professional role and identity during 12-months. Social/professional role and identity is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for social/professional role and identity.
Time Frame
12-months
Title
Beliefs about capabilities
Description
Change in beliefs about capabilities during 12-months. Beliefs about capabilities is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for beliefs about capabilities.
Time Frame
12-months
Title
Beliefs about consequences
Description
Change in beliefs about consequences during 12-months. Beliefs about consequences is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for beliefs about consequences.
Time Frame
12-months
Title
Reinforcement
Description
Change in reinforcement during 12-months. Reinforcement is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for reinforcement.
Time Frame
12-months
Title
Intentions
Description
Change in intention during 12-months. Intention is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for intention.
Time Frame
12-months
Title
Goals
Description
Change in goals during 12-months. Goals is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for goals.
Time Frame
12-months
Title
Environmental context and resources
Description
Change in environmental context and resources during 12-months. Environmental context and resources is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for environmental context and resources.
Time Frame
12-months
Title
Social influences
Description
Change in social influences during 12-months. Social influences is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for social influences.
Time Frame
12-months
Title
Behavioral regulation
Description
Change in behavioral regulation during 12-months. Behavioural regulation is assessed with items from the Theoretical Domains Framework (TDF)-questionnaire (Huijg et al., 2014). The TDF-questionnaire assesses factors influencing the implementation of the guideline. In the project the questionnaire will be used to asses potential mediators that influence guideline implementation. A sum-score will be calculated for behavioural regulation.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All personnel employed by the school Exclusion Criteria: Personnel not employed by the school (e.g. cleaning- and canteen-personnel)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydia Kwak, PhD
Phone
0046702867985
Email
lydia.kwak@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Björklund, PhD
Email
christina.bjorklund@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Kwak, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydia Kwak, PhD
Phone
0046707482414
Email
lydia.kwak@ki.se

12. IPD Sharing Statement

Learn more about this trial

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

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