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

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ClinicalTrials.gov Identifier: NCT05019937
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Lydia Kwak, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE August 9, 2021
First Posted Date  ICMJE August 25, 2021
Last Update Posted Date August 3, 2022
Actual Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
Guideline adherence [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
  • Self-perceived health [ Time Frame: 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)
  • Self-reported stress [ Time Frame: 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).
  • Psychosocial safety climate [ Time Frame: 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)
  • Organisational readiness to implement [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 19, 2021)
  • Knowledge [ Time Frame: 12-months ]
    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.
  • Skills [ Time Frame: 12-months ]
    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.
  • Social/professional role and identity [ Time Frame: 12-months ]
    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.
  • Beliefs about capabilities [ Time Frame: 12-months ]
    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.
  • Beliefs about consequences [ Time Frame: 12-months ]
    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.
  • Reinforcement [ Time Frame: 12-months ]
    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.
  • Intentions [ Time Frame: 12-months ]
    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.
  • Goals [ Time Frame: 12-months ]
    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.
  • Environmental context and resources [ Time Frame: 12-months ]
    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.
  • Social influences [ Time Frame: 12-months ]
    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.
  • Behavioral regulation [ Time Frame: 12-months ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exploring Effectiveness and Mechanism of Change of an Implementation Strategy on Guideline Implementation in Schools
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two-armed cluster-randomized controlled trail
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Mental Disorder
  • Stress
Intervention  ICMJE
  • Behavioral: Educational meeting
    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.
    Other Name: Conduct an educational meeting (15) - ERIC cluster Train and educate stakeholders
  • Behavioral: Implementation team
    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.
    Other Name: Organize implementation teams (48) - ERIC cluster Develop stakeholder inter-relationships
  • Behavioral: Workshops

    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.

    Other Name: Conduct ongoing training (19) - ERIC cluster Train and educate stakeholders
  • Behavioral: Plan-Do-Study-Act improvement cycles
    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.
    Other Name: Conduct cyclical small tests of change (14) - ERIC cluster Use evaluative and iterative strategies
  • Behavioral: Internal facilitator
    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.
    Other Name: Implementation facilitation (10) - ERIC cluster Provide interactive assistance
Study Arms  ICMJE
  • Experimental: Multifaceted implementation strategy
    Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components
    Interventions:
    • Behavioral: Educational meeting
    • Behavioral: Implementation team
    • Behavioral: Workshops
    • Behavioral: Plan-Do-Study-Act improvement cycles
    • Behavioral: Internal facilitator
  • Active Comparator: Single implementation strategy
    Schools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component
    Intervention: Behavioral: Educational meeting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2021)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All personnel employed by the school

Exclusion Criteria:

  • Personnel not employed by the school (e.g. cleaning- and canteen-personnel)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lydia Kwak, PhD 0046702867985 lydia.kwak@ki.se
Contact: Christina Björklund, PhD christina.bjorklund@ki.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05019937
Other Study ID Numbers  ICMJE 2020-01214
2020-01214 ( Other Grant/Funding Number: FORTE )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lydia Kwak, Karolinska Institutet
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lydia Kwak
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Swedish Council for Working Life and Social Research
Investigators  ICMJE
Principal Investigator: Lydia Kwak, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP