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

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

Tracking Information

• First Submitted Date: August 9, 2021
• First Posted Date: August 25, 2021
• Last Update Posted Date: August 3, 2022
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: 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.
• 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two-armed cluster-randomized controlled trail

Masking: None (Open Label)
Primary Purpose: Other

Condition

• Mental Disorder
• Stress

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 19, 2021): 1500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All personnel employed by the school

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Lydia Kwak, PhD; 0046702867985; lydia.kwak@ki.se

Contact: Christina Björklund, PhD; christina.bjorklund@ki.se

• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT05019937
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Lydia Kwak, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Lydia Kwak
• Original Study Sponsor: Same as current
• Collaborators: Swedish Council for Working Life and Social Research

Investigators

• Principal Investigator: Lydia Kwak, PhD; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: August 2022