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Towards evidence-based tailored implementation strategies for eHealth

Periodic Reporting for period 2 - ImpleMentAll (Towards evidence-based tailored implementation strategies for eHealth)

Reporting period: 2018-07-01 to 2019-12-31

Effective clinical innovations are currently developed at unprecedented rates. However, only 14% of new evidence-based interventions enter routine practice and those who make it, do so only 17 years after establishing their clinical efficacy. There is a need for effective strategies to promote their use in routine practice. Implementation, seen as a process in which people intend to bring into operation new or modified practices, takes place in a context and faces barriers that vary considerably from setting to setting. ImpleMentAll aims to provide an evidence-based answer to this problem through the development, application, and evaluation of tailored implementation strategies in a natural laboratory of on-going eHealth implementation initiatives in the EU and beyond.

Common mental health disorders account for an alarming proportion of the global burden of disease. Being regarded as an evidence-based psychotherapeutic eHealth intervention, Internet- based Cognitive Behavioural Therapy (iCBT), has the potential to answer to this societal challenge by providing an efficacious and efficient treatment from which more people can benefit. As a result, various iCBT implementation projects are currently conducted across the world. ImpleMentAll uses this natural laboratory to examine the effectiveness of tailored implementation compared to usual implementation of iCBT for common mental health disorders in routine practice.

The project pursues the following three objectives:
1) To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for tailored implementation of evidence-based clinical eHealth services.
2) To demonstrate the impact of the ItFits-toolkit on implementing iCBT services for common mental disorders in 9 European countries, incl. 2 Low-and-Middle-Income Countries, and Australia. This implementation study will answer the following research question: does tailored implementation lead to more effective and efficient implementation outcomes compared to usual implementation activities?
3) To disseminate the validated ItFits-toolkit for tailored implementation across Europe.

ImpleMentAll is a multidisciplinary international collaboration of 16 partners from Denmark, the Netherlands, United Kingdom, Germany, Spain, France, Italy, Kosovo, Albania, Belgium and Australia. The consortium unites key experts in clinical practice, health service innovation, clinical research, patients’ interests, and implementation science.
The project has a total duration of 51 months and it is divided into three main phases: (1) develop the ItFits-toolkit and prepare for the trial, (2) test the toolkit in a large-scale multisite implementation trial, and (3) analyse, improve, and deliver the ItFits-toolkit to the community. During the first 18 months of the project, effort and resources were dedicated to phase 1 and preparing for phase 2. In the second project period, the main emphasis was placed on starting and running the trial, and for preparing the analysis in phase 3.

The following main achievements in the second project reporting period can be accounted for:
• The trial has started successfully. Protocols and field guides were localised, ethical approvals obtained, and trial participants recruited by the trial sites.
• The ItFits-toolkit was released successfully for the trial. The technical development of the toolkit was finalised and successfully underwent various tests.
• In December 2019, 10 of the 12 sites had been trained and started working with the ItFits-toolkit succesfully.
• Regular data monitoring (monthly) indicate good data quality: very high response rates and low missingness for both organisation level and staff level outcomes.
• Data analysis scripts for the effectiveness study are developed and tested using synthetic data so that the analysis can be done efficiently once the data collection is completed.
• Theoretical work commenced on highly relevant and innovative implementation science topics using the process evaluation including concepts of tailored implementation and health/eco system-level aspects of implementing evidence-based interventions in routine practice.
• Initial feedback from ItFits users indicate positive added value to their roles and responsibilities in implementing the iCBT services.
• Technically, the online ItFits-toolkit and data collection systems work as designed and expected; no technical issues have occurred.
• Despite various challenges faced by the trial sites in implementing the iCBT services, varying from staff turnover in practically all sites to earth quakes in Albania, major legislative changes in Germany, and bush fires in Australia, all sites continued implementing the services in routine practice and are committed in doing so towards the end of the ImpleMentAll study.

In addition, the consortium has prominently been involved in a number of dissemination events to promote the project, among the most important ones: ISRII2019, HIMMS-EU, the Global Implementation Conference (GIC) 2019, Dutch Implementation Symposium 2019, and GAMIAN-Europe’s Annual Convention. In addition, significant interest in the project has been raised by academic institutes, hospitals, and intermediary networking organisations outside of the project consortium likely leading to future collaborations.

After 2/3 into the trial period, we expect that targets as specified in the study protocols and Description of Action will be reached within set budgetary and time frames. In phase 3, the data collected will be analysed and the ItFits-toolkit will be enhanced and disseminated.
The expected main impacts include:
• Reaching underserved population by implementing iCBT interventions in 9 European countries, incl. 2 Low-and-Middle-Income Countries, and Australia.
• More efficient and rapid normalisation of iCBT services in routine care as a result of applying evidence-informed tailored implementation strategies.
• Delivering a comprehensive and validated toolkit that guides implementers in developing tailored strategies for implementing eHealth solutions in routine care practice.
• Advancing implementation science by in-depth analysis of actual implementation processes and intervening in those processes in a controlled manner.

By developing, testing, and delivering the ItFits-toolkit, effective interventions such as iCBT might be implemented more effectively and efficiently ultimately leading to better outcomes in patients that are currently receiving sub-optimal mental health care. In addition, significant impact can be expected on the field of implementation science from the study into the concept of tailoring, the effectiveness of the toolkit itself, as well as the contribution to the methods and instruments that can be applied in studying implementation processes.

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