Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ImpleMentAll (Towards evidence-based tailored implementation strategies for eHealth)

Teaser

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...

Summary

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 Internet-based Cognitive Behavioural Therapy (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 data-driven tailored implementation and normalisation of innovative evidence-based clinical services.
2) To demonstrate the impact of the ItFits-toolkit on the implementation of eHealth interventions for common mental disorders in 9 European countries, incl. 2 Low-and-Middle-Income Countries, and Australia. This validation study will address the following research question: does tailoring implementation strategies lead to more effective and efficient implementation outcomes?
3) To disseminate the validated ItFits-toolkit for tailored implementation strategies to various healthcare contexts and interventions across Europe.

ImpleMentAll is a true 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 innovation, clinical research, patients’ interests, and implementation science.

Work performed

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) validate the toolkit in a large-scale multisite implementation trial
3) analyse, improve and deliver the ItFits-toolkit

During the first 18 months of the project effort and resources were dedicated to phase 1 and preparing for phase 2.

In phase 1 the required information, tools, and methods were developed to guide implementation sites in the process of tailoring and developing tailored implementation strategies. In addition, a comprehensive evaluation protocol was developed and the infrastructure required for conducting the trial in phase 2 was prepared. Work conducted in phase one resulted in five main achievements:

• A detailed understanding of the settings and context in which the implementation takes place including the clinical service, its provision modalities, and usual implementation activities in the participating sites.
• A first and trialable version of the ItFits-toolkit.
• A comprehensive evaluation framework (study protocols) designed to test the effectiveness and perform a process evaluation of the toolkit.
• Preparation of the trial sites
• Establishment of the project’s measures to maximise impact: External Advisory Board and dissemination and communication activities

The ItFits-toolkit functions as an online self-help toolkit with evidence-informed materials offering implementers a step-by-step process of tailoring site-specific implementation strategies. The ItFits-toolkit includes four modules that implementers need to work through: 1) identifying and prioritising implementation goals and determinants of practices, 2) matching up implementation determinants to strategies, 3) designing a plan for carrying out strategies in a local context, and 4) applying strategies, and reviewing progress. In each of these four modules, evidence-informed materials such as iCBT-relevant determinants of practices and implementation strategies, are included as well as methods for engaging with stakeholders to jointly create and apply tailored implementation strategies.

The effectiveness of the toolkit in achieving favourable implementation outcomes compared to usual implementation activities (IAU) will be tested in a multicentre stepped-wedge implementation trial. The primary outcomes are: uptake on organisational level, degree of normalisation in service deliverers, and implementation costs. The main research hypothesis is that the ItFits-toolkit will lead to higher service uptake and normalisation than IAU does. An in-depth process evaluation employing a Realist Evaluation approach will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work.

Phase 2 is focused on conducting the trial in twelve different organisations in nine countries. The trial started in June 2018. All implementation sites localised the study protocol, translated the measurement instruments, prepared the data collection infrastructure and filed for ethical approval.

In phase 3, the data collected will be analysed and the ItFits-toolkit will be enhanced and disseminated.

Final results

The expected main impacts of ImpleMentAll are:
• Reach underserved population by implementing and upscaling iCBT interventions in 9 European countries, incl. 2 Low-and-Middle-Income Countries, and Australia.
• Enable for more efficient and rapid normalisation of innovations in routine care as a result of applying tailored implementation strategies that are evidence and data driven and seamlessly fit with the needs and determinants of local practices.
• Deliver a comprehensive and validated toolkit that will guide end users (e.g. decision and policy makers, innovation managers) in developing a tailored strategy for implementing eHealth solutions in routine care practice.
• Contribute to Implementation Science by in-depth analysis of actual implementation processes and intervening in those processes in a controlled manner. This includes the development and psychometric validation of implementation measurement instruments.

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 to 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.

Please visit www.implementall.eu for more information and follow us under the handle @EU_ImpleMentAll on Twitter.

Website & more info

More info: http://www.implementall.eu.