ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth (ImpleMentAll)
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|ClinicalTrials.gov Identifier: NCT03652883|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
The ImpleMentAll (IMA) project aims to examine the effectiveness of tailored implementation compared to usual implementation of Internet-based Cognitive Behavioural Therapy (iCBT) for patients suffering from common mental disorders in routine practice. 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. ImpleMentAll will develop, apply, and evaluate tailored implementation strategies in the context of on-going eHealth implementation initiatives in the EU and beyond. The objectives are:
- To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for data-driven tailored implementation of evidence-based eHealth services.
- To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders.
- To disseminate the validated toolkit in various healthcare contexts across Europe.
Following a stepped-wedge trial design, the ItFits-toolkit will be introduced in twelve implementation sites in nine countries, and evaluated for its effectiveness in obtaining implementation success. An in-depth process evaluation using a realist evaluation methodology will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work. The resulting ItFits-toolkit will enable data driven evaluation of eHealth implementation projects and its methods, materials, and strategies will provide concrete guidance on tuning implementation interventions to local determinant of practice across a variety of health care systems.
|Condition or disease||Intervention/treatment||Phase|
|Tailored Implementation: Online ItFits-toolkit Implementation as Usual||Other: ItFits-toolkit Other: Implementation as Usual||Not Applicable|
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|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Stepped wedge trial design by which the time points at which implementation sites receive the ItFits-toolkit is randomised. By the end of the trial, all implementation sites have received the ItFits-toolkit sequentially acting as control and intervention condition. There are 6 groups and 2 implementation sites per group. Sites will be informed about the group they are allocated to three months before cross-over. Every three months, a new group crosses over from IAU to using the ItFits-toolkit.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||September 28, 2020|
|Estimated Study Completion Date :||March 31, 2021|
A generic 'Integrated Theory-based Framework for Implementation Tailoring Strategies' toolkit (the ItFits-toolkit) functions as an online self-help toolkit by which users are guided through the 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.
The ItFits-toolkit provides evidence-informed methods, materials, knowledge on determinants and implementation strategies, and concrete guidance on tailoring implementation strategies to local determinants of practices, apply them and evaluate their impact. It applies a standardised four-step approach to iteratively develop evidence-informed implementation strategies. The ItFits-toolkit is based on the Normalisation Process Theory (NPT), which suggests that lasting changes in practice only happen through people working together. The ItFits toolkit functions as an online self-help toolkit with minimal support. The toolkit will provide instructions for the IL to establish a core team and to create a sounding board consisting to enable co-creation.
Other Name: ItFits
Active Comparator: Implementation as Usual
Implementation-as-Usual (IAU) refers to any existing approaches and efforts to embed and integrate iCBT within an organisation. All implementation sites included in IMA are engaged in and conducting IAU. IAU activities can be, but are not necessarily planned or guided by scientific evidence and often emerge from practice experiences and other sources of information. No standardisation in IAU across the sites is applied except for the implementation objective. That is, all implementation sites pursue the goal of increasing the number of patients treated by the iCBT service.
Other: Implementation as Usual
IAU refers to any existing efforts to embed and integrate iCBT within an organisation.
Other Name: IAU
- Change in Uptake - referral rate (organisation level) [ Time Frame: Month 0, repeated every three months until month 27. ]Referral rate: Patients can be referred to the iCBT service in two ways: 1) self-referral or 2) referral by health care professionals. Only eligible patients are referred to the services and eligibility criteria follow routine practice guidelines and procedures for the specific iCBT service.
- Change in Uptake - completion rate (organisation level) [ Time Frame: Month 0, repeated every three months until month 27. ]
Completion rate refers to the extent to which the treatment was actually consumed by patients after receiving access to the iCBT service on the platform. Four categories of completion will be assessed: 1. Not started, 2. In treatment, 3. Drop-out, 4. Completed
All iCBT services that are implemented include the four generic therapeutic CBT. As the length and format of the specific iCBT service varies greatly between the sites, categories 3 and 4 will be measured in accordance with a service and site-specific definition of treatment completion.
- Change in Normalisation (staff level) [ Time Frame: Month 0, repeated every three months until month 27. ]Normalisation refers to the actions people do to embed and integrate an innovation in routine practice. The Normalisation Assessment Development (NoMAD) is a 23-item self-report questionnaire that taps the four core concepts (Coherence, Cognitive Participation, Collective Action, Reflexive Monitoring) of the NPT. NoMAD was validated in UK, Australian, and Dutch samples of healthcare staff involved in various implementation projects.
- Change in Efficiency (organisation level) [ Time Frame: Month 0, repeated every three months until month 27. ]Efficiency refers to implementation costs divided by outcomes (uptake and normalisation). Implementation costs are defined as the cost impact of an implementation effort. Measures of the cost of implementation effort allows for estimating the monetary efficiency of the ItFits-toolkit in relation to uptake and normalisation as compared to IAU. The following cost-indicators will be collected during the study: 1) Effort, 2) Consumables, equipment, and services, and 3) Overheads. Effort is a function of hours times hourly staff rates (wages). All costs will be collected in Euros.
- Exposure to the ItFits-toolkit (organisation level) [ Time Frame: Month 0, continuous log until month 27. ]Exposure to the ItFits-toolkit will be measured by logging use of individual ItFits-modules (use) and a binary confirmation of the existence of output of the module (result). Measurements are automated and follow platform use.
- Satisfaction with the ItFits-toolkit (organisation level) [ Time Frame: Month 27 ]Satisfaction will be assessed with the eight item Client Satisfaction Questionnaire (CSQ-3) (Larsen, Attkisson, Hargreaves, & Nguyen, 1979). CSQ-3 is a Likert scale with three items (short version of the CSQ-8) and a very brief instrument to investigate client satisfaction with the delivered services.
- Usability of the ItFits-toolkit (organisation level) [ Time Frame: Month 27 ]Usability will be measured with the System Usability Scale (SUS) (Brooke, 1996). SUS is a 10-item Likert scale and a brief instrument to measure perceived system usability.
- Organisational Readiness for Implementing Change (Staff level) [ Time Frame: Month 0, repeated every three months until month 27. ]To assess organizational readiness for change we will use the 'Organizational Readiness for Implementing Change' questionnaire (ORIC, Shea et al., 2014). Organizational readiness for change is measured using 12 items. Ratings of the items are done by a 5-Point-Likert scale. Shea et al. (2014) investigated the ORIC for different psychometric properties.
- Perceived impact on site specific implementation goals and determinants (organisational level) [ Time Frame: End of exposure period to the ItFits-toolkit (i.e. 6 months after crossing over from IAU to using the ItFits-toolkit). ]The impact of the ItFits-toolkit on site specific implementation goals will be explored. The overarching goal in all implementation sites is to increase the uptake of iCBT in routine practice. As part of module 1 of the ItFits-toolkit, implementation sites will tailor this goal towards objectives that are specific to the local circumstances and context. The perceived impact of the ItFits-toolkit in addressing these implementation objectives will be assessed by means of a Visual Analogue Scale (VAS; range 0-10).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652883
|Contact: Christiaan Vis, MAfirstname.lastname@example.org|
|Contact: Gentiana Qirjako, PhD email@example.com|
|Contact: Philip Batterham, PhD Philip.Batterham@anu.edu.au|
|Contact: Helen Christensen, PhD firstname.lastname@example.org|
|Contact: Kristine Tarp email@example.com|
|FDM||Active, not recruiting|
|Contact: Ingrid Titzler, Msc firstname.lastname@example.org|
|DF||Not yet recruiting|
|Contact: Caroline Oehler|
|Contact: Enrico Zanalda, PhD email@example.com|
|Contact: Naim Fanaj, PhD firstname.lastname@example.org|
|Contact: Josien Schuurmans, PhD J.Schuurmans@ggzingeest.nl|
|Contact: Judith Rosmalen, PhD email@example.com|
|Contact: Jordi Piera firstname.lastname@example.org|
|Study Director:||Christiaan Vis, MA||VU Amsterdam|
|Study Chair:||Heleen Riper, PhD||VU Amsterdam|