Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03652883 |
| Other study ID # |
1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
VU University of Amsterdam |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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:
1. 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.
2. To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for
common mental disorders.
3. 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.
Description:
ImpleMentAll aims to examine the effectiveness of tailored implementation (i.e. the
ItFits-toolkit) compared to usual implementation of Internet-based Cognitive Behavioural
Therapy (iCBT) in routine practice in twelve implementation sites in nine countries. The
project has a total duration of 51 months divided in three phases: 1) preparation (Jan 2017 -
May 2018), 2) trial period (June 2018 - September 2020), and 3) analysis and reporting
(October 2020 - March 2021). The preparation phase includes localising the generic study
protocol to local settings and for obtaining the required ethical clearances. In the trial
period, the ItFits-toolkit will be put into practice and data will be collected in each
implementation site. In the final phase, the data will be cleaned and analysed. Depending on
the results and conclusions of the study, the ItFits-toolkit will be further improved by
adapting it to the findings.
iCBT, an innovative psychotherapeutic intervention, has been found to be an efficacious
treatment alternative for a range of common mental health disorders. The iCBT service aims to
combine innovative Internet technology with a broad evidence-based definition of CBT. The
iCBT services that are being implemented apply different delivery formats ranging from
self-help, to therapist guided and blended with face-to-face therapy for depression and/or
anxiety disorders and/or in comorbidity with somatic symptom disorder. iCBT is currently
being implemented in twelve different sites in primary and specialised care in Italy, Spain,
Germany, France, the Netherlands, Denmark, Kosovo, Albania and Australia. All these sites are
in different phases providing a natural laboratory for the IMA study.
A generic 'Integrated Theory-based Framework for Implementation Tailoring Strategies' toolkit
(the ItFits-toolkit) is developed and will in introduced in these 12 implementation sites at
randomly chosen moments. ItFits 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.
By introducing the ItFits-toolkit in settings with ongoing implementation of iCBT services, a
comparison of the effectiveness and efficiency of the ItFits-toolkit with
Implementation-as-Usual (IAU) is possible. IAU refers to any existing efforts to embed and
integrate iCBT within an organisation. The main research hypothesis is that the
Itfits-toolkit will lead to better implementation outcomes than IAU does. Reaching better
outcomes can be expressed in two dimensions: the capability to establish the desired effects
(i.e. implementation effectiveness) and its efficiency (i.e. implementation costs in relation
to uptake and normalisation outcomes) by which the effects came about. Implementation
effectiveness is defined in terms of uptake and as the extent to which a service is regarded
as being a normal part of practice, i.e. normalisation degree. The question is whether the
ItFits-toolkit leads to a positive impact on uptake and normalisation. Parallel to the main
objective, the efficiency of the ItFits-toolkit in reaching the implementation outcomes as
compared to IAU will be explored. Organisational readiness for change will be investigated to
corroborate the uptake and normalisation outcomes adding to the development of measurement
instruments for implementation processes. In addition, the perceived satisfaction and
usability of the ItFits-toolkit will be explored for potential improvement of the toolkit. An
in-depth qualitative process evaluation using Realist Evaluation methods will be conducted
alongside this implementation effectiveness study.
A stepped-wedge trial (SWT) design is applied by which the time points at which
implementation sites receive the ItFits-toolkit are randomised. All implementation sites have
received the ItFits-toolkit sequentially acting as control and intervention condition at the
end of the trial. There are 6 groups and 2 implementation sites per group. Sites will be
informed about the group they are allocated to three months prior to cross-over. Every three
months, a new group crosses over from IAU to using the ItFits-toolkit.
There are two types of study participants: 1) implementers, and 2) staff involved in iCBT
service delivery. Implementers are directly involved in the development, coordination and
execution of implementation activities. Implementers are represented in the study by an
Implementation Lead (IL) who has a coordinating role in the implementation activities.
Implementers are first engaged with the Implementation-As-Usual activities and become users
of the ItFits-toolkit when the implementation site crosses-over to the ItFits-toolkit
condition (i.e. when they receive the ItFits-toolkit). When using the ItFits-toolkit, the IL
is supported by an implementation core team (1-3 persons), and a number of relevant
stakeholders providing feedback and advice on the implementation work through a process of
co-creation. The IL engages with the ItFits-toolkit user-interface directly and collects and
provides the data on implementation site level. Service delivery staff are the 'receivers' of
the implementation activities and are subject to changes in their daily work to implement
iCBT. Staff within the site are eligible for partaking in the study when they are involved in
iCBT delivery. Involvement refers to a distinct role in delivering iCBT: mental health
specialists, referrers, administration, and ICT support. Next to the study participants, each
site has a study team responsible for the preparation, coordination, and execution of the
local trials. These persons do not provide data themselves, but are involved in localising
the current protocol, obtaining ethical approvals, recruitment of study participants, data
collection, analysis, and reporting.
Implementation success is defined as a multidimensional concept that includes increases in
uptake of the iCBT service on organisational level, normalisation process in staff, and
efficiency outcomes on organisational level. Uptake is defined as a combination of referral
rates and the extent to which the service completed by patients; normalisation process as the
extent to which the new service is considered by staff to be a normal part of daily work; and
efficiency as costs of implementation effort per uptake and costs per degree of
normalisation. To be able to relate the effects of the ItFits-toolkit to these primary
outcomes, Implementation Leads' exposure to, perceived satisfaction with, and usability of
the ItFits-toolkit will be assessed. A measure for organisational readiness for change will
be used to corroborate the normalisation instrument.
The instruments used to measure the primary and exploratory outcomes are based on brief and
validated questionnaires. In addition, a number of newly developed measures are constructed
for measuring uptake (referral rate, completeness of use), implementation costs (effort,
other costs, and overheads), and exposure to the ItFits-toolkit (event-based log files).
Uptake, degree of normalisation, implementation costs, and organisational readiness for
change are measured at baseline and every three months for the total duration of the study.
Data on exposure to the ItFits-toolkit will be collected continuously, whereas satisfaction
and usability of the ItFits-toolkit will be assessed at the end of the exposure period in
which an implementation site has received and used the toolkit.
At local implementation sites, questionnaire data will be gathered using web-based surveys in
the ItFits-toolkit platform. Questionnaire measures for staff will be in local language.
Quantitative data that is collected will be anonymized at local research sites, and checked,
pruned, pooled, and packaged on a secure data server at Central Data Management. No data will
be collected or used without the explicit informed consent of the staff that are
participating in the IMA study. Study participants can withdraw at any point without
disadvantage. As part of the informed consent procedure, informed consent for data transfer
to other parties within the IMA consortium, and long-term preservation will also be asked.
The main aim of the analysis is to test whether the introduction of the ItFits-toolkit will
induce positive chances in the uptake and normalisation of iCBT, and in the efficiency of
this process (i.e. uptake and normalisation divided by implementation costs), across and
within sites. Generalized linear mixed models (GLMM) will be used to determine the extent to
which the total variation observed in uptake and normalisation is a result of the
introduction and use of the ItFits-toolkit. To analyse efficiency in terms of
cost-effectiveness, the costs for implementing iCBT using the ItFits-toolkit will be compared
to the costs for Implementation-as-Usual in relation to the achieved outcomes (i.e. uptake
and normalisation). In the analyses, all observed data will be included, in an effort to
implement the intention-to-treat principle.
