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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03652883




Registration number
NCT03652883
Ethics application status
Date submitted
20/08/2018
Date registered
29/08/2018
Date last updated
9/10/2019

Titles & IDs
Public title
ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth
Scientific title
ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth
Secondary ID [1] 0 0
1
Universal Trial Number (UTN)
Trial acronym
ImpleMentAll
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tailored Implementation: Online ItFits-toolkit 0 0
Implementation as Usual 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ItFits-toolkit
Other interventions - Implementation as Usual

Experimental: ItFits-toolkit - 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.

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 interventions: ItFits-toolkit
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 interventions: Implementation as Usual
IAU refers to any existing efforts to embed and integrate iCBT within an organisation.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Uptake - referral rate (organisation level) - 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.
Timepoint [1] 0 0
Month 0, repeated every three months until month 27.
Primary outcome [2] 0 0
Change in Uptake - completion rate (organisation level) - 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.
Timepoint [2] 0 0
Month 0, repeated every three months until month 27.
Primary outcome [3] 0 0
Change in Normalisation (staff level) - 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.
Timepoint [3] 0 0
Month 0, repeated every three months until month 27.
Primary outcome [4] 0 0
Change in Efficiency (organisation level) - 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.
Timepoint [4] 0 0
Month 0, repeated every three months until month 27.
Secondary outcome [1] 0 0
Exposure to the ItFits-toolkit (organisation level) - 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.
Timepoint [1] 0 0
Month 0, continuous log until month 27.
Secondary outcome [2] 0 0
Satisfaction with the ItFits-toolkit (organisation level) - 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.
Timepoint [2] 0 0
Month 27
Secondary outcome [3] 0 0
Usability of the ItFits-toolkit (organisation level) - 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.
Timepoint [3] 0 0
Month 27
Secondary outcome [4] 0 0
Organisational Readiness for Implementing Change (Staff level) - 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.
Timepoint [4] 0 0
Month 0, repeated every three months until month 27.
Secondary outcome [5] 0 0
Perceived impact on site specific implementation goals and determinants (organisational level) - 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).
Timepoint [5] 0 0
End of exposure period to the ItFits-toolkit (i.e. 6 months after crossing over from IAU to using the ItFits-toolkit).

Eligibility
Key inclusion criteria
There are two types of study participants, i.e. persons providing data: 1) implementers,
and 2) staff involved in iCBT service delivery at the local implementation sites.

Implementers Eligible implementers are individuals who are directly involved in the
development, coordination and execution of implementation activities within an
implementation site. The implementation sites are the organizations engaged in the
implementation processes as well as in iCBT service delivery. The implementation site
started the implementation processes at least three months prior to the baseline
measurement, and is committed to ongoing implementation of the iCBT service delivery.
Implementation sites have been selected and enrolment is closed. Implementers are
represented in the local trial by an Implementation Lead (IL) who has a coordinating role
in the implementation activities. The IL will collect and provide the data on
implementation site level and need to sign an informed consent form. Enrolment of
implementers is considered to be open due to possible staff-changes within the
participating implementation sites.

Inclusion criteria implementers and IL:

- Individuals that are directly involved in the development, coordination and execution
of implementation activities within an implementation site;

- is a reasonably profound user of the English language;

- the IL has a coordinating role in implementing the iCBT service.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria implementers and IL - Involved in trial management.

Staff involved in iCBT service delivery

Staff involved in service delivery are individuals who engage in the commissioning the iCBT
service to clients. Staff members can have different roles in the service delivery:

- As therapists such as psychologists, psychiatrists, or mental health nurses.

- As referrers such as GPs, pharmacists, community workers, or case managers.

- As, administrators such as clerical workers, or secretariats.

- As ICT support such as security officers, maintenance officers, or helpdesk staff.

Inclusion criteria service delivery staff:

- Involved in the delivery of the iCBT service

- In a process of adapting their current way of working in order to deliver iCBT service
to patients in routine care.

Exclusion criteria service delivery staff:

- Enrolled in the trial as implementer.

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ANU - Camberra
Recruitment hospital [2] 0 0
BDI - Sydney
Recruitment postcode(s) [1] 0 0
- Camberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
France
State/province [3] 0 0
Toulouse
Country [4] 0 0
Germany
State/province [4] 0 0
Erlangen
Country [5] 0 0
Germany
State/province [5] 0 0
Leipzig
Country [6] 0 0
Italy
State/province [6] 0 0
Turin
Country [7] 0 0
Kosovo
State/province [7] 0 0
Prizren
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Groningen
Country [10] 0 0
Spain
State/province [10] 0 0
Badalona

Funding & Sponsors
Primary sponsor type
Other
Name
VU University of Amsterdam
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Region of Southern Denmark
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian National University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Northumbria University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
GGZ inGeest
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Badalona Serveis Assistencials
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Fondation FondaMental
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Get.On
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Azienda Sanitaria Locale 3, Torino
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Academisch Ziekenhuis Groningen
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
London School of Hygiene and Tropical Medicine
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
European Alliance against Depression EV
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Zyra Per Shendet Mendor
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Qendres se Shendetit the Mireqenies Komunitare
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Global alliance of mental illness advocacy networks Europe AISBL
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Black Dog Institute
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
European Commission (funder)
Address [16] 0 0
Country [16] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03652883
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christiaan Vis, MA
Address 0 0
VU Amsterdam
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications