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ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth (ImpleMentAll)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652883
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Region of Southern Denmark
Australian National University
Northumbria University
GGZ inGeest
Badalona Serveis Assistencials
Fondation FondaMental
Get.On
Azienda Sanitaria Locale 3, Torino
Academisch Ziekenhuis Groningen
London School of Hygiene and Tropical Medicine
European Alliance against Depression EV
Zyra Per Shendet Mendor
Qendres se Shendetit the Mireqenies Komunitare
Global alliance of mental illness advocacy networks Europe AISBL
Black Dog Institute
European Commission (funder)
Information provided by (Responsible Party):
P.D.C. Vis, VU University of Amsterdam

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.


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
Allocation: Randomized
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

Arm Intervention/treatment
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.
Other: 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 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




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.


Information from the National Library of Medicine

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


Locations
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Albania
CMHTIR
Tirana, Albania
Australia
ANU
Camberra, Australia
BDI
Sydney, Australia
Denmark
Internet Psychiatrien
Odense, Denmark
France
FDM
Toulouse, France
Germany
Get.On
Erlangen, Germany
DF
Leipzig, Germany
Italy
ASLTO3
Turin, Italy
Kosovo
MHCPPriz
Prizren, Kosovo
Netherlands
GGZ InGeest
Amsterdam, Netherlands
UMCG
Groningen, Netherlands
Spain
BSA
Badalona, Spain
Sponsors and Collaborators
VU University of Amsterdam
Region of Southern Denmark
Australian National University
Northumbria University
GGZ inGeest
Badalona Serveis Assistencials
Fondation FondaMental
Get.On
Azienda Sanitaria Locale 3, Torino
Academisch Ziekenhuis Groningen
London School of Hygiene and Tropical Medicine
European Alliance against Depression EV
Zyra Per Shendet Mendor
Qendres se Shendetit the Mireqenies Komunitare
Global alliance of mental illness advocacy networks Europe AISBL
Black Dog Institute
European Commission (funder)
Investigators
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Study Director: Christiaan Vis, MA VU Amsterdam
Study Chair: Heleen Riper, PhD VU Amsterdam

Additional Information:
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Responsible Party: P.D.C. Vis, Associate Researcher, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT03652883    
Other Study ID Numbers: 1
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available on request following a standardised data accession form on relevant participant data. Note this data does not contain clinical outcomes.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Late 2021-mid 2022
Access Criteria: Accession will be granted through standardised accession form following review by project's dedicated data accession and publication committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by P.D.C. Vis, VU University of Amsterdam:
Implementation
Tailored implementation strategies
iCBT
Common mental disorders