ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

NCT03652883 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 456
• Locations: 9 countries
• Sites: 12

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. 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. 2.To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders.
3. 3.To disseminate the validated toolkit in various healthcare contexts across Europe.

Conditions

Tailored Implementation: Online ItFits-toolkit; Implementation as Usual

Keywords

Implementation; Tailored implementation strategies; iCBT; Common mental disorders

Outcome Measures

Primary Outcomes (4)

• 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.

  Month 0, repeated every three months until month 27.

• 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.

  Month 0, repeated every three months until month 27.

• 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.

  Month 0, repeated every three months until month 27.

• 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.

  Month 0, repeated every three months until month 27.

Secondary Outcomes (5)

• Exposure to the ItFits-toolkit (organisation level)

  Month 0, continuous log until month 27.

• Satisfaction with the ItFits-toolkit (organisation level)

  Month 27

• Usability of the ItFits-toolkit (organisation level)

  Month 27

• Organisational Readiness for Implementing Change (Staff level)

  Month 0, repeated every three months until month 27.

• Perceived impact on site specific implementation goals and determinants (organisational level)

  End of exposure period to the ItFits-toolkit (i.e. 6 months after crossing over from IAU to using the ItFits-toolkit).

Study Arms (2)

ItFits-toolkit

EXPERIMENTAL

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

Implementation as Usual

ACTIVE COMPARATOR

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

Interventions

ItFits-toolkit OTHER

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.

Also known as: ItFits

ItFits-toolkit

Implementation as Usual OTHER

IAU refers to any existing efforts to embed and integrate iCBT within an organisation.

Also known as: IAU

Implementation as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• \- Enrolled in the trial as implementer.

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Region of Southern Denmark: collaborator
• Australian National University: collaborator
• Northumbria University: collaborator
• GGZ inGeest: collaborator
• Badalona Serveis Assistencials: collaborator
• Fondation FondaMental: collaborator
• Get.On: collaborator
• Azienda Sanitaria Locale 3, Torino: collaborator
• Academisch Ziekenhuis Groningen: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• European Alliance against Depression EV: collaborator
• Zyra Per Shendet Mendor: collaborator
• Qendres se Shendetit the Mireqenies Komunitare: collaborator
• Global alliance of mental illness advocacy networks Europe AISBL: collaborator
• Black Dog Institute: collaborator
• European Commission: collaborator

Study Sites (12)

CMHTIR

Tirana, Albania

Location

ANU

Canberra, Australia

Location

BDI

Sydney, Australia

Location

Internet Psychiatrien

Odense, Denmark

Location

FDM

Toulouse, France

Location

Get.On

Erlangen, Germany

Location

DF

Leipzig, Germany

Location

ASLTO3

Turin, Italy

Location

MHCPPriz

Prizren, Kosovo

Location

GGZ InGeest

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

BSA

Badalona, Spain

Location

Related Publications (5)

• Freund J, Piotrowski A, Buhrmann L, Oehler C, Titzler I, Netter AL, Potthoff S, Ebert DD, Finch T, Koberlein-Neu J, Etzelmuller A. Validation of the German Normalisation Process Theory Measure G-NoMAD: translation, adaptation, and pilot testing. Implement Sci Commun. 2023 Oct 16;4(1):126. doi: 10.1186/s43058-023-00505-4.

  PMID: 37845776 DERIVED

• Potthoff S, Finch T, Buhrmann L, Etzelmuller A, van Genugten CR, Girling M, May CR, Perkins N, Vis C, Rapley T; ImpleMentAll consortium. Towards an Implementation-STakeholder Engagement Model (I-STEM) for improving health and social care services. Health Expect. 2023 Oct;26(5):1997-2012. doi: 10.1111/hex.13808. Epub 2023 Jul 4.

  PMID: 37403248 DERIVED

• Vis C, Schuurmans J, Aouizerate B, Atipei Craggs M, Batterham P, Buhrmann L, Calear A, Cerga Pashoja A, Christensen H, Dozeman E, Duedal Pedersen C, Ebert DD, Etzelmueller A, Fanaj N, Finch TL, Hanssen D, Hegerl U, Hoogendoorn A, Mathiasen K, May C, Meksi A, Mustafa S, O'Dea B, Oehler C, Piera-Jimenez J, Potthoff S, Qirjako G, Rapley T, Rosmalen J, Sacco Y, Samalin L, Skjoth MM, Tarp K, Titzler I, Van der Eycken E, van Genugten CR, Whitton A, Zanalda E, Smit JH, Riper H. Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial. J Med Internet Res. 2023 Feb 3;25:e41532. doi: 10.2196/41532.

  PMID: 36735287 DERIVED

• Doukani A, Cerga Pashoja A, Fanaj N, Qirjako G, Meksi A, Mustafa S, Vis C, Hug J. Organizational Readiness for Implementing an Internet-Based Cognitive Behavioral Therapy Intervention for Depression Across Community Mental Health Services in Albania and Kosovo: Directed Qualitative Content Analysis. JMIR Form Res. 2021 Nov 1;5(11):e29280. doi: 10.2196/29280.

  PMID: 34723822 DERIVED

• Buhrmann L, Schuurmans J, Ruwaard J, Fleuren M, Etzelmuller A, Piera-Jimenez J, Finch T, Rapley T, Potthoff S, Aouizerate B, Batterham PJ, Calear A, Christensen H, Pedersen CD, Ebert DD, Van der Eycken E, Fanaj N, van Genugten C, Hanssen D, Hegerl U, Hug J, Kleiboer A, Mathiasen K, May C, Mustafa S, Oehler C, Cerga-Pashoja A, Pope C, Qirjako G, Rosmalen J, Sacco Y, Samalin L, Skjoth MM, Tarp K, Titzler I, Zanalda E, Zbukvic I, Smit JH, Riper H, Vis C; ImpleMentAll consortium. Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial. Trials. 2020 Oct 28;21(1):893. doi: 10.1186/s13063-020-04686-4.

  PMID: 33115545 DERIVED

Related Links

• main project website
• Itfits toolkit

Study Officials

• Christiaan Vis, MA

  VU Amsterdam

  STUDY DIRECTOR

• Heleen Riper, PhD

  VU Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 29, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

NL (2); ES (1); FR (1); AU (2); KO (1); IT (1); DE (2); AL (1); DK (1)