ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 12
- 主要终点
- Change in Uptake - completion rate (organisation level)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ItFits-toolkit (Other)
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.
干预措施: Implementation as Usual (Other)
结局指标
主要结局
Change in Uptake - completion rate (organisation level)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Change in Uptake - referral rate (organisation level)
时间窗: 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.
次要结局
- 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).)
研究者
P.D.C. Vis
Associate Researcher
VU University of Amsterdam