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BACKGROUND: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation-STakeholder Engagement Model (I-STEM) in the context of an international, large-scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I-STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. METHODS: In-depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet-based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first- and third-generation Grounded Theory, including constant comparative method. RESULTS: We conducted 55 interviews and observed 19 implementation-related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I-STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. CONCLUSION: The I-STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I-STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. PATIENT OR PUBLIC CONTRIBUTION: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN-Europe at all stages-from grant development to dissemination. GAMIAN-Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN-Europe was involved in pilot testing the ItFits-toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits-toolkit. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018.
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Apoio Social , Participação dos Interessados , Humanos , Serviço Social , Austrália , Europa (Continente)RESUMO
BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.
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Terapia Cognitivo-Comportamental , Serviços de Saúde Mental , Humanos , Saúde Mental , Internet , Inquéritos e Questionários , Terapia Cognitivo-Comportamental/métodos , Resultado do TratamentoRESUMO
OBJECTIVES: Traditionally, health technology assessment (HTA) focuses on assessing the impact of pharmaceutical technologies on health and care. Resources are scarce and policy makers aim to achieve effective, accessible health care. eHealth innovations are increasingly more integrated in all healthcare domains. However, how eHealth is assessed prior to its implementation in care practices is unclear. To support evidence-informed policy making, this study aimed to identify frameworks and methods for assessing eHealth's impact on health care. METHODS: The scientific literature in five bibliographical databases was systematically reviewed. Articles were included if the study was conducted in a clinical setting, used an HTA framework and assessed an eHealth service. A systematic qualitative narrative approach was applied for analysis and reporting. RESULTS: Twenty-one HTA frameworks were identified in twenty-three articles. All frameworks addressed outcomes related to the technical performance and functionalities of eHealth service under assessment. The majority also addressed costs (n = 19), clinical outcomes (n = 14), organizational (n = 15) and system level aspects (n = 13). Most frameworks can be classified as dimensional (n = 13), followed by staged (n = 3), hybrid (n = 3), and business modeling frameworks (n = 2). Six frameworks specified assessment outcomes and methods. CONCLUSIONS: HTA frameworks are available for a-priori impact assessment of eHealth services. The frameworks vary in assessment outcomes, methods, and specificity. Demonstrated applicability in practice is limited. Recommendations include standardization of: (i) reporting characteristics of eHealth services, and (ii) specifying assessment outcomes and methods following a stepped-approach tailored to the functional characteristics of eHealth services. Standardization might improve the quality and comparability of eHTA assessments.
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Avaliação da Tecnologia Biomédica , TelemedicinaRESUMO
BACKGROUND: The process of tailored implementation is ill-defined and under-explored. The ItFits-toolkit was developed and subsequently tested as a self-guided online platform to facilitate implementation of tailored strategies for internet-based cognitive behavioural therapy (iCBT) services. In ImpleMentAll, ItFits-toolkit had a small but positive effect on the primary outcome of iCBT normalisation. This paper investigates, from a qualitative perspective, how implementation teams developed and undertook tailored implementation using the toolkit within the trial. METHODS: Implementation teams in thirteen sites from nine countries (Europe and Australia) used the ItFits-toolkit for six months minimum, consistent with the trial protocol. A qualitative process evaluation was conducted. Descriptive data regarding goals, barriers, strategies, and implementation plans collected within the toolkit informed qualitative data collection in real time. Qualitative data included remote longitudinal interviews (n = 55) with implementation team members (n = 30) and observations of support calls (n = 19) with study sites. Qualitative data were analysed thematically, using a team-based approach. RESULTS: Implementation teams developed and executed tailored implementation projects across all steps in the toolkit process. Working in a structured way but with room for flexibility, decisions were shaped by team members' ideas and goals, iterative stakeholder engagement, internal and external influences, and the context of the ImpleMentAll project. Although teams reported some positive impacts of their projects, 'time', both for undertaking the work, and for seeing project impacts, was described as a key factor in decisions about implementation strategies and assessments of success. CONCLUSION: This study responds directly to McHugh et al.'s (2022) call for empirical description of what implementation tailoring looks like in action, in service settings. Self-guided facilitation of tailored implementation enables implementers in service settings to undertake tailoring within their organisations. Implementation tailoring takes considerable time and involves detailed work but can be supported through the provision of implementation science informed guidance and materials, iterative and ongoing stakeholder engagement, and working reflectively in response to external influencing factors. Directions for advancement of tailored implementation are suggested.
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Terapia Cognitivo-Comportamental , Ciência da Implementação , Pesquisa Qualitativa , Humanos , Austrália , Terapia Cognitivo-Comportamental/métodos , Europa (Continente) , Internet , Intervenção Baseada em InternetRESUMO
BACKGROUND: Implementing evidence-based healthcare practices (EBPs) is a complex endeavour and often lags behind research-informed decision processes. Understanding and systematically improving implementation using implementation theory can help bridge the gap between research findings and practice. This study aims to translate, pilot, and validate a German version of the English NoMAD questionnaire (G-NoMAD), an instrument derived from the Normalisation Process Theory, to explore the implementation of EBPs. METHODS: Survey data has been collected in four German research projects and subsequently combined into a validation data set. Two versions of the G-NoMAD existed, independently translated from the original English version by two research groups. A measurement invariance analysis was conducted, comparing latent scale structures between groups of respondents to both versions. After determining the baseline model, the questionnaire was tested for different degrees of invariance (configural, metric, scalar, and uniqueness) across samples. A confirmatory factor analysis for three models (a four-factor, a unidimensional, and a hierarchical model) was used to examine the theoretical structure of the G-NoMAD. Finally, psychometric results were discussed in a consensus meeting, and the final instructions, items, and scale format were consented to. RESULTS: A total of 539 health care professionals completed the questionnaire. The results of the measurement invariance analysis showed configural, partial metric, and partial scalar invariance indicating that the questionnaire versions are comparable. Internal consistency ranged from acceptable to good (0.79 ≤ α ≤ 0.85) per subscale. Both the four factor and the hierarchical model achieved a better fit than the unidimensional model, with indices from acceptable (SRMR = 0.08) to good (CFI = 0.97; TLI = 0.96). However, the RMSEA values were only close to acceptable (four-factor model: χ2164 = 1029.84, RMSEA = 0.10; hierarchical model: χ2166 = 1073.43, RMSEA = 0.10). CONCLUSIONS: The G-NoMAD provides a reliable and promising tool to measure the degree of normalisation among individuals involved in implementation activities. Since the fit was similar in the four-factor and the hierarchical model, priority should be given to the practical relevance of the hierarchical model, including a total score and four subscale scores. The findings of this study support the further usage of the G-NoMAD in German implementation settings. TRIAL REGISTRATION: Both the AdAM project (No. NCT03430336, 06/02/2018) and the EU-project ImpleMentAll (No. NCT03652883, 29/08/2018) were registered on ClinicalTrials.gov. The ImplementIT study was registered at the German Clinical Trial Registration (No. DRKS00017078, 18/04/2019). The G-NoMAD validation study was registered at the Open Science Framework (No7u9ab, 17/04/2023).
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BACKGROUND: It requires thoughtful planning and work to successfully apply and sustain research-supported interventions like healthcare treatments, social support, or preventive programs in practice. Implementation support practitioners (ISPs) such as facilitators, technical assistance providers, knowledge brokers, coaches or consultants may be involved to actively support the implementation process. This article presents knowledge and attitudes ISPs bring to their work. METHODS: Building on a previously developed program logic, a systematic integrative review was conducted. Literature was sourced by searching nine electronic data bases, organizational websites, and by launching a call for publications among selected experts and social media. Article screening was performed independently by two researchers, and data from included studies were extracted by members of the research team and quality-assured by the lead researcher. The quality of included RCTs was assessed based on a framework by Hodder and colleagues. Thematic Analysis was used to capture information on knowledge and attitudes of ISPs across the included studies. Euler diagrams and heatmaps were used to present the results. RESULTS: Results are based on 79 included studies. ISPs reportedly displayed knowledge about the clinical practice they work with, implementation / improvement practice, the local context, supporting change processes, and facilitating evidence-based practice in general. In particular, knowledge about the intervention to be implemented and its target population, specific improvement / implementation methods and approaches, organizational structures and sensitivities, training, and characteristics of (good) research was described in the literature. Seven themes describing ISPs' attitudes were identified: 1) professional, 2) motivated / motivating / encouraging / empowering, 3) empathetic / respectful / sensitive, 4) collaborative / inclusive, 5) authentic, 6) creative / flexible / innovative / adaptive, and 7) frank / direct / honest. Pertaining to a professional attitude, being responsive and focused were the most prevalent indicators across included publications. CONCLUSION: The wide range and complexity of knowledge and attitudes found in the literature calls for a comprehensive and systematic approach to collaboratively develop a professional role for ISPs across disciplines. Embedding the ISP role in different health and social welfare settings will enhance implementation capacities considerably.
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Atitude , Prática Clínica Baseada em Evidências , Conhecimentos, Atitudes e Prática em Saúde , HumanosRESUMO
In 2015, Apple launched an open-source software framework called ResearchKit. ResearchKit provides an infrastructure for conducting remote, smartphone-based research trials through the means of Apple's App Store. Such trials may have several advantages over conventional trial methods including the removal of geographic barriers, frequent assessments of participants in real-life settings, and increased inclusion of seldom-heard communities. The aim of the current study was to explore the feasibility of participant recruitment and the potential for data collection in the non-clinical population in a smartphone-based trial using ResearchKit. As a case example, an app called eMovit, a behavioural activation (BA) app with the aim of helping users to build healthy habits was used. The study was conducted over a 9-month period. Any iPhone user with access to the App Stores of The Netherlands, Belgium, and Germany could download the app and participate in the study. During the study period, the eMovit app was disseminated amongst potential users via social media posts (Twitter, Facebook, LinkedIn), paid social media advertisements (Facebook), digital newsletters and newspaper articles, blogposts and other websites. In total, 1,788 individuals visited the eMovit landing page. A total of 144 visitors subsequently entered Apple's App Store through that landing page. The eMovit product page was viewed 10,327 times on the App Store. With 79 installs, eMovit showed a conversion rate of 0.76% from product view to install of the app. Of those 79 installs, 53 users indicated that they were interested to participate in the research study and 36 subsequently consented and completed the demographics and the participants quiz. Fifteen participants completed the first PHQ-8 assessment and one participant completed the second PHQ-8 assessment. We conclude that from a technological point of view, the means provided by ResearchKit are well suited to be integrated into the app process and thus facilitate conducting smartphone-based studies. However, this study shows that although participant recruitment is technically straightforward, only low recruitment rates were achieved with the dissemination strategies applied. We argue that smartphone-based trials (using ResearchKit) require a well-designed app dissemination process to attain a sufficient sample size. Guidelines for smartphone-based trial designs and recommendations on how to work with challenges of mHealth research will ensure the quality of these trials, facilitate researchers to do more testing of mental health apps and with that enlarge the evidence-base for mHealth.
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BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.
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Terapia Cognitivo-Comportamental , Serviços de Saúde Mental , Austrália , Europa (Continente) , Humanos , Internet , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Electronic mental health interventions (eMental health or eMH) can be used to increase accessibility of mental health services for mood disorders, with indications of comparable clinical outcomes as face-to-face psychotherapy. However, the actual use of eMH in routine mental health care lags behind expectations. Identifying the factors that might promote or inhibit implementation of eMH in routine care may help to overcome this gap between effectiveness studies and routine care. OBJECTIVE: This paper reports the results of a systematic review of the scientific literature identifying those determinants of practices relevant to implementing eMH for mood disorders in routine practice. METHODS: A broad search strategy was developed with high sensitivity to four key terms: implementation, mental health care practice, mood disorder, and eMH. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework was applied to guide the review and structure the results. Thematic analysis was applied to identify the most important determinants that facilitate or hinder implementation of eMH in routine practice. RESULTS: A total of 13,147 articles were screened, of which 48 studies were included in the review. Most studies addressed aspects of the reach (n=33) of eMH, followed by intervention adoption (n=19), implementation of eMH (n=6), and maintenance (n=4) of eMH in routine care. More than half of the studies investigated the provision of mental health services through videoconferencing technologies (n=26), followed by Internet-based interventions (n=20). The majority (n=44) of the studies were of a descriptive nature. Across all RE-AIM domains, we identified 37 determinants clustered in six main themes: acceptance, appropriateness, engagement, resources, work processes, and leadership. The determinants of practices are expressed at different levels, including patients, mental health staff, organizations, and health care system level. Depending on the context, these determinants hinder or facilitate successful implementation of eMH. CONCLUSIONS: Of the 37 determinants, three were reported most frequently: (1) the acceptance of eMH concerning expectations and preferences of patients and professionals about receiving and providing eMH in routine care, (2) the appropriateness of eMH in addressing patients' mental health disorders, and (3) the availability, reliability, and interoperability with other existing technologies such as the electronic health records are important factors for mental health care professionals to remain engaged in providing eMH to their patients in routine care. On the basis of the taxonomy of determinants of practices developed in this review, implementation-enhancing interventions can be designed and applied to achieve better implementation outcomes. Suggestions for future research and implementation practice are provided.