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Program drift and voltage drop. Illustrating the concepts of 'program drift,’ in which the expected effect of an intervention is presumed to decrease over time as practitioners adapt the delivery of the intervention (A), and 'voltage drop,’ in which the effect of an intervention is presumed to decrease as testing moves from Efficacy to Effectiveness to Dissemination and Implementation (D&I) research stages (B).

Program drift and voltage drop. Illustrating the concepts of 'program drift,’ in which the expected effect of an intervention is presumed to decrease over time as practitioners adapt the delivery of the intervention (A), and 'voltage drop,’ in which the effect of an intervention is presumed to decrease as testing moves from Efficacy to Effectiveness to Dissemination and Implementation (D&I) research stages (B).

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Despite growth in implementation research, limited scientific attention has focused on understanding and improving sustainability of health interventions. Models of sustainability have been evolving to reflect challenges in the fit between intervention and context. We examine the development of concepts of sustainability, and respond to two frequen...

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... Research findings are generated in controlled settings and often fail to be fully utilized in real-world settings because contextual factors that enhance the intervention's uptake are not appropriately addressed [10]. Previous studies have shown the importance of considering multi-level context and contextual factors a priori and throughout the dissemination and implementation process, as the context is always changing [11][12][13][14]. To decrease the difference in the lag time between completion of a phase III randomized controlled trial and adoption in the community, which is typically 17 years [15], we have demonstrated the importance of implanting a sustainability strategy prior to the start of a randomized controlled trial in this paper. ...
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Objectives Evidence-based practice for stroke prevention in high-income countries involves screening for abnormal transcranial Doppler (TCD) velocity and initiating regular blood transfusions for at least 1 year, followed by treatment with hydroxyurea. This practice has not been transferred to low-resource settings like Nigeria, the country with the highest global population density of SCD. Following a multi-center randomized controlled trial among children with SCA in northern Nigeria, screening for stroke and initiation of hydroxyurea was established as standard of care at the clinical trial sites and other locations. We aim to describe the critical steps we took in translating research into practice for stroke prevention in SCA in Nigeria. Guided by the PRISM framework, we describe how we translated results from a randomized controlled trial for primary prevention of stroke in children with sickle cell anemia into usual care for children with SCA in Kaduna, Nigeria. Results Findings from this study demonstrate the importance of organizational support and stakeholder involvement from the onset of a clinical trial. Having the dual objective of conducting an efficacy trial while simultaneously focusing on strategies for future implementation can significantly decrease the lag time between discovery and routine practice.
... It entails the mapping of relevant qualitative and quantitative information about the context (e.g., multilevel implementation determinants, practice patterns) in which an intervention will be delivered. Starting (prospectively) at the beginning of each IS project, the results of the contextual analysis become the basis of all subsequent phases of an IS project: they inform intervention development or adaption, guide choices regarding implementation strategies, help interpret implementation and effectiveness outcomes, and guide selection of sustainability strategies [7][8][9][10]. As context is dynamic and evolves, continuous monitoring of context including for example several assessments of context throughout the project is important. ...
... Identified stakeholders can be mapped on a matrix (i.e., influence-interest-capacity matrix) that specifies their characteristics, e.g., role, degree of influence, anticipated effects, and outcomes of involving them [40]. Throughout the project, continuous changes in context require continuous involvement of the stakeholders, e.g., via regular stakeholder meetings [10,30]. Furthermore, their needs must be continuously evaluated and adapted as necessary. ...
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Background Designing intervention and implementation strategies with careful consideration of context is essential for successful implementation science projects. Although the importance of context has been emphasized and methodology for its analysis is emerging, researchers have little guidance on how to plan, perform, and report contextual analysis. Therefore, our aim was to describe the Basel Approach for coNtextual ANAlysis (BANANA) and to demonstrate its application on an ongoing multi-site, multiphase implementation science project to develop/adapt, implement, and evaluate an integrated care model in allogeneic SteM cell transplantatIon facILitated by eHealth (the SMILe project). Methods BANANA builds on guidance for assessing context by Stange and Glasgow (Contextual factors: the importance of considering and reporting on context in research on the patient-centered medical home, 2013). Based on a literature review, BANANA was developed in ten discussion sessions with implementation science experts and a medical anthropologist to guide the SMILe project’s contextual analysis. BANANA’s theoretical basis is the Context and Implementation of Complex Interventions (CICI) framework. Working from an ecological perspective, CICI acknowledges contextual dynamics and distinguishes between context and setting (the implementation’s physical location). Results BANANA entails six components: (1) choose a theory, model, or framework (TMF) to guide the contextual analysis; (2) use empirical evidence derived from primary and/or secondary data to identify relevant contextual factors; (3) involve stakeholders throughout contextual analysis; (4) choose a study design to assess context; (5) determine contextual factors’ relevance to implementation strategies/outcomes and intervention co-design; and (6) report findings of contextual analysis following appropriate reporting guidelines. Partly run simultaneously, the first three components form a basis both for the identification of relevant contextual factors and for the next components of the BANANA approach. Discussion Understanding of context is indispensable for a successful implementation science project. BANANA provides much-needed methodological guidance for contextual analysis. In subsequent phases, it helps researchers apply the results to intervention development/adaption and choices of contextually tailored implementation strategies. For future implementation science projects, BANANA’s principles will guide researchers first to gather relevant information on their target context, then to inform all subsequent phases of their implementation science project to strengthen every part of their work and fulfill their implementation goals.
... Following the dynamic sustainability framework, 46 the team established a learning, problem-solving, and adaptation process, making the effort of fostering a high-functioning team dynamic and ongoing. This entailed monitoring of new opportunities to optimize care timing and sequencing, involving new specialties and forming new subteams. ...
Article
PURPOSE Delivering cancer care by high-functioning multidisciplinary teams promises to address care fragmentation, which threatens care quality, affects patient outcomes, and strains the oncology workforce. We assessed whether the 4R Oncology model for team-based interdependent care delivery and patient self-management affected team functioning in a large community-based health system. METHODS 4R was deployed at four locations in breast and lung cancers and assessed along four characteristics of high-functioning teams: recognition as a team internally and externally; commitment to an explicit shared goal; enablement of interdependent work to achieve the goal; and engagement in regular reflection to adapt objectives and processes. RESULTS We formed an internally and externally recognized team of 24 specialties committed to a shared goal of delivering multidisciplinary care at the optimal time and sequence from a patient-centric viewpoint. The team conducted 40 optimizations of interdependent care (22 for breast, seven for lung, and 11 for both cancers) at four points in the care continuum and established an ongoing teamwork adaptation process. Half of the optimizations entailed low effort, while 30% required high level of effort; 78% resulted in improved process efficiency. CONCLUSION 4R facilitated development of a large high-functioning team and enabled 40 optimizations of interdependent care along the cancer care continuum in a feasible way. 4R may be an effective approach for fostering high-functioning teams, which could contribute to improving viability of the oncology workforce. Our intervention and taxonomy of results serve as a blueprint for other institutions motivated to strengthen teamwork to improve patient-centered care.
... This article offers a unique perspective on the economics of adaptation, an evolving area of the field, by discussing practical approaches to evaluate the economic consequences of adaptation (i.e., what is planned at baseline vs. what gets delivered). This topic is of increased importance to public health and health care delivery with the introduction of new approaches that integrate adaptive, contextually sensitive continuous quality improvement, particularly within learning health care systems [5]. Previous research suggests that adaptations are widespread [6,7], underscoring the importance of understanding the effectiveness and economic implications of various adaptations to public health and health care delivery systems. ...
... The framework was based on a systematic review of adaptations to evidencebased interventions. The latest iteration of this framework [18] includes eight domains: (1) when and how in the implementation process the adaptation was made, (2) whether the adaptation was planned/proactive or unplanned/reactive, (3) who determined that the adaptation should be made, (4) what is adapted, (5) at what level of delivery the adaptation is made, (6) type or nature of context or content-level adaptations, (7) the extent to which the adaptation is fidelity-consistent, and (8) the reasons for the adaptation, including the intent or goal of the adaptation (e.g., improve fit, adapt to a different culture, reduce costs). Across all domains of the framework, there are economic drivers and implications that should be considered. ...
... The National Academy of Medicine has prioritized a paradigm shift towards a learning health care system, characterized by continuous learning and quality improvement with continuity in clinical data collection informing faster and more iterative adaptations [47]. This dynamic approach to evidence development and application integrates adaptative, contextually sensitive continuous quality improvement with the challenge of EBP sustainment [5]. Although a significant gap remains in achieving the goals of a learning health care system, progress will only be made if health systems can adapt to their evolving environments and the economic case for such adaptations can be demonstrated. ...
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Background Evidence-based practices (EBPs) are frequently adapted in response to the dynamic contexts in which they are implemented. Adaptation is defined as the degree to which an EBP is altered to fit the setting or to improve fit to local context and can be planned or unplanned. Although adaptations are common and necessary to maximizing the marginal impact of EBPs, little attention has been given to the economic consequences and how adaptations affect marginal costs. Discussion In assessing the economic consequences of adaptation, one should consider its impact on core components, the planned adaptive periphery, and the unplanned adaptive periphery. Guided by implementation science frameworks, we examine how various economic evaluation approaches accommodate the influence of adaptations and discuss the pros and cons of these approaches. Using the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME), mixed methods can elucidate the economic reasons driving the adaptations. Micro-costing approaches are applied in research that integrates the adaptation of EBPs at the planning stage using innovative, adaptive study designs. In contrast, evaluation of unplanned adaptation is subject to confounding and requires sensitivity analysis to address unobservable measures and other uncertainties. A case study is presented using the RE-AIM framework to illustrate the costing of adaptations. In addition to empirical approaches to evaluating adaptation, simulation modeling approaches can be used to overcome limited follow-up in implementation studies. Conclusions As implementation science evolves to improve our understanding of the mechanisms and implications of adaptations, it is increasingly important to understand the economic implications of such adaptations, in addition to their impact on clinical effectiveness. Therefore, explicit consideration is warranted of how costs can be evaluated as outcomes of adaptations to the delivery of EBPs.
... There is increasing interest [12,13] but still limited understanding of which contextual factors [3,[14][15][16][17] have an impact on the initial uptake; equitable implementation, reach, effectiveness; and sustained use of complex health interventions [18] in a variety of clinical and community settings, which inhibits the translation of research into practice [10]. More specifically, there is a need to document and understand the impact of the dynamic context in which interventions are integrated [19][20][21][22][23]. The Practical, Robust Implementation and Sustainability Model (PRISM) was developed to fill this need using key concepts from research on and models of chronic care, the diffusion of innovations, quality improvement, and measures of population-based effectiveness for translating research into practice [3,4]. ...
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Background The Practical, Robust Implementation and Sustainability Model (PRISM) was developed in 2008 as a contextually expanded version of the broadly used Reach, Adoption, Effectiveness, Implementation, and Maintenance (RE-AIM) framework. PRISM provides researchers a pragmatic and intuitive model to improve translation of research interventions into clinical and community practice. Since 2008, the use of PRISM increased across diverse topics, populations, and settings. This citation analysis and scoping systematic review aimed to assess the use of the PRISM framework and to make recommendations for future research. Methods A literature search was conducted using three databases (PubMed, Web of Science, Scopus) for the period of 2008 and September 2020. After exclusion, reverse citation searches and invitations to experts in the field were used to identify and obtain recommendations for additional articles not identified in the original search. Studies that integrated PRISM into their study design were selected for full abstraction. Unique research studies were abstracted for information on study characteristics (e.g., setting/population, design), PRISM contextual domains, and RE-AIM outcomes. Results A total of 180 articles were identified to include PRISM to some degree. Thirty-two articles representing 23 unique studies integrated PRISM within their study design. Study characteristics varied widely and included studies conducted in diverse contexts, but predominately in high-income countries and in clinical out-patient settings. With regards to use, 19 used PRISM for evaluation, 10 for planning/development, 10 for implementation, four for sustainment, and one for dissemination. There was substantial variation across studies in how and to what degree PRISM contextual domains and RE-AIM outcomes were operationalized and connected. Only two studies directly connected individual PRISM context domains with RE-AIM outcomes, and another four included RE-AIM outcomes without direct connection to PRISM domains. Conclusions This is the first systematic review of the use of PRISM in various contexts. While there were low levels of ‘integrated’ use of PRISM and few reports on linkage to RE-AIM outcomes, most studies included important context domains of implementation and sustainability infrastructure and external environment. Recommendations are provided for more consistent and comprehensive use of and reporting on PRISM to inform both research and practice on contextual factors in implementation.
... Fidelity refers to the degree to which an intervention is implemented as it is prescribed in the original protocol [37], adaptation is the degree to which an intervention is changed or modified by a user during adoption and implementation [38], and dose refers to the amount of the intervention delivered [39]. Program fidelity is a particularly contested area of implementation research, as there is tension between the extent that an intervention remains 'true' to the program protocol to maximise the potential for positive impact, versus the reality of implementation in practice where adaptation is expected and may be encouraged for quality improvement [40]. For improved research-practice translation, there is increasing acknowledgement that interventions, and their implementation, may require ongoing adaptation for contextual relevance [41]. ...
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Background TransformUs was a four-arm school-based intervention to increase physical activity and reduce sedentary behaviour among primary school children. Pedagogical and environmental strategies targeted the classroom, school grounds and family setting. The aims of this study were to evaluate program fidelity, dose, appropriateness, satisfaction and sustainability, and associations between implementation level and outcomes among the three intervention arms. Methods At baseline, 18-months (mid-intervention) and 30-months (post-intervention), teachers, parents and children completed surveys, and children wore GT3X ActiGraph accelerometers for 8 days at each time point to determine physical activity and sedentary time. Implementation data were pooled across the three intervention groups and teachers were categorised by level of implementation: (i) ‘Low’ (< 33% delivered); (ii) ‘Moderate’ (33–67% delivered); and (iii) ‘High’ (> 67% delivered). Linear and logistic mixed models examined between group differences in implementation, and the association with children’s physical activity and sedentary time outcomes. Qualitative survey data were analysed thematically. Results Among intervention recipients, 52% ( n = 85) of teachers, 29% ( n = 331) of parents and 92% ( n = 407) of children completed baseline evaluation surveys. At 18-months, teachers delivered on average 70% of the key messages, 65% set active/standing homework, 30% reported delivering > 1 standing lesson/day, and 56% delivered active breaks per day. The majority of teachers (96%) made activity/sports equipment available during recess and lunch, and also used this equipment in class (81%). Fidelity and dose of key messages and active homework reduced over time, whilst fidelity of standing lessons, active breaks and equipment use increased. TransformUs was deemed appropriate for the school setting and positively received. Implementation level and child behavioural outcomes were not associated. Integration of TransformUs into existing practices, children’s enjoyment, and teachers’ awareness of program benefits all facilitated delivery and sustainability. Conclusions This study demonstrated that intervention dose and fidelity increased over time, and that children’s enjoyment, senior school leadership and effective integration of interventions into school practices facilitated improved intervention delivery and sustainability. Teacher implementation level and child behavioural outcomes were unrelated, suggesting intervention efficacy was achieved irrespective of implementation variability. The potential translatability of TransformUs into practice contexts may therefore be increased. Findings have informed scale-up of TransformUs across Victoria, Australia. Trial registration International Standard Randomized Controlled Trial Number ISRCTN83725066; Australian New Zealand Clinical Trials Registry Number ACTRN12609000715279. Registered 19 August 2009. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=308387&isReview=true
... Existing evidence show that mental health programs, delivered by lay healthcare workers, are found to be more effective, compared to treatment as usual to treat common mental health disorders (CMDs) in adults in low-and middle-income countries (LMICs) [6]. However, ensuring program fidelity at scale remains a key implementation challenge to disseminating such programs in low-resource settings, globally [7]. Many guidelines and models have been recently published to effectively recruit, engage, train, and supervise healthcare workers (e.g., cascade model of training and supervision) to deliver mental healthcare in the community setting. ...
... However, one of the frequent concerns regarding the implementation of evidence-based practices by non-specialist at scale is the decrease in program fidelity and its effectiveness [7] due to the diverse mental health needs of the populations and challenges associated with maintaining the quality of training and supervision of non-specialists at scale. Mobile-based devices and services have been frequently used previously for data collection, training, and delivery of healthcare services by community providers and are promising strategies to improve healthcare delivery in LMICs [47]. ...
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Background As in many low-income countries, the treatment gap for developmental disorders in Pakistan is nearly 100%. The World Health Organization (WHO) has developed the mental Health Gap Intervention guide (mhGAP-IG) to train non-specialists in the delivery of evidence-based mental health interventions in low-resource settings. However, a key challenge to scale-up of non-specialist-delivered interventions is designing training programs that promote fidelity at scale in low-resource settings. In this case study, we report the experience of using a tablet device-based application to train non-specialist, female family volunteers in leading a group parent skills training program, culturally adapted from the mhGAP-IG, with fidelity at scale in rural community settings of Pakistan. Methods The implementation evaluation was conducted as a part of the mhGAP-IG implementation in the pilot sub-district of Gujar Khan. Family volunteers used a technology-assisted approach to deliver the parent skills training in 15 rural Union Councils (UCs). We used the Proctor and RE-AIM frameworks in a mixed-methods design to evaluate the volunteers’ competency and fidelity to the intervention. The outcome was measured with the ENhancing Assessment of Common Therapeutic factors (ENACT), during training and program implementation. Data on other implementation outcomes including intervention dosage, acceptability, feasibility, appropriateness, and reach was collected from program trainers, family volunteers, and caregivers of children 6 months post-program implementation. Qualitative and quantitative data were analyzed using the framework and descriptive analysis, respectively. Results We trained 36 volunteers in delivering the program using technology. All volunteers were female with a mean age of 39 (± 4.38) years. The volunteers delivered the program to 270 caregivers in group sessions with good fidelity (scored 2.5 out of 4 on each domain of the fidelity measure). More than 85% of the caregivers attended 6 or more of 9 sessions. Quantitative analysis showed high levels of acceptability, feasibility, appropriateness, and reach of the program. Qualitative results indicated that the use of tablet device-based applications, and the cultural appropriateness of the adapted intervention content, contributed to the successful implementation of the program. However, barriers faced by family volunteers like community norms and family commitments potentially limited their mobility to deliver the program and impacted the program’ reach. Conclusions Technology can be used to train non-specialist family volunteers in delivering evidence-based intervention at scale with fidelity in low-resource settings of Pakistan. However, cultural and gender norms should be considered while involving females as volunteer lay health workers for the implementation of mental health programs in low-resource settings.
... For developers of implementation strategies for either behavioral or biomedical interventions, we call for a reconceptualization of group-and network-based interventions that could lead to an expanded effect of prevention across a larger population and persist for a longer time period. Two major challenges in scaling up effective preventive interventions have been recognized (Chambers et al., 2013). Voltage drop implies that intervention effects often weaken as they move from efficacy to effectiveness to wide-scale use. ...
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Many preventive trials randomize individuals to intervention condition which is then delivered in a group setting. Other trials randomize higher levels, say organizations, and then use learning collaboratives comprised of multiple organizations to support improved implementation or sustainment. Other trials randomize or expand existing social networks and use key opinion leaders to deliver interventions through these networks. We use the term contextually driven to refer generally to such trials (traditionally referred to as clustering, where groups are formed either pre-randomization or post-randomization — i.e., a cluster-randomized trial), as these groupings or networks provide fixed or time-varying contexts that matter both theoretically and practically in the delivery of interventions. While such contextually driven trials can provide efficient and effective ways to deliver and evaluate prevention programs, they all require analytical procedures that take appropriate account of non-independence, something not always appreciated. Published analyses of many prevention trials have failed to take this into account. We discuss different types of contextually driven designs and then show that even small amounts of non-independence can inflate actual Type I error rates. This inflation leads to rejecting the null hypotheses too often, and erroneously leading us to conclude that there are significant differences between interventions when they do not exist. We describe a procedure to account for non-independence in the important case of a two-arm trial that randomizes units of individuals or organizations in both arms and then provides the active treatment in one arm through groups formed after assignment. We provide sample code in multiple programming languages to guide the analyst, distinguish diverse contextually driven designs, and summarize implications for multiple audiences.
... From 2019-2021, implementation of the KMMS has progressed across the primary healthcare providers in the Kimberley region. We have used the Dynamic Sustainability Framework [15] for planning the implementation and subsequent monitoring and evaluation of the KMMS. The Dynamic Sustainability Framework is an approach within the broader field of implementation science [16,17]. ...
... The Dynamic Sustainability Framework is an approach within the broader field of implementation science [16,17]. It is concerned with how an intervention, practice setting, and ecological system 'fit' together to support the implementation in an environment of ongoing change [15]. We have interpreted the domains of the Dynamic Sustainability Framework to refer to the KMMS as the intervention, the workforce and patient population as the practice setting, and the regional systems and structures that support primary healthcare delivery as the ecological system. ...
... This study uses a mixed methods approach [18] to explore real-world outcomes of KMMS implementation in the Kimberley using the Dynamic Sustainability Framework [15]. This study aligns to the Standards for Reporting Implementation Studies (StaRI) Statement [17] and our statement against the standards is available (S1 Checklist). ...
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The Kimberley Mum’s Mood Scale (KMMS) was co-designed with Aboriginal women and healthcare professionals to improve culturally appropriate screening practices for perinatal depression and anxiety. This paper describes the implementation of the KMMS across the remote Kimberley region of Western Australia from January 2018 to December 2021. We used the Dynamic Sustainability Framework to progress the implementation and assess at the intervention, practice setting and ecological system level using a mixed methods approach to analyse implementation. Rates of administration and results of screening were described using a retrospective audit of electronic medical records. Analyses of KMMS training registry, stakeholder engagement and sustainability initiatives were descriptive. KMMS acceptability was assessed using qualitative descriptive approaches to analyse patient feedback forms (n = 39), healthcare professional surveys (n = 15) and qualitative interviews with healthcare professionals (n = 6). We found a significant increase in overall recorded perinatal screening (pre-implementation: 30.4% v Year 3: 46.5%, P < 0.001) and use of the KMMS (pre-implementation: 16.4% v Year 3: 46.4%, P < 0.001). There was improved fidelity in completing the KMMS (from 2.3% to 61.8%, P < 0.001), with 23.6% of women screened recorded as being at increased risk of depression and anxiety. Most healthcare professionals noted the high levels of perinatal mental health concerns, stress, and trauma that their patients experienced, and identified the KMMS as the most appropriate perinatal screening tool. Aboriginal women reported that it was important for clinics to ask about mood and feelings during the perinatal period, and that the KMMS was appropriate. Aboriginal women consistently reported that it was good to have someone to talk to. This study demonstrates that innovation in perinatal depression and anxiety screening for Aboriginal women is possible and can be implemented into routine clinical care with the support of a sustained multi-year investment and strong partnerships.
... Many studies describe a "voltage drop" in effectiveness when interventions are used in community settings (Chambers et al., 2013). It may be that clinicians who participate in research trials are more willing to adopt EBPs like MBC because of beliefs about the importance of evidence-informed practice. ...
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Findings from research participants in effectiveness treatment trials (i.e., randomized control trials conducted in community rather than research settings) are considered more generalizable than those from participants in efficacy trials. This is especially true for clinician participants, whose characteristics like attitudes towards evidence-based practices (EBPs) may impact treatment implementation and the generalizability of research findings from effectiveness studies. This study compared background characteristics, attitudes toward EBPs, and attitudes towards measurement-based care (MBC) among clinicians participating in a National Institute of Mental-Health (NIMH) funded effectiveness trial, the Community Study of Outcome Monitoring for Emotional Disorders in Teens (COMET), to clinician data from nationally representative U.S. survey samples. Results indicated COMET clinicians were significantly younger, less clinically experienced, and were more likely to have a training background in psychology versus other disciplines compared to national survey samples. After controlling for demographics and professional characteristics, COMET clinicians held more positive attitudes towards EBPs and MBC compared to national survey samples. Implications for implementation efforts are discussed.