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Abstract Background Implementation science scholars have made significant progress identifying factors that enable or obstruct the implementation of evidence-based interventions, and testing strategies that may modify those factors. However, little research sheds light on how or why strategies work, in what contexts, and for whom. Studying implementation mechanisms—the processes responsible for change—is crucial for advancing the field of implementation science and enhancing its value in facilitating equitable policy and practice change. The Agency for Healthcare Research and Quality funded a conference series to achieve two aims: (1) develop a research agenda on implementation mechanisms, and (2) actively disseminate the research agenda to research, policy, and practice audiences. This article presents the resulting research agenda, including priorities and actions to encourage its execution. Method Building on prior concept mapping work, in a semi-structured, 3-day, in-person working meeting, 23 US-based researchers used a modified nominal group process to generate priorities and actions for addressing challenges to studying implementation mechanisms. During each of the three 120-min sessions, small groups responded to the prompt: “What actions need to be taken to move this research forward?” The groups brainstormed actions, which were then shared with the full group and discussed with the support of facilitators trained in structured group processes. Facilitators grouped critical and novel ideas into themes. Attendees voted on six themes they prioritized to discuss in a fourth, 120-min session, during which small groups operationalized prioritized actions. Subsequently, all ideas were collated, combined, and revised for clarity by a subset of the authorship team. Results From this multistep process, 150 actions emerged across 10 priority areas, which together constitute the research agenda. Actions included discrete activities, projects, or products, and ways to shift how research is conducted to strengthen the study of implementation mechanisms. Conclusions This research agenda elevates actions to guide the selection, design, and evaluation of implementation mechanisms. By delineating recommended actions to address the challenges of studying implementation mechanisms, this research agenda facilitates expanding the field of implementation science, beyond studying what works to how and why strategies work, in what contexts, for whom, and with which interventions.

Abstract Background In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes. Methods Design: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam. Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35). Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use. Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders. Discussion This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings. Trial registration NCT06094634 on clinicaltrials.gov. Registered 16 October 2023.

Abstract Background Most implementation science resources (e.g., taxonomies) are published in English. Linguistic inaccessibility creates a barrier to the conduct of implementation research among non-English-speaking populations, so translation of resources is needed. Translation into Spanish can facilitate widespread reach, given the large proportion of Spanish speakers around the world. This research aimed to systematically translate the Expert Recommendations for Implementation Change (ERIC) compilation into Spanish as an exemplar for the linguistic translation process. Methods Using the World Health Organization guidelines, this work translated the ERIC compilation strategy names, short definitions, and thematic clusters through a three-step process: 1) forward translation into Spanish by a native Spanish-speaking implementation scientist, 2) back-translation into English by a bilingual global health researcher, and 3) piloting via virtual focus group discussions with bilingual researchers not conducting implementation research. To achieve a generalizable translation, recruitment targeted a multicultural group of Spanish-speaking researchers. At the conclusion of each step, the transdisciplinary research team (N = 7) met to discuss discrepancies and refine translations. The Spanish version of the ERIC compilation was finalized through group consensus. Reflections from research team meetings and focus group discussions were synthesized qualitatively. Results Given that dialectical nuances exist between Spanish-speaking regions, efforts prioritized universally accepted terminology. Team discussions focused on difficult translations, word choice, and clarity of concepts. Seven researchers participated in two focus groups, where discussion surrounded clarity of concepts, alternative word choice for Spanish translations, linguistic formality, grammar, and conciseness. Translation difficulties highlighted lack of precision in implementation science terminology, and the lack of conceptual clarity of words underscored limitations in the application of the compilation. Conclusions The work demonstrated the feasibility of translating implementation science resources. As one of the first systematic efforts to translate implementation resources, this study can serve as a model for additional efforts, including translation into other languages and the expansion to conceptual modifications. Further, this work yielded insights into the need to provide conceptual clarity in implementation science terminology. Importantly, the development of Spanish resources will increase access to conduct implementation research among Spanish-speaking populations.

Abstract Background Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians’ attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians’ knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use. Methods Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians’ alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI. Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months. Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff’s alcohol use and clinic-level alcohol expectations in the EBAI arm. Discussion This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases. Trial Registration NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885 .

Abstract Background The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced-based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e. physical inactivity, poor diet, harmful alcohol use, and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such, this review will provide important evidence to advance the field of sustainability research. Methods This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) checklist. Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team, data screening and extraction will be performed in duplicate, strategies will be coded using an adapted sustainability-explicit taxonomy, and evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or programme within any of the eligible settings will be included. Article screening, data extraction, risk of bias, and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random-effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include the following: time period, single or multi-strategy, type of setting, and type of intervention. Differences between sub-groups will be statistically compared. Discussion/conclusion This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners. Systematic review registration PROSPERO CRD42022352333.

BackgroundOpinion leadership, educational outreach visiting, and innovation championing are commonly used strategies to address barriers to implementing innovations and evidence-based practices in healthcare settings. Despite voluminous research, ambiguities persist in how these strategies work and under what conditions they work well, work poorly, or work at all. The current paper develops middle-range theories to address this gap.MethodsConceptual articles, systematic reviews, and empirical studies informed the development of causal pathway diagrams (CPDs). CPDs are visualization tools for depicting and theorizing about the causal process through which strategies operate, including the mechanisms they activate, the barriers they address, and the proximal and distal outcomes they produce. CPDs also clarify the contextual conditions (i.e., preconditions and moderators) that influence whether, and to what extent, the strategy's causal process unfolds successfully. Expert panels of implementation scientists and health professionals rated the plausibility of these preliminary CPDs and offered comments and suggestions on them.FindingsTheoretically, opinion leadership addresses potential adopters' uncertainty about likely consequences of innovation use (determinant) by promoting positive attitude formation about the innovation (mechanism), which results in an adoption decision (proximal outcome), which leads to innovation use (intermediate outcome). As this causal process repeats, penetration, or spread of innovation use, occurs (distal outcome). Educational outreach visiting addresses knowledge barriers, attitudinal barriers, and behavioral barriers (determinants) by promoting critical thinking and reflection about evidence and practice (mechanism), which results in behavioral intention (proximal outcome), behavior change (intermediate outcome), and fidelity, or guideline adherence (distal outcome). Innovation championing addresses organizational inertia, indifference, and resistance (determinants) by promoting buy-in to the vision, fostering a positive implementation climate, and increasing collective efficacy (mechanisms), which leads to participation in implementation activities (proximal outcome), initial use of the innovation with increasing skill (intermediate outcome) and, ultimately, greater penetration and fidelity (distal outcomes). Experts found the preliminary CPDs plausible or highly plausible and suggested additional mechanisms, moderators, and preconditions, which were used to amend the initial CPD.DiscussionThe middle-range theories depicted in the CPDs furnish testable propositions for implementation research and offer guidance for selecting, designing, and evaluating these social influence implementation strategies in both research studies and practice settings.

Background: Internet psychoeducational interventions improve employees' mental health. However, implementing them for employees in micro- and small-sized enterprises (MSEs) is challenging. Objectives: This randomized controlled trial examined the effectiveness of a fully automated text-based stress management program, “WellBe-LINE,” in improving mental health and job-related outcomes for employees in workplaces with fewer than 50 employees. Methods: The program was developed based on stakeholder interviews and surveys of 1000 employees at MSEs. Adult full-time employees at an enterprise with fewer than 50 employees were recruited from registered members of a web survey company in Japan. Participants were randomly allocated to the intervention or control group (1:1). Participants in the intervention group were invited to register for the program using the LINE app. Psychological distress measured by Kessler 6 (K6) was a primary outcome, with self-administrated questionnaires at baseline, 2-month (post), and 6-month follow-ups. A mixed model for repeated measures conditional growth model analysis was conducted using a group ∗ time interaction as an intervention effect. Implementation outcomes were measured through implementation outcome scales for digital mental health (iOSDMH). Results: 1021 employees were included in this study. No significant effects were shown in any outcome. The reported implementation outcomes were positively evaluated, with 80 % acceptability, 86 % appropriateness, and feasibility (ease of understanding the contents [88 %], frequency [86 %], and length of content [86 %]). Conclusions: A simple text-message program for employees at MESs was acceptable, appropriate, and feasible; however, it did not result in improved mental health or job-related outcomes. Trial registration: UMIN clinical trial registration: UMIN000050624 (registration date: March 18, 2023).

Abstract Background Implementation science in health is an interdisciplinary field with an emphasis on supporting behavior change required when clinicians and other actors implement evidence-based practices within organizational constraints. Behavioral economics has emerged in parallel and works towards developing realistic models of how humans behave and categorizes a wide range of features of choices that can influence behavior. We argue that implementation science can be enhanced by the incorporation of approaches from behavioral economics. Main body First, we provide a general overview of implementation science and ways in which implementation science has been limited to date. Second, we review principles of behavioral economics and describe how concepts from BE have been successfully applied to healthcare including nudges deployed in the electronic health record. For example, de-implementation of low-value prescribing has been supported by changing the default in the electronic health record. We then describe what a behavioral economics lens offers to existing implementation science theories, models and frameworks, including rich and realistic models of human behavior, additional research methods such as pre-mortems and behavioral design, and low-cost and scalable implementation strategies. We argue that insights from behavioral economics can guide the design of implementation strategies and the interpretation of implementation studies. Key objections to incorporating behavioral economics are addressed, including concerns about sustainment and at what level the strategies work. Conclusion Scholars should consider augmenting implementation science theories, models, and frameworks with relevant insights from behavioral economics. By drawing on these additional insights, implementation scientists have the potential to boost efforts to expand the provision and availability of high quality care.

Abstract Background The Danish Health Authority recommended the implementation of new types of emergency departments. Organizational changes in the hospital sector challenged the role, identity, and autonomy of medical specialists. They tend to identify with their specialty, which can challenge successful implementation of change. However, investigations on specialty identity are rare in implementation science, and how the co-existence of different specialty identities influences the implementation of new emergency departments needs to be explored for the development of tailored implementation strategies. The aim of this study was to examine how medical specialty identity influences collaboration between physicians when implementing a new emergency department in Denmark. Methods Qualitative methods in the form of participants’ observations at 13 oilcloth sessions (a micro-simulation method) were conducted followed up by 53 individual semi-structured interviews with participants from the oilcloth sessions. Out of the 53 interviews, 26 were conducted with specialists. Data from their interviews are included in this study. Data were analysed deductively inspired by Social Identity Theory. Results The analysis yielded three overarching themes: [1] ongoing creation and re-creation of specialty identity through boundary drawing; [2] social categorization and power relations; and [3] the patient as a boundary object. Conclusions Specialty identity is an important determinant of collaboration among physicians when implementing a new emergency department. Specialty identity involves social categorization, which entails ongoing creation and re-creation of boundary drawing and exercising of power among the physicians. In some situations, the patient became a positive boundary object, increasing the possibility for a successful collaboration and supporting successful implementation, but direct expressions of boundaries and mistrust were evident. Both were manifested through a dominating power expressed through social categorization in the form of in- and out-groups and in an “us and them” discourse, which created distance and separation among physicians from different specialties. This distancing and separation became a barrier to the implementation of the new emergency department.

Abstract Background Cross-system interventions that integrate health, behavioral health, and social services can improve client outcomes and expand community impact. Successful implementation of these interventions depends on the extent to which service partners can align frontline services and organizational operations. However, collaboration strategies linking multiple implementation contexts have received limited empirical attention. This study identifies, describes, and specifies multi-level collaboration strategies used during the implementation of Ohio Sobriety Treatment and Reducing Trauma (Ohio START), a cross-system intervention that integrates services across two systems (child welfare and evidence-based behavioral health services) for families that are affected by co-occurring child maltreatment and parental substance use disorders. Methods In phase 1, we used a multi-site qualitative design with 17 counties that implemented Ohio START. Qualitative data were gathered from 104 staff from child welfare agencies, behavioral health treatment organizations, and regional behavioral health boards involved in implementation via 48 small group interviews about collaborative approaches to implementation. To examine cross-system collaboration strategies, qualitative data were analyzed using an iterative template approach and content analysis. In phase 2, a 16-member expert panel met to validate and specify the cross-system collaboration strategies identified in the interviews. The panel was comprised of key child welfare and behavioral health partners and scholars. Results In phase 1, we identified seven cross-system collaboration strategies used for implementation. Three strategies were used to staff the program: (1) contract for expertise, (2) provide joint supervision, and (3) co-locate staff. Two strategies were used to promote service access: (4) referral protocols and (5) expedited access agreements. Two strategies were used to align case plans: (6) shared decision-making meetings, and (7) sharing data. In phase 2, expert panelists specified operational details of the cross-system collaboration strategies, and explained the processes by which strategies were perceived to improve implementation and service system outcomes. Conclusions We identified a range of cross-system collaboration strategies that show promise for improving staffing, service access, and case planning. Leaders, supervisors, and frontline staff used these strategies during all phases of implementation. These findings lay the foundation for future experimental and quasi-experimental studies that test the effectiveness of cross-system collaboration strategies.

Abstract Background The impact of both implementation strategies (IS) and evidence-based interventions (EBI) can vary across contexts, and a better understanding of how and why this occurs presents fundamental but challenging questions that implementation science as a field will need to grapple with. We use causal epidemiologic methods to explore the mechanisms of why sharp distinctions between implementation strategies (IS) and efficacy of an evidence-based intervention (EBI) may fail to recognize that the effect of an EBI can be deeply intertwined and dependent on the context of the IS leading to its uptake. Methods We explore the use of instrumental variable (IV) analyses as a critical tool for implementation science methods to isolate three relevant quantities within the same intervention context when exposure to an implementation strategy is random: (1) the effect of an IS on implementation outcomes (e.g., uptake), (2) effect of EBI uptake on patient outcomes, and (3) overall effectiveness of the IS (i.e., ~ implementation*efficacy). We discuss the mechanisms by which an implementation strategy can alter the context, and therefore effect, of an EBI using the underlying IV assumptions. We illustrate these concepts using examples of the implementation of new ART initiation guidelines in Zambia and community-based masking programs in Bangladesh. Results Causal questions relevant to implementation science are answered at each stage of an IV analysis. The first stage assesses the effect of the IS (e.g., new guidelines) on EBI uptake (e.g., same-day treatment initiation). The second stage leverages the IS as an IV to estimate the complier average causal effect (CACE) of the EBI on patient outcomes (e.g., effect of same-day treatment initiation on viral suppression). The underlying assumptions of CACE formalize that the causal effect of EBI may differ in the context of a different IS because (1) the mechanisms by which individuals uptake an intervention may differ and (2) the subgroup of individuals who take up an EBI may differ. IV methods thus provide a conceptual framework for how IS and EBIs are linked and that the IS itself needs to be considered a critical contextual determinant. Moreover, it also provides rigorous methodologic tools to isolate the effect of an IS, EBI, and combined effect of the IS and EBI. Discussion Leveraging IV methods when exposure to an implementation strategy is random helps to conceptualize the context-dependent nature of implementation strategies, EBIs, and patient outcomes. IV methods formalize that the causal effect of an EBI may be specific to the context of the implementation strategy used to promote uptake. This integration of implementation science concepts and theory with rigorous causal epidemiologic methods yields novel insights and provides important tools for exploring the next generation of questions related to mechanisms and context in implementation science.

Abstract Background The Expert Recommendations for Implementing Change (ERIC) project developed a compilation of implementation strategies that are intended to standardize reporting and evaluation. Little is known about the application of ERIC in low- and middle-income countries (LMICs). We systematically reviewed the literature on the use and specification of ERIC strategies for health intervention implementation in LMICs to identify gaps and inform future research. Methods We searched peer-reviewed articles published through March 2023 in any language that (1) were conducted in an LMIC and (2) cited seminal ERIC articles or (3) mentioned ERIC in the title or abstract. Two co-authors independently screened all titles, abstracts, and full-text articles, then abstracted study, intervention, and implementation strategy characteristics of included studies. Results The final sample included 60 studies describing research from all world regions, with over 30% published in the final year of our review period. Most studies took place in healthcare settings (n = 52, 86.7%), while 11 (18.2%) took place in community settings and four (6.7%) at the policy level. Across studies, 548 distinct implementation strategies were identified with a median of six strategies (range 1–46 strategies) included in each study. Most studies (n = 32, 53.3%) explicitly matched implementation strategies used for the ERIC compilation. Among those that did, 64 (87.3%) of the 73 ERIC strategies were represented. Many of the strategies not cited included those that target systems- or policy-level barriers. Nearly 85% of strategies included some component of strategy specification, though most only included specification of their action (75.2%), actor (57.3%), and action target (60.8%). A minority of studies employed randomized trials or high-quality quasi-experimental designs; only one study evaluated implementation strategy effectiveness. Conclusions While ERIC use in LMICs is rapidly growing, its application has not been consistent nor commonly used to test strategy effectiveness. Research in LMICs must better specify strategies and evaluate their impact on outcomes. Moreover, strategies that are tested need to be better specified, so they may be compared across contexts. Finally, strategies targeting policy-, systems-, and community-level determinants should be further explored. Trial registration PROSPERO, CRD42021268374.

Abstract Background Audit and feedback (A&F) is an implementation strategy that can facilitate implementation tailoring by identifying gaps between desired and actual clinical care. While there are several theory-based propositions on which A&F components lead to better implementation outcomes, many have not been empirically investigated, and there is limited guidance for stakeholders when applying A&F in practice. The current study aims to illustrate A&F procedures in six community mental health clinics, with an emphasis on reporting A&F components that are relevant to theories of how feedback elicits behavior change. Methods Six clinics from a larger trial using a tailored approach to implement measurement-based care (MBC) were analyzed for feedback content, delivery mechanisms, barriers to feedback, and outcomes of feedback using archival data. Pattern analysis was conducted to examine relations between A&F components and changes in MBC use. Results Several sites utilized both aggregate and individualized data summaries, and data accuracy concerns were common. Feedback cycles featuring individual-level clinician data, data relevant to MBC barriers, and information requested by data recipients were related to patterns of increased MBC use. Conclusions These findings support extant theory, such as Feedback Intervention Theory. Mental health professionals wishing to apply A&F should consider establishing reciprocal feedback mechanisms on the quality and amount of data being received and adopting specific roles communicating and addressing data quality concerns. Trial registration ClinicalTrials.gov Identifier: NCT02266134.

Abstract Background Children’s Advocacy Centers (CACs) use multidisciplinary teams to investigate and respond to maltreatment allegations. CACs play a critical role in connecting children with mental health needs to evidence-based mental health treatment, especially in low-resourced rural areas. Standardized mental health screening and referral protocols can improve CACs’ capacity to identify children with mental health needs and encourage treatment engagement. In the team-based context of CACs, teamwork quality is likely to influence implementation processes and outcomes. Implementation strategies that target teams and apply the science of team effectiveness may enhance implementation outcomes in team-based settings. Methods We will use Implementation Mapping to develop team-focused implementation strategies to support the implementation of the Care Process Model for Pediatric Traumatic Stress (CPM-PTS), a standardized screening and referral protocol. Team-focused strategies will integrate activities from effective team development interventions. We will pilot team-focused implementation in a cluster-randomized hybrid type 2 effectiveness-implementation trial. Four rural CACs will implement the CPM-PTS after being randomized to either team-focused implementation (n = 2 CACs) or standard implementation (n = 2 CACs). We will assess the feasibility of team-focused implementation and explore between-group differences in hypothesized team-level mechanisms of change and implementation outcomes (implementation aim). We will use a within-group pre-post design to test the effectiveness of the CPM-PTS in increasing caregivers’ understanding of their child’s mental health needs and caregivers’ intentions to initiate mental health services (effectiveness aim). Conclusions Targeting multidisciplinary teams is an innovative approach to improving implementation outcomes. This study will be one of the first to test team-focused implementation strategies that integrate effective team development interventions. Results will inform efforts to implement evidence-based practices in team-based service settings. Trial registration Clinicaltrials.gov, NCT05679154 . Registered on January 10, 2023.

Background: Globally, mental health disorders rank as the greatest cause of disability. Low and middle-income countries (LMICs) hold a disproportionate share of the mental health burden, especially as it pertains to depression. Depression is highly prevalent among those with non-communicable diseases (NCDs), creating a barrier to successful treatment. While some treatments have proven efficacy in LMIC settings, wide dissemination is challenged by multiple factors, leading researchers to call for implementation strategies to overcome barriers to care provision. However, implementation strategies are often not well defined or documented, challenging the interpretation of study results and the uptake and replication of strategies in practice settings. Assessing implementation strategy fidelity (ISF), or the extent to which a strategy was implemented as designed, overcomes these challenges. This study assessed fidelity of two implementation strategies (a ‘basic’ champion strategy and an ‘enhanced’ champion ​+ ​audit and feedback strategy) to improve the integration of a depression intervention, measurement based care (MBC), at 10 NCD clinics in Malawi. The primary goal of this study was to assess the relationship between the implementation strategies and MBC fidelity using a mixed methods approach. Methods: We developed a theory-informed mixed methods fidelity assessment that first combined an implementation strategy specification technique with a fidelity framework. We then created corresponding fidelity indicators to strategy components. Clinical process data and one-on-one in-depth interviews with 45 staff members at 6 clinics were utilized as data sources. Our final analysis used descriptive statistics, reflexive-thematic analysis (RTA), data merging, and triangulation to examine the relationship between ISF and MBC intervention fidelity. Results: Our mixed methods analysis revealed how ISF may moderate the relationship between the strategies and MBC fidelity. Leadership engagement and implementation climate were critical for clinics to overcome implementation barriers and preserve implementation strategy and MBC fidelity. Descriptive statistics determined champion strategy fidelity to range from 61 to 93% across the 10 clinics. Fidelity to the audit and feedback strategy ranged from 82 to 91% across the 5 clinics assigned to that condition. MBC fidelity ranged from 54 to 95% across all clinics. Although correlations between ISF and MBC fidelity were not statistically significant due to the sample of 10 clinics, associations were in the expected direction and of moderate effect size. A coefficient for shared depression screening among clinicians had greater face validity compared to depression screening coverage and functioned as a proximal indicator of implementation strategy success. Conclusion: Fidelity to the basic and enhanced strategies varied by site and were influenced by leadership engagement and implementation climate. Champion strategies may benefit from the addition of leadership strategies to help address implementation barriers outside the purview of champions. ISF may moderate the relationship between strategies and implementation outcomes.

Abstract Background The Expert Recommendations for Implementing Change (ERIC) compilation includes 73 defined implementation strategies clustered into nine content areas. This taxonomy has been used to track implementation strategies over time using surveys. This study aimed to improve the ERIC survey using cognitive interviews with non-implementation scientist clinicians. Methods Starting in 2015, we developed and fielded annual ERIC surveys to evaluate liver care in the Veterans Health Administration (VA). We invited providers who had completed at least three surveys to participate in cognitive interviews (October 2020 to October 2021). Before the interviews, participants reviewed the complete 73-item ERIC survey and marked which strategies were unclear due to wording, conceptual confusion, or overlap with other strategies. They then engaged in semi-structured cognitive interviews to describe the experience of completing the survey and elaborate on which strategies required further clarification. Results Twelve VA providers completed surveys followed by cognitive interviews. The “Engage Consumer” and “Support Clinicians” clusters were rated most highly in terms of conceptual and wording clarity. In contrast, the “Financial” cluster had the most wording and conceptual confusion. The “Adapt and Tailor to Context” cluster strategies were considered to have the most redundancy. Providers outlined ways in which the strategies could be clearer in terms of wording (32%), conceptual clarity (51%), and clarifying the distinction between strategies (51%). Conclusions Cognitive interviews with ERIC survey participants allowed us to identify and address issues with strategy wording, combine conceptually indistinct strategies, and disaggregate multi-barreled strategies. Improvements made to the ERIC survey based on these findings will ultimately assist VA and other institutions in designing, evaluating, and replicating quality improvement efforts.

Abstract Background Evidence-based innovations can improve health outcomes, but only if successfully implemented. Implementation can be complex, highly susceptible to failure, costly and resource intensive. Internationally, there is an urgent need to improve the implementation of effective innovations. Successful implementation is best guided by implementation science, but organizations lack implementation know-how and have difficulty applying it. Implementation support is typically shared in static, non-interactive, overly academic guides and is rarely evaluated. In-person implementation facilitation is often soft-funded, costly, and scarce. This study seeks to improve effective implementation by (1) developing a first-in-kind digital tool to guide pragmatic, empirically based and self-directed implementation planning in real-time; and (2) exploring the tool’s feasibility in six health organizations implementing different innovations. Methods Ideation emerged from a paper-based resource, The Implementation Game©, and a revision called The Implementation Roadmap©; both integrate core implementation components from evidence, models and frameworks to guide structured, explicit, and pragmatic planning. Prior funding also generated user personas and high-level product requirements. This study will design, develop, and evaluate the feasibility of a digital tool called The Implementation Playbook©. In Phase 1, user-centred design and usability testing will inform tool content, visual interface, and functions to produce a minimum viable product. Phase 2 will explore the Playbook’s feasibility in six purposefully selected health organizations sampled for maximum variation. Organizations will use the Playbook for up to 24 months to implement an innovation of their choosing. Mixed methods will gather: (i) field notes from implementation team check-in meetings; (ii) interviews with implementation teams about their experience using the tool; (iii) user free-form content entered into the tool as teams work through implementation planning; (iv) Organizational Readiness for Implementing Change questionnaire; (v) System Usability Scale; and (vi) tool metrics on how users progressed through activities and the time required to do so. Discussion Effective implementation of evidence-based innovations is essential for optimal health. We seek to develop a prototype digital tool and demonstrate its feasibility and usefulness across organizations implementing different innovations. This technology could fill a significant need globally, be highly scalable, and potentially valid for diverse organizations implementing various innovations.

Abstract Background Child maltreatment (CM) is a pervasive public health problem and there is a critical need for brief, effective, scalable prevention programs. Problematic parent-child relationships lie at the heart of CM. Parents who maltreat their children are more likely to have punitive parenting styles characterized by high rates of negative interaction and ineffective discipline strategies with over-reliance on punishment. Thus, parenting interventions that strengthen parent-child relationships, teach positive discipline techniques, decrease harsh parenting, and decrease child behavioral problems hold promise as CM prevention strategies. Challenges in engaging parents, particularly low-income and minority parents, and a lack of knowledge regarding effective implementation strategies, however, have greatly limited the reach and impact of parenting interventions. Child Adult Relationship Enhancement in Primary Care (PriCARE)/Criando Niños con CARIÑO is a 6-session group parenting intervention that holds promise in addressing these challenges because PriCARE/CARIÑO was (1) developed and iteratively adapted with input from racially and ethnically diverse families, including low-income families and (2) designed specifically for implementation in primary care with inclusion of strategies to align with usual care workflow to increase uptake and retention. Methods This study is a multicenter randomized controlled trial with two parallel arms. Children, 2–6 years old with Medicaid/CHIP/no insurance, and their English- and Spanish-speaking caregivers recruited from pediatric primary care clinics in Philadelphia and North Carolina will be enrolled. Caregivers assigned to the intervention regimen will attend PriCARE/CARIÑO and receive usual care. Caregivers assigned to the control regimen will receive usual care only. The primary outcome is occurrence of an investigation for CM by child protective services during the 48 months following completion of the intervention. In addition, scores for CM risk, child behavior problems, harsh and neglectful parenting behaviors, caregiver stress, and caregiver-child interactions will be assessed as secondary outcome measures and for investigation of possible mechanisms of intervention-induced change. We will also identify PriCARE/CARIÑO implementation factors that may be barriers and facilitators to intervention referrals, enrollment, and attendance. Discussion By evaluating proximal outcomes in addition to the distal outcome of CM, this study, the largest CM prevention trial with individual randomization, will help elucidate mechanisms of change and advance the science of CM prevention. This study will also gather critical information on factors influencing successful implementation and how to optimize intervention referrals, enrollment, and attendance to inform future dissemination and practical applications. Trial registration This trial was registered on ClinicalTrials.gov (NCT05233150) on February 1, 2022, prior to enrolling subjects.

Abstract Background There is a fundamental gap in understanding the causal mechanisms by which strategies for implementing evidence-based practices address local barriers to effective, appropriate service delivery. Until this gap is addressed, scientific knowledge and practical guidance about which implementation strategies to use in which contexts will remain elusive. This research project aims to identify plausible strategy-mechanism linkages, develop causal models for mechanism evaluation, produce measures needed to evaluate such linkages, and make these models, methods, and measures available in a user-friendly website. The specific aims are as follows: (1) build a database of strategy-mechanism linkages and associated causal pathway diagrams, (2) develop psychometrically strong, pragmatic measures of mechanisms, and (3) develop and disseminate a website of implementation mechanisms knowledge for use by diverse stakeholders. Methods For the first aim, a combination of qualitative inquiry, expert panel methods, and causal pathway diagramming will be used to identify and confirm plausible strategy-mechanism linkages and articulate moderators, preconditions, and proximal and distal outcomes associated with those linkages. For the second aim, rapid-cycle measure development and testing methods will be employed to create reliable, valid, pragmatic measures of six mechanisms of common strategies for which no high-quality measures exist. For the third aim, we will develop a user-friendly website and searchable database that incorporates user-centered design, disseminating the final product using social marketing principles. Discussion Once strategy-mechanism linkages are identified using this multi-method approach, implementation scientists can use the searchable database to develop tailored implementation strategies and generate more robust evidence about which strategies work best in which contexts. Moreover, practitioners will be better able to select implementation strategies to address their specific implementation problems. New horizons in implementation strategy development, optimization, evaluation, and deployment are expected to be more attainable as a result of this research, which will lead to enhanced implementation of evidence-based interventions for cancer control, and ultimately improvements in patient outcomes.

Abstract Background Despite their potential to ameliorate health disparities and address youth substance use, prevention programs have been poorly disseminated and implemented across Hawai‘i, which begs the question: Why are effective prevention programs not being used in communities most in need of them? Implementing and sustaining culturally grounded prevention programs is critical to address equitable healthcare and minimize health disparities in communities. The field of implementation science provides frameworks, theories, and methods to examine factors associated with community adoption of these programs. Method Our project applies concept mapping methods to a culturally grounded youth drug prevention program with state level educational leadership in rural Hawai‘i schools. The goal is to integrate barrier and facilitator salience collected through teacher and school staff surveys and specific implementation strategies to regionally tailored implementation plans on Hawai‘i island. This protocol paper describes the concept mapping steps and how they will be applied in public and public-charter schools. Discussion Improving prevention program implementation in rural schools can result in sustained support for populations that need it most. The project will integrate implementation science and culturally grounded methods in rural Hawai‘i, where most youth are of Native Hawaiian and Pacific Islander descent. This project addresses health disparities among Native Hawaiian and Pacific Islander youth and provides actionable plans for rural Hawai‘i communities to implement effective prevention programming.

Abstract Background Fidelity measurement of implementation strategies is underdeveloped and underreported, and the level of reporting is decreasing over time. Failing to properly measure the factors that affect the delivery of an implementation strategy may obscure the link between a strategy and its outcomes. Barriers to assessing and reporting implementation strategy fidelity among researchers are not well understood. The aims of this qualitative study were to identify barriers to fidelity measurement and pragmatic pathways towards improvement. Methods We conducted in-depth interviews among researchers conducting implementation trials. We utilized a theory-informed interview approach to elicit the barriers and possible solutions to implementation strategy fidelity assessment and reporting. Reflexive-thematic analysis guided coding and memo-writing to determine key themes regarding barriers and solutions. Results Twenty-two implementation researchers were interviewed. Participants agreed that implementation strategy fidelity was an essential element of implementation trials and that its assessment and reporting should improve. Key thematic barriers focused on (1) a current lack of validated fidelity tools with the need to assess fidelity in the short term, (2) the complex nature of some implementation strategies, (3) conceptual complications when assessing fidelity within mechanisms-focused implementation research, and (4) structural issues related to funding and publishing. Researchers also suggested pragmatic solutions to overcome each barrier. Respondents reported using specification and tracking data in the short term until validated tools become available. Participants suggested that researchers with strategy-specific content expertise lead the way in identifying core components and setting fidelity requirements for them. Addressing the third barrier, participants provided examples of what pragmatic prospective and retrospective fidelity assessments might look like along a mechanistic pathway. Finally, researchers described approaches to minimize costs of data collection, as well as more structural accountability like adopting and enforcing reporting guidelines or changing the structure of funding opportunities. Discussion We propose short- and long-term priorities for improving the assessment and reporting of implementation strategy fidelity and the quality of implementation research. Conclusions A better understanding of the barriers to implementation strategy fidelity assessment may pave the way towards pragmatic solutions.

Abstract Background The use of low-value care (LVC) is a persistent problem that calls for knowledge about strategies for de-implementation. However, studies are dispersed across many clinical fields, and there is no overview of strategies that can be used to support the de-implementation of LVC. The extent to which strategies used for implementation are also used in de-implementing LVC is unknown. The aim of this scoping review is to (1) identify strategies for the de-implementation of LVC described in the scientific literature and (2) compare de-implementation strategies to implementation strategies as specified in the Expert Recommendation for Implementing Change (ERIC) and strategies added by Perry et al. Method A scoping review was conducted according to recommendations outlined by Arksey and O’Malley. Four scientific databases were searched, relevant articles were snowball searched, and the journal Implementation Science was searched manually for peer-reviewed journal articles in English. Articles were included if they were empirical studies of strategies designed to reduce the use of LVC. Two reviewers conducted all abstract and full-text reviews, and conflicting decisions were discussed until consensus was reached. Data were charted using a piloted data-charting form. The strategies were first coded inductively and then mapped onto the ERIC compilation of implementation strategies. Results The scoping review identified a total of 71 unique de-implementation strategies described in the literature. Of these, 62 strategies could be mapped onto ERIC strategies, and four strategies onto one added category. Half (50%) of the 73 ERIC implementation strategies were used for de-implementation purposes. Five identified de-implementation strategies could not be mapped onto any of the existing strategies in ERIC. Conclusions Similar strategies are used for de-implementation and implementation. However, only a half of the implementation strategies included in the ERIC compilation were represented in the de-implementation studies, which may imply that some strategies are being underused or that they are not applicable for de-implementation purposes. The strategies assess and redesign workflow (a strategy previously suggested to be added to ERIC), accountability tool, and communication tool (unique new strategies for de-implementation) could complement the existing ERIC compilation when used for de-implementation purposes.

Abstract Background This study will explore implementation mechanisms through which a single implementation strategy and a multifaceted implementation strategy operate to affect the implementation outcome, which is fidelity to the Guideline For The Prevention of Mental Ill Health within schools. The guideline gives recommendations on how workplaces can prevent mental ill health among their personnel by managing social and organizational risks factors in the work environment. Schools are chosen as the setting for the study due to the high prevalence of mental ill health among teachers and other personnel working in schools. The study builds on our previous research, in which we compared the effectiveness of the two strategies on fidelity to the guideline. Small improvements in guideline adherence were observed for the majority of the indicators in the multifaceted strategy group. This study will focus on exploring the underlying mechanisms of change through which the implementation strategies may operate to affect the implementation outcome. Methods We will conduct a cluster-randomized-controlled trial among public schools (n=55 schools) in Sweden. Schools are randomized (1:1 ratio) to receive a multifaceted strategy (implementation teams, educational meeting, ongoing training, Plan-Do-Study-Act cycles) or a single strategy (implementation teams, educational meeting). The implementation outcome is fidelity to the guideline. Hypothesized mediators originate from the COM-B model. A mixed-method design will be employed, entailing a qualitative study of implementation process embedded within the cluster-randomized controlled trail examining implementation mechanisms. The methods will be used in a complementary manner to get a full understanding of the implementation mechanisms. Discussion This implementation study will provide valuable knowledge on how implementation strategies work (or fail) to affect implementation outcomes. The knowledge gained will aid the selection of effective implementation strategies that fit specific determinants, which is a priority for the field. Despite recent initiatives to advance the understanding of implementation mechanisms, studies testing these mechanisms are still uncommon. Trial registration ClinicalTrials.org dr.nr 2020-01214.

Abstract Background Efforts to generate evidence for implementation strategies are frustrated by insufficient description. The Expert Recommendations for Implementing Change (ERIC) compilation names and defines implementation strategies; however, further work is needed to describe the actions involved. One potentially complementary taxonomy is the behaviour change techniques (BCT) taxonomy. We aimed to examine the extent and nature of the overlap between these taxonomies. Methods Definitions and descriptions of 73 strategies in the ERIC compilation were analysed. First, each description was deductively coded using the BCT taxonomy. Second, a typology was developed to categorise the extent of overlap between ERIC strategies and BCTs. Third, three implementation scientists independently rated their level of agreement with the categorisation and BCT coding. Finally, discrepancies were settled through online consensus discussions. Additional patterns of complementarity between ERIC strategies and BCTs were labelled thematically. Descriptive statistics summarise the frequency of coded BCTs and the number of strategies mapped to each of the categories of the typology. Results Across the 73 strategies, 41/93 BCTs (44%) were coded, with ‘restructuring the social environment’ as the most frequently coded (n=18 strategies, 25%). There was direct overlap between one strategy (change physical structure and equipment) and one BCT (‘restructuring physical environment’). Most strategy descriptions (n=64) had BCTs that were clearly indicated (n=18), and others where BCTs were probable but not explicitly described (n=31) or indicated multiple types of overlap (n=15). For some strategies, the presence of additional BCTs was dependent on the form of delivery. Some strategies served as examples of broad BCTs operationalised for implementation. For eight strategies, there were no BCTs indicated, or they did not appear to focus on changing behaviour. These strategies reflected preparatory stages and targeted collective cognition at the system level rather than behaviour change at the service delivery level. Conclusions This study demonstrates how the ERIC compilation and BCT taxonomy can be integrated to specify active ingredients, providing an opportunity to better understand mechanisms of action. Our results highlight complementarity rather than redundancy. More efforts to integrate these or other taxonomies will aid strategy developers and build links between existing silos in implementation science.

Abstract Background Implementation science is at a sufficiently advanced stage that it is appropriate for the field to reflect on progress thus far in achieving its vision, with a goal of charting a path forward. In this debate, we offer such reflections and report on potential threats that might stymie progress, as well as opportunities to enhance the success and impact of the field, from the perspective of a group of US-based researchers. Main body Ten mid-career extramurally funded US-based researchers completed a “pre-mortem” or a group brainstorming exercise that leverages prospective hindsight to imagine that an event has already occurred and to generate an explanation for it — to reduce the likelihood of a poor outcome. We came to consensus on six key themes related to threats and opportunities for the field: (1) insufficient impact, (2) too much emphasis on being a “legitimate science,” (3) re-creation of the evidence-to-practice gap, (4) difficulty balancing accessibility and field coherence, (5) inability to align timelines and priorities with partners, and (6) overly complex implementation strategies and approaches. Conclusion We submit this debate piece to generate further discussion with other implementation partners as our field continues to develop and evolve. We hope the key opportunities identified will enhance the future of implementation research in the USA and spark discussion across international groups. We will continue to learn with humility about how best to implement with the goal of achieving equitable population health impact at scale.

Abstract Background The aim of this study was to explore healthcare professionals, managers, and other key employees’ experiences of oilcloth sessions as a strategy when implementing new emergency departments in Denmark, based on their participations in these sessions. The study addresses the importance of securing alignment in implementation strategies. Too often, this does not get enough attention in the literature and in practice. In this study, alignment among components was achieved in an educational implementation strategy called oilcloth sessions. Methods The study is based on participants’ observations of 13 oilcloth sessions and follow-up via 53 semi-structured interviews with the board of directors, managers, and key employees from the present emergency department and different specialty departments. Data were analysed deductively using Biggs and Tang’s model of didactic alignment. Results The analysis showed the complexity of challenges when using oilcloth sessions as a strategy when implementing a new emergency department described in terms of three phases and nine main themes (a–i): the preparation phase: (a) preparing individually and collectively, (b) objectives, (c) involving participants, (d) selecting cases; the execution phase: (e) using materials, (f) facilitating the sessions, (g) temporal structures; evaluation: (h) following up on the sessions, (i) adapting to the context. Conclusions This study shows that it is important to ensure alignment among elements in implementation strategies. Thus, oilcloth sessions with high alignment are useful if the challenges experienced are to be overcome and the strategy will be experienced as a useful way to support the implementation of a new emergency department from the participants’ point of view. Bigg and Tang's didactic model is useful as an analytical framework to ensure alignment in implementation strategies in general.

Abstract Background Implementation science has grown rapidly as a discipline over the past two decades. An examination of how publication patterns and other scholarly activities of implementation scientists are weighted in the tenure and promotion process is needed given the unique and applied focus of the field. Methods We surveyed implementation scientists (mostly from the USA) to understand their perspectives on the following matters: (1) factors weighted in tenure and promotion for implementation scientists, (2) how important these factors are for success as an implementation scientist, (3) how impact is defined for implementation scientists, (4) top journals in implementation science, and (5) how these journals are perceived with regard to their prestige. We calculated univariate descriptive statistics for all quantitative data, and we used Wilcoxon signed-rank tests to compare the participants’ ratings of various factors. We analyzed open-ended qualitative responses using content analysis. Results One hundred thirty-two implementation scientists completed the survey (response rate = 28.9%). Four factors were rated as more important for tenure and promotion decisions: number of publications, quality of publication outlets, success in obtaining external funding, and record of excellence in teaching. Six factors were rated as more important for overall success as an implementation scientist: presentations at professional meetings, involvement in professional service, impact of the implementation scientist’s scholarship on the local community and/or state, impact of the implementation scientist’s scholarship on the research community, the number and quality of the implementation scientist’s community partnerships, and the implementation scientist’s ability to disseminate their work to non-research audiences. Participants most frequently defined and described impact as changing practice and/or policy. This expert cohort identified Implementation Science as the top journal in the field. Conclusions Overall, there was a significant mismatch between the factors experts identified as being important to academic success (e.g., tenure and promotion) and the factors needed to be a successful implementation scientist. Findings have important implications for capacity building, although they are largely reflective of the promotion and tenure process in the USA.

Abstract Background The aim of the study is two-fold. It explores how managers and key employees at the Emergency Department (ED) and specialist departments in a university hospital in the Capital Region of Denmark respond to the planned change to a new ED, and how they perceive the change involved in the implementation of the new ED. The study investigates what happens when health professionals are confronted with implementation of policy that changes their organization and everyday work lives. Few studies provide in-depth investigations of health professionals’ reactions to the implementation of new EDs, and particularly how they influence the implementation of a nationwide organizational change framed within a political strategy. Methods The study used semi-structured individual interviews with 51 health professionals involved in implementation activities related to an organizational change of establishing a new ED with new patient pathways for acutely ill patients. The data was deductively analyzed using Leon Coetsee’s theoretical framework of change responses, but the analysis also allowed for a more inductive reading of the material. Results Fourteen types of responses to establishing a new ED were identified and mapped onto six of the seven overall change responses in Coetsee’s framework. The participants perceived the change as particularly three changes. Firstly, they wished to create the best possible acute patient pathway in relation to their specialty. Whether the planned new ED would redeem this was disputed. Secondly, participants perceived the change as relocation to a new building, which both posed potentials and worries. Thirdly, both hopeful and frustrated statements were given about the newly established medical specialty of emergency medicine (EM), which was connected to the success of the new ED. Conclusions The study showcases how implementation processes within health care are not straightforward and that it is not only the content of the implementation that determines the success of the implementation and its outcomes but also how these are perceived by managers and employees responsible for the process and their context. In this way, managers must recognize that it cannot be pre-determined how implementation will proceed, which necessitates fluid implementation plans and demands implementation managements skills.

Abstract Background This article provides a generalizable method, rooted in co-design and stakeholder engagement, to identify, specify, and prioritize implementation strategies. To illustrate this method, we present a case example focused on identifying strategies to promote pediatric hypertension (pHTN) Clinical Practice Guideline (CPG) implementation in community health center-based primary care practices that involved meaningful engagement of pediatric clinicians, clinic staff, and patients/caregivers. This example was chosen based on the difficulty clinicians and organizations experience in implementing the pHTN CPG, as evidenced by low rates of guideline-adherent pHTN diagnosis and treatment. Methods We convened a Stakeholder Advisory Panel (SAP), comprising 6 pediatricians and 5 academic partners, for 8 meetings (~12 h total) to rigorously identify determinants of pHTN CPG adherence and to ultimately develop a testable multilevel, multicomponent implementation strategy. Our approach expanded upon the Expert Recommendations for Implementation Change (ERIC) protocol by incorporating a modified Delphi approach, user-centered design methods, and the Implementation Research Logic Model (IRLM). At the recommendation of our SAP, we gathered further input from youth with or at-risk for pHTN and their caregivers, as well as clinic staff who would be responsible for carrying out facets of the implementation strategy. Results First, the SAP identified 17 determinants, and 18 discrete strategies were prioritized for inclusion. The strategies primarily targeted determinants in the domains of intervention characteristics, inner setting, and characteristics of the implementers. Based on SAP ratings of strategy effectiveness, feasibility, and priority, three tiers of strategies emerged, with 7 strategies comprising the top tier implementation strategy package. Next, input from caregivers and clinic staff confirmed the feasibility and acceptability of the implementation strategies and provided further detail in the definition and specification of those strategies. Conclusions This method—an adaptation of the ERIC protocol—provided a pragmatic structure to work with stakeholders to efficiently identify implementation strategies, particularly when supplemented with user-centered design activities and the intuitive organizing framework of the IRLM. This generalizable method can help researchers identify and prioritize strategies that align with the implementation context with an increased likelihood of adoption and sustained use.

Abstract Background Implementation facilitation is an effective strategy to support the implementation of evidence-based practices (EBPs), but our understanding of multilevel strategies and the mechanisms of change within the “black box” of implementation facilitation is limited. This implementation trial seeks to disentangle and evaluate the effects of facilitation strategies that separately target the care team and leadership levels on implementation of a collaborative care model in pediatric primary care. Strategies targeting the provider care team (TEAM) should engage team-level mechanisms, and strategies targeting leaders (LEAD) should engage organizational mechanisms. Methods We will conduct a hybrid type 3 effectiveness–implementation trial in a 2 × 2 factorial design to evaluate the main and interactive effects of TEAM and LEAD and test for mediation and moderation of effects. Twenty-four pediatric primary care practices will receive standard REP training to implement Doctor–Office Collaborative Care (DOCC) and then be randomized to (1) Standard REP only, (2) TEAM, (3) LEAD, or (4) TEAM + LEAD. Implementation outcomes are DOCC service delivery and change in practice-level care management competencies. Clinical outcomes are child symptom severity and quality of life. Discussion This statewide trial is one of the first to test the unique and synergistic effects of implementation strategies targeting care teams and practice leadership. It will advance our knowledge of effective care team and practice-level implementation strategies and mechanisms of change. Findings will support efforts to improve common child behavioral health conditions by optimizing scale-up and sustainment of CCMs in a pediatric patient-centered medical home. Trial registration ClinicalTrials.gov, NCT04946253 . Registered June 30, 2021.

Abstract Background Sustained delivery of evidence-based treatments (EBTs) is essential to addressing the public health and economic impacts of youth mental health problems, but is complicated by the limited and fragmented funding available to youth mental health service agencies (hereafter, “service agencies”). Strategic planning tools are needed that can guide these service agencies in their coordination of sustainable funding for EBTs. This protocol describes a mixed-methods research project designed to (1) develop and (2) evaluate our novel fiscal mapping process that guides strategic planning efforts to finance the sustainment of EBTs in youth mental health services. Method Participants will be 48 expert stakeholder participants, including representatives from ten service agencies and their partners from funding agencies (various public and private sources) and intermediary organizations (which provide guidance and support on the delivery of specific EBTs). Aim 1 is to develop the fiscal mapping process: a multi-step, structured tool that guides service agencies in selecting the optimal combination of strategies for financing their EBT sustainment efforts. We will adapt the fiscal mapping process from an established intervention mapping process and will incorporate an existing compilation of 23 financing strategies. We will then engage participants in a modified Delphi exercise to achieve consensus on the fiscal mapping process steps and gather information that can inform the selection of strategies. Aim 2 is to evaluate preliminary impacts of the fiscal mapping process on service agencies’ EBT sustainment capacities (i.e., structures and processes that support sustainment) and outcomes (e.g., intentions to sustain). The ten agencies will pilot test the fiscal mapping process. We will evaluate how the fiscal mapping process impacts EBT sustainment capacities and outcomes using a comparative case study approach, incorporating data from focus groups and document review. After pilot testing, the stakeholder participants will conceptualize the process and outcomes of fiscal mapping in a participatory modeling exercise to help inform future use and evaluation of the tool. Discussion This project will generate the fiscal mapping process, which will facilitate the coordination of an array of financing strategies to sustain EBTs in community youth mental health services. This tool will promote the sustainment of youth-focused EBTs.

Abstract Background Selecting appropriate strategies to target barriers to implementing interventions represents a considerable challenge in implementation research and practice. The aim was to investigate what categories of implementation strategies were selected by health care practitioners and their managers in a co-design process and how they justified these strategies aimed at facilitating the implementation of the WALK-Cph intervention. Methods The study used a qualitative research design to explore what implementation strategies were selected and the justifications for selecting these strategies. Workshops were used because this qualitative method is particularly well suited for studying co-design processes that involve substantial attention to social interaction and the context. Data were 1) analyzed deductively based on the Proctor et al. taxonomy of implementation strategies, 2) categorized in accordance with the ERIC compilation of implementation strategies by Powell et al., and 3) analyzed to examine the justification for the selected strategies by the Proctor et al. framework for justifications of implementation strategies. Results Thirteen different types of implementation strategies were chosen across two hospitals. The deductive analysis showed that selection of implementation strategies was based on pragmatic and theoretical justifications. The contents of the two types of justifications were thematized into nine subthemes. Conclusion This study contributes with knowledge about categories and justification of implementation strategies selected in a co-design process. In this study, implementation strategies were selected through pragmatic and theoretical justifications. This points to a challenge in balancing strategies based on practice-based and research-based knowledge and thereby selection of strategies with or without proven effectiveness.

Abstract Background While few countries and healthcare systems are on track to meet the World Health Organization’s hepatitis C virus (HCV) elimination goals, the US Veterans Health Administration (VHA) has been a leader in these efforts. We aimed to determine which implementation strategies were associated with successful national viral elimination implementation within the VHA. Methods We conducted a five-year, longitudinal cohort study of the VHA Hepatic Innovation Team (HIT) Collaborative between October 2015 and September 2019. Participants from 130 VHA medical centers treating HCV were sent annual electronic surveys about their use of 73 implementation strategies, organized into nine clusters as described by the Expert Recommendations for Implementing Change taxonomy. Descriptive and nonparametric analyses assessed strategy use over time, strategy attribution to the HIT, and strategy associations with site HCV treatment volume and rate of adoption, following the Theory of Diffusion of Innovations. Results Between 58 and 109 medical centers provided responses in each year, including 127 (98%) responding at least once, and 54 (42%) responding in all four implementation years. A median of 13–27 strategies were endorsed per year, and 8–36 individual strategies were significantly associated with treatment volume per year. Data warehousing, tailoring, and patient-facing strategies were most commonly endorsed. One strategy—“identify early adopters to learn from their experiences”—was significantly associated with HCV treatment volume in each year. Peak implementation year was associated with revising professional roles, providing local technical assistance, using data warehousing (i.e., dashboard population management), and identifying and preparing champions. Many of the strategies were driven by a national learning collaborative, which was instrumental in successful HCV elimination. Conclusions VHA’s tremendous success in rapidly treating nearly all Veterans with HCV can provide a roadmap for other HCV elimination initiatives.

Background Mental health is a critical component of wellness. Public policies present an opportunity for large-scale mental health impact, but policy implementation is complex and can vary significantly across contexts, making it crucial to evaluate implementation. The objective of this study was to (1) identify quantitative measurement tools used to evaluate the implementation of public mental health policies; (2) describe implementation determinants and outcomes assessed in the measures; and (3) assess the pragmatic and psychometric quality of identified measures. Method Guided by the Consolidated Framework for Implementation Research, Policy Implementation Determinants Framework, and Implementation Outcomes Framework, we conducted a systematic review of peer-reviewed journal articles published in 1995–2020. Data extracted included study characteristics, measure development and testing, implementation determinants and outcomes, and measure quality using the Psychometric and Pragmatic Evidence Rating Scale. Results We identified 34 tools from 25 articles, which were designed for mental health policies or used to evaluate constructs that impact implementation. Many measures lacked information regarding measurement development and testing. The most assessed implementation determinants were readiness for implementation, which encompassed training ( n = 20, 57%) and other resources ( n = 12, 34%), actor relationships/networks ( n = 15, 43%), and organizational culture and climate ( n = 11, 31%). Fidelity was the most prevalent implementation outcome ( n = 9, 26%), followed by penetration ( n = 8, 23%) and acceptability ( n = 7, 20%). Apart from internal consistency and sample norms, psychometric properties were frequently unreported. Most measures were accessible and brief, though minimal information was provided regarding interpreting scores, handling missing data, or training needed to administer tools. Conclusions This work contributes to the nascent field of policy-focused implementation science by providing an overview of existing measurement tools used to evaluate mental health policy implementation and recommendations for measure development and refinement. To advance this field, more valid, reliable, and pragmatic measures are needed to evaluate policy implementation and close the policy-to-practice gap. Plain Language Summary Mental health is a critical component of wellness, and public policies present an opportunity to improve mental health on a large scale. Policy implementation is complex because it involves action by multiple entities at several levels of society. Policy implementation is also challenging because it can be impacted by many factors, such as political will, stakeholder relationships, and resources available for implementation. Because of these factors, implementation can vary between locations, such as states or countries. It is crucial to evaluate policy implementation, thus we conducted a systematic review to identify and evaluate the quality of measurement tools used in mental health policy implementation studies. Our search and screening procedures resulted in 34 measurement tools. We rated their quality to determine if these tools were practical to use and would yield consistent (i.e., reliable) and accurate (i.e., valid) data. These tools most frequently assessed whether implementing organizations complied with policy mandates and whether organizations had the training and other resources required to implement a policy. Though many were relatively brief and available at little-to-no cost, these findings highlight that more reliable, valid, and practical measurement tools are needed to assess and inform mental health policy implementation. Findings from this review can guide future efforts to select or develop policy implementation measures.

Background: Tailoring strategies to target the salient barriers to and enablers of implementation is considered a critical step in supporting successful delivery of evidence based interventions in healthcare. Theory, evidence, and stakeholder engagement are considered key ingredients in the process however, these ingredients can be combined in different ways. There is no consensus on the definition of tailoring or single method for tailoring strategies to optimize impact, ensure transparency, and facilitate replication. Aim: The purpose of this scoping review is to describe how tailoring has been undertaken within healthcare to answer questions about how it has been conceptualised, described, and conducted in practice, and to identify research gaps. Methods: The review will be conducted in accordance with best practice guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for scoping reviews (PRISMA-ScR) will be used to guide the reporting. Searches will be conducted of MEDLINE, Embase, Web of Science, Scopus, from 2005 to present. Reference lists of included articles will be searched. Grey literature will be searched on Google Scholar. Screening and data extraction will be conducted by two or more members of the research team, with any discrepancies resolved by consensus discussion with a third reviewer. Initial analysis will be quantitative involving a descriptive numerical summary of the characteristics of the studies and the tailoring process. Qualitative content analysis aligned to the research questions will also be conducted, and data managed using NVivo where applicable. This scoping review is pre-registered with the Open Science Framework. Conclusions: The findings will serve a resource for implementation researchers and practitioners to guide future research in this field and facilitate systematic, transparent, and replicable development of tailored implementation strategies.

Background Strategies to implement evidence-based interventions (EBIs) in children’s mental health services have complex direct and indirect causal impacts on multiple outcomes. Ripple effects are outcomes caused by EBI implementation efforts that are unplanned, unanticipated, and/or more salient to stakeholders other than researchers and implementers. The purpose of the current paper is to provide a compilation of possible ripple effects associated with EBI implementation strategies in children’s mental health services, to be used for implementation planning, research, and quality improvement. Methods Participants were identified via expert nomination and snowball sampling. Online surveys were completed by 81 participants, each representing one of five roles: providers of mental health services to children or youth, researchers, policy makers, caregivers, and youth. A partially directed conventional content analysis with consensus decision making was used to code ripple effects. Results Four hundred and four unique responses were coded into 66 ripple effects and 14 categories. Categories include general knowledge, skills, attitudes, and confidence about using EBIs; general job-related ripple effects; EBI treatment adherence, fidelity, and alignment; gaming the system; equity and stigma; shifting roles, role clarity, and task shifting; economic costs and benefits; EBI treatment availability, access, participation, attendance, barriers, and facilitators; clinical process and treatment quality; client engagement, therapeutic alliance, and client satisfaction; clinical organization structure, relationships in the organization, process, and functioning; youth client and caregiver outcomes; and use of EBI strategies and insights in one’s own life. Conclusions This research advances the field by providing children’s mental health implementers, researchers, funders, policy makers, and consumers with a menu of potential ripple effects. It can be a practical tool to ensure compliance with guidance from Quality Improvement/Quality Assurance, Complexity Science, and Diffusion of Innovation Theory. Future phases will match potential ripple effects with salient children’s mental health implementation strategies for each participant role. Plain Language Summary: This qualitative study of multiple stakeholders in children’s mental health services identifies several possible ripple effects of implementation strategies, opening a new area of study for implementation science. Ripple effects can be positive, negative, or neutral within the full balance of implementation quality and impact. The list of ripple effects will provide implementation scientists, developers, and others with a useful tool during implementation planning and evaluation. This expert-informed methodology can provide a model for other fields for exploring possible ripple effects within implementation science.

Abstract Background Sustainment has been defined as the sustained use or delivery of an intervention in practice following cessation of external implementation support. This review aimed to identify and synthesise factors (barriers and facilitators) that influence the sustainment of interventions (policies, practices, or programmes) in schools and childcare services that address the leading risk factors of chronic disease. Methods Seven electronic databases and relevant reference lists were searched for articles, of any design, published in English, from inception to March 2020. Articles were included if they qualitatively and/or quantitatively reported on school or childcare stakeholders’ (including teachers, principals, administrators, or managers) perceived barriers or facilitators to the sustainment of interventions addressing poor diet/nutrition, physical inactivity, obesity, tobacco smoking, or harmful alcohol use. Two independent reviewers screened texts, and extracted and coded data guided by the Integrated Sustainability Framework, an existing multi-level sustainability-specific framework that assesses factors of sustainment. Results Of the 13,158 articles identified, 31 articles met the inclusion criteria (8 quantitative, 12 qualitative, 10 mixed-methods, and 1 summary article). Overall, 29 articles were undertaken in schools (elementary n=17, middle n=3, secondary n=4, or a combination n=5) and two in childcare settings. The main health behaviours targeted included physical activity (n=9), diet (n=3), both diet and physical activity (n=15), and smoking (n=4), either independently (n=1) or combined with other health behaviours (n=3). Findings suggest that the majority of the 59 barriers and 74 facilitators identified to impact on intervention sustainment were similar across school and childcare settings. Factors predominantly relating to the ‘inner contextual factors’ of the organisation including: availability of facilities or equipment, continued executive or leadership support present, and team cohesion, support, or teamwork were perceived by stakeholders as influential to intervention sustainment. Conclusions Identifying strategies to improve the sustainment of health behaviour interventions in these settings requires a comprehensive understanding of factors that may impede or promote their ongoing delivery. This review identified multi-level factors that can be addressed by strategies to improve the sustainment of such interventions, and suggests how future research might address gaps in the evidence base. Trial registration This review was prospectively registered on PROSPERO: CRD42020127869 , Jan. 2020.

Abstract Background Developing effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for describing how strategies are adapted and modified in practice. We built on existing implementation science methods to provide novel methods for tracking strategy modifications. Methods These methods were developed within a stepped-wedge trial of an implementation strategy package designed to help community clinics adopt social determinants of health-related activities: in brief, an ‘Implementation Support Team’ supports clinics through a multi-step process. These methods involve five components: 1) describe planned strategy; 2) track its use; 3) monitor barriers; 4) describe modifications; and 5) identify / describe new strategies. We used the Expert Recommendations for Implementing Change taxonomy to categorize strategies, Proctor et al.’s reporting framework to describe them, the Consolidated Framework for Implementation Research to code barriers / contextual factors necessitating modifications, and elements of the Framework for Reporting Adaptations and Modifications-Enhanced to describe strategy modifications. Results We present three examples of the use of these methods: 1) modifications made to a facilitation-focused strategy (clinics reported that certain meetings were too frequent, so their frequency was reduced in subsequent wedges); 2) a clinic-level strategy addition which involved connecting one study clinic seeking help with community health worker-related workflows to another that already had such a workflow in place; 3) a study-level strategy addition which involved providing assistance in overcoming previously encountered (rather than de novo) challenges. Conclusions These methods for tracking modifications made to implementation strategies build on existing methods, frameworks, and guidelines; however, as none of these were a perfect fit, we made additions to several frameworks as indicated, and used certain frameworks’ components selectively. While these methods are time-intensive, and more work is needed to streamline them, they are among the first such methods presented to implementation science. As such, they may be used in research on assessing effective strategy modifications and for replication and scale-up of effective strategies. We present these methods to guide others seeking to document implementation strategies and modifications to their studies. Trial registration clinicaltrials.gov ID: NCT03607617 (first posted 31/07/2018).

Abstract Background Implementation researchers are increasingly using economic evaluation to explore the benefits produced by implementing evidence-based practices (EBPs) in healthcare settings. However, the findings of typical economic evaluations (e.g., based on clinical trials) are rarely sufficient to inform decisions about how health service organizations and policymakers should finance investments in EBPs. This paper describes how economic evaluations can be translated into policy and practice through complementary research on financing strategies that support EBP implementation and sustainment. Main body We provide an overview of EBP implementation financing, which outlines key financing and health service delivery system stakeholders and their points of decision-making. We then illustrate how economic evaluations have informed decisions about EBP implementation and sustainment with three case examples: (1) use of Pay-for-Success financing to implement multisystemic therapy in underserved areas of Colorado, USA, based in part on the strength of evidence from economic evaluations; (2) an alternative payment model to sustain evidence-based oncology care, developed by the US Centers for Medicare and Medicaid Services through simulations of economic impact; and (3) use of a recently developed fiscal mapping process to collaboratively match financing strategies and needs during a pragmatic clinical trial for a newly adapted family support intervention for opioid use disorder. Conclusions EBP financing strategies can help overcome cost-related barriers to implementing and sustaining EBPs by translating economic evaluation results into policy and practice. We present a research agenda to advance understanding of financing strategies in five key areas raised by our case examples: (1) maximize the relevance of economic evaluations for real-world EBP implementation; (2) study ongoing changes in financing systems as part of economic evaluations; (3) identify the conditions under which a given financing strategy is most beneficial; (4) explore the use and impacts of financing strategies across pre-implementation, active implementation, and sustainment phases; and (5) advance research efforts through strong partnerships with stakeholder groups while attending to issues of power imbalance and transparency. Attention to these research areas will develop a robust body of scholarship around EBP financing strategies and, ultimately, enable greater public health impacts of EBPs.

Abstract Background Antibiotic-resistant infections have become a public health crisis that is driven by the inappropriate use of antibiotics. In the USA, antibiotic stewardship programs (ASP) have been established and are required by regulatory agencies to help combat the problem of antibiotic resistance. Post-operative antibiotic use in surgical cases deemed low-risk for infection is an area with significant overuse of antibiotics in children. Consensus among leading public health organizations has led to guidelines eliminating post-operative antibiotics in low-risk surgeries. However, the best strategies to de-implement these inappropriate antibiotics in this setting are unknown. Methods/design A 3-year stepped wedge cluster randomized trial will be conducted at nine US Children’s Hospitals to assess the impact of two de-implementation strategies, order set change and facilitation training, on inappropriate post-operative antibiotic prescribing in low risk (i.e., clean and clean-contaminated) surgical cases. The facilitation training will amplify order set changes and will involve a 2-day workshop with antibiotic stewardship teams. This training will be led by an implementation scientist expert (VRM) and a pediatric infectious diseases physician with antibiotic stewardship expertise (JGN). The primary clinical outcome will be the percentage of surgical cases receiving unnecessary post-operative antibiotics. Secondary clinical outcomes will include the rate of surgical site infections and the rate of Clostridioides difficile infections, a common negative consequence of antibiotic use. Monthly semi-structured interviews at each hospital will assess the implementation process of the two strategies. The primary implementation outcome is penetration, which will be defined as the number of order sets changed or developed by each hospital during the study. Additional implementation outcomes will include the ASP team members’ assessment of the acceptability, appropriateness, and feasibility of each strategy while they are being implemented. Discussion This study will provide important information on the impact of two potential strategies to de-implement unnecessary post-operative antibiotic use in children while assessing important clinical outcomes. As more unnecessary medical practices are identified, de-implementation strategies, including facilitation, need to be rigorously evaluated. Along with this study, other rigorously designed studies evaluating additional strategies are needed to further advance the burgeoning field of de-implementation. Trial registration NCT04366440. Registered April 28, 2020, https://clinicaltrials.gov/ct2/show/NCT04366440 .

Background: This practical implementation report describes a primary care-based group parenting intervention—Child–Adult Relationship Enhancement in Primary Care (PriCARE)—and the approach taken to understand and strengthen the referral process for PriCARE within a pediatric primary care clinic through the deployment of synergistic implementation strategies to promote physician referrals. PriCARE has evidence of effectiveness for reducing child behavior problems, harsh and permissive parenting, and parent stress from three randomized controlled trials (RCTs). The integration of evidence-based parenting interventions into pediatric primary care is a promising means for widespread dissemination. Yet, even when integrated into this setting, the true reach will depend on parents knowing about and attending the intervention. A key factor in this process is the endorsement of and referral to the intervention by the child's pediatrician. Therefore, identifying strategies to improve physician referrals to parenting interventions embedded in primary care is worthy of investigation. Method: Through lessons learned from the RCTs and key informant interviews with stakeholders, we identified barriers and facilitators to physician referrals of eligible parent–child dyads to PriCARE. Based on this data, we selected and implemented five strategies to increase the PriCARE referral rate. We outline the selection process, the postulated synergistic interactions, and the results of these efforts. Conclusions: The following five discrete strategies were implemented: physician reminders, direct advertising to patients, incentives/public recognition, interpersonal patient narratives, and audit and feedback. These discrete strategies were synergistically combined to create a multifaceted approach to improve physician referrals. Following implementation, referrals increased from 13% to 55%. Continued development, application, and evaluation of implementation strategies to promote the uptake of evidence-based parenting interventions into general use in the primary care setting are discussed. Plain Language Summary There is strong evidence that parenting interventions are effective at improving child behavioral health outcomes when delivered in coordination with pediatric primary care. However, there is a lack of focus on the implementation, including the screening and referral process, of parenting interventions in the primary care setting. This is contributing to the delay in the scale-up of parenting interventions and to achieving public health impact. To address this gap, we identified barriers and facilitators to physician screening and referrals to a primary care-based parenting intervention, and selected and piloted five synergistic strategies to improve this critical process. This effort successfully increased physician referrals of eligible patients to the intervention from 13% to 55%. This demonstration project may help advance the implementation of evidence-based interventions by providing an example of how to develop and execute multilevel strategies to improve intervention referrals in a local context.

Elvin Hsing Geng and colleagues discuss mechanism mapping and its utility in conceptualizing and understanding how implementation strategies produce desired effects.

Abstract Background Cirrhosis is a rapidly increasing cause of global mortality. To improve cirrhosis care, the Veterans Health Administration (VHA) developed the Hepatic Innovation Team (HIT) Collaborative to support VA Medical Centers (VAMCs) to deliver evidence-based cirrhosis care. This randomized HIT program evaluation aims to develop and assess a novel approach for choosing and applying implementation strategies to improve the quality of cirrhosis care. Methods Evaluation aims are to (1) empirically determine which combinations of implementation strategies are associated with successful implementation of evidence-based practices (EBPs) for Veterans with cirrhosis, (2) manualize these “data-driven” implementation strategies, and (3) assess the effectiveness of data-driven implementation strategies in increasing cirrhosis EBP uptake. Aim 1 will include an online survey of all VAMCs’ use of 73 implementations strategies to improve cirrhosis care, as defined by the Expert Recommendations for Implementing Change taxonomy. Traditional statistical as well as configurational comparative methods will both be employed to determine which combinations of implementation strategies are associated with site-level adherence to EBPs for cirrhosis. In aim 2, semi-structured interviews with high-performing VAMCs will be conducted to operationalize successful implementation strategies for cirrhosis care. These data will be used to inform the creation of a step-by-step guide to tailoring and applying the implementation strategies identified in aim 1. In aim 3, this manualized implementation intervention will be assessed using a hybrid type III stepped-wedge cluster randomized design. This evaluation will be conducted in 12 VAMCs, with four VAMCs crossing from control to intervention every 6 months, in order to assess the effectiveness of using data-driven implementation strategies to improve guideline-concordant cirrhosis care. Discussion Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care. This evaluation will provide implementation support tools that can be applied to enhance the implementation of other evidence-based practices. Trial registration This project was registered at ClinicalTrials.Gov ( NCT04178096 ) on 4/29/20.

Abstract Background Implementation research infrequently addresses economic factors, despite the importance of understanding the costs of implementing evidence-based practices (EBPs). Though partnerships with health economists have the potential to increase attention to economic factors within implementation science, barriers to forming these collaborations have been noted. This study investigated the experiences of health economists and implementation researchers who have partnered across disciplines to inform strategies to increase such collaborations. Methods A purposeful sampling approach was used to identify eight health economists and eight implementation researchers with experience participating in cross-disciplinary research. We used semi-structured interviews to gather information about participants’ experiences with collaborative research. Thematic analysis was conducted to identify core themes related to facilitators and barriers to collaborations. Results Health economists and implementation researchers voiced different perspectives on collaborative research, highlighting the importance of increasing cross-disciplinary understanding. Implementation researchers described a need to measure costs in implementation studies, whereas many health economists described that they seek to collaborate on projects that extend beyond conducting cost analyses. Researchers in both disciplines articulated motivations for collaborative research and identified strategies that promote successful collaboration, with varying degrees of convergence across these themes. Shared motivations included improving methodological rigor of research and making a real-world impact. Strategies to improve collaboration included starting partnerships early in the study design period, having a shared interest, and including health economists in the larger scope of the research. Conclusions Health economists and implementation researchers both conduct research with significant policy implications and have the potential to inform one another’s work in ways that might more rapidly advance the uptake of EBPs. Collaborative research between health economists and implementation science has the potential to advance the field; however, researchers will need to work to bridge disciplinary differences. By beginning to develop strong working relationships; increasing their understanding of one another’s disciplinary culture, methodology, and language; and increasing the role economists have within research design and execution, both implementation researchers and health economists can support successful collaborations and robust and informative research.

Abstract Background People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam. Methods Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs. Participants: HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months. Outcomes: Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm. Discussion Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation. Trial registration NCT03952520 on Clinialtrials.gov. Registered 16 May 2019.

Abstract Background Cross-system interventions can help integrate services across different service delivery systems but require organizations to establish strong collaborative relationships for implementation. Contingency theory suggests that the effectiveness of different collaborative strategies (i.e. specific ways organizations align operations and services) varies by context. This paper describes a study of different strategies for fostering collaboration between child welfare and substance abuse treatment agencies and the conditions under which they are effective for implementation. We also describe the development and piloting of the Collaborating Across Systems for Program Implementation (CASPI) tool—a decision-making guide intended to help researchers and organizational leaders identify and use appropriate collaborative strategies for their context. Methods/design This multisite longitudinal, mixed methods study, leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma). START is a child welfare model that requires strong collaboration with local substance use treatment organizations to promote integrated services. During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features. We will conduct a convergent mixed methods study drawing on worker surveys, agency documents, administrative data, formal partner agreements, and group interviews. Data will be integrated and analyzed using Qualitative Comparative Analysis (QCA). To develop the CASPI, an expert panel comprised of implementation experts, and community stakeholders will convene to synthesize our findings and develop contents (including a decision tree). During the final year of the study, we will assess the acceptability, appropriateness, and feasibility of the CASPI in a randomized vignette experiment, and a pilot-test with 3 child welfare agencies that have not yet implemented START. Discussion Our results will lay the groundwork for a larger controlled trial that will test the CASPI’s effectiveness for supporting effective and efficient implementation of cross-system interventions like START. The CASPI is expected to help leaders and researchers select and use collaboration strategies tailored to their context and be applicable in a wide range of settings including rural communities. Our work also advances system-level implementation strategies. Trial registration NCT03931005 , Registered April 29, 2019.

Abstract Background One of the key conceptual challenges in advancing our understanding of how to more effectively sustain innovations in health care is the lack of clarity and agreement on what sustainability actually means. Several reviews have helped synthesize and clarify how researchers conceptualize and operationalize sustainability. In this study, we sought to identify how individuals who implement and/or sustain evidence-informed innovations in health care define sustainability. Methods We conducted in-depth, semi-structured interviews with implementation leaders and relevant staff involved in the implementation of evidence-based innovations relevant to cancer survivorship care (n = 27). An inductive approach, using constant comparative analysis, was used for analysis of interview transcripts and field notes. Results Participants described sustainability as an ongoing and dynamic process that incorporates three key concepts and four important conditions. The key concepts were: (1) continued capacity to deliver the innovation, (2) continued delivery of the innovation, and (3) continued receipt of benefits. The key conditions related to (2) and (3), and included: (2a) innovations must continue in the absence of the champion or person/team who introduced it and (3a) adaptation is critical to ensuring relevancy and fit, and thus to delivering the intended benefits. Conclusions Participants provided a nuanced view of sustainability, with both continued delivery and continued benefits only relevant under certain conditions. The findings reveal the interconnected elements of what sustainability means in practice, providing a unique and important perspective to the academic literature.

Abstract Background Implementing and sustaining evidence-based programs with fidelity may require multiple implementation strategies tailored to address multi-level, context-specific barriers and facilitators. Ideally, selecting and tailoring implementation strategies should be guided by theory, evidence, and input from relevant stakeholders; however, methods to guide the selection and tailoring of strategies are not well-developed. There is a need for more rigorous methods for assessing and prioritizing implementation determinants (barriers and facilitators) and linking implementation strategies to determinants. The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment. COAST-IS will enable organizational leaders and clinicians to use Intervention Mapping to select and tailor implementation strategies to address their site-specific needs. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change. Methods COAST-IS will be piloted with community mental health organizations that are working to address the needs of children and youth who experience trauma-related emotional or behavioral difficulties by engaging in a learning collaborative to implement an evidence-based psychosocial intervention (trauma-focused cognitive behavioral therapy). Organizations will be matched and then randomized to participate in the learning collaborative only (control) or to receive additional support through COAST-IS. The primary aims of this study are to (1) assess the acceptability, appropriateness, feasibility, and perceived utility of COAST-IS; (2) evaluate the organizational stakeholders’ fidelity to the core elements of COAST-IS; and (3) demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. Discussion COAST-IS is a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. If effective, COAST-IS has the potential to improve the implementation and sustainment of a wide range of evidence-based practices in mental health and other sectors. Trial registration This study was registered in ClinicalTrials.gov ( NCT03799432 ) on January 10, 2019 (last updated August 5, 2019).