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Abstract Background Implementation strategies can help support the adoption and implementation of health interventions that are appropriate for a local context and acceptable to decision makers and community members. Implementation strategies should be designed to handle the complexity of the multi-level, dynamic contexts in which interventions are implemented. Systems science theories and methods explicitly attend to complexity and can be valuable for specifying implementation strategies. Group Model Building (GMB) combines research partner engagement strategies with systems science to support researchers’ and partners’ learning about complex problems and to identify solutions through consensus. This paper specifies how GMB can operationalize implementation strategies — methods for supporting evidence implementation in real-world practice — and describes how GMB can aid in selecting and tailoring both health interventions and implementation strategies. A case study in child maltreatment prevention planning is provided to illustrate how GMB was used to specify the “actions” — strategy activities — for three implementation strategies (conduct local consensus discussions; build a coalition; model and simulate change) during the earliest implementation phases, with the goal of supporting intervention selection decisions. Examples are provided of generalizable research products that can be produced concurrently through GMB, in addition to contextually-driven implementation support. Methods Participants (n = 8) were engaged over four sessions using tailored GMB activities. Participants generated a qualitative system dynamics model that described their theory of change for how to prevent child maltreatment in their communities. This theory of change reflected a dynamic understanding of the interconnected determinants of child maltreatment. Results GMB was acceptable to participants and resulted in products that could be used for implementation planning (e.g., to model and simulate change) and future research. GMB fostered trust and idea sharing between participants. Conclusion GMB can facilitate learning about which outcomes are (or are not) impacted by interventions, which resources and approaches are required for quality implementation (e.g., implementation strategies), and tradeoffs in outcomes and resources between interventions. GMB also provides a structured, effective process to generate a shared implementation vision amongst participants. Lessons learned include methods for developing trust with and between participants, and the need for researchers to tailor GMB actions for participant and project needs.

Abstract Background In healthcare research and practice, intervention and implementation fidelity represent the steadfast adherence to core components of research-supported interventions and the strategies employed for their implementation. Evaluating fidelity involves determining whether these core components were delivered as intended. Without fidelity data, the results of complex interventions cannot be meaningfully interpreted. Increasingly, the necessity for firmness and strict adherence by implementers and their organizations has been questioned, with calls for flexibility to accommodate contextual conditions. This shift makes contemporary fidelity a balancing act, requiring researchers to navigate various tensions. This debate paper explores these tensions, drawing on experiences from developing fidelity assessments in two ongoing effectiveness-implementation hybrid trials. Main body First, given often scarce knowledge about the core components of complex interventions and implementation strategies, decisions about fidelity requirements involve a degree of subjective reasoning. Researchers should make these decisions transparent using theory or logic models. Second, because fidelity is context-dependent and applies to both interventions and implementation strategies, researchers must rethink fidelity concepts with every study while balancing firmness and flexibility. This is particularly crucial for hybrid studies, with their differing emphasis on intervention and implementation fidelity. Third, fidelity concepts typically focus on individual behaviors. However, since organizational and system factors also influence fidelity, there is a growing need to define fidelity criteria at these levels. Finally, as contemporary fidelity concepts prioritize flexible over firm adherence, building, evaluating, and maintaining fidelity in healthcare research has become more complex. This complexity calls for intensified efforts to expand the knowledge base for pragmatic and adaptive fidelity measurement in trial and routine healthcare settings. Conclusion Contemporary conceptualizations of fidelity place greater demands on how fidelity is examined, necessitating the expansion of fidelity frameworks to include organizational and system levels, the service- and study-specific conceptualizations of intervention and implementation fidelity, and the development of pragmatic approaches for assessing fidelity in research and practice. Continuing to build knowledge on how to balance requirements for firmness and flexibility remains a crucial task within the field of implementation science.

Abstract Background Studies of implementation strategies range in rigor, design, and evaluated outcomes, presenting interpretation challenges for practitioners and researchers. This systematic review aimed to describe the body of research evidence testing implementation strategies across diverse settings and domains, using the Expert Recommendations for Implementing Change (ERIC) taxonomy to classify strategies and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework to classify outcomes. Methods We conducted a systematic review of studies examining implementation strategies from 2010-2022 and registered with PROSPERO (CRD42021235592). We searched databases using terms “implementation strategy”, “intervention”, “bundle”, “support”, and their variants. We also solicited study recommendations from implementation science experts and mined existing systematic reviews. We included studies that quantitatively assessed the impact of at least one implementation strategy to improve health or health care using an outcome that could be mapped to the five evaluation dimensions of RE-AIM. Only studies meeting prespecified methodologic standards were included. We described the characteristics of studies and frequency of implementation strategy use across study arms. We also examined common strategy pairings and cooccurrence with significant outcomes. Findings Our search resulted in 16,605 studies; 129 met inclusion criteria. Studies tested an average of 6.73 strategies (0-20 range). The most assessed outcomes were Effectiveness (n=82; 64%) and Implementation (n=73; 56%). The implementation strategies most frequently occurring in the experimental arm were Distribute Educational Materials (n=99), Conduct Educational Meetings (n=96), Audit and Provide Feedback (n=76), and External Facilitation (n=59). These strategies were often used in combination. Nineteen implementation strategies were frequently tested and associated with significantly improved outcomes. However, many strategies were not tested sufficiently to draw conclusions. Conclusion This review of 129 methodologically rigorous studies built upon prior implementation science data syntheses to identify implementation strategies that had been experimentally tested and summarized their impact on outcomes across diverse outcomes and clinical settings. We present recommendations for improving future similar efforts.

Abstract Background Implementation science researchers often cite clinical champions as critical to overcoming organizational resistance and other barriers to the implementation of evidence-based health services, yet relatively little is known about who champions are or how they effect change. To inform future efforts to identify and engage champions to support HPV vaccination, we sought to describe the key characteristics and strategies of vaccine champions working in adolescent primary care. Methods In 2022, we conducted a national survey with a web-based panel of 2527 primary care professionals (PCPs) with a role in adolescent HPV vaccination (57% response rate). Our sample consisted of pediatricians (26%), family medicine physicians (22%), advanced practice providers (24%), and nursing staff (28%). Our survey assessed PCPs’ experience with vaccine champions, defined as health care professionals “known for helping their colleagues improve vaccination rates.” Results Overall, 85% of PCPs reported currently working with one or more vaccine champions. Among these 2144 PCPs, most identified the champion with whom they worked most closely as being a physician (40%) or nurse (40%). Almost all identified champions worked to improve vaccination rates for vaccines in general (45%) or HPV vaccine specifically (49%). PCPs commonly reported that champion implementation strategies included sharing information (79%), encouragement (62%), and vaccination data (59%) with colleagues, but less than half reported that champions led quality improvement projects (39%). Most PCPs perceived their closest champion as being moderately to extremely effective at improving vaccination rates (91%). PCPs who did versus did not work with champions more often recommended HPV vaccination at the earliest opportunity of ages 9–10 rather than later ages (44% vs. 33%, p < 0.001). Conclusions Findings of our national study suggest that vaccine champions are common in adolescent primary care, but only a minority lead quality improvement projects. Interventionists seeking to identify champions to improve HPV vaccination rates can expect to find them among both physicians and nurses, but should be prepared to offer support to more fully engage them in implementing interventions.

Abstract Background Facilitation is an implementation strategy that supports the uptake of evidence-based practices. Recently, use of virtual facilitation (VF), or the application of facilitation using primarily video-based conferencing technologies, has become more common, especially since the COVID-19 pandemic. Thorough assessment of the literature on VF, however, is lacking. This scoping review aimed to identify and describe conceptual definitions of VF, evaluate the consistency of terminology, and recommend “best” practices for its use as an implementation strategy. Methods We conducted a scoping review to identify literature on VF following the PRISMA-ScR guidance. A search of PubMed, Embase, Web of Science, and CINAHL databases was conducted in June 2022 for English language articles published from January 2012 through May 2022 and repeated in May 2023 for articles published from January 2012 through April 2023. Identified articles, including studies and conference abstracts describing VF, were uploaded into Covidence and screened independently by two reviewers. Data extraction was done by two reviewers in Microsoft Excel; additionally, studies were evaluated based on the Proctor et al. (2013) reporting guidelines for specifying details of implementation strategies. Results The search strategy identified 19 articles. After abstract and full-text screening, eight studies described by 10 articles/abstracts were included in analysis. Best practices summarized across studies included (1) stakeholder engagement, (2) understanding the recipient’s organization, (3) facilitator training, (4) piloting, (5) evaluating facilitation, (6) use of group facilitation to encourage learning, and (7) integrating novel tools for virtual interaction. Three papers reported all or nearly all components of the Proctor et al. reporting guidelines; justification for use of VF was the most frequently omitted. Conclusions This scoping review evaluated available literature on use of VF as a primary implementation strategy and identified significant variability on how VF is reported, including inconsistent terminology, lack of details about how and why it was conducted, and limited adherence to published reporting guidelines. These inconsistencies impact generalizability of these methods by preventing replicability and full understanding of this emerging methodology. More work is needed to develop and evaluate best practices for effective VF to promote uptake of evidence-based interventions. Trial registration N/A.

Abstract Background The United States (US) continues to face decades-long increases in opioid overdose fatalities. As an opioid overdose reversal medication, naloxone can dramatically reduce opioid overdose mortality rates when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND). Syringe services programs (SSPs) are ideal venues for OEND with staff who are culturally competent in providing services for people who are at risk of experiencing or observing an opioid overdose. We carried out a randomized controlled trial of SSPs to understand the effectiveness of the organize and mobilize for implementation effectiveness (OMIE) approach at improving OEND implementation effectiveness within SSPs. Methods Using simple randomization, 105 SSPs were enrolled into the trial and assigned to one of two study arms — (1) dissemination of OEND best practice recommendations (Control SSPs) or the OMIE approach along with dissemination of the OEND best practice recommendations (i.e., OMIE SSPs). OMIE SSPs could participate in 60-min OMIE sessions once a month for up to 12 months. At 12-month post-baseline, 102 of 105 SSPs (97%) responded to the follow-up survey. Results The median number of sessions completed by OMIE SSPs was 10. Comparing OMIE SSPs to control SSPs, we observed significant increases in the number of participants receiving naloxone (incidence rate ratio: 2.15; 95% CI: 1.42, 3.25; p

Abstract Background Eating disorders have one of the highest mortality rates among psychiatric illnesses. Timely intervention is crucial for effective treatment, as eating disorders tend to be chronic and difficult to manage if left untreated. Clinical practice guidelines play a vital role in improving healthcare delivery, aiming to minimize variations in care and bridge the gap between research and practice. However, research indicates an active guideline implementation approach is crucial to effective uptake. Methods Mixed methods will be used to inform and evaluate our guideline implementation approach. Semi-structured focus groups will be conducted in each of the eight provinces in Canada. Each focus group will comprise 8–10 key stakeholders, including clinicians, program administrators, and individuals with lived experience or caregivers. Qualitative data will be analyzed using conventional content analysis and the constant comparison technique and the results will be used to inform our implementation strategy. The study will then evaluate the effectiveness of our implementation approach through pre- and post-surveys, comparing changes in awareness, use, and impact of the guidelines in various stakeholder groups. Discussion Through a multifaceted implementation strategy, involving the co-creation of educational materials, tailored training, and context-specific strategies, this study intends to enhance guideline uptake and promote adherence to evidence-based practices. Our study will also contribute valuable information on the impact of our implementation strategies.

Abstract Background For approximately one in five children who have social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the USA, schools are the primary setting for children’s SEB service delivery. Still, EBPPs are rarely adopted and implemented by front-line educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance impact. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators’ behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy as applied to Positive Greetings at the Door, a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement. Methods This project uses a blocked randomized cohort design with an active comparison control (ACC) condition. We will recruit and include approximately 276 teachers from 46 schools randomly assigned to BASIS-T or ACC conditions. Aim 1 will evaluate the main effects of BASIS-T on proximal implementation mechanisms (attitudes, subjective norms, self-efficacy, intentions to implement, and maintenance self-efficacy), implementation outcomes (adoption, reach, fidelity, and sustainment), and child outcomes (SEB, attendance, discipline, achievement). Aim 2 will examine how, for whom, under what conditions, and how efficiently BASIS-T works, specifically by testing whether the effects of BASIS-T on child outcomes are (a) mediated via its putative mechanisms of behavior change, (b) moderated by teacher factors or school contextual factors, and (c) cost-effective. Discussion This study will provide a rigorous test of BASIS-T—a pragmatic, theory-driven, and generalizable implementation strategy designed to target theoretically-derived motivational mechanisms—to increase the yield of standard EBPP training and support strategies. Trial registration ClinicalTrials.gov ID: NCT05989568. Registered on May 30, 2023.

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 Numerous transitional care innovations (TCIs) are being developed and implemented to optimize care continuity for older persons when transferring between multiple care settings, help meet their care needs, and ultimately improve their quality of life. Although the implementation of TCIs is influenced by contextual factors, the use of effective implementation strategies is largely lacking. Thus, to improve the implementation of TCIs targeting older persons receiving long-term care services, we systematically developed a set of viable strategies selected to address the influencing factors. Methods As part of the TRANS-SENIOR research network, a stepwise approach following Implementation Mapping (steps 1 to 3) was applied to select implementation strategies. Building on the findings of previous studies, existing TCIs and factors influencing their implementation were identified. A combination of four taxonomies and overviews of change methods as well as relevant evidence on their effectiveness were used to select the implementation strategies targeting each of the relevant factors. Subsequently, individual consultations with scientific experts were performed for further validation of the process of mapping strategies to implementation factors and for capturing alternative ideas on relevant implementation strategies. Results Twenty TCIs were identified and 12 influencing factors (mapped to the Consolidated Framework for Implementation Research) were designated as priority factors to be addressed with implementation strategies. A total of 40 strategies were selected. The majority of these target factors at the organizational level, e.g., by using structural redesign, public commitment, changing staffing models, conducting local consensus discussions, and organizational diagnosis and feedback. Strategies at the level of individuals included active learning, belief selection, and guided practice. Each strategy was operationalized into practical applications. Conclusions This project developed a set of theory and evidence-based implementation strategies to address the influencing factors, along further tailoring for each context, and enhance the implementation of TCIs in daily practice settings. Such work is critical to advance the use of implementation science methods to implement innovations in long-term care successfully.

Abstract Background The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention — the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP. Methods We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes. Results We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%). Conclusion Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility. Trial registration Trial registered on ClinicalTrial.gov as NCT03574129.

Abstract Background There is a lack of consensus about how to prioritize potential implementation strategies for HIV pre-exposure prophylaxis (PrEP) delivery. We compared several prioritization methods for their agreement and pragmatism in practice in a resource-limited setting. Methods We engaged diverse stakeholders with clinical PrEP delivery and PrEP decision-making experience across 55 facilities in Kenya to prioritize 16 PrEP delivery strategies. We compared four strategy prioritization methods: (1) “past experience surveys” with experienced practitioners reflecting on implementation experience (N = 182); (2 and 3) “pre- and post-small-group ranking” surveys before and after group discussion (N = 44 and 40); (4) “go-zone” quadrant plots of perceived effectiveness vs feasibility. Kendall’s correlation analysis was used to compare strategy prioritization using the four methods. Additionally, participants were requested to group strategies into three bundles with up to four strategies/bundle by phone and online survey. Results The strategy ranking correlation was strongest between the pre- and post-small-group rankings (Tau: 0.648; p

Abstract Background As people living with HIV (PLWH) experience earlier and more pronounced onset of noncommunicable diseases (NCDs), advancing integrated care networks and models in low-resource-high-need settings is critical. Leveraging current health system initiatives and addressing gaps in treatment for PLWH, we report our approach using a late-stage (T4) implementation research study to test the adoption and sustainability of a proven-effective implementation strategy which has been minimally applied in low-resource settings for the integration of hypertension control into HIV treatment. We detail our protocol for the Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT) trial, which uses a stepped wedge cluster randomized trial (SW-CRT) design to evaluate the effectiveness of practice facilitation on the adoption of a hypertension treatment program for PLWH receiving care at primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria. Design In partnership with the Nigerian Federal Ministry of Health (FMOH) and community organizations, the MAP-IT trial takes place in 30 PHCs. The i-PARiHS framework guided pre-implementation needs assessment. The RE-AIM framework will guide post-implementation activities to evaluate the effect of practice facilitation on the adoption, implementation fidelity, and sustainability of a hypertension program, as well as blood pressure (BP) control. Using a SW-CRT design, PHCs sequentially crossover from the hypertension program only (usual care) to hypertension plus practice facilitation (experimental condition). PHCs will recruit and enroll an average of 28–32 patients to reach a maximum of 960 PLWH participants with uncontrolled hypertension who will be followed longitudinally for BP outcomes. Discussion Given the need for integrated NCD-HIV care platforms in low-resource settings, MAP-IT will underscore the challenges and opportunities for integrating hypertension treatment into HIV care, particularly concerning adoption and sustainability. The evaluation of our integration approach will also highlight the potential impact of a health systems strengthening approach on BP control among PLWH. Trial registration Clinicaltrials.gov ( NCT05031819 ). Registered on 2nd September 2021.

Abstract Background Chagas is a public health problem, especially in Latin America, exacerbated by migratory movements and increasing urbanization. Argentina is among the countries with the highest estimated prevalence in the region, with 1,500,000 people infected, with mother to child as the main mode of transmission. Vertical transmission has been significantly reduced by treating women of childbearing age; several guidelines in the region recommend treatment as a primary prevention strategy for the child and a secondary prevention strategy for women and their families. Despite recommendations, women of childbearing age are not always treated, and children do not receive timely diagnosis and treatment. The objective of this research was to design an implementation strategy to improve using Chagas guidelines focused on attending women of childbearing age and children at the primary healthcare level and pilot it in three primary health care centers in Argentina. Methods We conducted a pilot feasibility study using the Consolidated Framework for Implementation Research. A qualitative process evaluation was conducted using semi-structured interviews with health care providers and observations in primary health care centers. Results We developed a multifaceted implementation strategy including training, flowcharts and reminders, a register of suspected and confirmed cases, and the selection of a management facilitator. The pilot study took place between September 2019 and May 2020. The implementation level was heterogeneous and varied depending on the components, being the facilitating factors, the simplicity of the intervention, professionals’ willingness to expand the indication of serologic tests, and staff commitment to the adoption of intervention components. The main barriers found were the change of authorities at the local level, some professionals´ reluctance to administer etiological treatment, staff shortages, lack of diagnostic supplies, and the health emergency caused by the COVID-19 pandemic. Conclusions Behavioral change strategies should be applied to improve implementation to address some of the main barriers, including support actions offered by opinion leaders, medical experts, and local health authorities. Rapid diagnostic tests should be readily available to maintain behavior changes. We suggest further refinement of the strategy and its implementation in more centers to assess outcomes prospectively with a hybrid implementation research design.

Abstract Background Significant gaps remain in HIV testing and counseling (HTC) in family planning (FP) clinics. To address these gaps, our group tested an implementation strategy called the Systems Analysis and Improvement Approach (SAIA), an evidenced-based multi-component implementation strategy focused on improving entire care cascades. In a cluster randomized trial of 24 FP clinics in Mombasa County, Kenya, SAIA led to a significant increase in HTC in intervention clinics compared to control clinics. The objective of this manuscript was to evaluate SAIA using the Consolidated Framework for Implementation Research (CFIR) and assess the Implementation Outcomes Framework outcomes of acceptability, appropriateness, and feasibility. Methods This qualitative assessment was nested within the cluster-randomized trial. Data collection included questionnaires to assess modifiable and non-modifiable health system factors related to HTC and in-depth interviews to query clinic norms, priorities, communication strategies, and readiness for change. The primary outcomes of interest were feasibility, appropriateness, and acceptability of SAIA. Data on inner setting and structural characteristics of FP clinics were collected to inform how context may impact outcomes. All interviews were recorded and analyzed using a rapid assessment approach. Results Of the 12 intervention clinics, 6 (50%) were public facilities. Availability of resources varied by clinic. Most clinics had a positive implementation climate, engaged leadership, and access to resources and information. While not all clinics identified HTC as a clinic priority, most reported a strong culture of embracing change and recognition of the importance of HIV testing within FP clinics. Interviews highlighted very high acceptability, appropriateness, and feasibility of SAIA. The implementation strategy was not complicated and fit well into existing clinic processes. In particular, staff appreciated that SAIA allowed clinic staff to generate contextually relevant solutions that they implemented. Conclusions SAIA was implemented in FP clinics of varying sizes, capacity, and management support and was found to be acceptable, appropriate, and feasible. The agency that clinic staff felt in proposing and implementing their own solutions was likely part of SAIA’s success. We anticipate this will continue to be a mechanism of SAIA’s success when it is scaled up to more clinics in future trials. Trial registration ClinicalTrials.gov (NCT02994355) registered 16 December 2016.

Abstract Background Internationally, government policies mandating schools to provide students with opportunities to participate in physical activity are poorly implemented. The multi-component Physically Active Children in Education (PACE) intervention effectively assists schools to implement one such policy. We evaluated the value of investment by health service providers tasked with intervention delivery, and explored where adaptations might be targeted to reduce program costs for scale-up. Methods A prospective trial-based economic evaluation of an implementation intervention in 61 primary schools in New South Wales (NSW), Australia. Schools were randomised to the PACE intervention or a wait-list control. PACE strategies included centralised technical assistance, ongoing consultation, principal's mandated change, identifying and preparing in-school champions, educational outreach visits, and provision of educational materials and equipment. Effectiveness was measured as the mean weekly minutes of physical activity implemented by classroom teachers, recorded in a daily log book at baseline and 12-month follow-up. Delivery costs (reported in $AUD, 2018) were evaluated from a public finance perspective. Cost data were used to calculate: total intervention cost, cost per strategy and incremental cost (overall across all schools and as an average per school). Incremental cost-effectiveness ratios (ICERs) were calculated as the incremental cost of delivering PACE divided by the estimated intervention effect. Results PACE cost the health service provider a total of $35,692 (95% uncertainty interval [UI] $32,411, $38,331) to deliver; an average cost per school of $1151 (95%UI $1046, $1236). Training in-school champions was the largest contributor: $19,437 total; $627 ($0 to $648) average per school. Educational outreach was the second largest contributor: $4992 total; $161 ($0 to $528) average per school. The ICER was $29 (95%UI $17, $64) for every additional minute of weekly physical activity implemented per school. Conclusion PACE is a potentially cost-effective intervention for increasing schools implementation of a policy mandate. The investment required by the health service provider makes use of existing funding and infrastructure; the additional cost to assist schools to implement the policy is likely not that much. PACE strategies may be adapted to substantially improve delivery costs. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12617001265369; Prospectively registered 1st September 2017 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373520

Abstract Background The clinical Pandemic Practice Champion (PPC) role was created in a large tertiary pediatric hospital as a knowledge translation (KT) strategy for implementing COVID-19 evidence-based knowledge. We aimed to describe the core components of the PPC role, the process of implementing the role, and the factors that hindered or facilitated role implementation. Methods An exploratory case study was undertaken. Semi-structured interviews were conducted virtually with stakeholders including PPC, managers, and front-line health care professionals (HCP). A directed approach to qualitative content analysis consistent with the Consolidated Framework for Implementation Research (CFIR) guided the analytic process. Inductive analyses and three stages of thematic synthesis were also conducted. Results Four PPC, 3 managers, and 6 HCP were interviewed. The core components of the PPC role consisted of (a) acting as knowledge experts and educators, (b) problem-solving for complex patient care issues, (c) conducting crisis management, and (d) acting as a resource to management, HCP, and families. Facilitators for successful implementation included access to external information, a supportive organizational context and culture, dedicated time and resources, and leadership support. Lack of clarity of role definition, insufficient time, pandemic uncertainty and fatigue, inability to change infrastructure, and access to external information hindered implementation. Conclusion The PPC role was successfully implemented within a crisis context. Key barriers (role clarity, time, resources) and facilitators (organizational and leadership support) need to be considered when implementing the PPC role in practice. Future studies are needed to determine the intervention effectiveness of the champion role in changing HCP behavior and health outcomes and further examine implementation processes and mechanisms.

Abstract Background Understanding the cost and/or cost-effectiveness of implementation strategies is crucial for organizations to make informed decisions about the resources needed to implement and sustain evidence-based interventions (EBIs). This economic evaluation protocol describes the methods and processes that will be used to assess costs and cost-effectiveness across implementation strategies used to improve the reach, adoption, implementation, and organizational maintenance of an evidence-based pediatric weight management intervention- Building Health Families (BHF). Methods A within-trial cost and cost-effectiveness analysis (CEA) will be completed as part of a hybrid type III effectiveness-implementation trial (HEI) designed to examine the impact of an action Learning Collaborative (LC) strategy consisting of network weaving, consultee-centered training, goal-setting and feedback, and sustainability action planning to improve the adoption, implementation, organizational maintenance, and program reach of BHF in micropolitan and surrounding rural communities in the USA, over a 12-month period. We discuss key features of implementation strategy components and the associated cost collection and outcome measures and present brief examples on what will be included in the CEA for each discrete implementation strategy and how the results will be interpreted. The cost data will be collected by identifying implementation activities associated with each strategy and using a digital-based time tracking tool to capture the time associated with each activity. Costs will be assessed relative to the BHF program implementation and the multicomponent implementation strategy, included within and external to a LC designed to improve reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of BHF. The CEA results will be reported by RE-AIM outcomes, using the average cost-effectiveness ratio or incremental cost-effectiveness ratio. All the CEAs will be performed from the community perspective. Discussion The proposed costing approach and economic evaluation framework for dissemination and implementation strategies and EBI implementation will contribute to the evolving but still scant literature on economic evaluation of implementation and strategies used and facilitate the comparative economic analysis. Trial registration ClinicalTrials.gov NCT04719442 . Registered on January 22, 2021.

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 There is limited research on prevention of mental ill-health of school personnel and the systematic management of school work environments. The aim of this study was to assess the effectiveness of implementing the guideline recommendations for the prevention of mental ill-health in schools, in particular, whether there was a difference in adherence to guideline recommendations between a multifaceted (group 1) and single implementation strategy (group 2) from baseline to 6 and to 12 months. Method We conducted a cluster-randomized controlled trial with a 6- and 12-month follow-up. Data was collected from nearly 700 participants in 19 Swedish schools. Participants were school personnel working under the management of a school principal. The single implementation strategy consisted of one educational meeting, while the multifaceted implementation strategy comprised an educational meeting, an ongoing training in the form of workshops, implementation teams and Plan-Do-Study-Act cycles. Adherence was measured with a self-reported questionnaire. Generalized Linear Mixed Models were used to assess the difference between groups in adherence to the guideline between baseline, 6-, and 12-months follow-up. Results There were no statistically significant differences between the groups in improvements in adherence to the guideline between baseline, 6-, and 12-months follow-up. However, among those schools that did not undergo any organizational changes during the 12 months of the study significant differences between groups were observed at 12 months for one of the indicators. Conclusions The multifaceted strategy was no more effective than the single strategy in improving guideline adherence. There are some limitations to the study, such as the measurement of the implementation outcome measure of adherence. The outcome measure was developed in a systematic manner by the research team, assessing specific target behaviors relevant to the guideline recommendations, however not psychometrically tested, which warrants a careful interpretation of the results. Trial registration ClinicalTrials.gov, 150571 . Registered 12 September 2017.

Abstract Background Children with medical complexity (CMC) have inter-related health and social needs; however, interventions to identify and respond to social needs have not been adapted for CMC. The objective of this study was to evaluate the feasibility of implementing social needs screening and assessment within pediatric complex care programs. Methods We implemented systematic social needs assessment for CMC (SSNAC) at two tertiary care centers in three phases: (1) pre-implementation, (2) implementation, and (3) implementation monitoring. We utilized a multifaceted implementation package consisting of discrete implementation strategies within each phase. In phase 1, we adapted questions from evidence-informed screening tools into a 21-item SSNAC questionnaire, and we used published frameworks to inform implementation readiness and process. In phases 2–3, clinical staff deployed the SSNAC questionnaire to parents of CMC in-person or by phone as part of usual care and adapted to local clinical workflows. Staff used shared decision-making with parents and addressed identified needs by providing information about available resources, offering direct assistance, and making referrals to community agencies. Implementation outcomes included fidelity, feasibility, acceptability, and appropriateness. Results Observations from clinical staff characterized fidelity to use of the SSNAC questionnaire, assessment template, and shared decision-making for follow-up on unmet social needs. Levels of agreement (5-point Likert scale; 1 = completely disagree; 5 = completely agree) rated by staff for key implementation outcomes were moderate to high for acceptability (mean = 4.7; range = 3–5), feasibility (mean = 4.2; range = 3–5), and appropriateness (mean = 4.6; range = 4-5). 49 SSNAC questionnaires were completed with a 91% response rate. Among participating parents, 37 (76%) reported ≥ 1 social need, including food/nutrition benefits (41%), housing (18%), and caregiver needs (29%). Staff responses included information provision (41%), direct assistance (30%), and agency referral (30%). Conclusions It was feasible for tertiary care center-based pediatric complex care programs to implement a standardized social needs assessment for CMC to identify and address parent-reported unmet social needs.

Abstract Background Audit and feedback as an implementation strategy leads to small, but potentially important improvements in practice. Yet, audit and feedback is time and personnel intensive. Many interventions designed for inpatient care are meant to be utilized by care teams all days of the week, including weekends when research staff are at a minimum. We aimed to determine if audit and feedback regarding use of an evidence-based inpatient obstetric intervention performed only on weekdays could have a sustained impact over the weekend. Methods This study was performed as a secondary analysis of a prospective cohort study examining the impact of implementation of a validated calculator that predicts the likelihood of cesarean delivery during labor induction. During the 1 year postimplementation period, Monday through Friday, a member of the study team contacted clinicians daily to provide verbal feedback. While the same clinician pool worked weekend shifts, audit and feedback did not occur on Saturdays or Sundays. The primary outcome was intervention use, defined as documentation of counseling around the cesarean risk calculator result, in the electronic health record. Intervention use was compared between those with (weekdays) and without (weekends) audit and feedback. Results Of the 822 women meeting eligibility criteria during the postimplementation period (July 1, 2018–June 30, 2019), 651 (79.2%) were admitted on weekdays when audit and feedback was occurring and 171 (20.8%) on weekends without audit and feedback. The use of the cesarean risk calculator was recorded in 676 of 822 (82.2%) of eligible patient charts. There was no significant difference in cesarean risk calculator use overall by days when audit and feedback occurred versus days without audit and feedback (weekday admissions 82.0% vs. weekend admissions 83.0%, aOR 0.90 95% CI [0.57–1.40], p = 0.76). There was no significant trend in the relationship between calculator use and weekday versus weekend admission by month across the study period (p = 0.21). Conclusions Daily weekday audit and feedback for implementation of an evidence-based inpatient obstetric intervention had sustained impact over the weekends. This finding may have implications for both research staffing, as well as sustainability efforts. Further research should determine the lowest effective frequency of audit and feedback to produce implementation success.

Abstract Background Blunt chest wall injuries can lead to complications, especially without early intervention. A blunt Chest Injury Protocol (ChIP) was developed to help improve the consistency of evidence-based care following admission to the emergency department. Implementation strategy fidelity is the extent to which the strategies of implementation are delivered in line with the intended plan. The aim of this study was to assess fidelity to the strategies of the implementation plan developed for ChIP. Methods A retrospective evaluation of strategies used for implementation was performed, specifically the behaviour change techniques (BCTs). BCTs were used as part of an implementation plan derived based on the Behaviour Change Wheel from results from a staff survey at two hospitals. Levels of implementation or adaptation for BCTs were scored by implementers as follows: ‘Were the behaviour change interventions implemented?’ (0 = ‘not implemented’, 1 = partially implemented, and 2 = fully implemented); ‘Were adaptations made to the implementation plan?’, scored 1 (many changes from plan) to 4 (just as planned). Free text explanation to their responses was also collected with supporting evidence and documentation (such as emails, implementation checklists, audit reports, and incident reports). Results There was high overall fidelity of 97.6% for BCTs partially or fully implemented. More than three quarters (32/42, 76.2%) of the BCTs were fully implemented with an additional 9/42 (21.4%) partially implemented. BCTs that were not fully implemented were social support, feedback on behaviour, feedback on outcomes of behaviour, adding objects to the environment, and restructuring the environment. The modes of delivery with poorer implementation or increased adaptations were clinical champions and audit/feedback. Conclusions This study describes the evaluation of implementation strategy fidelity in the acute care context. The systematic use and application of the behaviour change wheel was used to develop an implementation plan and was associated with high implementation strategy fidelity. A fidelity checklist developed during the implementation process may help implementers assess fidelity. Trial registration Trial registered on ANZCTR. Registration number ACTRN12618001548224 , date approved 17/09/2018

Abstract Background Although there is increasing investment to implement evidence-based practices (EBPs) in public systems across the USA, continued or sustained use of EBPs after initial implementation remains a challenge. The low integration of EBPs in routine practice severely limits their public health impact, highlighting the need to understand factors that affect the return on costly investments in EBP implementation. This study aims to (1) characterize trajectories of EBP delivery volume through a reimbursement-driven implementation and (2) examine impacts of system-level policy regulatory activity and state-level mental health services funding on the implementation reimbursement strategy. Methods This study involved secondary data analyses. Psychotherapy administrative claims and regulatory site visit data from the Los Angeles County Department of Mental Health and California state mental health expenditures were extracted from 2010 to 2017. Multilevel regression examined EBP claims volume over time with state expenditures and regulatory compliance as predictors. Results EBP claims volume trajectories demonstrated a rapid initial increase, followed by a period of decrease, and a small increase in the final year. State mental health expenditures increased across time reflecting increased funding availability. State mental health expenditures and system regulatory compliance were inversely related to EBP claims volume. Conclusions The impact of reimbursement-driven EBP implementation strategy is sensitive to multiple outer-context determinants. At the system level, commitment to fidelity of implementation regulations resulted in reduced use of the reimbursement strategy. Alternative reimbursement streams not tied to EBPs coupled with an expanded array of reimbursable services also impacted the use of the reimbursement strategy to implement EBPs.

Abstract Background The American Dental Association (ADA) recommends dental providers apply dental sealants to the occlusal surfaces of permanent molars for the prevention or treatment of non-cavitated dental caries. Despite the evidence-based support for this guideline, adherence among general dentists is low, ranging from less than 5 to 38.5%. Thus, an evidence-to-practice gap exists, and it is unclear which implementation strategies would best support providers in adopting and implementing the evidence-based practice. One potential approach to selecting and tailoring implementation strategies is a deliberative loop process, a stakeholder-engaged approach to decision-making. This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice. Methods Sixteen dental clinics within Kaiser Permanente Northwest Dental will be cluster randomized to determine the timing of receiving the intervention in this stepped-wedge trial. In the three-part deliberative loop intervention, clinic stakeholders engage in the following activities: (1) receive background information, (2) participate in facilitated small-group discussions designed to promote learning from each other’s lived experiences and develop informed opinions about effective clinic-level implementation strategies, and (3) share their informed opinions with clinic leaders, who may then choose to select and deploy implementation strategies based on the stakeholders’ informed opinions. The primary outcome of Reach will be defined as patient-level receipt of guideline-concordant care. Secondary outcomes will include the cost-effectiveness, acceptability, and feasibility of the deliberative loop process. Implementation strategies deployed will be catalogued over time. Discussion These results will establish the extent to which the deliberative loop process can help leaders select and tailor implementation strategies with the goal of improving guideline-concordant dental care. Trial registration This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730

Abstract Background The most efficient procedures to engage and guide healthcare professionals in collaborative processes that seek to optimize practice are unknown. The PREDIAPS project aims to assess the effectiveness and feasibility of different procedures to perform a facilitated interprofessional collaborative process to optimize type 2 diabetes prevention in routine primary care. Methods A type II hybrid cluster randomized implementation trial was conducted in nine primary care centers of the Basque Health Service. All centers received training on effective healthy lifestyle promotion. Headed by a local leader and an external facilitator, centers conducted a collaborative structured process—the PVS-PREDIAPS implementation strategy—to adapt the intervention and its implementation to their specific context. The centers were randomly allocated to one of two groups: one group applied the implementation strategy globally, promoting the cooperation of all health professionals from the beginning, and the other performed it sequentially, centered first on nurses, who later sought the pragmatic cooperation of physicians. The following patients were eligible for inclusion: all those aged ≥ 30 years old with at least one known cardiovascular risk factor and an impaired fasting glucose level (≥ 110-125 mg/dl) but without diabetes who attended centers during the study period. The main outcome measures concerned changes in type 2 diabetes prevention practice indicators after 12 months. Results After 12 months, 3273 eligible patients at risk of type 2 diabetes had attended their family physician at least once, and of these, 490 (15%) have been addressed by assessing their healthy lifestyles in both comparison groups. The proportion of at-risk patients receiving a personalized prescription of lifestyle change was slightly higher (8.6%; range 13.5-5.9% vs 6.8%; range 7.2-5.8%) and 2.3 times more likely (95% CI for adjusted hazard ratio, 1.38-3.94) in the sequential than in the global centers, after 8 months of the intervention program implementation period. The probability of meeting the recommended levels of physical activity and fruit and vegetable intake were four- and threefold higher after the prescription of lifestyle change than only assessment and provision of advice. The procedure of engagement in and execution of the implementation strategy does not modify the effect of prescribing healthy habits (p interaction component of intervention by group, p > 0.05). Discussion Our results show that the PVS-PREDIAPS implementation strategy manages to integrate interventions with proven efficacy in the prevention of type 2 diabetes in clinical practice in primary care. Further, they suggest that implementation outcomes were somewhat better with a sequential facilitated collaborative process focused on enhancing the autonomy and responsibility of nurses who subsequently seek a pragmatic cooperation of GPs. Trial registration Clinicaltrials.gov identifier: NCT03254979 . Registered 16 August 2017—retrospectively registered.

Abstract Background Many evidence-based interventions (EBIs) found to be effective in research studies often fail to translate into meaningful patient outcomes in practice. The purpose of this study was to identify facilitators and barriers that affect the implementation of three EBIs to improve colorectal cancer (CRC) screening in an urban federally qualified health center (FQHC) and offer actionable recommendations to improve future implementation efforts. Methods We conducted 16 semi-structured interviews guided by the Consolidation Framework for Implementation Research (CFIR) to describe diverse stakeholders’ implementation experience. The interviews were conducted in the participant’s clinic, audio-taped, and professionally transcribed for analysis. Results We used the five CFIR domains and 39 constructs and subconstructs as a coding template to conduct a template analysis. Based on experiences with the implementation of three EBIs, stakeholders described barriers and facilitators related to the intervention characteristics, outer setting, and inner setting. Implementation barriers included (1) perceived burden and provider fatigue with EHR (Electronic Health Record) provider reminders, (2) unreliable and ineffectual EHR provider reminders, (3) challenges to providing health care services to diverse patient populations, (4) lack of awareness about CRC screening among patients, (5) absence of CRC screening goals, (6) poor communication on goals and performance, and (7) absence of printed materials for frontline implementers to educate patients. Implementation facilitators included (1) quarterly provider assessment and feedback reports provided real-time data to motivate change, (2) integration with workflow processes, (3) pressure from funding requirement to report quality measures, (4) peer pressure to achieve high performance, and (5) a culture of teamwork and patient-centered mentality. Conclusions The CFIR can be used to conduct a post-implementation formative evaluation to identify barriers and facilitators that influenced the implementation. Furthermore, the CFIR can provide a template to organize research data and synthesize findings. With its clear terminology and meta-theoretical framework, the CFIR has the potential to promote knowledge-building for implementation. By identifying the contextual determinants, we can then determine implementation strategies to facilitate adoption and move EBIs to daily practice.

Abstract Background There is substantial evidence that facilitation can address the challenges of implementing evidence-based innovations. However, facilitators need a wide variety of complex skills; lack of these can have a negative effect on implementation outcomes. Literature suggests that novice and less experienced facilitators need ongoing support from experts to develop these skills. Yet, no studies have investigated the transfer process. During a test of a facilitation strategy applied at 8 VA primary care clinics, we explored the techniques and processes an expert external facilitator utilized to transfer her skills to two initially novice internal facilitators who became experts. Methods In this qualitative descriptive study, we conducted monthly debriefings with three facilitators over a 30-month period and documented these in detailed notes. Debriefings with the expert facilitator focused on how she trained and mentored facilitation trainees. We also conducted, recorded, and transcribed two semi-structured qualitative interviews with each facilitator and queried them about training content and process. We used a mix of inductive and deductive approaches to analyze data; our analysis was informed by a review of mentoring, coaching, and cognitive apprenticeship literature. We also used a case comparison approach to explore how the expert tailored her efforts. Results The expert utilized 21 techniques to transfer implementation facilitation skills. Techniques included both active (providing information, modeling, and coaching) and participatory ones. She also used techniques to support learning, i.e., cognitive supports (making thinking visible, using heuristics, sharing experiences), psychosocial supports, strategies to promote self-learning, and structural supports. Additionally, she transferred responsibility for facilitation through a dynamic process of interaction with trainees and site stakeholders. Finally, the expert varied the level of focus on particular skills to tailor her efforts to trainee and local context. Conclusions This study viewed the journey from novice to expert facilitator through the lens of the expert who transferred facilitation skills to support implementation of an evidence-based program. It identified techniques and processes that may foster transfer of these skills and build organizational capacity for future implementation efforts. As the first study to document the implementation facilitation skills transfer process, findings have research and practical implications.

Abstract Background Implementation strategies are necessary to ensure that evidence-based practices are successfully incorporated into routine clinical practice. Such strategies, however, are frequently modified to fit local populations, settings, and contexts. While such modifications can be crucial to implementation success, the literature on documenting and evaluating them is virtually nonexistent. In this paper, we therefore describe the development of a new framework for documenting modifications to implementation strategies. Discussion We employed a multifaceted approach to developing the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS), incorporating multiple stakeholder perspectives. Development steps included presentations of initial versions of the FRAME-IS to solicit structured feedback from individual implementation scientists (“think-aloud” exercises) and larger, international groups of researchers. The FRAME-IS includes core and supplementary modules to document modifications to implementation strategies: what is modified, the nature of the modification (including the relationship to core elements or functions), the primary goal and rationale for the modification, timing of the modification, participants in the modification decision-making process, and how widespread the modification is. We provide an example of application of the FRAME-IS to an implementation project and provide guidance on how it may be used in future work. Conclusion Increasing attention is being given to modifications to evidence-based practices, but little work has investigated modifications to the implementation strategies used to implement such practices. To fill this gap, the FRAME-IS is meant to be a flexible, practical tool for documenting modifications to implementation strategies. Its use may help illuminate the pivotal processes and mechanisms by which implementation strategies exert their effects.

Abstract Background Assessing the fidelity of an implementation strategy is important to understand why and how the strategy influences the uptake of evidence-based interventions. The present study aims to assess the fidelity of the two procedures for engaging primary care (PC) professionals and for the deployment of an implementation strategy for optimizing type 2 diabetes prevention in routine PC within the PREDIAPS randomized cluster implementation trial. Method We conducted a mixed-method fidelity evaluation study of the PVS-PREDIAPS implementation strategy. Nine PC centers from the Basque Health Service (Osakidetza) were allocated to two different procedures to engage physicians and nurses and deploy a implementation strategy to model and adapt the clinical intervention and its implementation to their specific contexts: a Global procedure, promoting the cooperation of all healthcare professionals from the beginning; or a Sequential procedure, centered first on nurses who then pursued the pragmatic cooperation of physicians. Process indicators of the delivery and receipt of implementation strategy actions, documented modifications to the planned implementation strategy, and a structured group interview with centers’ leaders were all used to assess the following components of fidelity: adherence, dose, quality of delivery, professionals’ responsiveness and program differentiation. Results Generally, the procedures compared for professionals engagement and deployment of the implementation strategy were carried out with the planned differentiation. Nonetheless, some unexpected between-group differences were observed, the initial rate of collaboration of nurses being higher in the Sequential (93%) than in the Global (67%) groups. Exposure rate to the programed implementation actions (% of hours received out of those delivered) were similar in both groups by professional category, with nurses (86%) having a higher rate of exposure than physicians (75%). Professionals identified half of the planned discrete strategies and their rating of strategies’ perceived usefulness was overwhelmingly positive, with few differences between Sequential and Global centers. Conclusions The PVS-PREDIAPS implementation strategy has been implemented with high fidelity and minor unplanned reactive modifications. Professionals’ exposure to the implementation strategy was high in both groups. The centers’ organizational context (i.e., work overload) led to small mismatches between groups in participation and exposure of professionals to implementation actions. Trial registration Clinicaltrials.gov identifier: NCT03254979 . Registered 16 August 2017.

Abstract Background More than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services—schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes. Methods Using a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4–6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness. Discussion This study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS—a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation—to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting. Trial registration ClinicalTrials.gov registration number NCT04451161 . Registered on June 30, 2020.

Abstract Background Implementation of new clinical programs across diverse facilities in national healthcare systems like the Veterans Health Administration (VHA) can be extraordinarily complex. Implementation is a dynamic process, influenced heavily by local organizational context and the individual staff at each medical center. It is not always clear in the midst of implementation what issues are most important to whom or how to address them. In recognition of these challenges, implementation researchers within VHA developed a new systemic approach to map the implementation work required at different stages and provide ongoing, detailed, and nuanced feedback about implementation progress. Methods This observational pilot demonstration project details how a novel approach to monitoring implementation progress was applied across two different national VHA initiatives. Stage-specific grids organized the implementation work into columns, rows, and cells, identifying specific implementation activities at the site level to be completed along with who was responsible for completing each implementation activity. As implementation advanced, item-level checkboxes were crossed off and cells changed colors, offering a visual representation of implementation progress within and across sites across the various stages of implementation. Results Applied across two different national initiatives, the SIPREP provided a novel navigation system to guide and inform ongoing implementation within and across facilities. The SIPREP addressed different needs of different audiences, both described and explained how to implement the program, made ample use of visualizations, and revealed both what was happening and not happening within and across sites. The final SIPREP product spanned distinct stages of implementation. Conclusions The SIPREP made the work of implementation explicit at the facility level (i.e., who does what, and when) and provided a new common way for all stakeholders to monitor implementation progress and to help keep implementation moving forward. This approach could be adapted to a wide range of settings and interventions and is planned to be integrated into the national deployment of two additional VHA initiatives within the next 12 months.

Abstract Background Screening for colorectal cancer (CRC) not only detects disease early when treatment is more effective but also prevents cancer by finding and removing precancerous polyps. Because many of our nation’s most disadvantaged and vulnerable individuals obtain health care at federally qualified health centers, these centers play a significant role in increasing CRC screening among the most vulnerable populations. Furthermore, the full benefits of cancer screenings must include timely and appropriate follow-up of abnormal results. Thus, the purpose of this study is to implement a multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care in federally qualified health centers, as well as simultaneously to observe and to gather information on the implementation process to improve the adoption, implementation, and sustainment of the intervention. The multilevel intervention will target three different levels of influences: organization, provider, and individual. It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation. Methods This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four clusters of clinics from four different FQHC systems. In the first phase, there will be a 3-month waiting period during which no intervention components will be implemented. After the 3-month waiting period, we will randomize two clusters to cross from the control to the intervention and the remaining two clusters to follow 3 months later. All clusters will stay at the same phase for 9 months, followed by a 3-month transition period, and then cross over to the next phase. Discussion There is a pressing need to reduce disparities in CRC outcomes, especially among racial/ethnic minority populations and among populations who live in poverty. Single-level interventions are often insufficient to lead to sustainable changes. Multilevel interventions, which target two or more levels of changes, are needed to address multilevel contextual influences simultaneously. Multilevel interventions with multiple components will affect not only the desired outcomes but also each other. How to take advantage of multilevel interventions and how to implement such interventions and evaluate their effectiveness are the ultimate goals of this study. Trial registration This protocol is registered at clinicaltrials.gov ( NCT04514341 ) on 14 August 2020.

Background Effective implementation strategies might facilitate patient-centered medical home (PCMH) uptake and spread by targeting barriers to change. Evidence-based quality improvement (EBQI) is a multi-faceted implementation strategy that is based on a clinical-researcher partnership. It promotes organizational change by fostering innovation and the spread of those innovations that are successful. Previous studies demonstrated that EBQI accelerated PCMH adoption within Veterans Health Administration primary care practices, compared with standard PCMH implementation. Research to date has not documented fidelity to the EBQI implementation strategy, limiting usefulness of prior research findings. This paper develops and assesses clinical participants’ fidelity to three core EBQI elements for PCMH (EBQI-PCMH), explores the relationship between fidelity and successful QI project completion and spread (the outcome of EBQI-PCMH), and assesses the role of the clinical-researcher partnership in achieving EBQI-PCMH fidelity. Methods Nine primary care practice sites and seven across-sites, topic-focused workgroups participated (2010–2014). Core EBQI elements included leadership-frontlines priority-setting for QI, ongoing access to technical expertise, coaching, and mentoring in QI methods (through a QI collaborative), and data/evidence use to inform QI. We used explicit criteria to measure and assess EBQI-PCMH fidelity across clinical participants. We mapped fidelity to evaluation data on implementation and spread of successful QI projects/products. To assess the clinical-researcher partnership role in EBQI-PCMH, we analyzed 73 key stakeholder interviews using thematic analysis. Results Seven of 9 sites and 3 of 7 workgroups achieved high or medium fidelity to leadership-frontlines priority-setting. Fidelity was mixed for ongoing technical expertise and data/evidence use. Longer duration in EBQI-PCMH and higher fidelity to priority-setting and ongoing technical expertise appear correlated with successful QI project completion and spread. According to key stakeholders, partnership with researchers, as well as bi-directional communication between leaders and QI teams and project management/data support were critical to achieving EBQI-PCMH fidelity. Conclusions This study advances implementation theory and research by developing measures for and assessing fidelity to core EBQI elements in relationship to completion and spread of QI innovation projects or tools for addressing PCMH challenges. These results help close the gap between EBQI elements, their intended outcome, and the finding that EBQI-PCMH resulted in accelerated adoption of PCMH.

Abstract Background Despite recent international efforts to develop resource-stratified clinical practice guidelines for cancer, there has been little research to evaluate the best strategies for dissemination and implementation in low- and middle-income countries (LMICs). Guideline publication alone is insufficient. Extensive research has shown that structured, multifaceted implementation strategies that target barriers to guideline use are most likely to improve adherence; however, most of this research has been conducted in high-income countries. There is a pressing need to develop and evaluate guideline implementation strategies for cancer management in LMICs in order to address stark disparities in cancer outcomes. Methods In preparation for the launch of Tanzania’s first National Cancer Treatment Guidelines, we developed a theory-driven implementation strategy for guideline-based practice at Ocean Road Cancer Institute (ORCI). Here, we use the Intervention Mapping framework to provide a detailed stepwise description of our process. First, we conducted a needs assessment to identify barriers and facilitators to guideline-based practice at ORCI. Second, we defined both proximal and performance objectives for our implementation strategy. Third, we used the Capability, Opportunity, Motivation and Behavior/Behavior Change Wheel (COM-B/BCW) framework to categorize the barriers and facilitators, choose behavior change techniques most likely to overcome targeted barriers and leverage facilitators, and select a feasible mode of delivery for each technique. Fourth, we organized these modes of delivery into a phased implementation strategy. Fifth, we operationalized each component of the strategy. Sixth, we identified the indicators of the process, outcome, and impact of our intervention and developed an evaluation plan to measure them using a mixed methods approach. Discussion We developed a robust, multifaceted guideline implementation strategy derived from a prominent behavior change theory for use in Tanzania. The barriers and strategies we generated are consistent with those well established in the literature, enhancing the validity and generalizability of our process and results. Through our rigorous evaluation plan and systematic account of modifications and adaptations, we will characterize the transferability of “proven” guideline implementation strategies to LMICs. We hope that by describing our process in detail, others may endeavor to replicate it, meeting a widespread need for dedicated efforts to implement cancer guidelines in LMICs.

Abstract Background Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes. Methods This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs (N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching. Discussion This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations. Trial registration This trial was registered at ClinicalTrials.gov (NCT03900767) on April 4th, 2019.

Abstract Background Implementation science experts define champions as “supporting, marketing, and driving through an implementation, overcoming indifference or resistance that the intervention may provoke in an organization.” Many hospitals use designated clinical champions—often called “hand hygiene (HH) champions”—typically to improve hand hygiene compliance. We conducted an ethnographic examination of how infection control teams in the Veterans Health Administration (VHA) use the term “HH champion” and how they define the role. Methods An ethnographic study was conducted with infection control teams and frontline staff directly involved with hand hygiene across 10 geographically dispersed VHA facilities in the USA. Individual and group semi-structured interviews were conducted with hospital epidemiologists, infection preventionists, multi-drug-resistant organism (MDRO) program coordinators, and quality improvement specialists and frontline staff from June 2014 to September 2017. The team coded the transcripts using thematic content analysis content based on a codebook composed of inductive and deductive themes. Results A total of 173 healthcare workers participated in interviews from the 10 VHA facilities. All hand hygiene programs at each facility used the term HH champion to define a core element of their hand hygiene programs. While most described the role of HH champions as providing peer-to-peer coaching, delivering formal and informal education, and promoting hand hygiene, a majority also included hand hygiene surveillance. This conflation of implementation strategies led to contradictory responsibilities for HH champions. Participants described additional barriers to the role of HH champions, including competing priorities, staffing hierarchies, and turnover in the role. Conclusions Healthcare systems should consider narrowly defining the role of the HH champion as a dedicated individual whose mission is to overcome resistance and improve hand hygiene compliance—and differentiate it from the role of a “compliance auditor.” Returning to the traditional application of the implementation strategy may lead to overall improvements in hand hygiene and reduction of the transmission of healthcare-acquired infections.

Abstract Background Individual-level implementation determinants, such as clinician attitudes, commonly influence the successful adoption of evidence-based practices, but few explicit strategies have been tested with regard to their ability to impact these key mechanisms of change. This paper reports on an initial test of a blended, theoretically informed pre-implementation strategy designed to target malleable individual-level determinants of behavior change. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a brief and pragmatic pre-implementation strategy that uses strategic education, social influence techniques, and group-based motivational interviewing to target implementation attitudes, perceived social norms, perceived behavioral control, and behavioral intentions to implement among mental health clinicians working in the education sector. Methods As part of a pilot trial, 25 school mental health clinicians were randomized to BASIS (n = 12) or an attention control placebo (n = 13), with both conditions receiving training and consultation in an evidence-based intervention for youth experiencing trauma (the Cognitive Behavioral Intervention for Trauma in Schools). Theorized mechanisms of change (attitudes, perceived social norms, perceived behavioral control, and behavioral intentions) were assessed at baseline, post-training, and 4-month follow-up. Clinician participation in post-training consultation and intervention adoption were also tracked. Results A series of regression models and independent sample t tests indicated that BASIS had significant, medium to large effects on the majority of its proximal mechanisms from baseline to post-training. BASIS was also associated with a greater latency between initial training in the intervention and discontinuation of participation in post-training consultation, with clinicians in the BASIS condition persisting in consultation for an average of 134 days versus 32 days for controls, but this difference was not statistically significant. At 4-month follow-up, most differences in the theorized mechanisms had attenuated, and approximately the same small number of BASIS clinicians adopted the trauma intervention as controls. Conclusion Findings suggest that the brief BASIS pre-implementation strategy had a significant influence on its proximal mechanisms of change, but that these changes did not persist over time or translate into adoption of the trauma intervention. Implications for theory refinement, revisions to the BASIS protocol, and next steps for research surrounding individual-level implementation strategies are discussed. Trial registration ClinicalTrials.gov Identifier: NCT03791281. Registered 31 December 2018—Retrospectively registered

Abstract Background There is a lack of evidence concerning the effectiveness of different strategies to engage healthcare professionals in collaborative processes that seek to optimise clinical practice. The PREDIAPS project aims to assess the effect of different primary health care (PHC) providers’ engagement procedures in the creation and execution of a facilitated interprofessional collaborative process to optimise the integration of the recommended clinical practice for the prevention of type-2 diabetes (T2D) in routine PHC. Methods This will be a randomised cluster type II hybrid implementation trial. Nine PHC centres from the Basque Health Service (Osakidetza) will be allocated to two different procedures to engage family doctors and nurses and create an interprofessional collaborative practice to optimise the integration of a T2D primary prevention programme. All centres and PHC professionals will receive training on current guidelines in primary prevention of T2D and effective interventions to promote healthy lifestyles. Headed by a local leader and an external facilitator, centres will conduct a collaborative structured process to model and adapt the intervention and its implementation to the specific context of professionals and centres. One of the groups will apply this strategy globally, promoting the cooperation of all health professionals from the beginning. The other will perform it sequentially, centred first on nurses, who will then seek the pragmatic cooperation of doctors. All patients without diabetes aged ≥ 30 years old who attend collaborating centres at least once during the study period and found to be at high risk of developing T2D will be eligible for programme inclusion. The main outcome measures focus on changes observed in indicators of T2D prevention clinical practice at centre level after 12 and 24 months, associated with the application of one or other engagement procedure. Secondary outcomes will compare their clinical effectiveness in changing eligible exposed patients’ main lifestyle behaviours and risk factors (physical activity and diet, weight, etc.) after 12 months. Discussion The PREDIAPS project will generate scientific knowledge on procedures for engaging PHC professional to facilitate feasible and effective adoption of proven interventions for the prevention of T2D in routine clinical practice through the application of implementation strategies. Trial registration Clinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017.

Abstract Background Implementation tools (iTools) may enhance uptake of guidelines. However, little evidence exists on their use by primary care clinicians. This study explored which iTools clinicians used and how often; how satisfied clinicians were with the tools; whether tool use was associated with practice changes; and identified mediators for practice change(s) related to breast cancer screening (BCS). Methods Canadian primary care providers who are members of the Practice-Based Small Group Learning Program (n = 1464) were invited to participate in this mixed methods study. An educational module was discussed in a small group learning context, and data collection included an on-line survey, practice reflection tools (PRTs), and interviews. The module included both the Canadian Task Force on Preventive Health Care revised guideline on BCS and iTools for clinician and/or patient use. After discussing the module and at 3 months, participants completed PRTs identifying their planned practice change(s) and documenting implementation outcome(s). Use of the iTools was explored via online survey and individual interviews. Results Seventy participants agreed to participate. Of these, 48 participated in the online survey, 43 completed PRTs and 14 were interviewed. Most survey participants (77%) reported using at least one of seven tools available for implementing BCS guideline. Of these (78%) reported using more than one tool. Almost all participants used tools for clinicians (92%) and 62% also used tools for patients. As more tools were used, more practice changes were reported on the survey and PRTs. Interviews provided additional findings. Once information from an iTool was internalized, there was no further need for the tool. Participants did not use tools (23%) due to disagreements with the BCS guideline, patients’ expectations, and/or experiences with diagnosis of breast cancer. Conclusion This study found that clinicians use tools to implement practice changes related to BCS guideline. Tools developed for clinicians were used to understand and consolidate the recommendations before tools to be used with patients were employed to promote decision-making. Mediating factors that impacted tool use confirmed previous research. Finally, use of some iTools decreased over time because information was internalized.

Abstract Background The Centers for Disease Control (2018) estimates that 1 in 59 children has autism spectrum disorder, and the annual cost of ASD in the U.S. is estimated to be $236 billion. Evidence-based interventions have been developed and demonstrate effectiveness in improving child outcomes. However, research on generalizable methods to scale up these practices in the multiple service systems caring for these children has been limited and is critical to meet this growing public health need. This project includes two, coordinated studies testing the effectiveness of the T ranslating E vidence-based Interventions (EBI) for A SD: M ulti-Level Implementation S trategy (TEAMS) model. TEAMS focuses on improving implementation leadership, organizational climate, and provider attitudes and motivation in order to improve two key implementation outcomes—provider training completion and intervention fidelity and subsequent child outcomes. The TEAMS Leadership Institute applies implementation leadership strategies and TEAMS Individualized Provider Strategies for training applies motivational interviewing strategies to facilitate provider and organizational behavior change. Methods A cluster randomized implementation/effectiveness Hybrid, type 3, trial with a dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. Study #1 will test the TEAMS model with AIM HI (An Individualized Mental Health Intervention for ASD) in publicly funded mental health services. Study #2 will test TEAMS with CPRT (Classroom Pivotal Response Teaching) in education settings. Thirty-seven mental health programs and 37 school districts will be randomized, stratified by county and study, to one of four groups (Standard Provider Training Only, Standard Provider Training + Leader Training, Enhanced Provider Training, Enhanced Provider Training + Leader Training) to test the effectiveness of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. Implementation outcomes including provider training completion, fidelity (coded by observers blind to group assignment) and child behavior change will be examined for 295 mental health providers, 295 teachers, and 590 children. Discussion This implementation intervention has the potential to increase quality of care for ASD in publicly funded settings by improving effectiveness of intervention implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in community services. Trial registration This study is registered with Clinicaltrials.gov (NCT03380078). Registered 20 December 2017, retrospectively registered.

Abstract Background Detailed descriptions of implementation strategies are lacking, and there is a corresponding dearth of information regarding methods employed in implementation strategy development. This paper describes methods and findings related to the alpha testing of eLearning modules developed as part of the Housing First Technical Assistance and Training (HFTAT) program’s development. Alpha testing is an approach for improving the quality of a product prior to beta (i.e., real world) testing with potential applications for intervention development. Methods Ten participants in two cities tested the modules. We collected data through (1) a structured log where participants were asked to record their experiences as they worked through the modules; (2) a brief online questionnaire delivered at the end of each module; and (3) focus groups. Results The alpha test provided useful data related to the acceptability and feasibility of eLearning as an implementation strategy, as well as identifying a number of technical issues and bugs. Each of the qualitative methods used provided unique and valuable information. In particular, logs were the most useful for identifying technical issues, and focus groups provided high quality data regarding how the intervention could best be used as an implementation strategy. Conclusions Alpha testing was a valuable step in intervention development, providing us an understanding of issues that would have been more difficult to address at a later stage of the study. As a result, we were able to improve the modules prior to pilot testing of the entire HFTAT. Researchers wishing to alpha test interventions prior to piloting should balance the unique benefits of different data collection approaches with the need to minimize burdens for themselves and participants.

Introduction: Reinforcing integrated healthcare systems requires systematic adoption of health promotion interventions by primary care professionals to reduce chronic disease burden caused by inadequate diet, physical inactivity, tobacco smoking and alcohol consumption. Despite the effectiveness of health promotion interventions and the strategic position of primary care professionals for optimistic health behaviour change interventions, health promotion is not systematically integrated into routine practice owing to the existence of multiple barriers. The purpose of this Scoping Review (SR) is to identify and describe implementation strategies used to increase adoption and maintenance of health promotion interventions into primary care and community organizations. Theory / Methods: Five steps guided this SR (two independent reviewers involved): Systematic bibliographic search. Inclusion criteria for study selection (implementation strategy; health promotion intervention to modify risk habits; primary care and community organizations; evaluation of implementation strategy). Quality assessment. Data extraction of each implementation strategy (analytical unit). Qualitative narrative synthesis. SR fits well with our aim of identifying and synthesizing emerging evidence related to implementation strategies and to detect the most relevant research questions in this field. Results: After screening 1641 titles and assessing 118 full-texts, 45 publications on 35 implementation projects were included. Most of them used dissemination strategies (i.e. “conduct educational meetings”) to change clinical practice, focusing more on individual characteristics than on inner and outer settings. Projects published after 2010 applied more complex strategies -combining at least 4 discrete components- to operate at multiple levels (see attached graphic). Implementation researchers focused more on adoption than on maintenance. Discussion: Integration of health promotion into primary care organizations is an unsolved implementation problem despite the sound evidence of these interventions and their potential impact to reduce chronic disease burden in general population. The spread use of dissemination strategies is insufficient to guarantee a sustainable change. The advance toward an integrated primary care system constitutes an opportunity to act over structural barriers located in inner and outer settings thought implementation research. Conclusions: This SR highlights the need of more consistent and transparent reporting of implementation strategies to rigorously evaluate their effectiveness and to understand how they exert their effects. The lack of specification of strategies, the weak use of theory and the moderate quality of evaluations make difficult replication and generalization. We recommend the application of the StaRI (Standards for Reporting Implementation Studies) guidelines for improving reporting. Lessons learned: Improving the design of implementation strategies requires some conditions: use of theory, previous identification of barriers, stakeholders’ active engagement (patients and community agents) and application of methods for selecting and adapting implementation strategies. Limitations: The small number of projects identified, the different designs and the diverse range of outcomes have made impossible to conduct a systematic review and a meta-analysis to estimate the effectiveness of implementation strategies. SR fits well with this immature research field. Suggestions for future research: We will conduct a Qualitative Comparative Analysis with implementation projects of this SR to identify which combinations of strategies are more effective to change clinical practice.

Abstract Background Implementation of the ‘Sepsis Six’ clinical care bundle within an hour of recognition of sepsis is recommended as an approach to reduce mortality in patients with sepsis, but achieving reliable delivery of the bundle has proved challenging. There remains little understanding of the barriers to reliable implementation of bundle components. We examined frontline clinical practice in implementing the Sepsis Six. Methods We conducted an ethnographic study in six hospitals participating in the Scottish Patient Safety Programme Sepsis collaborative. We conducted around 300 h of non-participant observation in emergency departments, acute medical receiving units and medical and surgical wards. We interviewed a purposive sample of 43 members of hospital staff. Data were analysed using a constant comparative approach. Results Implementation strategies to promote reliable use of the Sepsis Six primarily focused on education, engaging and motivating staff, and providing prompts for behaviour, along with efforts to ensure that equipment required was readily available. Although these strategies were successful in raising staff awareness of sepsis and engagement with implementation, our study identified that completing the bundle within an hour was not straightforward. Our emergent theory suggested that rather than being an apparently simple sequence of six steps, the Sepsis Six actually involved a complex trajectory comprising multiple interdependent tasks that required prioritisation and scheduling, and which was prone to problems of coordination and operational failures. Interventions that involved allocating specific roles and responsibilities for completing the Sepsis Six in ways that reduced the need for coordination and task switching, and the use of process mapping to identify system failures along the trajectory, could help mitigate against some of these problems. Conclusions Implementation efforts that focus on individual behaviour change to improve uptake of the Sepsis Six should be supplemented by an understanding of the bundle as a complex trajectory of work in which improving reliability requires attention to coordination of workflow, as well as addressing the mundane problems of interruptions and operational failures that obstruct task completion.

Abstract Background Sciatica is a common condition worldwide that is characterized by radiating leg pain and regularly caused by a herniated disc with nerve root compression. Sciatica patients with persisting leg pain after six to eight weeks were found to have similar clinical outcomes and associated costs after prolonged conservative treatment or surgery at one year follow-up. Guidelines recommend that the team of professionals involved in sciatica care and patients jointly decide about treatment options, so-called interprofessional shared decision making (SDM). However, there are strong indications that SDM for sciatica patients is not integrated in daily practice. We designed a study aiming to explore the barriers and facilitators associated with the everyday embedding of SDM for sciatica patients. All related relevant professionals and patients are involved to develop a tailored strategy to implement SDM for sciatica patients. Methods The study consists of two phases: identification of barriers and facilitators and development of an implementation strategy. First, barriers and facilitators are explored using semi-structured interviews among eight professionals of each (para)medical discipline involved in sciatica care (general practitioners, physical therapists, neurologists, neurosurgeons, and orthopedic surgeons). In addition, three focus groups will be conducted among patients. Second, the identified barriers and facilitators will be ranked using a questionnaire among a representative Dutch sample of 200 GPs, 200 physical therapists, 200 neurologists, all 124 neurosurgeons, 200 orthopedic surgeons, and 100 patients. A tailored team-based implementation strategy will be developed based on the results of the first phase using the principles of intervention mapping and an expert panel. Discussion Little is known about effective strategies to increase the uptake of SDM. Most implementation strategies only target a single discipline, whereas multiple disciplines are involved in SDM among sciatica patients. The results of this study can be used as an example for implementing SDM in other patient groups receiving multidisciplinary complex care (e.g., elderly) and can be generalized to other countries with similar context, thereby contributing to a worldwide increase of SDM in preference sensitive choices.

Abstract Background Total hip and knee arthroplasties are two of the most commonly performed procedures in orthopedic surgery. Different blood-saving measures (BSMs) are used to reduce the often-needed allogenic blood transfusions in these procedures. A recent large randomized controlled trial showed it is not cost effective to use the BSMs of erythropoietin and perioperative autologous blood salvage in elective primary hip and knee arthroplasties. Despite dissemination of these study results, medical professionals keep using these BSMs. To actually change practice, an implementation strategy is needed that is based on a good understanding of target groups and settings and the psychological constructs that predict behavior of medical professionals. However, detailed insight into these issuses is lacking. Therefore, this study aims to explore which groups of professionals should be targeted at which settings, as well as relevant barriers and facilitators that should be taken into acount in the strategy to implement evidence-based, cost-effective blood transfusion management and to de-implement BSMs. Methods The study consists of three phases. First, a questionnaire survey among all Dutch orthopedic hospital departments and independent treatment centers (n = 99) will be conducted to analyze current blood management practice. Second, semistructured interviews will be held among 10 orthopedic surgeons and 10 anesthesiologists to identify barriers and facilitators that are relevant for the uptake of cost-effective blood transfusion management. Interview questions will be based on the Theoretical Domains Interview framework. The interviews will be followed by a questionnaire survey among 800 medical professionals in orthopedics and anesthesiology (400 professionals per discipline) in which the identified barriers and facilitators will be ranked by frequency and importance. Finally, an implementation strategy will be developed based on the results from the previous phases, using principles of intervention mapping and an expert panel. Discussion The developed strategy for cost-effective blood transfusion management by de-implementing BSMs is likely to reduce costs for elective hip and knee arthroplasties. In addition, this study will lead to generalized knowledge regarding relevant factors for the de-implementation of non-cost-effective interventions and insight in the differences between implementation and de-implementation strategies.