Search

Abstract Background Few implementation science (IS) measures have been evaluated for validity, reliability and utility – the latter referring to whether a measure captures meaningful aspects of implementation contexts. We present a real-world case study of rigorous measure development in IS that assesses Barriers and Facilitators in Implementation of Task-Sharing in Mental Health services (BeFITS-MH), with the objective of offering lessons-learned and a framework to enhance measurement utility. Methods We summarize conceptual and empirical work that informed the development of the BeFITS-MH measure, including a description of the Delphi process, detailed translation and local adaptation procedures, and concurrent pilot testing. As validity and reliability are key aspects of measure development, we also report on our process of assessing the measure’s construct validity and utility for the implementation outcomes of acceptability, appropriateness, and feasibility. Results Continuous stakeholder involvement and concurrent pilot testing resulted in several adaptations of the BeFITS-MH measure’s structure, scaling, and format to enhance contextual relevance and utility. Adaptations of broad terms such as “program,” “provider type,” and “type of service” were necessary due to the heterogeneous nature of interventions, type of task-sharing providers employed, and clients served across the three global sites. Item selection benefited from the iterative process, enabling identification of relevance of key aspects of identified barriers and facilitators, and what aspects were common across sites. Program implementers’ conceptions of utility regarding the measure’s acceptability, appropriateness, and feasibility clustered across several common categories. Conclusions This case study provides a rigorous, multi-step process for developing a pragmatic IS measure. The process and lessons learned will aid in the teaching, practice and research of IS measurement development. The importance of including experiences and knowledge from different types of stakeholders in different global settings was reinforced and resulted in a more globally useful measure while allowing for locally-relevant adaptation. To increase the relevance of the measure it is important to target actionable domains that predict markers of utility (e.g., successful uptake) per program implementers’ preferences. With this case study, we provide a detailed roadmap for others seeking to develop and validate IS measures that maximize local utility and impact.

Abstract Background Dissemination and implementation science is an evolving field that focuses on the strategies and mechanisms by which scientific evidence is adopted, used, and sustained in clinical and community practice. Main body Implementation scientists are confronted by the challenge to balance rigor and generalizability in their work while also attempting to speed the translation of evidence into clinical and community practice. Hybrid Effectiveness-Implementation studies and the RE-AIM framework were conceptualized to address these challenges. Hybrid Effectiveness-Implementation (HEI) studies provide methods of examining the effectiveness of health promoting interventions while concurrently assessing the utility of dissemination and implementation strategies designed to enhance the application of evidence-based principles in practice. RE-AIM provides a set of planning and evaluation dimensions that can be assessed with a goal to balance internal and external validity. The purpose of this commentary is to provide clarity on definitions of each approach and how to effectively use them together to answer research questions that will advance dissemination and implementation science for health promotion. Conclusions We provide examples of concerted use of RE-AIM within HEI studies from the literature and focus on language to provide a clarity and consistency across research questions, designs, and settings. We share how to operationalize RE-AIM dimensions in HEI studies for both dissemination and implementation strategies. Future directions include refining, defining, and evaluating each RE-AIM dimension within hybrid studies.

Abstract Background Implementation strategies are key to enhancing the translation of new innovations but there is a need to systematically design and tailor strategies to match the targeted implementation context and address determinants. There are increasing methods to inform the development and tailoring of implementation strategies to maximize their usability, feasibility, and appropriateness in new settings such as the Cognitive Walkthrough for Implementation Strategies (CWIS) approach. The aim of the current project is to apply the CWIS approach to inform the redesign of a multifaceted selection-quality implementation toolkit entitled Adoption of Curricular supports Toolkit: Systematic Measurement of Appropriateness and Readiness for Translation in Schools (ACT SMARTS) for use in middle and high schools. Methods We systematically applied CWIS as the second part of a community-partnered iterative redesign of ACT SMARTS for schools to evaluate the usability and inform further toolkit redesign areas. We conducted three CWIS user testing sessions with key end users of school district administrators (n = 3), school principals (n = 6), and educators (n = 6). Results Our CWIS application revealed that end users found ACT SMARTS acceptable and relevant but anticipate usability issues engaging in the ACT SMARTS process. Results informed the identification of eleven usability issues and corresponding redesign solutions to enhance the usability of ACT SMARTS for use in middle and high schools. Conclusions Results indicated the utility of CWIS in assessing implementation strategy usability in service of informing strategy modification as part of our broader redesign to improve alignment with end user, end recipient, and setting needs. Recommendations regarding the use of this participatory approach are discussed.

Abstract Background A significant issue with innovative problem-solving in healthcare is an existing deficiency in continuing education for many healthcare professionals, which hinders the successful implementation of inventive solutions and progress in the field. Educators play a crucial role in guiding students to cultivate the knowledge and skills necessary to confront these challenges, including problem solving, collaboration, and the use of rapidly advancing technologies. It is vital to design educational programs that empower and motivate students to develop the proficiency and knowledge they need to be effective problem solvers, collaborators, and cultivators of innovative solutions. This project aims to assess the implementation and effectiveness of a codesigned postgraduate university program for a multidisciplinary health workforce. Methods The Leading Health Services Innovation Project is a hybrid type 2 mixed method implementation trial of a codesigned Graduate Certificate in Health Services Innovation. In collaboration with a large tertiary and quaternary health service, we developed a codesign process to guide the project, with time quarantined to create space for two-way learning between health sector partners and healthcare academics. Qualitative interviews and quantitative surveys for primary users will evaluate the implementation strategies. The reach, effectiveness, adoption implementation, and maintenance (RE-AIM) framework will guide the evaluation and maintenance of the program. Results Integrating a codesign strategy complemented by a well-structured implementation and evaluation protocol that is a combination of implementation science theoretical frameworks (Knowledge to Action, Evidence-Based Co-design, RE-AIM) may lead to translational competence as a potential outcome. Anticipated outcomes The application, resourcing and commitment to codesigned tertiary-level learning and qualification will demonstrate the achievement of a contemporary and comprehensive postgraduate university degree program in health innovation management.

Abstract Objective To evaluate implementation of a patient decision aid for symptomatic uterine fibroid management to improve shared decision-making at five clinical settings across the United States. Methods We used a type 3 hybrid effectiveness-implementation stepped-wedge design and the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) planning and evaluation framework. We conducted clinician training, monthly reach tracking with feedback to site clinical leads, patient and clinician surveys, and visit audio-recordings. Implementation strategies included assessment of organizational readiness for shared decision-making, synchronous clinician training, audit and feedback of decision aid reach, and access to multiple decision aid formats. Outcomes and analyses included patient-level reach, clinician-level adoption, and associations of patient-reported decision aid exposure (as treated) and setting-level implementation (intention-to-treat) with patient-reported (collaboRATE measure) and observed (OPTION-5 measure) shared decision-making. We also designed and assessed setting-level plans for sustainability and other factors impacting sustained decision aid use. Results The decision aid was adopted by 72 of the 74 eligible gynecologists (97%) and reached 2553 patients across five settings. CollaboRATE scores improved among patients who reported receiving the decision aid (as-treated analysis, 69% vs. 59%; OR 1.6, 95% CI 1.16–2.27). CollaboRATE scores remained consistent before and after setting-level decision aid implementation (intention-to-treat analysis, 64% vs. 63%; OR 0.86, 95% CI 0.61–1.22). Participants would prefer to receive a decision aid at multiple time points (91.9% before the visit, 90.7% during the visit, 86.5% after the visit). Shared decision-making experiences did not improve when comparing pre vs. post-implementation collaboRATE scores across included settings (intention-to-treat, 64% vs. 63%; OR 0.86, 95% CI 0.61–1.22). Conclusion When patients with symptomatic uterine fibroids are given decision aids, they report higher shared decision-making scores. However, the differences we observed between the as-treated and intention-to-treat results suggest that unaddressed implementation challenges continue to limit the extent to which patients receive decision aids and likely hinder their overall impact. Future efforts to implement decision aids should explore enhancing their integration into clinical workflows and standard operating procedures, supported by organizational incentives that prioritize shared decision-making. Trial registration ClinicalTrials.gov NCT03985449; registered 6 June 2019.

The enhanced recovery after surgery (ERAS) pathway is a perioperative care pathway intended to facilitate early recovery and minimize hospital stays among patients undergoing major surgery. Critical factors for successful ERAS implementation, which may vary depending on care processes, include a multidisciplinary team, organizational commitment to change, and a real-time system for compliance and outcome audits. As most clinicians and health organizations can attest, incorporating and implementing new evidence-based practice changes almost always involves overcoming systemic challenges and obstacles. The same holds true for ERAS programs. The main barriers to ERAS protocol implementation have been resistance to change, lack of time and resources, and inadequate communication and coordination among departments. According to evidence-based ERAS guidelines, the best way to efficiently implement all recommendations into practice is to discover. Implementation science aims to identify and address care gaps, support change in practice, and enhance healthcare quality. Implementation research should also build a robust and generalizable evidence base to inform implementation practice. Most implementation investigations focus on one of two approaches to achieving change. Implementation can progress through top-down or bottom-up processes depending on factors such as national policies, organizational properties, or the implementation culture of society, especially for health issues. Although the ERAS guidelines are based on evidence-based knowledge, only a limited number of health centers around the world have officially been able to implement them. The purpose of this review is to analyze the implementation of the ERAS pathways in theory and practice in Turkey, considering the absence of an ERAS-qualified center in Turkey.

Abstract Background In clinical oncology practice, patient-reported outcomes (PROs) are essential for assessing the symptom burden, quality of life, and psychological status of patients. However, there remains a gap between the use of PROs in an oncologic setting and its implementation. Furthermore, numerous reviews in PRO implementation are often based on one particular technology, setting, or health condition, making it difficult to obtain a comprehensive and coherent summary of available evidence to help plan and undertake implementation. This systematic review aims to identify and integrate enablers and barriers to PRO implementation through the comprehensive framework for implementation research (CFIR) to provide a reference for implementing patient-reported outcomes management in oncology settings. Methods This review strictly observed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Web of Science, CINAHL, Embase, and PsycINFO databases were systematically searched using a three-step search strategy. The search was limited from the inception of each database to April 2024. Articles describing facilitators and barriers to implementing PROs in clinical oncology practice were included. Two researchers screened the literature independently, and the quality assessment of cross-sectional, qualitative, and mixed studies was completed using the critical appraisal tools recommended by Joanna Briggs Institute (JBI) and the mixed methods assessment tool, respectively. Basic information about the included studies and determinants affecting PRO implementation was extracted, and coding categorization of facilitators and barriers was completed based on the 48 constructs provided by the CFIR framework. Results We included 30 studies from 5,649 search results, including 25 original and 5 review studies. The quality of the literature for qualitative studies was generally good, and the quality for quantitative and mixed studies was assessed as fair. We identified 52 facilitators and 50 barriers in the included literature, covering the domains used in the CFIR framework and 39 constructs, mainly including "Innovation Evidence-Base", "Innovation Complexity", "Innovation Design", "Structural Characteristics", "Compatibility", "Incentive Systems", "Access to Knowledge & Information", "Innovation Deliverers", "Innovation Recipients", and "Planning". Conclusions This systematic review integrated facilitators and barriers affecting PRO implementation in routine oncology clinical practice settings and categorized them through the CFIR framework. These influencing factors should be fully considered in future clinical practice to ensure the successful implementation of PROs. Trial registration It has been registered prospectively in PROSPERO under the registration number 42024532983.

Abstract Background HIV treatment programs in Africa have implemented centralized testing for routine viral load monitoring (VLM), which may result in specimen processing delays inhibiting timely return of viral load results. Decentralized, point-of-care (PoC) VLM is a promising tool for expediting HIV clinical decision-making but remains unavailable in most African settings. We qualitatively explored the perceived feasibility and appropriateness of PoC VLM to address gaps along the viral load monitoring continuum in rural Uganda. Methods Between May and September 2022, we conducted 15 in-depth interviews with HIV clinicians (facility in-charges, clinical officers, nurses, counselors) and six focus group discussions with 47 peer health workers from three south-central Ugandan districts. Topics explored centralized VLM implementation and opportunities/challenges to optimizing routine VLM implementation with PoC testing platforms. We explored perspectives on PoC VLM suitability and feasibility using iterative thematic analysis. Applying the Framework Method, we then mapped salient constraints and enablers of PoC VLM to constructs from the Consolidated Framework for Implementation Research. Results Clinicians and peers alike emphasized centralized viral load monitoring’s resource-intensiveness and susceptibility to procedural/infrastructural bottlenecks (e.g., supply stockouts, testing backlogs, community tracing of clients with delayed VLM results), inhibiting timely clinical decision-making. Participants reacted enthusiastically to the prospect of PoC VLM, anticipating accelerated turnarounds in specimen processing, shorter and/or fewer client encounters with treatment services, and streamlined efficiencies in HIV care provision (including expedited VLM-driven clinical decision-making). Anticipated constraints to PoC VLM implementation included human resource requirements for processing large quantities of specimens (especially when machinery require repair), procurement and maintenance costs, training needs in the existing health workforce for operating point-of-care technology, and insufficient space in lower-tier health facilities to accommodate installation of new laboratory equipment. Conclusions Anticipated implementation challenges, primarily clustering around resource requirements, did not diminish enthusiasm for PoC VLM monitoring among rural Ugandan clinicians and peer health workers, who perceived PoC platforms as potential solutions to existing inefficiencies within the centralized VLM ecosystem. Prioritizing PoC VLM rollout in facilities with available resources for optimal implementation (e.g., adequate physical and fiscal infrastructure, capacity to manage high specimen volumes) could help overcome anticipated barriers to decentralizing viral load monitoring.

Abstract Background In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services. Methods We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA). Results Between May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit. Conclusions Semiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.

Abstract Introduction Evaluation of implementation strategies is core to implementation trials, but implementation strategies often deviate from the original plan to adjust to the real-world conditions. The optimal approach to track modifications to implementation strategies is unclear, especially in low-resource settings. Using data from an implementation trial for people who inject drugs (PWID) with HIV in Vietnam, we describe the tracking of implementation strategy modifications and present findings of this process. Methods SNaP (Systems Navigation and Psychosocial Counseling) is a hybrid type-III effectiveness-implementation randomized controlled trial aiming to scale up the evidence-based intervention, integrated systems navigation and psychosocial counseling, for PWID with HIV in Vietnam. Forty-two HIV testing sites were randomized 1:1 to a standard or tailored arm. While the standard arm (SA) received a uniform package of strategies, implementation strategies for the tailored arm (TA) were tailored to address specific needs of each site. The central research team also met monthly with the TA to document how their tailored strategies were implemented over time. Five components were involved in the tracking process: describing the planned strategies; tracking strategy use; monitoring barriers and solutions; describing modifications; and identifying and describing any additional strategies. Results Our approach allowed us to closely track the modifications to implementation strategies in the tailored arms every month. TA sites originally identified 27 implementation strategies prior to implementation. During implementation, five strategies were dropped by four sites and two new strategies were added to twelve sites. Modifications of five strategies occurred at four sites to accommodate their changing needs and resources. Difficulties related to the COVID-19 pandemic, low number of participants recruited, high workload at the clinic, lack of resources for HIV testing and high staff turnover were among barriers of implementing the strategies. A few challenges to tracking modifications were noted, including the considerable amount of time and efforts needed as well as the lack of motivation from site staff to track and keep written documentations of modifications. Conclusions We demonstrated the feasibility of a systematic approach to tracking implementation strategies for a large-scale implementation trial in a low-resource setting. This process could be further enhanced and replicated in similar settings to balance the rigor and feasibility of implementation strategy tracking. Our findings can serve as additional guidelines for future researchers planning to report and track modifications to implementation strategies in large, complex trials. Trial registration : clinicaltrials.gov ID: NCT03952520 (first posted 2019-05-16).

Abstract Background Pediatric depression is a global concern that has fueled efforts for enhanced detection and treatment engagement. As one example, the US Preventive Services Task Force recommends depression screening for adolescents ages 12–18 years. While many health systems have implemented components of depression screening protocols, there is limited evidence of effective follow-up for pediatric depression. A key barrier is timely team communication and coordination across clinicians and staff within and across service areas for prompt service linkage. However, team effectiveness interventions have been shown to improve team processes and outcomes and can be applied in healthcare settings. Methods This project aims to refine and test a team communication training implementation strategy to improve implementation of an existing pediatric depression screening protocol in a large pediatric healthcare system. The team will be defined as part of the study but is expected to include medical assistants, nurses, physicians, and behavioral health clinicians within and across departments. The implementation strategy will target team mechanisms at the team-level (i.e., intra-organizational alignment and implementation climate) and team member-level (i.e., communication, coordination, psychological safety, and shared cognition). First, the project will use mixed methods to refine the team training strategy to fit the organizational context and workflows. Next, a hybrid type 3 implementation-effectiveness pilot trial will assess the initial effectiveness of the team communication training (implementation strategy) paired with the current universal depression screening protocol (clinical intervention) on implementation outcomes (i.e., feasibility, acceptability, appropriateness, workflow efficiency) and clinical/services outcomes (increased frequency of needed screening and reduced time to service linkage). Finally, the study will assess mechanisms at the team and team member levels that may affect implementation outcomes. Discussion Team communication training is hypothesized to lead to improved, efficient, and effective decision-making to increase the compliance with depression screening and timely service linkage. Findings are expected to yield better understanding and examples of how to optimize team communication to improve efficiency and effectiveness in the pediatric depression screening-to-treatment cascade. This should also culminate in improved implementation outcomes including patient engagement critical to address the youth mental health crisis. Trial registration NCT06527196. Trial Sponsor: University of California San Diego.

The World Health Organization Global Hearts initiative (HEARTS) and technical package aim to improve the primary health care management of hypertension and other risk factors for cardiovascular disease at the population level. This study describes the first HEARTS implementation pilot project in Guatemala’s Ministry of Health (MOH) primary health care system. This pilot began in April 2022 in six primary health care facilities in three rural indigenous municipalities. The project consisted of HEARTS-aligned strategies adapted to enhance program sustainability in Guatemala. Outcomes were defined using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. The primary reach outcome was treatment count, defined as the absolute number of patients per month receiving medication treatment for hypertension. The primary effectiveness outcomes were mean systolic blood pressure (BP), mean diastolic BP, and proportion of patients with BP control (

Abstract Background Despite receiving adequate treatment, many tuberculosis (TB) survivors are left with post-tuberculosis complications, possibly due to lung tissue damage incurred during the active period of the disease. Current TB programs worldwide deliver quality care throughout the course of active TB treatment, yet often fail to provide organized follow-up once treatment ends. Post-tuberculosis lung disease (PTLD) is a prominent, yet underrecognized cause of chronic lung disease, managed similarly to chronic respiratory diseases with pharmacotherapy and/or personalized pulmonary rehabilitation interventions. Basic pulmonary rehabilitation packages for people finishing TB treatment are still lacking in low- and middle-income countries (LMICs). We offer a study protocol to evaluate the implementation of spirometry and symptom screening for PTLD among people who have completed TB treatment in a rural district in Mozambique. Methods The overall objective of this study is to evaluate the introduction of a new screening program that utilizes symptom screening and spirometry for diagnosing PTLD among adolescents and adults that have completed TB treatment. This research protocol consists of three complementary components: 1) assessing the prevalence of PTLD among patients enrolled in the National TB Control Program (NTCP) at Carmelo Hospital (CHC) in Chókwè District, Mozambique; 2) evaluating anticipated implementation outcomes through the identification of the site-, provider-, and individual-level determinants that either facilitate or hinder the successful adoption, implementation, and maintenance of the spirometry screening program, and 3) evaluating the real-time implementation outcomes/processes in order to provide practical evidence-based key indicators of successful implementation of the spirometry screening program. Discussion Providing well-organized, evidence-based care for individuals with a history of TB who are experiencing symptoms of PTLD can relieve chronic respiratory issues, enhance quality of life, and potentially lower the risk of further pulmonary infections, including recurrent TB. However, there is a significant gap in the literature regarding the implementation of best practices of HIV and TB health services delivery. Addressing this gap could assist Mozambique in improving diagnosis, treatment, and continuity of care for people formerly living with TB. The insights from this study will help decision-makers improve spirometry screening coverage, enhance intervention effectiveness, and translate our findings to evidence-based programming. Trial registration ISRCTN92021748 retrospectively registered.

Abstract Background The cost of implementation is typically not accounted for in published economic evaluations, which determine the relative value for money of health innovations and are important for allocating scarce resources. Despite key papers outlining relevant implementation costs, they continue to be under reported in the literature and often not considered in practice. This study sought to understand and outline current practices for capturing the costs associated with implementation efforts, with examples from the digital health setting. Methods A qualitative study of semi-structured interviews with purposefully sampled experts in implementation science, health economics and/or digital health was conducted. The interview guide was informed by a literature review and was pilot tested. Interviews were digitally recorded and transcribed. A hybrid inductive/deductive framework analysis was conducted using thematic analysis to elicit key concepts related to the research question. Results Interviews were conducted with sixteen participants with specialist expertise in implementation science (n = 8), health economics (n = 6), and/or digital health (n = 8). Five participants were experienced in more than one field. Four key themes were elicited from the data: difficulty identifying and collecting implementation cost data; variation in approaches for collecting implementation cost data; the value of implementation costs; and collaboration enables implementation costing. Broadly, while interviewees recognised implementation costs as important, only some costs were considered in practice likely due to the perceived ill-defined boundaries and inconsistencies in terminology. A variety of methods were used to collect and estimate implementation costs; the most frequent approach was staff time tracking. Multidisciplinary collaboration facilitated this process, but the burden of collecting the necessary data was also highlighted. Conclusions In current practice, standardised methods are not commonly used for data collection or estimation of implementation costs. Improved data collection through standardised practices may support greater transparency and confidence in implementation cost estimates. Although participants had industry exposure, most were also academic researchers and findings may not be representative of non-academic industry settings.

Abstract Objective To identify innovation and implementation determinants of HIV testing, diagnosis, and linkage-to-care in the U.S. Data sources and study setting Between November 2020 and January 2022, a broad search strategy was employed in three literature databases: Ovid MEDLINE, PsycINFO, and Web of Science. Study design A systematic review guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Data collection/extraction methods A team of master’s and Ph.D.-level researchers screened eligible studies against the inclusion criteria and extracted the data using COVIDENCE software in pairs with consensus performed by a senior member of the team. Barriers and facilitators were extracted and analyzed according to the Consolidated Framework for Implementation Research (CFIR). Frequency of determinants across studies was mapped according to CFIR, valence, study design, delivery setting, unit of analysis, population of interest, region of the U.S., and year. Results We identified 1,739 implementation and innovation determinants from 186 articles. Most determinants were for HIV testing rather than linkage-to-care. Most determinants were identified in the inner setting and individuals domains of CFIR, with the fewest identified in the process and innovations domains. Determinants of providers were only slightly more frequently identified than determinants of recipients. However, determinants of organizations and systems were rarely identified. Conclusion This review provides a synthesis of innovation and implementation determinants of HIV testing and linkage-to-care using the most-cited implementation science (IS) framework, CFIR. This synthesis enables the larger field of HIV science to utilize IS in efforts to end the HIV epidemic and positions IS to consider the application of IS frameworks to fields like HIV.

Abstract Background Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. Methods This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs (“hospital-HHA” dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF’s implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. Discussion As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. Trial registration This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1 .

Abstract Background Electronic Prospective Surveillance Models (ePSMs) remotely monitor the rehabilitation needs of people with cancer via patient-reported outcomes at pre-defined time points during cancer care and deliver support, including links to self-management education and community programs, and recommendations for further clinical screening and rehabilitation referrals. Previous guidance on implementing ePSMs lacks sufficient detail on approaches to select implementation strategies for these systems. The purpose of this article is to describe how we developed an implementation plan for REACH, an ePSM system designed for breast, colorectal, lymphoma, and head and neck cancers. Methods Implementation Mapping guided the process of developing the implementation plan. We integrated findings from a scoping review and qualitative study our team conducted to identify determinants to implementation, implementation actors and actions, and relevant outcomes. Determinants were categorized using the Consolidated Framework for Implementation Research (CFIR), and the implementation outcomes taxonomy guided the identification of outcomes. Next, determinants were mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy of strategies using the CFIR-ERIC Matching Tool. The list of strategies produced was refined through discussion amongst our team and feedback from knowledge users considering each strategy’s feasibility and importance rating via the Go-Zone plot, feasibility and applicability to the clinical contexts, and use among other ePSMs reported in our scoping review. Results Of the 39 CFIR constructs, 22 were identified as relevant determinants. Clinic managers, information technology teams, and healthcare providers with key roles in patient education were identified as important actors. The CFIR-ERIC Matching Tool resulted in 50 strategies with Level 1 endorsement and 13 strategies with Level 2 endorsement. The final list of strategies included 1) purposefully re-examine the implementation, 2) tailor strategies, 3) change record systems, 4) conduct educational meetings, 5) distribute educational materials, 6) intervene with patients to enhance uptake and adherence, 7) centralize technical assistance, and 8) use advisory boards and workgroups. Conclusion We present a generalizable method that incorporates steps from Implementation Mapping, engages various knowledge users, and leverages implementation science frameworks to facilitate the development of an implementation strategy. An evaluation of implementation success using the implementation outcomes framework is underway.

Abstract Background Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya’s national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow. Methods The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO’s effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data. Discussion We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention’s integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented. Trial registration ClinicalTrials.gov, NCT05187897 . The CHV-NEO study was registered on January 12, 2022.

Implementation strategies are targeted interventions aimed at promoting the adoption, implementation, and sustainment of research findings or evidence-based practices in routine healthcare. If implementation strategies can precisely match implementation barriers and facilitators, the likelihood of successful implementation will increase. The CFIR-ERIC matching tool, which can match corresponding ERIC implementation strategies based on CFIR barriers, is a convenient and direct tool for developing implementation strategies. This paper provides a detailed overview of the origins and development of the CFIR-ERIC matching tool, outlines its contents and usage, and illustrates how to apply the tool to develop implementation strategies by using a brief smoking cessation intervention project as an example. The paper also discusses the advantages and limitations of using this tool for developing implementation strategies, with the aim of providing methodological reference for other researchers.

Abstract Background In March 2020, British Columbia, Canada, introduced prescribed safer supply involving the distribution of pharmaceutical grade alternatives to the unregulated toxic drug supply. Prior research has demonstrated positive impacts on overdose mortality, but with limited reach to people who use substances. Objectives of this study were to (1) identify barriers to accessing safer supply prescribing among people who use substances; and (2) determine whether and how barriers differed between people with and without prescriptions, and between urban and rural settings. Methods We conducted a participatory mixed-methods study guided by the Consolidated Framework for Implementation Research. Participants (≥ 19 years old) had received a safer supply prescription or were seeking one (survey n = 353; interviews n = 54). Results Participants who had a prescription were more likely to be living in a large urban centre, compared to medium/smaller centres and rural areas (78.5% vs. 65.8%, standardized mean difference = 0.286). Participants who did not have a prescription were more likely to report an array of structural, interpersonal, and health-related barriers (compared to those who had a prescription). In interviews, participants linked experiences of barriers to stigma and criminalization, low availability of services, lack of information and prescribers, not being able to get what they need, and anxieties, worries and doubts stemming from personal circumstances. There were no notable differences between large urban centres and medium/smaller centres and rural areas in the presence of specific types of barriers. Conclusions Findings demonstrate restricted access to safer supply prescribing outside of large urban centres and provide future targets for enhancing implementation. Attention is needed to promote equity and counter systemic barriers in the implementation of responses to the ongoing toxic drug emergency.

Abstract Background The benefits of lean adoption in healthcare include improved process efficiency and quality of patient care. However, research indicates that lean implementation in healthcare, and specifically hospitals, is often not sustained. Furthermore, there is a need for maturity models that guide lean implementation, specifically in hospitals. This study develops a prescriptive maturity model named the Sustaining of Lean Adoption in Hospitals Roadmap (SOLAR) that acts as a practical guideline for the sustainable adoption of lean in hospitals. Methods The SOLAR has three theoretical foundations, namely lean implementation success factors in hospitals, implementation science, and change management theory. A systematic literature review was conducted to determine the lean implementation success factors in hospitals as the first building block. Secondly, practices from implementation science were used to create the action items in the SOLAR. Ten change steps were elicited from change management theory as the third theoretical building block of the roadmap. We refined the roadmap through three Delphi rounds that verified its useability in hospitals. Results The final SOLAR consists of four maturity phases (prepare, plan, experiment and learn, and sustain) and includes action items for each phase related to the hospital’s strategy, resources, engaging of people, and culture. The action items and change management steps shown in the SOLAR are not intended as an exhaustive list but provide guidelines on aspects hospitals must consider when they aim to adopt lean sustainably. Conclusions The strong theoretical base of the SOLAR enables hospitals to safely experiment and learn which implementation methods are best suited to their unique environment. The SOLAR is, therefore, an actionable guideline that informs both academics and practitioners involved in lean adoption in hospitals. This roadmap can guide future retrospective longitudinal or action research.

Abstract Background Back pain is very common and a leading cause of disability worldwide. Due to health care system inequalities, Indigenous communities have a disproportionately higher prevalence of injury and acute and chronic diseases compared to the general Canadian population. Indigenous communities, particularly in northern Canada, have limited access to evidence-based spine care. Strategies established in collaboration with Indigenous peoples are needed to address unmet healthcare needs, including spine care (chiropractic and movement program) services. This study aimed to understand the views and perspectives of Cross Lake community leaders and clinicians working at Cross Lake Nursing Station (CLNS) in northern Manitoba regarding the implementation of the Global Spine Care Initiative (GSCI) model of spine care (MoC) and related implementation strategies. Method A qualitative exploratory design using an interpretivist paradigm was used. Twenty community partners were invited to participate in semi-structured interviews underpinned by the Theoretical Domains Framework (TDF) adapted to capture pertinent information. Data were analyzed deductively and inductively, and the interpretation of findings were explored in consultation with community members and partners. Results Community leaders (n = 9) and physicians, nurses, and allied health workers (n = 11) emphasized: 1) the importance of contextualizing the MoC (triaging and care pathway) and proposed new services through in-person community engagement; 2) the need and desire for local non-pharmacological spine care approaches; and 3) streamlining patient triage and CLNS workflow. Recommendations for the streamlining included reducing managerial/administrative duties, educating new incoming clinicians, incorporating follow-up appointments for spine pain patients, and establishing an electronic medical record system along with a patient portal. Suggestions regarding how to sustain the new spine care services included providing transportation, protecting allocated clinic space, resolving insurance coverage discrepancies, addressing misconceptions about chiropractic care, instilling the value of physical activity for self-care and pain relief, and a short-term (30-day) incentivised movement program which considers a variety of movement options and offers a social component after each session. Conclusion Community partners were favorable to the inclusion of a refined GSCI MoC. Adapting the TDF to unique Indigenous needs may help understand how best to implement the MoC in communities with similar needs.

Abstract Background Over 80% of people who experience a stroke present with residual impairment of the upper extremity, such as the shoulder, elbow, wrist, and hand. However, rarely do stroke rehabilitation practitioners (e.g., occupational therapists) use standardized outcome measures to objectively evaluate upper extremity function. Accordingly, the purpose of this project was to develop a bundle of implementation strategies that supports practitioners’ adoption of the Fugl-Meyer Assessment of the Upper Extremity in stroke rehabilitation practice. Methods We used tenets of Implementation Mapping to guide the development of our implementation strategy bundle. We partnered with one, large academic health system serving over 200 stroke patients annually through intensive rehabilitation care. Strategies were selected and developed through a multi-method process that included a review of the literature, qualitative input from our health system’s practitioners and managers, and expert consultation. We also specified the hypothesized implementation “mechanisms” our strategies intended to change. Practitioners’ adoption (yes/no) of the Fugl-Meyer Assessment was calculated by analyzing electronic health record documentation of the 6-month time frame before strategies were deployed compared to the 6-month time frame after deployment. Results Practitioners were exposed to the following implementation strategies to support Fugl-Meyer adoption: conduct educational meetings, prepare outcome measure champions, provide equipment, develop training materials, and adapt documentation systems. In the 6-months before deployment of our implementation strategies, practitioners implemented the Fugl-Meyer with 14.8% of stroke patients. In the six months after deployment, adoption of the Fugl-Meyer increased to 73.8% (p

Abstract Background Addressing mental health disparities following COVID-19 requires adaptive, multi-sectoral, equity-focused, and community-based approaches. Mental health task-sharing in gateway settings has been found to address mental health care gaps in low- and middle-income countries, but is not a common practice in the U.S., especially in non-medical settings, such as low-income housing developments (LIH). This research study will evaluate the effectiveness of a multisectoral community-engaged collaborative for task-sharing mental health care on consumer, provider, and implementation outcomes, as well as identify barriers and facilitators for implementation. Methods In this stepped-wedge randomized controlled trial with technology supplementation, LIH and primary care sites will be randomly assigned to one of five sequences of three implementation strategies: (1) Education and Resources (E&R), which involves online training and resources on basic mental health task-sharing skills, (2) Multisectoral Community Collaborative Care (MCC), which consists of all E&R resources plus additional community responsive implementation supports and participation in a multisectoral coalition and (3) MCC + Technology, which combines the MCC condition resources with a community crowdsourced technology solution to support implementation. The primary outcome is the effectiveness in meeting consumers’ needs through direct service (e.g., adequately addressing depression and anxiety symptoms), and through implementation to increase access to mental health care (reach). The secondary outcome examines additional consumer outcomes including health functioning and social risks, as well as implementation outcomes including provider skills, program adoption, and factors related to barriers and facilitators of quality implementation. A total of 700 consumers receiving mental health care at 20 sites will be surveyed at baseline, 6-, and 12-month follow-ups. Additionally, 100 providers will be evaluated at baseline, 6-, 12-, and 24-month follow-ups before training and after randomization. Discussion We hypothesize that MCC and MCC + Technology conditions will demonstrate significantly higher efficacy in changing primary outcomes compared to E&R, and the MCC + Technology supplement will show significantly higher levels of reach of mental health tasks compared to the MCC condition alone. These findings will demonstrate the feasibility of mental health integration into accessible, non-medical community settings such as LIH. Moreover, it will help establish a multilevel system solution based on community engagement and planning with a multisectoral collaboration that can be sustained community-wide. Trial registration NCT05833555 on Clinicaltrials.gov. Registered April 26, 2023

Abstract Background Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle’s effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. Methods This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. Discussion This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. Trial registration This study was registered with ClinicalTrials.gov as “Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE).” Registration number NCT06002165, August 21, 2023: https://clinicaltrials.gov/study/NCT06002165 .

Abstract Background Innovative models of care have the potential to improve the sustainability of health systems by improving patient and provider experiences and population outcomes while simultaneously reducing costs. Yet, it is challenging to recognize the distinctive points during research and quality improvement processes that contribute to sustainment of effective interventions. The business concept of an inflection point—the position on the curve of a trajectory where the progress in implementation of an intervention is accelerated or decelerated—may be useful to understand implementation and improve sustainability and ultimately sustainment of effective interventions. The purpose of this study was to retrospectively identify and describe strategic inflection points that accelerated the sustainability process and led to the sustainment of Alberta Family Integrated Care. Methods This qualitative study was conducted in Alberta, Canada and employed an interpretive description design. Purposively sampled documents (proposals, project management plans, reports to funders and sponsors, meeting minutes, and fidelity audit and feedback checklists) from the Alberta Family Integrated Care cluster randomized controlled trial and quality improvement project constituted data for this study. Results To accelerate sustainability in the research context, we identified (1) alignment with strategic priorities, (2) iterative, user-centered co-design, and (3) contextualization of implementation as strategic inflection points. To accelerate sustainability in the health system context, we identified (1) the learning health system, (2) enduring partnerships, (3) responsivity to societal and system change, (4) embedded governance, and (5) intentional integration into the health system as strategic inflection points. Capitalizing on these strategic inflection points led to sustainment of Alberta Family Integrated Care in the provincial health system. Conclusions We identified key inflection points in the research and health system contexts that led to sustainment of Alberta Family Integrated Care. By anticipating, recognizing, and leveraging inflection points in the sustainability process, researchers may be able to accelerate implementation and achieve sustainment of multi-component interventions in complex systems. Trial registration ClinicalTrials.gov: NCT02879799. Registration date: May 27, 2016. Protocol version: June 9, 2016; version 2. Protocol publication: https://doi.org/10.1186/s13063-017-2181-3 .

Abstract Introduction The increasing rates of HIV among Latino men who have sex with men (MSM) necessitate innovative and rigorous studies to evaluate prevention and treatment strategies. Pre-exposure prophylaxis (PrEP) is a highly effective tool in preventing HIV acquisition and plays a crucial role in the Ending the HIV Epidemic in the U.S. initiative. However, there is a scarcity of PrEP research specifically focused on Latino MSM, and the factors influencing its implementation remain largely unknown. Methods To address this gap, we conducted a comprehensive review exploring the determinants (barriers and facilitators) of PrEP implementation among Latino MSM, as well as the change methods (implementation strategies and adjunctive interventions) that have been evaluated to promote its adoption. Our review encompassed 43 peer-reviewed articles examining determinants and four articles assessing change methods. Determinants were coded using the updated Consolidated Framework for Implementation Research (CFIR 2.0) to understand the multilevel barriers and facilitators associated with implementation. Results The majority of research has focused on PrEP recipients (i.e., patients), primarily examining their awareness and willingness to use PrEP. Fewer studies have explored the factors influencing clinicians and service delivery systems. Additionally, the evaluation of change methods to enhance clinician adoption and adherence to PrEP and recipient adherence to PrEP has been limited. Conclusion It is evident that there is a need for culturally adapted strategies tailored specifically for Latino MSM, as the current literature remains largely unexplored in this regard. By incorporating principles from implementation science, we can gain a clearer understanding of the knowledge, skills, and roles necessary for effective cultural adaptations. Future research should emphasize factors influencing implementation from a clinician standpoint and focus on innovative change methods to increase PrEP awareness, reach, adoption, and sustained adherence among Latino MSM.

Abstract The United States has seen increasing trends of maternal mortality in recent years. Within this health crisis there are large disparities whereby underserved and minoritized populations are bearing a larger burden of maternal morbidity and mortality. While new interventions to improve maternal health are being developed, there are opportunities for greater integration of existing evidence-based interventions into routine practice, especially for underserved populations, including those residing in maternity care deserts. In fact, over 80 percent of maternal deaths are preventable with currently available interventions. To spur equitable implementation of existing interventions, the National Heart, Lung, and Blood Institute launched the Maternal-Health Community Implementation Program (MH-CIP) in 2021. In 2023, the National Institutes of Health’s Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative partnered with the NHLBI to launch the IMPROVE Community Implementation Program (IMPROVE-CIP). By design, CIPs engage disproportionately impacted communities and partner with academic researchers to conduct implementation research. This commentary overviews the impetus for creating these programs, program goals, structure, and offers a high-level overview of the research currently supported. Lastly, the potential outcomes of these programs are contextualized within the landscape of maternal health initiatives in the United States.

Abstract Background Implementing research evidence into clinical practice is challenging. This study aim was to explore implementation of two intrapartum trials with compelling findings: BUMPES (position in second stage of labour in nulliparous women with epidural), and RESPITE (remifentanil intravenous patient-controlled analgesia). Methods A qualitative interview study set in UK National Health Service Trusts and Universities. Purposively sampled investigators from RESPITE and BUMPES trials and clinicians providing intrapartum care: midwives, anaesthetists, and obstetricians, were recruited using existing networks and snowball sampling. Semi-structured virtual interviews were conducted. Thematic analysis was underpinned by Capability Opportunity Motivation Behaviour Change Framework. Results Twenty-nine interview participants across 19 maternity units: 11 clinical academics, 10 midwives, 4 obstetricians, 4 anaesthetists. Most (25/29) were aware of one or both trials. BUMPES had been implemented in 4/19 units (one original trial site) and RESPITE in 3/19 units (two trial sites). Access to sufficient resources, training, exposure to interventions, support from leaders, and post-trial dissemination and implementation activities all facilitated uptake of interventions. Some clinicians were opposed to the intervention or disagreed with trial conclusions. However competing priorities in terms of staff time and a plethora of initiatives in maternity care, emerged as a key barrier to implementation. Conclusions Compelling trial findings were not implemented widely, and numerous barriers and facilitators were identified. Large-scale improvement programmes and evidence-based national guidelines may mean single trials have limited potential to change practice. There is a need to examine how intervention implementation is prioritised to optimise safety outcomes in the context of workforce restrictions, limited resources and large arrays of competing priorities including statutory requirements, that have increased in maternity care.

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

Abstract Introduction In low-resource settings, introducing child health programs into community services may compete for caregiver time. We analyzed the impact of a new early childhood development (ECD) program in rural Madagascar on family attendance at other health services and of adding at-home play materials on program attendance. Methods We randomized 75 communities where community health workers (CHWs) implement an existing child health and nutrition program (Projet d’Amélioration des Résultats Nutritionnels or PARN), the status quo. We offered two 6-month cycles of 12 ECD sessions to eligible caregiver-child dyads (6–30 months) in 25 sites [T]; we added take-home play materials in Cycle 2 to 25 sites [T+]. We used differences-in-differences with administrative data to analyze the effect of offering ECD sessions on monthly PARN attendance (T+/T vs. C) among age-eligible children and the impact of toy boxes/libraries on monthly ECD session attendance (T + vs. T). We used random intercept models to analyze characteristics associated with program registration. Results We analyzed data for 9,408 dyads; 30% and 32% registered for the program in Cycle 1 and 2 (respectively). On average, CHWs delivered 11.4 sessions (SD: 1.5). Children from wealthier households who already attended PARN sessions were more likely to register, and we found no effect of T or T + on PARN attendance. Adding play materials did not affect monthly ECD session attendance. Children from more populated sites were less likely to participate in both ECD and PARN sessions. Conclusions Integrating new services for ECD into the health system was feasible and did not reduce dyad participation in existing services. Investment in health services in more populated areas is needed to provide coverage to all eligible children. Novel strategies should be explored to engage the most vulnerable children in new and existing health services. Trial registration AEA Social Science Registry (AEARCTR-0004704) on November 15, 2019 (prospective registration) and ClinicalTrials.gov (NCT05129696) on November 22, 2021 (retrospective registration).

Abstract Background In low- and middle-income countries (LMICs), such as Tanzania, the competency of healthcare providers critically influences the quality of pediatric care. To address this issue, we introduced Pediatric Acute Care Education (PACE), an adaptive learning program to enhance provider competency in Tanzania’s guidelines for managing seriously ill children. Adaptive learning is a promising alternative to current in-service education, yet optimal implementation strategies in LMIC settings are unknown. Objectives (1) To evaluate the initial PACE implementation in Mwanza, Tanzania, using the construct of normalization process theory (NPT); (2) To provide insights into its feasibility, acceptability, and scalability potential. Methods Mixed-methods study involving healthcare providers at three facilities. Quantitative data was collected using the Normalization MeAsure Development (NoMAD) questionnaire, while qualitative data was gathered through in-depth interviews (IDIs) and focus groups discussions (FGDs). Results Eighty-two healthcare providers completed the NoMAD survey. Additionally, 24 senior providers participated in IDIs, and 79 junior providers participated in FGDs. Coherence and cognitive participation were high, demonstrating that PACE is well understood and resonates with existing healthcare goals. Providers expressed a willingness to integrate PACE into their practices, distinguishing it from existing educational methods. However, challenges related to resources and infrastructure, particularly those affecting collective action, were noted. Early indicators point toward the potential for long-term sustainability of the PACE, but assessment of reflexive monitoring was limited due to the study’s focus on PACE’s initial implementation. Conclusion This study offers vital insights into the feasibility and acceptability of implementing PACE in a Tanzanian context. While PACE aligns well with healthcare objectives, addressing resource and infrastructure challenges as well as conducting a longer-term study to assess reflexive monitoring is crucial for its successful implementation. Furthermore, the study underscores the value of the NPT as a framework for guiding implementation processes, with broader implications for implementation science and pediatric acute care in LMICs.

Abstract Background Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice. Methods The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure. Discussion This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices. Trial registration ClinicalTrials.gov, NCT06438640

Abstract Background Adolescents with chronic medical conditions (CMC) use alcohol and marijuana at levels equal to or even greater than their peers without CMC and are more likely to initiate substance use at 14 years or younger. Approximately 33% of adolescents with CMC binge drink alcohol and 20% use marijuana. When using substances, adolescents with CMC are at elevated risk for problem use and adverse consequences given their medical conditions. Although there has recently been progress integrating substance use services into adult hospitals, there has been almost no implementation of standardized substance use services into pediatric hospitals for adolescents with CMC. Screening, Brief Intervention, and Referral to Treatment (SBIRT) for adolescents is an evidence-based, public health approach to promote the early detection and intervention of risky alcohol use in high-risk youth. This paper describes a study protocol combining two leading implementation science frameworks, the Consolidated Framework for Implementation Research (CFIR) and the Health Equity Implementation framework (HEIF), to engage pediatric hospital partners (hospital staff and clinicians, patients with CMC, and caregivers) to identify and specify contextual determinants of SBIRT implementation, which can be used to derive implementation strategies to optimize SBIRT adoption, reach, and fidelity. Method This study will use semi-structured interviews and focus groups with pediatric hospital partners (e.g., hospital staff and clinicians, adolescent patients, and caregivers) to identify SBIRT implementation determinants, using semi-structured interview and focus group guides that integrate CFIR and HEIF dimensions. Discussion Understanding implementation determinants is one of the first steps in the implementation science process. The use of two determinant frameworks highlighting a comprehensive set of determinants including health equity and justice will enable identification of barriers and facilitators that will then map on to strategies that address these factors. This study will serve as an essential precursor to further work evaluating the feasibility of and the degree of engagement with SBIRT among this vulnerable pediatric population.

Abstract Background HIV self-testing (HIVST) offers an innovative and promising approach to increasing HIV testing among Black men in the United States, a population disproportionately affected by HIV. However, engaging Black men in traditional HIV prevention programs has been challenging due to stigma, medical mistrust, and limited access to preventive health services. This formative qualitative study aimed to explore the potential of utilizing barbershops as an example of a nontraditional healthcare venue to promote and distribute HIVST. Methods Four virtual focus group discussions (FGDs) consisting of 19 participants in North Carolina were conducted with Black men, including barbershop business owners, barbers, and their customers, to assess perceptions of HIVST and the acceptability of partnering with barbershop businesses to promote HIVST. FGDs were digitally recorded, transcribed, and analyzed using a deductive coding approach to thematic analysis. Results Participants reported that the trusting relationship between barbers and their customers, which may not exist between Black men and health care providers, is a facilitator of collaborating with barbershop businesses to reach Black men for HIVST distribution. Participants recommended providing education for barbers on the use of HIVST, as well as how to inform self-testers about linkage to care following HIVST to build the credibility of the barbers in delivering the intervention. Participants also raised the issue of the cost of HIVST to barbershop customers as a potential barrier to implementation, as well as the possibility that the implementation of such interventions could be seen as out of place in a barbershop business venue. Participants also expressed a strong belief that compensation to barbershops and their employees should accompany any intervention. Conclusion These findings suggest that barbershop business venues may provide an appropriate venue for HIVST promotion and distribution, though factors like cost, training, and incentivization of implementers are necessary to consider in implementation planning. Furthermore, partnerships between public health actors and the business community must be built on equitable engagement to ensure the long-term viability of these critical initiatives.

Abstract Background Parents were at the forefront of responding to the needs of children during the COVID-19 pandemic. This study used the RE-AIM framework to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of a global inter-agency initiative that adapted evidence-based parenting programs to provide immediate support to parents. Methods Data were collected via short surveys sent via email, online surveys, and analysis of social media metrics and Google Analytics. Retrospective surveys with 1,303 parents and caregivers in 11 countries examined impacts of the resources on child maltreatment, positive relationship building, parenting efficacy, and parenting stress. Results The parenting resources were translated into over 135 languages and dialects; reached an estimated minimum 212.4 million people by June 2022; were adopted by 697 agencies, organizations, and individuals; and were included in 43 national government COVID-19 responses. Dissemination via social media had the highest reach (n = 144,202,170, 67.9%), followed by radio broadcasts (n = 32,298,525, 15.2%), text messages (n = 13,565,780, 6.4%), and caseworker phone calls or visits (n = 8,074,787, 3.8%). Retrospective surveys showed increased parental engagement and play, parenting self-efficacy, confidence in protecting children from sexual abuse, and capacity to cope with stress, as well as decreased physical and emotional abuse. Forty-four organizations who responded to follow-up surveys in April 2021 reported sustained use of the resources as part of existing services and other crisis responses. Conclusion This study highlights the importance of a) establishing an international collaboration to rapidly adapt and disseminate evidence-based content into easily accessible resources that are relevant to the needs of parents; b) creating open-source and agile delivery models that are responsive to local contexts and receptive to further adaptation; and c) using the best methods available to evaluate a rapidly deployed global emergency response in real-time. Further research is recommended to empirically establish the evidence of effectiveness and maintenance of these parenting innovations.

Abstract Background The purpose of this paper is to report on the process for developing an online RE-AIM evaluation toolkit in partnership with organizations that provide physical activity programming for persons with disabilities. Methods A community-university partnership was established and guided by an integrated knowledge translation approach. The four-step development process included: (1) identify, review, and select knowledge (literature review and two rounds of Delphi consensus-building), (2) adapt knowledge to local context (rating feasibility of outcomes and integration into online platform), (3) assess barriers and facilitators (think-aloud interviews), and (4) select, tailor, implement (collaborative dissemination plan). Results Step 1: Fifteen RE-AIM papers relevant to community programming were identified during the literature review. Two rounds of Delphi refined indicators for the toolkit related to reach, effectiveness, adoption, implementation, and maintenance. Step 2: At least one measure was linked with each indicator. Ten research and community partners participated in assessing the feasibility of measures, resulting in a total of 85 measures. Step 3: Interviews resulted in several recommendations for the online platform and toolkit. Step 4: Project partners developed a dissemination plan, including an information package, webinars, and publications. Discussion This project demonstrates that community and university partners can collaborate to develop a useful, evidence-informed evaluation resource for both audiences. We identified several strategies for partnership when creating a toolkit, including using a set of expectations, engaging research users from the outset, using consensus methods, recruiting users through networks, and mentorship of trainees. The toolkit can be found at et.cdpp.ca. Next steps include disseminating (e.g., through webinars, conferences) and evaluating the toolkit to improve its use for diverse contexts (e.g., universal PA programming).

Background and objective: Data on interaction of patients with artificial intelligence (AI) are limited, primarily derived from small-scale studies, cross-sectional surveys, and qualitative reviews. Most patients have not yet encountered AI in their clinical experience. This study explored patients’ confidence in AI, specifically large language models, after a direct interaction with a chatbot in a clinical setting. Through hands-on experience, the study sought to reduce potential biases due to an anticipated lack of AI experience in a real-world urological patient sample. Methods: A total of 300 patients scheduled for counseling were enrolled from February to July 2024. Participants voluntarily conversed about their medical questions with a GPT-4 powered chatbot, followed by a survey assessing their confidence in clinical capabilities of AI compared with their counseling urologists. Clinical capabilities included history taking, diagnostics, treatment recommendation, anxiety reduction, and time allocation. Key findings and limitations: Of the 292 patients who completed the study, AI was significantly preferred to physicians for consultation time allocation (p

Abstract Background Penicillin allergy is the most frequently reported drug allergy, yet most patients can tolerate the drug if challenged. Despite this discrepancy, large scale penicillin allergy de-labeling interventions have not been widely implemented in many health care systems. The application of a multi-method implementation science approach can provide key tools to study this evidence to practice gap and provide insight to successfully operationalize penicillin allergy evaluation in real-world clinical settings. Methods We followed a four-step process that leverages qualitative analysis to design evidence-based, actionable strategies to develop an intervention. First, we specified the clinician-perceived barriers to penicillin allergy de-labeling (intervention targets). We then mapped intervention targets onto Theoretical Domains Framework (domains and constructs) and found the root causes of behavior. Next, we linked root causes of behavior with intervention functions (BCW). In the final step, we synthesized participants’ suggestions for process improvement with implementation strategies aligning with the intervention functions. Results Evidence-based strategies such as focused education and training in penicillin allergy evaluation can address knowledge and confidence barriers reported by frontline clinicians. Other key strategies involve developing a system of champions, improving communications systems, and restructuring the healthcare team. Implementation mapping can provide a powerful multi-method framework to study, design, and customize intervention strategies. Conclusion: Empowering clinicians beyond allergy specialists to conduct penicillin allergy assessments requires designing new workflows and systems and providing additional knowledge to those clinicians.

Abstract Background Mississippi (MS) experiences disproportionally high rates of new HIV infections and limited availability of pre-exposure prophylaxis (PrEP). Federally Qualified Health Centers (FQHCs) are poised to increase access to PrEP. However, little is known about the implementation strategies needed to successfully integrate PrEP services into FQHCs in MS. Purpose The study had two objectives: identify barriers and facilitators to PrEP use and to develop tailored implementation strategies for FQHCs. Methods Semi-structured interviews were conducted with 19 staff and 17 PrEP-eligible patients in MS FQHCs between April 2021 and March 2022. The interview was guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework which covered PrEP facilitators and barriers. Interviews were coded according to the i-PARIHS domains of context, innovation, and recipients, followed by thematic analysis of these codes. Identified implementation strategies were presented to 9 FQHC staff for feedback. Results Data suggested that PrEP use at FQHCs is influenced by patient and clinic staff knowledge with higher levels of knowledge reflecting more PrEP use. Perceived side effects are the most significant barrier to PrEP use for patients, but participants also identified several other barriers including low HIV risk perception and untrained providers. Despite these barriers, patients also expressed a strong motivation to protect themselves, their partners, and their communities from HIV. Implementation strategies included education and provider training which were perceived as acceptable and appropriate. Conclusions Though patients are motivated to increase protection against HIV, multiple barriers threaten uptake of PrEP within FQHCs in MS. Educating patients and providers, as well as training providers, are promising implementation strategies to overcome these barriers.

Abstract Background Long-acting injectable cabotegravir plus rilpivirine (LAI CAB/RPV) has several potential benefits over daily oral formulations for HIV treatment, including the potential to facilitate long-term adherence and reduce pill fatigue. We aimed to assess facilitators of and barriers to LAI CAB/RPV implementation and delivery through the perspectives of physicians and clinical staff, and the experiences of LAI CAB/RPV use among people living with HIV (PLWH) at a Ryan-White supported safety-net clinic in North Texas. Methods We conducted semi-structured interviews with recruited clinic staff (physicians, nurses, and support staff) involved with LAI CAB/RPV implementation and PLWH who switched to LAI CAB/RPV and consented to participate in individual interviews. Data were collected from July to October 2023. Our interview guide was informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM), and Proctor Implementation Outcomes frameworks. Qualitative data were analyzed using a rapid qualitative analysis approach to summarize key themes. Results We recruited and interviewed 15 PLWH who transitioned to LAI CAB/RPV and 11 clinic staff serving these patients. PLWH conveyed that emotional and informational support from family or a trusted clinician influenced their decision to switch to LAI CAB/RPV. PLWH also reported that injectable treatment was more effective, convenient, and acceptable than oral antiretroviral therapy. Clinic staff and physicians reported that staff training, pharmacist-led medication switches, flexible appointments, refrigeration space and designated room for injection delivery facilitated implementation. Clinic staff cited medication costs, understaffing, insurance prior authorization requirements, and lack of medication access through state drug assistance programs as critical barriers. Conclusions Our study offers insights into real-world experiences with LAI usage from the patient perspective and identifies potential strategies to promote LAI CAB/RPV uptake. The barriers to and facilitators of LAI CAB/RPV program implementation reported by clinic staff in our study may be useful for informing strategies to optimize LAI CAB/RPV programs.

Abstract Background Although HIV vertical transmission has declined significantly in sub-Saharan Africa, incident HIV infection in pregnant and postpartum women is estimated to account for over one-third of HIV vertical transmission. Oral pre-exposure prophylaxis (PrEP) for pregnant and breastfeeding women (PBFW) is included in South African PrEP guidelines since 2021; however, integration of PrEP services within ante- and postnatal care remains limited. Methods Between March 2022 and September 2023, we evaluated the integration of PrEP for PBFW in eight antenatal clinics in Cape Town, South Africa, following training and mentorship of providers. We applied an adapted Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to evaluate the integration of PrEP services for pregnant and breastfeeding women. Before the study, PrEP was not routinely offered. We implemented a staff didactic/practice-based training and mentorship on PrEP provision targeting PBFW. We evaluated the following: (1) Reach as the proportion of women initiating PrEP among women counselled and tested for HIV, (2) effectiveness as PrEP continuation up to 3 months by pregnant vs. breastfeeding women, (3) adoption of PrEP integration via pre- and post-training assessments and ongoing mentorship assessments, (4) implementation through clinic trends of PrEP offer over time, and (5) maintenance: continued PrEP offer 3 months following the intervention. Results In 8 facilities providing ante- and postnatal care, we trained 224 healthcare providers (127 nurses and 37 counsellors). Of those, we mentored 60 nurses, midwives, and HIV counsellors working with pregnant and breastfeeding women, with 80% of nurse/midwives and 65% of counsellors scoring ≥ 80% on the final mentoring assessment. Overall, 12% of HIV-negative pregnant women started PrEP, and 41% of those continued PrEP up to 3 months. Among HIV-negative breastfeeding women, 14% initiated PrEP, and 25% continued PrEP up to 3 months. All eight facilities continued providing PrEP 3 months post intervention. Conclusions In these high HIV prevalence clinics, the proportion of pregnant and breastfeeding women initiating and continuing PrEP rapidly increased but was limited among breastfeeding women. Staff training, mentorship, and PrEP integration were well-adopted by nurses and counsellors, and services continued following the intervention. Barriers included limited HIV testing of breastfeeding mothers and need for additional PrEP-trained nurses.

Objectives. This paper describes and analyzes embedded implementation research and the empirical processes of planning for utilization, strategies to promote utilization and the sustainability of utilization of results from research led by decision-makers in Latin America and the Caribbean. Methods. This qualitative, descriptive and interpretive study is based on the findings from semistructured interviews with members of teams working under the Embedding Research for the Sustainable Development Goals initiative (2018–2019) as well as their responses to a self-assessment follow-up questionnaire 1 year after the project was completed. Results. Altogether 13 teams from 11 countries participated in the Initiative. Nine teams had a core team composed of a decision-maker as the principal investigator assisted by a researcher as co-principal investigator. Four teams included more than one co-principal investigator; and in five teams, the originally assigned principal investigator was replaced. There was an interesting relationship between the expected utilization of research results, the utilization strategies, the sustainability of research uptake and the teams’ collaboration modalities. When decision-makers and co-principal investigators were active participants, the intention to use the results and strategies for utilization were clearly oriented to improve implementation. In teams with basically a formal collaboration between the two principals, plans for utilization were unclear or focused on producing academic knowledge. The participation of implementers below the rank of principal investigator decision-maker may be relevant. Conclusions. Embedded implementation research is an innovative tool that may foster the utilization of research and strengthen health programs and services. Considering the internal dynamics of such research teams will enhance planning and strategies for research utilization as well as the sustainability of practical and actionable findings.

This Special Report aims to outline the development process of the first National Clinical and Policy guidelines on Intimate Partner Violence and Sexual Violence in Trinidad and Tobago and to support the implementation of quality standards for survivors. The study used an implementation science approach to identify key evidence-based practice recommendations from guidance documents on health care for women who are subjected to violence and from relevant national legislation, policy, and practices. The process engaged stakeholders in discussions on the appropriateness, implementation, and use of these recommendations in the context of local health care delivery. Multidisciplinary teams of frontline health workers were consulted in groups in each of the five Regional Health Authorities. Interviews were held with senior government stakeholders responsible for health policy and with representatives of four civil society agencies. Participants provided recommendations to integrate quality standards into routine practice. These were incorporated into the guidelines, which include human rights principles and pathways of care for identifying violence, providing psychosocial and clinical care, safety planning, referrals, care during emergencies, and prevention of intimate partner violence and sexual violence. The guidelines were approved by the Ministry of Health of Trinidad and Tobago on 15 August 2022. Training of trainers has been undertaken to support implementation.

Abstract Background Sierra Leone has one of the world’s highest maternal and infant mortality rates and suffers from a shortage of well-trained health professionals, including midwives. Prior to engaging in systematic interventions, it is critical to measure organizational readiness to gauge members’ psychological and behavioral preparedness to implement change. We aimed to measure the organizational readiness for implementing change and compare results among midwives and administrative leaders at two schools of midwifery in Sierra Leone prior to the rollout of a midwifery preceptor program. Methods The Organizational Readiness for Implementing Change (ORIC) survey is a validated 12-item questionnaire designed to assess two domains of organizational readiness for change: change commitment (motivation) and change efficacy (capacity). All survey items begin with the same prompt and a five-item Likert scale response, with seven questions about change commitment and five about change efficacy. Data collection occurred in two schools of midwifery in Sierra Leone during two day-long meetings with stakeholders. Statistical analysis was conducted using descriptive statistics and Wilcoxon rank-sum test to compare independent samples: School 1 versus School 2 (site), midwife versus other roles (role). Results Participants included 42 respondents (mean age 41 years, 95% female). Surveys were distributed evenly between the two sites. Occupations included midwifery faculty (n = 8), administrators (n = 5), clinicians (n = 25), and clinical educators (n = 4). Domain 1 (change commitment) had a mean score of 4.72 (SD 0.47) while Domain 2 (change efficacy) had a mean score of 4.53 (SD 0.54) out of a total potential score of five. There were no statistically significant differences between site responses for Domain 1 (p = 0.5479) and Domain 2 (p = 0.1026) nor role responses for Domain 1 (p = 0.0627) and Domain 2 (p = 0.2520). Conclusion Stakeholders had very high overall readiness for change across all ORIC questions for both change commitment and change efficacy. Mean scores for change commitment were slightly higher which is not surprising given the low-resourced settings stakeholders work in while training students. High mean scores across sites and roles is encouraging as this novel preceptor program is currently being rolled out.

Abstract Background Germline genetic testing is recommended for an increasing number of conditions with underlying genetic etiologies, the results of which impact medical management. However, genetic testing is underutilized in clinics due to system, clinician, and patient level barriers. Behavioral economics provides a framework to create implementation strategies, such as nudges, to address these multi-level barriers and increase the uptake of genetic testing for conditions where the results impact medical management. Methods Patients meeting eligibility for germline genetic testing for a group of conditions will be identified using electronic phenotyping algorithms. A pragmatic, type 3 hybrid cluster randomization study will test nudges to patients and/or clinicians, or neither. Clinicians who receive nudges will be prompted to either refer their patient to genetics or order genetic testing themselves. We will use rapid cycle approaches informed by clinician and patient experiences, health equity, and behavioral economics to optimize these nudges before trial initiation. The primary implementation outcome is uptake of germline genetic testing for the pre-selected health conditions. Patient data collected through the electronic health record (e.g. demographics, geocoded address) will be examined as moderators of the effect of nudges. Discussion This study will be one of the first randomized trials to examine the effects of patient- and clinician-directed nudges informed by behavioral economics on uptake of genetic testing. The pragmatic design will facilitate a large and diverse patient sample, allow for the assessment of genetic testing uptake, and provide comparison of the effect of different nudge combinations. This trial also involves optimization of patient identification, test selection, ordering, and result reporting in an electronic health record-based infrastructure to further address clinician-level barriers to utilizing genomic medicine. The findings may help determine the impact of low-cost, sustainable implementation strategies that can be integrated into health care systems to improve the use of genomic medicine. Trial registration ClinicalTrials.gov. NCT06377033. Registered on March 31, 2024. https://clinicaltrials.gov/study/NCT06377033?term=NCT06377033&rank=1

Abstract Background The Diabetes Prevention Program (DPP) is a nationally disseminated lifestyle intervention shown to prevent type 2 diabetes (diabetes). However, enrollment in the program remains variable. We sought to identify patient characteristics associated with enrollment in a virtual DPP program among women Veterans to inform ongoing diabetes prevention efforts. Methods We conducted a retrospective analysis of 2021–2024 Department of Veterans Affairs (VA) data collected through the VA Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER) 2.0 Program, an effectiveness-implementation trial to expand access to preventative health services for women Veterans. We included women meeting DPP eligibility criteria (BMI ≥ 25 kg/m2 [or ≥ 23 if Asian] with ≥ 1 risk factor for diabetes [e.g., prediabetes]) who received care at six VA sites implementing virtual DPP. We used logistic regression to examine the association between DPP enrollment and prior use of VA preventive services for weight management or diabetes prevention including the VA MOVE! clinic, Whole Health visits, nutrition visits, weight loss medications, and/or metformin. We adjusted for sociodemographic factors, comorbidities, number of DPP recruitment contacts, and site. Results A total of 1473 women Veterans received DPP outreach. On average, their age was 53 years (range 20–96), BMI 34 kg/m2, HbA1c 5.9%, 0.7% were Asian, 44% Black, 2% Hispanic, and 44% White. In our adjusted models, prior use of VA preventative services was not significantly associated with DPP enrollment. Younger women (OR:0.97, p = 0.002) and those who received more recruitment contacts (OR:2.63, p

Yiwen Zhou,1,* Yuyan Huang,1,* Yingwen Wang,2 Xiaofeng Xu,1 Zhuowen Yu,1 Ying Gu3 1Department of Gastroenterology, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, 201102, People’s Republic of China; 2Centre for Clinical Practice Guideline Production and Evaluation, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, 201102, People’s Republic of China; 3Nursing Department, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, 201102, People’s Republic of China*These authors contributed equally to this workCorrespondence: Ying Gu, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, 201102, People’s Republic of China, Email guying0128@aliyun.com Zhuowen Yu, Department of Gastroenterology, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, 201102, People’s Republic of China, Email yzw100@126.comBackground: The Theoretical Domains Framework (TDF) is among the most extensively utilised foundational frameworks in implementation science. It was developed from 33 psychological theories, with the latest version identifying 14 domains encompassing 84 theoretical constructs. These domains and constructs capture the complexity of factors that affect behaviours, making the framework a valuable tool for designing and implementing interventions within health and social care settings.Objective: To summarise the development, hot topics, and future trends in TDF-related research and provide implementation practitioners with more information on the application of TDF.Methods: We used TDF as the topic and searched the ISI Web of Science Core Collection, identifying 1382 relevant publications. We used analytical tools such as Excel, Tableau, VOSviewer, and Citespace to conduct a bibliometric analysis of the relevant publication.Results: We identified the United Kingdom as the primary contributor, with University College London as the key institution. Susan Michie ranked highest in total citations. The analysis highlighted cancer and stroke as primary clinic medicine-related topics using TDF. Emerging themes encompass abuse, violence, maternal health, antenatal care, patient involvement, and trauma-informed care et al. “Nurse” and “qualitative research” emerged as recent and enduring hotspots, possibly indicating future research trends.Conclusion: This article represents the first attempt to summarise the TDF using bibliometric analysis. We suggest this method can be used to analyse other theoretical frameworks in scientific implementation of its objectivity and quantifiability. Overall, the application scope of TDF is shifting from public health towards more specialised clinical directions, although its application in the field of public health is continuously expanding. In the future, the number of users of TDF is also expected to expand from implementation scientists to professional technical personnel.Keywords: theoretical domains framework, bibliometric analysis, visualization, implementation science

Abstract Background Asthma is a leading cause of children’s hospitalizations, emergency department visits, and missed school days. Our school-based asthma intervention has reduced asthma exacerbations for children experiencing health disparities in the Denver Metropolitan Area, due partly to addressing care coordination for asthma and social determinants of health (SDOH), such as access to healthcare and medications. Limited dissemination of school-based asthma programs has occurred in other metropolitan and rural areas of Colorado. We formed and engaged community advisory boards in socioeconomically diverse regions of Colorado to develop two implementation strategy packages for delivering our school-based asthma intervention — now termed “Better Asthma Control for Kids (BACK)" — with tailoring to regional priorities, needs and resources. Methods In this proposed type 2 hybrid implementation-effectiveness trial, where the primary goal is equitable reach to families to reduce asthma disparities, we will compare two different packages of implementation strategies to deliver BACK across four Colorado regions. The two implementation packages to be compared are: 1) standard set of implementation strategies including Tailor and Adapt to context, Facilitation and Training termed, BACK-Standard (BACK-S); 2) BACK-S plus an enhanced implementation strategy, that incorporates network weaving with community partners and consumer engagement with school families, termed BACK-Enhanced (BACK-E). Our evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, including its Pragmatic Robust Implementation Sustainability Model (PRISM) determinants of implementation outcomes. Our central hypothesis is that our BACK-E implementation strategy will have significantly greater reach to eligible children/families than BACK-S (primary outcome) and that both BACK-E and BACK-S groups will have significantly reduced asthma exacerbation rates (“attacks”) and improved asthma control as compared to usual care. Discussion We expect both the BACK-S and BACK-E strategy packages will accelerate dissemination of our BACK program across the state – the comparative impact of BACK-S vs. BACK-E on reach and other RE-AIM outcomes may inform strategy selection for scaling BACK and other effective school-based programs to address chronic illness disparities. Trial registration Clinicaltrials.gov identifier: NCT06003569, registered on August 22, 2023, https://classic.clinicaltrials.gov/ct2/show/NCT06003569 .

Abstract Background Addressing Indigenous food security and food sovereignty calls for community-driven strategies to improve access to and availability of traditional and local food. Participatory approaches that integrate Indigenous leadership have supported successful program implementation. Learning Circles: Local Healthy Food to School is a participatory program that convenes a range of stakeholders including food producers, educators and Knowledge Keepers to plan, implement and monitor local food system action. Pilot work (2014–2015) in Haida Gwaii, British Columbia (BC), showed promising results of the Learning Circles (LC) approach in enhancing local and traditional food access, knowledge and skills among youth and adolescents. The objective of the current evaluation was therefore to examine the process of scaling-up the LC vertically within the Haida Nation; and horizontally across three diverse First Nations contexts: Gitxsan Nation, Hazelton /Upper Skeena, BC; Ministikwan Lake Cree Nation, Saskatchewan; and Black River First Nation, Manitoba between 2016 and 2019. Methods An implementation science framework, Foster-Fishman and Watson’s (2012) ABLe Change Framework, was used to understand the LC as a participatory approach to facilitate community capacity building to strengthen local food systems. Interviews (n = 52), meeting summaries (n = 44) and tracking sheets (n = 39) were thematically analyzed. Results The LC facilitated a collaborative process to: (1) build on strengths and explore ways to increase readiness and capacity to reclaim traditional and local food systems; (2) strengthen connections to land, traditional knowledge and ways of life; (3) foster community-level action and multi-sector partnerships; (4) drive actions towards decolonization through revitalization of traditional foods; (5) improve availability of and appreciation for local healthy and traditional foods in school communities; and (6) promote holistic wellness through steps towards food sovereignty and food security. Scale-up within Haida Gwaii supported a growing, robust local and traditional food system and enhanced Haida leadership. The approach worked well in other First Nations contexts, though baseline capacity and the presence of champions were enabling factors. Conclusions Findings highlight LC as a participatory approach to build capacity and support iterative planning-to-action in community food systems. Identified strengths and challenges support opportunities to expand, adopt and modify the LC approach in other Indigenous communities with diverse food systems.