Approaches to achieving health equity in implementation science are critical to ameliorating disparities resulting from social, economic, and racial injustices. The field needs to grow transdisciplinary tools, processes, and increased workforce capacity to lead health equity research, particularly among scholars from groups that are underrepresented in science. This project, perhaps the first of its kind, used mixed methods to develop and pilot a robust, actionable model for mentoring and training to advance health equity in implementation science. To inform the content and design, we conducted concept mapping with implementation science and equity researchers (N = 69) and qualitative one-on-one interviews with leaders (N = 6) and past trainees (N = 14) of established programs with a health equity or disparities focus. We piloted the training among 17 scholars (100% underrepresented in science, 88% women) over 2.5 days. It followed engagement and active learning principles with small group discussions, speed mentoring, problem-based learning, and peer-to-peer teaching. Concept mapping identified priority competencies of engaging the community, equity-relevant methods, cultural humility, and mentoring to integrate into the training. Interviewees discussed the importance of designing the program based on participants' needs. Therefore, we added a pre-program survey to determine scholars' priorities. Interviewees emphasized the importance of having presenters from underrepresented backgrounds discuss their journeys and opportunities to learn equity content from other scholars, which informed a panel of junior investigators on navigating academia. They recommended including presentations led by community members, historical perspectives on health equity, and equity-focused methods, which informed a community engagement and measurement lecture co-led by an academic-community partnership. Scholars identified mentorship opportunities, a supportive environment, diverse perspectives of scholars and faculty, and engaging discussions as program strengths. This study applied a user-informed, data-driven approach to designing an implementation science training that prioritizes the interests of diverse scholars. We identified curriculum competencies and processes to build capacity for an implementation science workforce that centers on equity.
Implementation of complex nursing interventions remains challenging, with success varying substantially across healthcare settings. Most implementation research assesses barriers and facilitators at single timepoints, limiting understanding of how these determinants evolve. Therefore, we aimed to understand how barriers and facilitators evolve over time during different implementation phases across three categories of implementation outcomes. Following the "Exploration, Preparation, Implementation, and Sustainment" (EPIS) framework, this longitudinal qualitative study examined barriers and facilitators during implementation of the PREDOCS nursing intervention across twelve Dutch cardiothoracic centers from 2016 to 2019. We conducted 252 structured interviews across eight measurement waves with diverse healthcare professionals. Data were systematically coded for barriers and facilitators using the Capability, Opportunity, Motivation-Behaviour (COM-B) model through a hybrid approach combining Large Language Model (LLM)-assisted analysis with rigorous human verification. Hospitals were categorized into three implementation outcome groups: Implementation (n = 4), Delayed-Implementation (n = 5), and No-Implementation (n = 3). Barriers and facilitators evolved systematically across EPIS phases. Motivation remained universally high across all outcome groups throughout all phases. Fundamental knowledge gaps about intervention components during the Exploration phase were present in all three No-Implementation hospitals and absent in the Implementation group. Opportunity-domain factors, specifically the presence or absence of organizational infrastructure, resources, and management support, differed systematically between outcome groups across phases. As implementation progressed, the Implementation group reported a shift in the Capability domain from training barriers to available training and competent staff, a pattern absent in the Delayed and No-Implementation groups. Successful hospitals reported compensatory opportunity facilitators alongside persistent barriers, whereas hospitals that discontinued implementation reported sustained belief in intervention value in the absence of enabling organizational conditions. Implementation success depends less on motivation-building than on developing organizational infrastructure to translate intention into practice. Implementation determinants are not static: early knowledge gaps and absence of organizational facilitators functioned as early signals of later failure, and support strategies should therefore be phase-specific and longitudinally monitored rather than assessed at a single point in time.
Depression is a common mental health disorder which frequently co-occurs with increased body mass index or increased waist circumference (hereafter 'overweight'), causing heightened cardiovascular risk. Unhealthy lifestyle behaviours underlie both conditions. The Multimodal Lifestyle Intervention (MLI) LEEF integrates physical activity, nutrition, and behavioural strategies, tailored to motivational challenges common in depression, offering a dual focus on mental and physical health. However, unpublished process data revealed very limited referral to MLI‑LEEF from both primary and secondary care, and consequently low initiation rates, signalling clear implementation challenges. This study addresses this gap by translating prioritised implementation determinants into conceptually and empirically grounded implementation strategies and examining what works, how, and under which conditions. This quasi‑experimental, explanatory sequential mixed‑methods study will implement MLI‑LEEF across ten general practices and three secondary mental health care outpatient clinics in the Northern Netherlands. Implementation strategies will be developed and tailored using Causal Pathway Diagramming and applied over a six‑month period. Quantitative data will be collected before, during, and after implementation to assess proximal implementation outcomes (the immediate, observable effects of an implementation strategy), distal implementation outcomes (adoption and sustainability), service‑level penetration, and patient outcomes. Following the implementation period, semi‑structured interviews will be conducted with referrers from each participating organisation. Site‑specific topic guides, informed by each organisation's implementation plan, causal pathway diagrams, and quantitative implementation outcomes, will probe how strategies generate change (mechanisms), how they influence targeted determinants, and which contextual conditions (preconditions, moderators) shape implementation strategy functioning. This study will respond to fieldwide calls in implementation science for rigorous, transparent, and context-sensitive approaches to developing and evaluating implementation strategies. By examining how strategies shape referral and initiation in routine general practice and specialist mental health services, and by clarifying the mechanisms and contextual conditions under which they are effective, the study will generate actionable insight into why implementation succeeds or falters in real-world care. These insights will provide essential groundwork for strengthening the reach and adoption of MLI-LEEF and will offer transferable guidance for embedding multimodal lifestyle interventions into everyday care, while advancing generalizable knowledge of how implementation strategies produce change. 10.17605/OSF.IO/XJHCB.
Implementation research plays a key role in bridging the gap between evidence and practice, particularly in low-resource settings. In Ethiopia, persistent challenges in healthcare access, quality, and system performance highlight the need for context-specific implementation evidence. Although implementation research has been advancing in the country, its scope, practice, and contribution to health system improvement remain insufficiently characterized and documented. This gap underscores the need to assess the landscape of healthcare and health system implementation research in Ethiopia to inform decisions about health policies, programs, and practices. Therefore, this scoping review aimed to comprehensively investigate the current landscape of healthcare and health system implementation research in Ethiopia. We conducted a scoping review in accordance with Joanna Briggs Institute guidance and PRISMA-ScR reporting standards. A systematic search of major electronic databases and relevant sources was performed using the Population, Concept, and Context (PCC) framework, which involved keywords and MeSH terms. Two researchers independently screened the studies and extracted data using a piloted form, resolving and discrepancies through discussion. Extracted data included study characteristics, outcomes, contextual factors, and implementation strategies. We categorized implementation strategies using ERIC frameworks. The findings were analyzed through descriptive and thematic approaches and organized across key health system blocks and contextual dimensions. The search identified 10,853 studies. One hundred sixty-four articles underwent full-text review, and 96 were included in the analysis. The studies included in the review used 40 mixed methods, 23 quantitative, and 33 qualitative approaches. According to the health system building blocks, 70 studies focused on service delivery, 16 on health information systems, and 5 on leadership or health financing. Among the service delivery studies, neonatal, child, maternal, and reproductive health were most commonly addressed topics. Key implementation outcomes included fidelity, feasibility, acceptability, sustainability, and cost-effectiveness. Forty-three studies used determinant, process, or evaluation frameworks, including Consolidated Framework for Implementation Research; Reach, Effectiveness, Adoption, Implementation, and Maintenance framework; Exploration, Preparation, Implementation, and Sustainment; Theoretical Domains Framework; Medical Research Council Framework; diffusion and social network theories; and Donabedian's quality framework. Fifty studies involved stakeholders in implementation research. Global funders supported 72 studies. A total of 55 studies reported the use of implementation strategies, with 27 out of 39 maternal and child health studies including such strategies. This review highlights implementation research conducted with a strong focus on service delivery, particularly in maternal, neonatal, and child health. Stakeholder engagement played a crucial role, while global funding supported research efforts. The broad use of implementation strategies demonstrates ongoing efforts to translate research into practice. These findings underscore the need for continued investment in implementation science to enhance healthcare delivery and outcomes.
Hospital-at-Home (HaH) has been shown to be clinically and cost effective, but many programs struggle to scale. We conducted a systematic review of HaH studies reporting implementation contexts, strategies and outcomes with the primary aim to synthesise the implementation evidence on HaH. Our secondary aim was to develop a framework of HaH implementation outcome indicators for future studies to apply. We searched the literature PubMed, Embase and Scopus, for publications from 2012 to 2022. We included studies related to HaH that included at least one implementation context and at least one implementation outcome variable, excluding clinical outcomes measures. At least two reviewers independently selected studies, abstracted data and assessed quality. We coded the implementation determinants to the Consolidated Framework for Implementation Research (CFIR); implementation strategies to the Expert Recommendations for Implementing Change (ERIC); and implementation outcomes to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) frameworks. We included 27 studies in the final review, which reported 24 CFIR contextual factors, 25 ERIC strategies, and all domains of the RE-AIM evaluation framework. The most commonly reported implementation determinant, identified in six studies, was information technology infrastructure, which included streamlining documentation processes and improving access to patient records. Five studies described the following implementation factors: (i) work infrastructure, focusing on organising manpower effectively; (ii) capability of innovation deliverers, referring to staff posessing the necessary skills to perform their roles; and (iii) local conditions, such as the geographical challenges associated with HaH. The most frequently referenced implementation strategies were conducting ongoing training (nine studies), creating new clinical teams (eight studies), and promoting adaptability (seven studies). All assessed implementation outcomes were aligned to the RE-AIM framework, with volume of admissions, patient-reported experiences or outcome measures, and home visit frequency being most commonly reported (four studies each). The majority of implementation measures lacked a common denominator, and use of validated tools across studies was lacking. We identified a list of implementation determinants, strategies and outcomes that can be used to inform scale-up of HaH, and have developed a framework for consistent reporting of HaH implementation studies grounded onto RE-AIM.
Participatory approaches are crucial for identifying the determinants of successful implementation and informing the development of implementation strategies. However, systematic knowledge regarding the nature of participatory approaches for tailoring implementation strategies in healthcare remains limited. Therefore, we explored and mapped participatory approaches used in tailoring implementation strategies, characterized them, and conducted an exploratory analysis of their reported links to implementation outcomes. A scoping review of contemporary literature was conducted using MEDLINE via PubMed, PsycINFO and CINAHL via EBSCOhost that included literature published between January 2019 and December 2023. The search was updated for 2024. Backward and forward citation tracking was applied for studies that included labeled participatory approaches and quantitative outcomes. Two raters independently screened the literature. An adapted Intervention Component Analysis (ICA) was conducted as an exploratory approach to analyze reported characteristics. Based on 24,240 citations, 129 studies were identified. Among them, 71 studies reported labeled participatory approaches, summarized in seven main categories: co-approaches, design, research, engagement, mapping, knowledge translation and other approaches. Nearly two-thirds were common approaches such as co-design, while slightly more than one-third were specific, such as the Person-Based Approach. More than half of these were implementation-specific, e.g., implementation mapping. Among these approaches, the linking of determinants to implementation strategies was based primarily on interest-holder theory (experience-based). Empirically measured quantitative outcomes were identified in 12 studies, six of which were eligible for ICA. All six studies reported positive findings of participatory approaches applied to the tailoring of implementation strategies. Among them, three studies reported results for each tailoring step and linked them to the participatory approach used. Three studies reported significant quantitative outcomes. However, no method showed a notable link to the success of participatory approaches for tailoring implementation strategies. This scoping review identified diverse participatory approaches that were applied for tailoring implementation strategies in healthcare. The emergence of implementation-specific participatory approaches highlights the need to consider specialized methods in implementation science. The lack of rigorously evaluated studies across all tailoring phases emphasizes the need for further research to facilitate a comprehensive understanding of effective participatory approaches for tailoring implementation strategies. Protocol registered on Open Science Framework (24 April 2024, https://doi.org/10.17605/OSF.IO/RQKTP ).
Effective implementation of evidence-based programmes in real-world settings requires the capacity to adapt programmes and tailor implementation strategies to local contexts. Many primary cancer prevention (PCP) programmes that are effective in controlled settings struggle in routine practice. Although several frameworks outline principles of adaptation and tailoring, practical guidance on how to operationalise these processes remains limited. The PIECES project aims to help address this gap by developing, implementing, and evaluating structured support for tailored implementation of PCP programmes. Within the PIECES project, a toolkit was co-developed with practitioners and researchers to provide theory- and evidence-informed guidance for adapting, tailoring, implementing, and evaluating PCP programmes. The toolkit aims to strengthen implementation competencies through structured planning, collaborative learning, and evidence-informed decision-making. This paper presents the protocol for the PIECES study which evaluates the toolkit's usability, feasibility, and mechanisms of impact of PCP programmes across diverse healthcare and community settings. The PIECES study uses a multi-site pre-post comparative case study design with a mixed-methods implementation evaluation across 11 sites in Europe and Australia, reflecting variation in organisational structures, resources, and cultural contexts. The primary outcome is change in implementation competencies among toolkit users. Guided by the UK MRC Process Evaluation Framework and Proctor's implementation outcomes, the process evaluation examines toolkit usability, feasibility, user satisfaction, and perceived impact on implementation processes and outcomes. Quantitative and qualitative data, toolkit log data, and structured field notes will be collected at six-month intervals (2025-2027). In parallel, a realist evaluation will explore how, why, and under what conditions the toolkit supports tailored implementation. Together, these approaches provide complementary descriptive and explanatory insights into the mechanisms and contextual factors shaping tailored implementation of PCP programmes. This study is expected to contribute to implementation science by evaluating a structured, evidence-informed tool designed to strengthen capacity for tailored implementation of PCP programmes. Its multi-country design offers a natural field-laboratory to explore how implementation support tools function across varying contexts. By integrating process and realist evaluation approaches, the study is designed to generate practical and theoretical evidence to inform scalable, context-sensitive strategies and enhance the sustainability and impact of evidence-based prevention efforts. ClinicalTrials.gov ID NCT06718322.
A persistent challenge in implementation science is the gap between the pace and priorities of academic research and the needs of decision-makers. While traditional research emphasizes methodological rigor, policymakers often require timely, relevant, and stakeholder-engaged evidence to inform decisions. We conducted a real-time discrete choice experiment (DCE) with participants at an implementation science conference in Washington, D.C. during a 75-minute session on rapid implementation science. At the midpoint of the panel, the audience were invited to participate in a 10-minute DCE based on a vignette describing a hypothetical study on implementing a new vaccine facing public hesitancy. Choice sets included six attributes: rapidity of study, study design, primary outcome, level of community engagement, leadership, and costs. We used a mixed logit model to analyze preferences in real time and presented results back to the audience at the end of the session. Ninety-four participants completed the DCE; all reported working in research and 83% reported working in program implementation. Respondents placed high value on timing of results, with strong preferences for receiving results in 6 months compared 12 months (β=-1.1, 95% CI: - 1.6- - 0.6; p < 0.001) and 18 months (β=-1.7,-2.3- - 1.0; p < 0.001). Participants preferred the primary outcome to be vaccine uptake rather than vaccine acceptability (β = 1.7, 1.1-2.2; p < 0.001) and the study to be community-engaged rather than expert-led (β = 1.6, 1.0-2.2; p < 0.001). We found no preference for randomization compared to before and after (p = 0.88), nor leadership by the ministry of health versus academic institutions (p = 0.12). Respondents were willing to wait 11.3 (95% CI 7.0-15.5) additional months for a program developed with engaged stakeholders compared to expert-driven (p < 0.001) and 11.9 months (95% CI 8.1-15.8) for results on vaccine uptake rather than acceptability (p < 0.001). This real-time DCE demonstrated that with adequate preparation, it is feasible-to generate robust, interpretable, and actionable results within an hour. Findings challenge the assumption that randomization is the highest priority in research design, highlighting instead the importance of outcome and community engagement. By aligning more closely with the values of decision-makers, rapid science approaches such as real-time DCEs may help bridge the research-policy gap.
Implementation science seeks to accelerate the adoption, integration, and scale-up of evidence-based interventions (EBIs) to improve health and reduce disparities. As the field expanded, demand for trained implementation scientists rapidly outpaced workforce capacity. To address this need, the National Heart, Lung, and Blood Institute (NHLBI) launched the institutional Research Career Development Programs in T4 Implementation Research (K12) Next Generation of Implementation Science (iNexIS) in 2016. The program aimed to expand the national pool of rigorous implementation researchers prepared to conduct late-stage translation (T4) studies focused on heart, lung, blood, and sleep (HLBS) conditions. This report presents early outcomes from the inaugural K12 implementation science cohort to assess preliminary workforce growth and productivity. A retrospective cohort analysis was conducted using NIH RePORTER, Query/View/ Report (QVR), and Research Performance Progress Reports (RPPRs) for all awards funded through RFA-HL-17-016. Data extracted (through September 2025) included institutional characteristics, scholar demographics, training duration, grant applications and awards, and peer-reviewed publication output. Productivity measures encompassed: (1) Career Development Awards (CDAs), (2) Research Project Grants (RPGs) and equivalents, and (3) Loan Repayment Program (LRP) applications/awards. Descriptive statistics were used to characterize scholar output, time to first CDA or RPG, and cumulative citation metrics. Ten institutions were funded, supporting 75 scholars across diverse disciplines, primarily pulmonary/critical care medicine (16%), internal medicine (15%), and pediatrics (13%). Most scholars were women (58%); 42% held PhDs and 32% held MDs. Of 215 grant submissions, 95 awards were made to 54 scholars (44% success rate overall; 36% excluding LRPs). Scholars achieved 32 RPGs (24% success rate across RPG submissions) and 27 CDAs. Median time to CDA was 31 months, and to RPG was 43 months-shorter than typical NIH-wide timelines. Scholars collectively generated an estimated 393 publications with a median Relative Citation Ratio of 1.64, reflecting strong research influence. Post-training positions span academic health centers, VA medical centers, community health organizations, research institutes, and industry settings across 17 states. Early findings suggest that NHLBI's iNexIS K12 program effectively expanded the implementation science workforce, accelerated progression to independent funding, and fostered high research productivity. While long-term impact will require follow-up at beyond 10-years post-program, current metrics indicate strong return on investment. Continued support for structured implementation science training programs remains critical to meet growing workforce demands and advance late-stage translational research.
Interest in implementation science (IS) has grown rapidly in recent years, leading to the development of academic centers and programs across the United States (U.S.). Limited information exists regarding how these entities are structured, funded, and sustained. This study characterizes the infrastructure, funding models, service offerings, and organizational structures and practices of IS centers and programs within U.S. academic institutions. We conducted a convergent mixed methods study using a structured web-based review and a REDCap survey. Targeted Google searches of .edu and .org domains were used to identify IS centers and programs based at U.S. academic medical and public health institutions. Forty-eight centers met the inclusion criteria after screening. Website data included institutional affiliation, leadership structure, focus areas, partnerships and service offerings. Program leaders from identified centers were invited to complete a survey examining funding sources, success metrics, workforce development, partnerships, and leadership succession. Quantitative data were analyzed descriptively, and open-ended responses were analyzed using rapid qualitative methods. Findings were integrated during interpretation. The 48 centers and programs were distributed across all major U.S. regions, with 54.2% located at public institutions. Research combined with mentorship and/or teaching was the most common focus area (77.0%). Training (54.2%) and consultation (45.8%) were the most reported service offerings, whereas only 27.1% publicly described community engagement support. Among 12 of 13 survey respondents with complete funding data, grants were the most frequently reported funding source (83.3%), followed by institutional support (50.0%), with limited funding diversification. Integration of quantitative and qualitative findings suggested that workforce development, mentorship, and partnerships were viewed as important strengths among survey participants, while sustainability challenges were linked to reliance on external funding, staffing constraints, and limited succession planning. Quantitative findings related to funding concentration and traditional success metrics were reinforced by qualitative themes describing Clinical and Translational Science Award (CTSA) dependence, workforce challenges, and misalignment between academic incentives and long-term implementation impact. Academic IS centers and programs play an important role in workforce development, mentorship, training, and implementation support but continue to rely substantially on external funding to support core activities. Findings highlight the need for diversified funding strategies, stronger institutional investments, proactive succession planning, and broader impact-oriented success metrics that better capture long-term implementation impact and systems change.
Despite comprising over 70% of the global healthcare workforce, women remain significantly underrepresented in healthcare leadership. This imbalance has implications for care quality, as leadership diversity is increasingly recognised as a determinant of care quality, equitable outcomes, and health system performance. Structural barriers persist across academic medicine, health services, and professional organisations, limiting career progression and leadership opportunities for women. Existing efforts have largely prioritised individual-level interventions, with limited attention to the systems- and organisational-level determinants that influence adoption, implementation, and sustainability of gender equity initiatives. Coordinated action is needed to address gender inequality through sustainable, evidence-informed systems change. This protocol outlines the Organisational Change Management workstream within the Australian Advancing Women in Healthcare Leadership initiative, a nationally implemented, multi-sector partnership. Using a mixed-methods, co-produced implementation research approach, the workstream will implement and evaluate multi-level interventions and associated implementation strategies across system and organisational levels. Guided by the Consolidated Framework for Implementation Research, the Learning Health System framework, and the Reach, Effectiveness, Adoption, Implementation and Maintenance evaluation model, stakeholders are engaged across outer (policy, regulation, funding) and inner (organisational culture, leadership structures) settings. Data collection includes administrative datasets and policy documents, semi-structured interviews, and surveys. Qualitative data will be analysed thematically and quantitative data analysed descriptively. Findings will be triangulated to inform the selection, tailoring, and evaluation of implementation strategies and a codesigned implementation toolkit, supported by iterative learning cycles. This protocol describes a national initiative applying a systems- and organisational-level, co-produced approach to advancing gender equality in healthcare leadership, engaging health services, professional colleges and associations, government, and women in the workforce. By leveraging implementation science and systems change methodologies, the initiative aims to support sustainable organisational transformation. The protocol provides a replicable framework for advancing gender equality in healthcare leadership and beyond and contributes to implementation science by demonstrating how multiple established frameworks can be integrated to operationalise large-scale, system-level organisational change in complex healthcare systems.
Reporting guidelines for implementation strategies are important for transparency, measurement, and replicability. Yet, recent calls within implementation science highlight that foundational research commitments to advance minority health remain underspecified in current implementation strategy reporting guidelines. In response, our research team sought to expand Proctor and colleagues' guidelines for reporting and specifying implementation strategies to advance minority health. We first identified and synthesized key elements for specification from relevant literature. We then applied potential supplemental reporting criteria to our Literacy Promotion for Latinos (LPL) study as a case example to iterate and refine the suggested supplemental criteria. LPL implemented text messages and streamlined access to community resources as implementation strategies to enhance uptake of Reach Out and Read, an evidence-based pediatric clinic-based literacy promotion intervention specifically among Latino families. Our suggested supplemental reporting criteria integrate elements of community-engagement and health disparities research foundational for advancing minority health. We offer a new category, (1) Prioritize It, to describe processes of defining and prioritizing the (a) health outcome gap of interest and (b) performance gap of the evidence-based intervention. We add criteria to Proctor and colleagues' (2) Specify It category, which outlines the description of the implementation strategies, to describe processes of implementation strategy (a) selection, (b) development, and (c) tailoring. Lastly, we suggest a new category, (3) Evaluate It, to include community-engaged evaluation processes. In our case example, we explain the team's processes and engagement of relevant community members and partners in (a) prioritizing disparities in linguistic and socio-emotional development for Latino children related to school readiness and performance gaps in Reach Out and Read for families in local clinic communities; (b) specifying the selection, development, and tailoring of implementation strategies to focus on social and structural drivers of this health disparity; and (c) facilitating community partnerships to evaluate the strategies. Expansion of implementation strategy criteria for reporting can help ensure commitments to advancing minority health are fulfilled. Future efforts should convene researchers and community partners to create expert consensus on the specifications required for implementation strategies for addressing drivers of disparities and advancing minority health. ClinicalTrials.gov, Literacy Promotion for Latinos Study, NCT04609553, first posted October 30, 2020: https://clinicaltrials.gov/ct2/show/NCT04609553.
Meaningful community engagement is fundamental to sustained and effective implementation of HIV interventions, yet partnership engagement quality is rarely measured. We assessed meaningful engagement among community and academic partnerships from 2021-2022 United States Ending the HIV Epidemic (EHE) Implementation Science (IS) Awards. Awardees were invited to complete a cross-sectional, online survey. We applied adapted, validated community engagement importance and quality measures across six 'engagement principles' (EPs) and 12 attributes of 'trust' using 5-point Likert scales (1='poor' to 5='excellent'). Level of community partner engagement was assessed along a continuum. Differences in EP scores between academic partners and community partners were assessed using Mann-Whitney U Test. Bivariate associations between engagement level, EPs, and trust used Spearman's rank correlations. Open-ended responses were thematically analyzed. From July-December 2023, we received 53 (65%) surveys from academic partners and 29 (35%) from community partners, including 1:1 paired responses for 18/57 (32%) projects. Community partners and academic partners reported high median quality engagement summary scores (3.6 vs 4.1, p = 0.04) and trust scores (>67% and >69% reporting "very good" or "excellent"). All trust attributes were highly valued, with >85% of participants rating each "important" or "very important." Academic partners reported lower median summary scores than community partners for quality and frequency of EPs [3.6 vs 4.1, p = 0.04; 3.8 vs 4.3, p = 0.02]. 'Fostering co-learning' was the only individual EP scored significantly lower by academic than community partners (quality [-2.6, p = 0.01], frequency [-2.6, p = 0.01]). For trust, academic partners reported the lowest quality scores for dependability, while community partners reported the lowest for mutual benefit. Among academic partners, level of community engagement was positively correlated with quality across all six EPs (p < 0.05). While among community partners, quality of all trust attributes were positively correlated with EP quality (p < 0.5). In open-ended responses, structural barriers to engagement and concern about community partner burden were prominent themes. EHE awards largely supported trusting and meaningful partnerships. Differences between academic and community responses indicate a need to develop shared understanding of engagement quality. Strategies to strengthen trust, support greater engagement, and enhance the engagement quality will optimize partnerships and their potential positive impact on implementation and effectiveness outcomes.
Extant approaches to close the gap between implementation evidence and practice have been unsuccessful due in part to overreliance on researcher engagement. In practice, change is often driven by mid-level managers. We developed Context-Driven Co-Design (CD2) to equip mid-level managers with a theory- and evidence-based approach to implementation planning. We used a two-pronged design. First, we engaged six established implementation researchers in a modified Delphi process, involving two hour-long meetings and asynchronous feedback to develop and refine a CD2 prototype. Second, we piloted an in-person CD2 training and conducted an hour-long focus group to solicit feedback from mid-level managers on the potential value of CD2 for addressing implementation challenges and opportunities for improving the training. We incorporated focus group feedback and iteratively refined CD2 materials, codified each step of the approach, and further articulated CD2's key features through two empirical applications. Delphi panelists unanimously agreed that prototype content would be best delivered through interactive training. The resulting one-time, three-hour in-person training was piloted with 17 mid-level managers affiliated with the National Cancer Institute Community Oncology Research Program who were often tasked with implementing cancer care delivery interventions and research protocols. Focus group participants (N = 5) appreciated the training's practical tools, suggested that the training should focus on a common intervention, and requested more opportunities for peer learning before and after the training. CD2, further refined through subsequent empirical application, involves three steps: (1) agreeing upon an intervention to address a clinical problem and identifying the intervention's effectiveness-driving features; (2) understanding the context in which the intervention will be implemented, including potential end-users, their workflows, and features of their environment; and (3) co-design session(s) to identify intervention adaptations, context modifications, and exogenous implementation strategies needed to facilitate the intervention's implementation. We codified CD2, a theory-driven approach to harmonizing interventions, implementation contexts, and implementation strategies. Mid-level managers found CD2 to be an appropriate and acceptable approach to implementation planning. CD2 is consistent with perspectives that advocate humility and deference of researchers to individuals and contexts that biomedical research often positions as subjects. Future work is needed to enhance CD2's feasibility and scalability.
Researchers and funders increasingly see potential for integrating human-centered design (HCD) and implementation science (IS) approaches to enhance the design and uptake of health interventions and implementation strategies. These approaches offer complementary strengths. HCD prioritizes developing compelling, intuitive, and adoptable innovations grounded in user and contextual needs; IS focuses on ensuring evidence-based practices reach and work for their intended populations. Integrating HCD and IS creates challenges that existing IS proposal writing guidelines do not address. HCD's inherent uncertainty-since final designs are developed through iteration rather than pre-determined-can unsettle researchers and funders accustomed to more defined endpoints. Variation in how HCD is understood adds further difficulty when collaborating across disciplines or communicating with funders. There are currently no published recommendations to help researchers design strong studies integrating HCD and IS and communicate them effectively to funders. We present tips to support both rigorous study design and effective proposal writing that integrate HCD and IS. This draws from our experiences leading, supporting, and reviewing both funded and unfunded projects. Our considerations are informed primarily by experiences with teams in the United States in the mental health and behavioral health domains; however, we have found our findings also apply to projects globally and in other health sectors. Our intent is that this guide will advance good research that leverages both approaches and is viable for funding. We also hope that the tips will support funders in developing solicitations and evaluating proposals. There is untapped potential for innovative health research integrating HCD and IS, but realizing it requires both rigorous study design and an ability to attract funding. We offer practice guidance to help researchers and funders develop quality projects and proposals, and we encourage others to build on these recommendations.
HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, yet uptake and retention among populations vulnerable to HIV acquisition remain below target levels. Telehealth has emerged as a promising strategy to overcome barriers to accessing PrEP. However, significant gaps remain in our understanding of the implementation of telehealth programs for PrEP. This study examines implementation barriers and facilitators in the Philadelphia TelePrEP Program (PTP), assesses program acceptability, usability and satisfaction, and investigates associations between client characteristics and implementation outcomes. We conducted a mixed-methods evaluation from October 2023 to February 2025 of the PTP using web-based surveys with 113 participants and in-depth interviews with 5 staff members. We assessed implementation outcomes (i.e., program acceptability, usability, and satisfaction) and explored implementation determinants through qualitative analysis guided by the Consolidated Framework for Implementation Research. We used linear regression to examine associations between sociodemographic and clinical characteristics of participants and implementation outcomes. Survey participants were predominantly cisgender men with diverse racial/ethnic backgrounds. Participants reported high levels of acceptability, usability, and satisfaction with the PTP, though those with less than full-time employment reported significantly lower acceptability and usability compared to those with full-time employment. Mixed-methods analysis identified patient navigators as a central facilitator of program success, with both staff and clients emphasizing their role in creating a supportive, stigma-free care environment. Key implementation barriers included billing complexity, platform integration challenges, and privacy concerns. Although designed as a fully remote program, substantial demand for in-person services (particularly for injectable PrEP) emerged as a central implementation theme, underscoring the need for flexible hybrid service models. Staff also identified gaps in reaching priority populations, including Black and Latine communities, despite the program's broad digital outreach efforts. TelePrEP programs can achieve high user satisfaction when supported by dedicated navigation services and flexible care options. However, realizing the full potential of this model may require additional strategies to enhance program reach, streamline multi-organizational coordination, and support hybrid service models that accommodate diverse patient preferences and socioeconomic circumstances.
Simulation is an established evidence-based tool in healthcare. It is widely used for medical education (simulation-based medical education [SBME]), quality improvement, capacity building, audit and feedback, and probing healthcare systems for latent safety threats. Implementation science (IS) currently subsumes these functions under broad taxonomy categories such as "conduct ongoing training" or "cyclical tests of change." This framing fails to capture simulation's distinct mechanisms and its unique potential to close the evidence-to-practice gap. We argue that the time has come for implementation scientists and the healthcare simulation community to come together around a shared question: does simulation, as it is already practiced in healthcare, meet the criteria for a discrete, named implementation strategy within taxonomies such as the Expert Recommendations for Implementing Change (ERIC)? Drawing on the ERIC definition of an implementation strategy as "methods or techniques used to enhance the adoption, implementation, and sustainability of a clinical program or practice," we argue that simulation in healthcare already functions in this role across at least three distinct domains: developing individual and team competencies (SBME); probing healthcare systems for latent hazards and driving quality improvement; and operationalizing evidence-based interventions (EBIs) and clinical decision supports (CDS) under realistic conditions. We specify simulation using established IS frameworks-including the Consolidated Framework for Implementation Research (CFIR), the EPIS framework (Exploration, Preparation, Implementation, Sustainment), and the PRISM (Practical, Robust Implementation and Sustainability Model)-and propose a research agenda at the intersection of these two fields. High-reliability industries including aviation, astronautics, and nuclear power provide useful analogies, but the healthcare simulation literature has developed a robust and distinct evidence base in its own right, exemplified by translational simulation paradigms. Simulation is not simply a training technique. It is a multi-mechanism, multi-level strategy with proven applications in healthcare education, QI, and systems change. Formally recognizing simulation within IS strategy taxonomies would sharpen conceptual clarity, enable more precise evaluation, and open a productive dialogue between two scientific communities whose work is more convergent than current frameworks suggest.
Food insecurity (FI) is associated with poorer physical and mental health outcomes, exacerbation of chronic diseases, and decreased access to healthcare. Children experiencing FI face additional risks, including lower psychosocial functioning and reduced academic achievement. Although national initiatives call for integrating nutrition support services into healthcare, clinical workflows for FI screening and referral remain inconsistently implemented and difficult to sustain. The goal of this study is to refine, adapt, and optimize a comprehensive FI screening and referral program, and identify effective implementation strategies for pediatric healthcare systems. We will use a RollOut Implementation and Optimization (ROIO) trial design to iteratively implement and refine the implementation strategies for our FI screening and referral program (I-FRESH: Implementing Food Referrals for Equity and Sustained Health) across 4 pediatric clinics. I-FRESH includes: (1) FI screening; (2) assessment of family needs and readiness to access services; (3) referral and navigation support to community nutrition programs; and (4) follow-up to assess fit, utilization, and ongoing needs. The Pragmatic, Robust Implementation and Sustainability Model (PRISM) will guide adaptation and evaluation of contextual determinants, while RE-AIM will guide assessment of outcomes (implementation feasibility and acceptability, fidelity, adoption, reach, effectiveness, and maintenance). We will identify several implementation strategies to increase the likelihood that I-FRESH can be successfully implemented and sustained in a pediatric healthcare system. We will enroll 240 participants and assess preliminary effectiveness on family‑level food security and pediatric nutrition‑related health outcomes (e.g. weight status, blood pressure, lipids, HbA1c, liver function tests). The information gathered in this trial will be utilized in the development of a fully powered Type 2 Hybrid Effectiveness-Implementation Trial that will test the effectiveness of the identified implementation strategies and impact of the FI program on clinical outcomes. By integrating PRISM and RE-AIM within an iterative ROIO design, this study will generate a scalable, contextresponsive implementation model for addressing FI in pediatric healthcare settings. Findings will inform sustainable strategies that link families to highquality nutrition support programs and improve nutritionrelated health outcomes for lowincome children. NCT06661538.
A theory- and practice-based implementation strategy bundle (ISB) was developed to support physical therapists and dieticians during implementation of the combined lifestyle intervention ProMuscle for community-dwelling older adults in multiple community-care settings. Alongside a 42-week hybrid type III stepped-wedge randomized cluster implementation effectiveness trial, a process evaluation was conducted to explore possible working mechanisms of the ISB on the adoption, reach, and fidelity of ProMuscle by describing a causal pathway. Additionally, barriers and facilitators for the use of the ISB were identified. During the 6-week transitional period in which clusters transitioned from the control to the intervention group and at the end of the 42-week trial, (group)interviews were held with physical therapists and dieticians. Interview guides were informed by the RE-AIM framework and supplemented with quantitative data from surveys and ISB tracking activity. Interviews were transcribed and thematically analyzed. Insights from the process evaluation informed a causal pathway diagram and the identification of barriers and facilitators for the use of the ISB. Twenty-five physical therapists and dieticians were interviewed during the transitional period, and fifteen participated in the group interviews at the end of the trial. The causal pathway diagram revealed that individual factors (knowledge and beliefs about the intervention, convincing others, and networking), and organizational- and system-level factors (facilitation, collaboration, and support) moderated the influence of the ISB on the implementation outcomes. Particularly organizational and system-level factors could not always be addressed by individual professionals. The fidelity of the ISB was low, according to the healthcare professionals, due to timing of receiving the ISB and lack of education on its use. The results highlight the complexity of real-world implementation in multiple community-care settings and address the need for organizational and policy-level facilitation to enhance the implementation, sustainment, and scale-up of lifestyle interventions for community-dwelling older adults. Additionally, low fidelity of the ISB probably contributed to the non-significant effect of the ISB on the adoption of ProMuscle. Future implementation studies should take the timely delivery of an ISB into account and provide adequate education to healthcare professionals about the use of implementation strategies. ClinicalTrials.gov (NCT05672004) registered at 12/07/2022 https://clinicaltrials.gov/ct2/show/NCT05672004.
Scaling up is a complex process. As a multi-dimensional concept, it requires efforts to (1) increase population coverage (coverage), (2) expand or diversify what is included in the health service package (expansion), and/or (3) institutionalise a health innovation or new practice into health system services (institutionalisation). In this paper, we provide the theoretical basis for the model joining linear as well as complex pathways - stemming from implementation and complexity science - towards three-dimensional scaling. Our scale-up model positions expansion as the backbone for scale-up, and proposes multiple back-and-forth waves between institutionalisation and coverage. This allows an incrementalist approach, going step-by-step from one to the other scale-up dimension, as well as a multi-player complexity approach, emphasising the interactions between scale-up dimensions and actors involved, to achieving population health. By offering a dual incrementalist-complexity focus, we acknowledge that there is a starting point to scale-up, and thus path dependency, in addition to highly contextual cultural, historical, socio-political, and economic forces that underpin population health and any attempt at scaling up access and integration of health services, thereby pointing at their fragmented and incomplete nature. The visualisation and underlying hypotheses offer speculation on potential pathways for scale-up, which are key processes to understand and untangle in future research.