De-implementation is a critical, understudied area within implementation science, particularly de-implementation strategy development. Aligned with most national guidelines, de-implementation of routine mammography screening among older women (without considering patient preferences, health, life expectancy), is a compelling area for advancing de-implementation science. While previously applied for implementation, this research seeks to advance understanding of Innovation Tournaments (InTs) as a participatory methodology to inform de-implementation strategy development. Building on formative qualitative research and informed by User-Centered Design (UCD), we conducted an InT to generate, confirm, and refine de-implementation strategies among purposively selected providers and administrators across two healthcare systems in New York City. InT development began 07/2021 and launched 11/2022-05/2023. A key challenge in co-creating, launching, and maintaining the InT was difficulty communicating about de-implementation, especially given differences in opinion about guidelines across provider specialties. To address this complexity, we collaborated with experts in InTs, shared decision-making, healthcare informatics, communication, creative content development, and UCD. Based on input during the UCD process and to facilitate engagement across participants with varying opinions, we expanded the InT to assess ideas and opinions about mammography guidelines for older women and appropriateness of de-implementation, in addition to assessing de-implementation strategy ideas. We conducted descriptive analyses of InT forum engagement data and content analysis of forum posts/comments. Of 47 participants who entered the InT website, 36 engaged in the forum (voted, commented, or posted). Participants voted 256 times on posted ideas/opinions/strategies and comments, submitted 71 comments, and posted 13 new ideas/opinions/strategies. Most participants engaged in the forum during their initial visit to the InT, with limited engagement over time. Content analysis of posts/comments identified de-implementation strategy categories largely aligned with the ERIC taxonomy (e.g., patient education, provider training/reminders), though system-level strategies specific to de-implementation emerged. Findings advance de-implementation methods by indicating importance of formative qualitative research and UCD to inform InT development and engagement (particularly if stakeholders disagree on de-implementation appropriateness). Unique considerations include: how best to seed InT content; challenges in generating new strategies that meaningfully expand upon formative qualitative research findings; and time and resources needed to develop, elicit and sustain stakeholder engagement over time.
Type 2 Diabetes prevalence is rapidly increasing in low- and middle-income countries (LMICs), where constrained health budgets and inequitable resource distribution limit access to quality care. Primary healthcare is central to addressing these challenges; however, the implementation of evidence-based diabetes care remains inconsistent. This scoping review mapped implementation strategies for integrating diabetes care into primary healthcare settings in LMICs and identified associated barriers and facilitators influencing implementation. This review focuses on type 2 diabetes, given its predominance and relevance to primary healthcare delivery in LMICs, and followed the Joanna Briggs Institute methodology for scoping reviews and was reported in accordance with PRISMA-ScR guidelines. The search strategy was peer-reviewed using the PRESS checklist. Eight electronic databases were searched for studies published between January 1996 and November 2024. Eligible studies were conducted in LMICs, as defined by the World Bank, and described the implementation, adaptation, or evaluation of evidence-based Type 2 diabetes care in primary healthcare settings. Two reviewers independently screened titles, abstracts, and full texts. Implementation strategies were mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy, while reported barriers and facilitators were coded using the Consolidated Framework for Implementation Research (CFIR). Ninety-two articles describing 85 studies across 27 LMICs were included. Implementation strategies most frequently clustered within Engage Consumers, Change Infrastructure, and Use Evaluative and Iterative Strategies, whereas Adapt and Tailor to Context and Utilise Financial Strategies were less often explicitly reported. Forty-three studies reported clinical outcomes only, 11 reported implementation outcomes only, and 31 reported both. Studies more frequently reported improvements in clinical and/or implementation outcomes that combined multiple strategies, particularly provider training and decision support alongside patient or family engagement and pragmatic system redesign. Co-occurrence analyses indicated that Train and Educate Stakeholders was frequently paired with Engage Consumers, supported by supervision, feedback mechanisms, and infrastructure strengthening. CFIR mapping suggested that workflow integration, leadership engagement, regular supervision, and reliable medicine and diagnostic supplies were commonly associated with improved adoption and fidelity, while connectivity challenges, stock-outs, and high workload disrupted implementation and limited scale-up. Reporting of adoption, fidelity, and acceptability remained uneven, and financial strategies were poorly described despite their relevance to sustainability. In LMIC primary healthcare settings, diabetes care implementation most commonly emphasises provider training, infrastructure strengthening, and interactive support strategies, while explicit attention to contextual adaptation and financial mechanisms is less frequently reported. Implementation outcomes were reported to be influenced by leadership engagement, digital tools, and community involvement, alongside persistent constraints related to workforce capacity, supply chains, and feedback systems. Future implementation efforts should more explicitly address contextual fit, system integration, and sustainability when designing and scaling diabetes care interventions in primary healthcare.
The Quality Implementation Framework (QIF) is a widely used process model in implementation science (IS). Since its publication in 2012, the field of IS has expanded considerably, yet QIF has never undergone formal revision. Given recent advances and the complexity in implementation research and practice, this study examines whether QIF continues to capture the full scope of implementation quality and its challenges. An umbrella review of reviews was conducted on literature published between 2012 and 2025. Eligible articles reported on the development, application, or update of implementation frameworks within healthcare or social science. Data were deductively mapped to the four phases and 14 steps of the original QIF and inductively mapped to identify knowledge not included in the original framework. A total of 15 reviews met the inclusion criteria. Most aligned with the core structure of QIF, supporting its continued relevance. However, several reviews highlighted the need to add a pre-implementation phase focusing on evidence appraisal, and a post-implementation phase addressing sustainability. Four cross-cutting domains (service user, intervention deliverer, context, and technology) were identified as critical factors throughout the implementation process. An updated version of QIF is proposed, building on the original framework while introducing two new phases and four cross-cutting domains. This expanded model reflects recent developments in the literature and provides more comprehensive guidance to support implementation across complex real-world settings; it has important implications for implementation research and implementation practice. PROSPERO registration number: CRD42023475994.
Many implementation studies focus on assessing the effectiveness of implementation strategies without investigating the mechanisms explaining their effects. This study investigates the specific mechanisms through which a multifaceted implementation strategy is hypothesized to improve guideline fidelity. This is done by tracing the specific mechanisms through which each discrete strategy achieved proximal outcomes that precede guideline fidelity. Process tracing with comparative case studies was used to analyze qualitative data from a subsample of 16 implementers participating in a cluster-randomized controlled trial exploring the mechanisms by which a multifaceted strategy affects fidelity to a guideline for prevention of mental problems in schools. The study involved four steps: (1) Organizing a traceable process theory of change; (2) Gathering data to validate, modify, or expand the theory; (3) Coding data through qualitative content analysis; and (4) Causal analysis to articulate the theory's mechanisms, including temporal order and key contextual conditions that explain success or failure. The unit of analysis was implementers who were members of the schools' implementation teams, with each implementer representing a case. The analyses illuminated distinct pathways that explain how each of the five discrete strategies led to implementation success. (1) Organizing Implementation Teams enabled participation in implementation activities, as principals created an environment with dedicated resources, enabling social influences; (2) Educational meetings influenced the decision to implement the guideline through the educators' who promoted knowledge acquisition among the implementers and shaped their beliefs about the implementation; (3) Ongoing Training influenced the intention for implementation and enactment of activities through educators' engaged processes around ongoing acquisition and refinement of skills, which gradually built belief in implementation capability; (4) Small Cyclical Tests of Change influenced behavioral regulation as the workshops engaged repeated engagement in goal setting, action planning, reflection, and adjustment; (5) Facilitation supported implementers' goal setting and prioritization by creating an environmental context, enabling implementers' social influence through receiving social support from facilitators. Unsuccessful pathways for each strategy were also identified and explained. This study traced the specific sequences of actions and interactions through which five discrete implementation strategies contributed to guideline implementation. The findings illustrate how the mechanisms of the multifaceted strategy can be successfully engaged and why they may fail under certain conditions. The trial was registered the 9th of August 2021 at Clinicaltrials.gov with Trial registration number: NCT05019937.
Efforts to improve healthcare quality and safety and optimise resource use are increasingly focused on deimplementation-the reduction or cessation of existing practice. Reimplementation, a common form of deimplementation, involving the reintroduction of an existing intervention with some degree of modification, is under-researched, particularly in the context of standardising clinical tools. Recent initiatives, such as the national rollout of a standardised paediatric early warning system (PEWS) in England, highlight the need to understand the processes and challenges of substitution, especially from nursing and paediatric perspectives. This qualitative study employed a comparative case study design across four diverse hospital sites. Data collection (June 2023-November 2024) included semi-structured interviews with staff (n = 29), site-specific workshops and a final stakeholder workshop. Thematic analysis, informed by the Theoretical Domains Framework, was used to analyse interview and workshop data, with cross-case comparisons to identify influences on the reimplementation of PEWS. Buy-in and firm commitment (purchase) was identified as a central influence on the reimplementation effort and was in turn influenced by factors falling into four key categories: product and process (characteristics of, familiarity with and confidence using the system being reimplemented - connected to specific training needs and gaps); people (the people involved in or providing support for reimplementation - having strong leadership across roles and seniority, ward champions and peer support); purpose and promise (belief in the value of the reimplementation); and practice (practical and contextual influences on reimplementation efforts - staffing pressures, removal of the previous system, and acknowledgement that the change would require an initial adjustment period). The considerations identified in this study provide a simple '5P' framework to help understand and support reimplementation, which maps to and is grounded in existing theory. Those considering reimplementation efforts should consider (1) the people, (2) the product and process, (3) the purpose and promise, and (4) the practical influences when reimplementing systems or initiatives. These factors greatly influence (5) purchase - buy-in and commitment - and, we suggest, ultimate success. This will be important in the wider roll-out of a national PEWS as well as other standardisation efforts in the NHS.
Low-value care remains pervasive across healthcare systems and consumes scarce resources while exposing patients to avoidable harms. De-implementation, the purposeful process of reducing, restricting, replacing, or discontinuing low-value practices, has gained momentum, yet the field still lacks clear methodological guidance grounded in theory. De-implementation is often treated as "reverse implementation", despite accumulating evidence that stopping practices can activate distinct mechanisms and constraints. In this paper, we synthesize and contrast theories, process models, and frameworks relevant to de-implementation of low-value care to generate actionable methodological guidance. Drawing on a theory-informed narrative review and constant-comparative synthesis, we identify where de-implementation converges with implementation (e.g., staged processes; multilevel determinants; use of established determinant, strategy, and outcome frameworks) and where it diverges in ways that matter for design and evaluation. Across sources, three recurring lenses structure these divergences: (i) the psychology of stopping (habit disruption, loss aversion, cognitive biases, professional identity threats), (ii) multi-level constraints and politics (incentives, regulation, professional norms, stakeholder interests), and (iii) the nature of the low-value practice and endpoint (reduction vs. restriction vs. elimination; replacement vs. disenchantment discontinuance). We translate these contrasts into ten streamlined methodological recommendations that specify what investigators should state and report in practice, including configuration (stand-alone vs. embedded/paired), low-value classification, explicit determinant-to-strategy-to-mechanism logic, inclusion of patient experience and unintended consequences, and dual-trajectory evaluation when substitution is involved. De-implementation is not simply implementation in reverse. Methodological rigor in de-implementation research requires explicitly specifying configuration and endpoint, aligning strategies with stopping-specific mechanisms and multilevel constraints, and evaluating beyond utilization to include mechanisms, patient experience, equity-relevant impacts, and unintended consequences. This paper provides a practical, theory-grounded set of recommendations to strengthen the design, evaluation, and reporting of future de-implementation studies.
The HEARTS model (Healthy-lifestyle counseling, Evidence-based treatment protocols, Access to essential medicines and technologies, Risk-based management, Team-based care, and Systems for monitoring) is recommended by the World Health Organization and the Pan American Health Organization to improve primary care management of hypertension, diabetes, and other cardiovascular disease risk factors in national health systems. The objective of this study is to evaluate HEARTS implementation in the Ministry of Health primary care system in Guatemala, where a scale-up project covering approximately 10% of the country began in 2024. This is a prospective, observational evaluation using a hybrid type 3 effectiveness-implementation design with three sequential periods: pre-implementation, implementation, and maintenance. The six HEARTS-aligned multilevel implementation strategies are: (1) training and supportive supervision for health workers, (2) standardized treatment protocols, (3) strengthening availability of medications and diagnostics, (4) task sharing with non-physician health workers, (5) quality monitoring systems, and (6) patient engagement and community outreach. The evaluation is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Co-primary outcomes are hypertension and diabetes treatment rates (Reach), estimated from MOH administrative data using a difference-in-differences approach comparing intervention districts with non-HEARTS comparator districts. Additional quantitative outcomes include treatment intensity and retention (Reach), disease control (Effectiveness), district-level uptake (Adoption), strategy-specific fidelity (Implementation), and sustainment of outcomes after external support concludes (Maintenance). To explain variation in quantitative outcomes, semi-structured interviews will be conducted with MOH staff, government officials, international advisors, and civil society stakeholders using an explanatory sequential mixed methods design. The study will include a cost-effectiveness analysis and budget impact analysis to inform policy decisions on scale-up and sustainability. This study will provide evidence on HEARTS implementation in Guatemala. Findings will inform decisions about national scale-up and contribute to the global evidence base on implementation of hypertension and diabetes management in primary care health systems. This study is registered on the Open Science Framework (https://osf.io/easm9).
Antibiotics are commonly overused to treat upper respiratory tract infections (URTIs) in HIV-infected adults in primary healthcare settings, even though viruses cause most URTIs. Therefore, a de-implementation of unnecessary antibiotic prescribing for URTIs was implemented in these settings. Thus, this study aimed to evaluate a strategy to de-implement unnecessary antibiotic prescriptions among ambulatory HIV-infected adults with acute URTI symptoms using the reach-effectiveness-adoption-implementation-maintenance (RE-AIM) framework. We conducted a three-phase (pre-implementation, adaptation-implementation, and post-implementation), hybrid type II effectiveness-implementation study utilizing a two-arm, parallel cluster-randomized controlled trial design involving HIV-infected adults recruited from six primary healthcare facilities (intervention 1o de Maio, Bagamoyo, and Matola-2, whilst Alto Maé, Hulene, and Ndlavela as control) in Mozambique. Quantitative data were collected from June to September 2024, while qualitative data were collected from October to December 2024. The intervention included a clinical decision support algorithm (CDSA), training and supervision of clinicians, and prescription audits. The intervention was evaluated using four dimensions of the RE-AIM framework: reach, effectiveness, adoption, and implementation. We used Pearson's chi-square test and relative risk to assess the effect of the intervention. Among 387 HIV-infected adults approached, 379 (97.9%) were successfully recruited, with 182 (48%) in the intervention and 197 (52%) in the control group. Among the recruited patients, the mean age was 44 ± 12.3 years, and 286 (75.5%) were female. The intervention resulted in 33.2% fewer antibiotics prescribed compared to controls (RR = 0.41; 95% CI: 0.31-0.55). The antibiotic prescribing rate was 23.1% in the intervention and 56.3% in the control group. All three intervention sites (100%) and all clinicians (100%) demonstrated a commitment to de-implementing antibiotics. The implementation protocol was delivered as planned. Almost all participants (n = 21) in focus group discussions (FGD) were either satisfied or very satisfied with the intervention. They reported the effectiveness of the CDSA and the change in attitudes and antibiotic prescribing practices. Based on the RE-AIM evaluation, the implementation of the planned intervention was successful as it effectively promoted de-implementation and reduced unnecessary antibiotics for URTIs. The strategy employed in this study should be evaluated in other areas to determine if the same findings are observed elsewhere. ISRCTN, ISRCTN88272350. Registered 16 May 2024, https://www.isrctn.com/ISRCTN88272350.
This study aimed to determine the barriers, enablers, strategies and costs of implementing an alternative catheter locking solution for CVADs in paediatric cancer care. This qualitative implementation evaluation and cost analysis study conducted semi-structured interviews with clinicians and key decision makers based on the Consolidated Framework for Implementation Research. Following rapid analysis, implementation barriers were matched with the Expert Recommendations for Implementing Change tool to provide optimal implementation strategies, and budgeted using the Costing Implementation Strategies instrument. Among interviewed participants (N = 23), the most common barriers to implementation were innovation cost, partnerships and connections, work infrastructure, communications, tension for change, and innovation deliverers. Based on these constructs, developing strong networks, identifying change champions and accessing funding to facilitate implementation were selected as the most suitable strategies for successful implementation. The estimated total cost of the strategy bundle per site would be AUD$29,752. Understanding the barriers and enablers to implementing an alternative catheter locking solution in paediatric cancer care allows optimal strategies and implementation enhancement plans to be developed and costed, streamlining the transition from research to practice, fast-tracking approvals through purchasing departments. Addressing structural, relational, and financial barriers while leveraging enablers, is essential for adoption and sustained impact of an alternative catheter locking solution.
Champions are individuals who demonstrate strong commitment to promoting sustained implementation efforts through their expertise, enthusiasm, and influence, and are known to enable the implementation of evidence-based educational programs. However, existing research has predominantly examined champion effectiveness during implementation and early sustainment phases, with limited attention to their role in long-term program or innovation sustainment. This study investigated how champions influence organisational capacity for sustained program implementation over extended timeframes. A multiple case study design examined champion dynamics across three Australian organisations sustaining implementation of the Abecedarian Approach Australia (3a) for 10 or more years. Semi-structured interviews were conducted with 25 participants, including senior leaders, program managers, educational leaders, and practitioners. Thematic analysis informed by critical realist epistemology identified mechanisms through which champions influenced long-term sustainability. Cross-case analysis suggested the presence of what we term a 'champion paradox': the factors that make champions effective in driving implementation may simultaneously create systemic vulnerabilities that can threaten long-term program sustainability. Across these cases, the paradox appeared to operate through three interconnected mechanisms: (1) knowledge concentration, where expertise accumulates in individuals rather than organisational systems; (2) dependency creation, where organisations become reliant on champions for quality assurance, problem-solving, and program continuity; and (3) system capacity prevention, where champion effectiveness conceals organisational need for systematic capacity building. These mechanisms were interpreted as forming a self-reinforcing cycle that may strengthen champion dependency while inhibiting organisational independent capacity. The champion paradox framework invites reconsideration of widespread assumptions that individual champions inherently strengthen organisational implementation capacity. Findings suggest potential value of a shift from champion-dependent to more system-dependent implementation models, with implications for champion selection and development, organisational design, sustainability assessment, and policy frameworks. Implementation strategies may be strengthened by positioning champions as transitional resources focused on building collective organisational capacity rather than as permanent drivers of program quality.
Schools are increasingly recognized as critical settings for delivering mental health interventions. The successful implementation of school-based programs like THRIVE, a parent-child intervention, is likely influenced by the organizational context and the school's readiness for change. This mixed methods study, part of a Type 2 hybrid implementation-effectiveness RCT, aimed to explore baseline contextual factors that may influence the implementation of THRIVE in school settings. Using a convergent mixed methods design, we investigated the climate of schools implementing THRIVE. Twenty-five interventionists were recruited from six school districts. Quantitative data were collected using the School Implementation Climate Scale (SICS) and Organizational Readiness for Change (ORC). Individual qualitative interviews guided by the Consolidated Framework for Implementation Research (CFIR) were also conducted. Schools were classified as resource-rich or resource-constrained using the Social Vulnerability Index. Descriptive and bivariate statistics were performed. Deductive thematic analysis was conducted. Results were integrated through a joint display table to identify convergences and divergences. The overall SICS score averaged 3.27 (SD = 0.66) and the overall ORC score averaged 3.79 (SD = 0.42), suggesting moderately positive school implementation climate and readiness. On average, participating schools demonstrated a strong focus on evidence-based practice (EBP) and high availability of training and resources for EBP, while providing limited incentives for EBP use (M = 2.09, SD = 0.93). They also presented a collaborative and supportive working environment with shared values but insufficient communication (M = 3.36, SD = 0.73). Qualitative findings are mostly consistent with quantitative results. Most interventionists (n = 24) believed THRIVE aligns with school values and family needs and remained optimistic despite barriers such as time commitment and negative perceptions. Compared to resource-rich schools (n = 11), resource-constrained schools (n = 14) placed less emphasis on EBP (t(23) = 2.37, p < .05) and had fewer facilitators (n = 5), but perceived greater benefits in implementing THRIVE (n = 14). This study found a moderately positive implementation climate and organizational readiness for change in schools adopting the THRIVE intervention. However, limited incentives, communication challenges, and resource constraints may hinder successful implementation. The divergence between strong support for EBPs and the lack of resources suggests that implementation strategies must be tailored and flexible to promote buy-in and address structural barriers. ClinicalTrials.gov NCT06139874. Registered on November 27, 2023.
Preparation factors in implementation are critical for success but remain relatively unexplored in rural healthcare. This evaluative study investigated the introduction of a virtual medical officer model in three acute wards of a rural health service in Victoria, Australia. The paper describes the innovation and identifies important features of preparation in implementation. The evaluation was process-outcome orientated, undertaken from December 2022 to June 2023; deemed the innovation's pilot phase. Multi-method data collection involved a review of documents pertaining to the model, an electronic survey specific to nurses at two time points (preparation and implementation), and semi-structured interviews targeting two groups; Group one, health system stakeholders (nurses, doctors, managers and virtual medical officers) and Group two, patients. Implementation frameworks informed the evaluation design, data collection and analysis. The document review emphasised the important preparation factors undertaken as an interdependent platform for subsequent implementation stages, for example having a clear understanding of determinants such as the rural context, the problem and need. Interview findings (n = 77), involving Group one (n = 39); and Group two (n = 38), were categorised into three overarching themes; Facilitators of the telemedicine model, Barriers to the telemedicine model, and Sustaining telemedicine innovation gains for the future of rural healthcare. Critical preparation factors identified were the relational culture of collaboration and partnership during innovation design negotiation, and the importance of organisational and individual leadership. Implementation factors highlighted the effectiveness of the project management approach, and responsive adaptation, such as active feedback loops leading to model adjustment to increase acute ward routine efficiency. Sustainment factors were predicted to be impeded or aided by preparation actions. The role of preparation in implementation requires clearer articulation with its features included in implementation plans. It is an active process which can influence any stage and eventual sustainability. Our description of facilitators and barriers, and contextual determinants, as contributors to implementation success, would aid decision makers when designing, introducing and adapting rural healthcare innovations. This study has policy implications for the development of rural medical workforce strategies and the planning of a rural digital healthcare strategy.
Intra-hospital transfers (IHT) of hospitalized children are unavoidable practices often performed with emergency patients and postoperative patients. Standardizing IHT processes to minimize adverse events might improve children's outcomes. We developed an evidence-based clinical practice IHT guideline for hospitalized children. The aim of this study was to evaluate the implementation process and the effectiveness of the implementation of this guideline on patient outcomes, healthcare professionals' knowledge and behavior, and hospital organizational context. A type III hybrid effectiveness-implementation design was adopted, using a pre-post intervention trial (January-December 2024). Data of patient demographics, transport-related outcomes, and healthcare providers' knowledge and compliance were collected. We used the RE-AIM framework to assess effectiveness across four dimensions: Reach, Effectiveness, Adoption, and Implementation. Totally, 110 healthcare professionals conducted 213 IHTs of eligible children (109 children in the pre-intervention group and 104 in post-intervention group). The Reach outcomes demonstrated that participation among hospitalized children (n = 312) was suboptimal at 33% (104/312). No differences were observed between the pre- and post-intervention group regarding gender, disease distribution, or pediatric early warning scores. The implementation showed favorable outcomes in the dimensions Effectiveness, Adoption, and Implementation. Healthcare professionals engagement was 95%, with 86% (19/22) of the implementation strategies successfully completed. Healthcare professionals' knowledge in the pre-intervention group (n = 109) improved from median 40 (IQR 28;52) to median 76 (IQR 64;84) in the post-intervention group (n = 104; p < 0.001). Clinically, the new guideline reduced adverse events (12 vs 4; p = 0.047), reduced the median minutes of bedside handover time from 5 (IQR 3;7) to 4 (IQR 3;5; p < 0.001), and improved handover information completeness from median score of 5 (IQR 4;6) to 20 (IQR 12;23, p < 0.001). The total transport time increased from 14 to 19 minutes in the post-intervention group (p < 0.05), while no significant changes were observed in handover interruptions or post-transfer vital sign stability (p > 0.05). The RE-AIM-based evaluation confirmed that the implementation strategies effectively enhanced healthcare professionals' knowledge and compliance while reducing adverse events and optimizing handover efficiency. However, the limited patient participation rate and increased transport duration highlight areas requiring further refinement to maximize the guideline's impact. ClinicalTrials.gov, NCT06512805. Registered 27 June 2024.
The Department of Veterans Affairs Cooperative Studies Program (CSP) added implementation science teams to select trials to accelerate the uptake of research evidence into practice. CSP study #2008, "Pentoxifylline in Diabetic Kidney Disease", evaluates whether adding pentoxifylline to usual care reduces the incidence of end-stage renal disease and mortality in patients with diabetic kidney disease. This implementation science sub-study aims to develop a VA-wide implementation plan by identifying key implementation outcomes, identifying and interviewing key stakeholders, and identifying critical barriers and facilitators to implementing findings. Using an exploratory sequential mixed methods approach in this hybrid type 1 design, we conducted semi-structured interviews with nephrologists, primary care physicians, and pharmacists from ten VA facilities that were enrolling Veterans in the CSP 2008 clinical trial. The interviews were analyzed using the Tailored Implementation in Chronic Disease (TICD) framework. Findings informed a web-based survey distributed to nephrologists, primary care physicians, and pharmacists from 15 additional participating facilities. Interviews identified five facilitators: 1) providers are willing to prescribe an older medication; 2) providers are not concerned about the side effects of pentoxifylline; 3) providers believe that pentoxifylline is inexpensive; 4) providers report widespread comfort with off-label prescribing; and 5) providers state they would be comfortable prescribing pentoxifylline if colleagues they trust recommend it. Survey data confirmed that providers are not concerned with prescribing an older medication, but there were mixed responses about off-label prescribing. Barriers included: 1) concerns about possible drug interactions; 2) providers self-identified as late adopters; 3) concerns about polypharmacy; 4) prescribers prefer newer drugs; and 5) providers want ample evidence that pentoxifylline works for this indication. Survey data confirmed all the identified barriers except for providers identifying as late adopters. Interview data provided early evidence of facilitators that may support pentoxifylline adoption if the trial shows positive results. Survey data reinforced and broadened these insights across a larger clinician sample. Together, these findings will guide development of targeted implementation strategies to support effective and timely dissemination of trial findings across the VA health system. The CSP 2008 study ClinicalTrials.gov ID is NCT03625648.
Latine people in the U.S. face unequal access to mental healthcare, particularly families and parents with limited English proficiency. Community health workers (CHWs) are well-positioned to increase access to care if integrated into mental health services. The Common Elements Treatment Approach (CETA) is a transdiagnostic evidence-based treatment (EBT) designed to be delivered by lay providers with little to no prior mental health training (i.e., CHWs). CHWs have demonstrated effectiveness in delivering CETA and other EBTs globally; however, there is limited evidence to guide domestic implementation of these models. This study aims to evaluate the implementation of CHW-delivered CETA with Spanish-speaking Latine parents to establish initial feasibility and proof of concept prior to expanding the study of CHW EBT models across other populations and settings. This protocol outlines a three phase study. Phase 1 involves collaboration with key partners to refine CETA fit for the local context using the ADAPT-ITT model, an implementation framework for EBT refinement. Phase 2 will use mixed methods to assess multilevel contextual determinants during the CETA training period, which includes initial CHW implementation with clients, and using key partner feedback for implementation planning. Phase 3 involves conducting a randomized feasibility pilot of CHW-delivered CETA in Spanish with Latine parents who will be randomized to receive CETA immediately or after a 5-month delay. Key outcomes will include administrative data (i.e., patient attendance and retention over the course of the intervention), patient-report data (i.e., implementation questionnaire, validated mental health symptom measures pre-, during-, and post-intervention), provider-report data (i.e., fidelity, implementation questionnaire), and qualitative interviews to evaluate feasibility, acceptability, and preliminary effectiveness of CHW-delivered CETA. This study stands to have a significant public health impact by advancing an innovative mental health model, i.e., CHW-delivered EBTs, that has great potential for expanding mental health service access for marginalized families who are underserved in traditional models of care. This project begins with one population (Spanish-speaking Latine parents) to establish initial feasibility and proof of concept prior to expanding the study of these models to other diverse populations and settings. Prospectively registered on February 4, 2026, at ClinicalTrials.gov no. NCT07390630.
Familial hypercholesterolaemia (FH) is a common but underdiagnosed genetic condition that leads to high low-density lipoprotein cholesterol and premature cardiovascular disease. Cascade genetic testing remains underutilised as a screening approach. Implementation strategies can increase the diffusion of innovations such as genetic medicine into non-genetic specialty settings more rapidly through dissemination networks. This study aimed to evaluate the success of a multifaceted implementation strategy to increase cascade testing for relatives of a person diagnosed with FH using a primary-tertiary shared care model. A multisite effectiveness-implementation hybrid type III pre-post study was conducted between 2022 and 2024 to compare the implementation of a new shared care model for FH cascade testing in NSW, Australia. During the control period, cascade testing of relatives was offered to FH index cases by a genetic counsellor at the lipid clinic. In the implementation strategy period, FH index cases were offered a cascade testing expression of interest form to provide to their relatives. Relatives were contacted by a genetic counsellor and provided with a pre- and post-cascade testing package, which was also provided to their general practitioner. A total of n = 25 index and n = 6 cascade cases were included in the control period and n = 81 index and n = 56 cascade cases in the implementation period. The number of cascade genetic tests per index case increased significantly from 0.24 in the control period to 0.52 in the implementation strategy period (incident rate ratio = 4.62; 95% CI: 0.39, 8.84; p = 0.032). Among relatives tested, there was no difference in the proportion with a confirmed FH gene change per index case (IRR = 2.15; 95% CI: 0.65, 7.01; p = 0.207). There was no difference in the proportion of index cases with at least one cascade test (OR = 1.49; 95% CI: 0.53, 4.19; p = 0.442). Implementation of our model increased FH cascade testing compared to previous standard care. These findings suggest a greater role for cascade testing in primary care settings. This opens new opportunities for integrating genetic screening into routine general practice, particularly for autosomal dominant conditions such as FH.
The prevalence of diabetes in Appalachian Kentucky is among the highest in the United States. Diabetes self-management education and support (DSMES) is a cost-effective, evidence-based intervention that improves patient outcomes yet is underutilized due to multilevel barriers. Throughout 2023-2024, we implemented a 9-month learning collaborative with two regional healthcare systems to increase DSMES referrals and documented their clinical strategies. At study conclusion, we assessed clinical perceptions of each strategy's feasibility, acceptability, appropriateness, as well as likelihood of sustainment of the clinical DSMES referral program. After 6 months of participation and at study conclusion, participants (N = 13) described timing and intended outcomes for activities, which were then mapped to relevant Expert Recommendations for Implementing Change (ERIC) domains. Intended outcomes were coded to Practical, Robust Implementation and Sustainability Model (PRISM) contextual factors and implementation outcomes, and refinements to implementation strategies were documented iteratively throughout the study. At study end, participants (n = 9) individually assessed each strategy's acceptability, appropriateness, and feasibility, as well as its potential for sustainment. Assessments used 5-point unidimensional Likert scales that were summed and averaged, with higher numbers indicating greater favorability. To help facilitate DSMES referrals, clinic learning collaborative participants most frequently employed implementation strategies within the ERIC stakeholder interrelationshipsand supporting clinicians domains. Specific activities included creating a new electronic health record referral system, utilizing morning huddles to identify eligible patients, and creating patient face sheets for providers to review during visits. Strategies were refined minimally, primarily to increase provider and staff participation and patient and provider acceptability of activities. Across all strategies, mean scores for acceptability, appropriateness, and feasibility were mostly high, as was the overall likelihood of sustainment. The process of developing and refining implementation strategies to fit context was associated with positive clinical perceptions of acceptability, appropriateness, feasibility, and sustainability. Systematically documenting strategies along with their intended outcome targets throughout an intervention can help contextualize the dynamic nature of implementation and inform future scale-up.
Few caregiver support interventions have been scaled nationally; thus, gaps remain regarding the optimal level of support needed to successfully adopt caregiver trainings in diverse clinical contexts. We evaluated the effectiveness of two implementation support approaches on implementation outcomes for a family caregiver training (Caregivers FIRST) in partnership with the Veterans Health Administration Caregiver Support Program (CSP). In a hybrid type III effectiveness-implementation trial, we enrolled 25 non-adopter sites six months following the national mandate Caregivers FIRST to compare two different implementation support approaches (foundational support or foundational support with the addition of group external facilitation (enhanced support)). Co-primary site-level penetration outcomes at 12-months were 1) percentage of caregivers attending ≥ 1 class among those with any caregiver referral or enrolled in CSP and 2) number of classes delivered. Secondary outcomes were fidelity and adoption. Fidelity was proportion of expected classes delivered of those promised; adoption was delivering at least one round of classes to 5 or more caregivers. Secondary analysis examined outcomes at six and 18-months separately. We fit generalized linear models to examine differences in outcomes between arms. Survey, interview, and administrative data were used to contextualize findings and assess implementation support costs. Twelve sites were randomized to foundational support and 13 to enhanced support. At 12-months, the estimated mean percentage of qualifying caregivers attending ≥ 1 class was 8.3% and mean number of classes offered was 9.4 for enhanced support and in foundational support were 6.1% and 5.4, respectively. No differences were found by arm at 12-months in mean percentage of caregivers attending a class (mean difference = 2.2%; 95% CI -1.8%,6.1%; p = 0.26) or mean number of classes offered (rate ratio = 1.7; 95% CI 0.9,3.4; p = 0.11). Neither fidelity nor adoption were different by arm at 12-months, and similar patterns were found at additional timepoints. The added cost of delivering enhanced support per site was $3,678 over a one-year period (median foundational =$14,985 vs. enhanced =$18,663). Foundational support allowed most sites (75% foundational, 100% enhanced) to successfully adopt by 18 months. While not reaching a priori benchmarks in magnitude, observed means of implementation outcomes at enhanced support sites were higher at 12 months. This study was registered on April 8, 2022 at ClinicalTrials.gov (identifier NCT05319535). https://clinicaltrials.gov/ct2/show/NCT05319535.
Cervical cancer (CC) is the leading cause of cancer-related mortality in sub-Saharan Africa (SSA), disproportionally affecting women living with HIV. Integration of CC screening and treatment of precancerous lesions into established HIV care systems supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) has resulted in screening of millions of women and treatment of tens of thousands of precancerous lesions. Despite these gains, research has largely focused on patient-level barriers to screening, with limited attention to provider attitudes, organizational climate, and leadership support within PEPFAR-supported HIV clinics. A cross-sectional survey was conducted with 46 clinic staff at seven affiliated faith-based HIV clinics overseen by the Coptic Hope Center for Infectious Diseases in Nairobi County, Kenya. The Coptic Hope Center is funded by PEPFAR through the Centers for Disease Control and Prevention (CDC). Clinic staff completed three validated implementation science instruments: the Evidence-Based Practice Attitude Scale (EBPAS-36), the Implementation Climate Scale (ICS), and the Implementation Leadership Scale (ILS). Total and subscale scores were computed, and Mann-Whitney U tests were conducted to examine associations between staff and clinic characteristics and total scores. Clinic staff reported moderate overall EBPAS-36 scores, median (M) = 3.06 on a 0-4 scale, reflecting positive attitudes towards CC screening implementation. The highest ratings were observed for Feedback, Fit, Openness, and Appeal subscales, indicating both the appeal of current screening methods and openness to novel approaches. ICS (M = 2.36) and ILS (M = 3.62 for staff; 2.71 for supervisors) scores indicated moderate to strong organizational and leadership support, though lower scores on Rewards and Selection for EBP subscales suggest limited institutional incentives. No significant differences were observed by clinic type, staff role and years in position. Staff attitudes, leadership engagement, and organizational climate were broadly supportive of CC screening implementation across PEPFAR-supported clinics in Nairobi, Kenya. As countries in SSA seek to sustain the gains achieved through integrated HIV and CC prevention programs and adapt to evolving donor funding landscapes, preserving positive provider environments is essential to effective service delivery and keeping countries on the path toward CC elimination.
The World Health Organization develops evidence-based recommendations for postpartum hemorrhage (PPH) prevention, detection, and treatment. However, persistently high PPH-related mortality suggests recommendations are poorly implemented, especially in low-resource settings. This study aimed to identify implementation bottlenecks to inform action. Drawing on public policy, implementation science, and health behavior, we constructed a multi-level framework to identify bottlenecks affecting recommendation uptake. This informed the development of a survey assessing which bottlenecks affected specific WHO recommendations. Surveys were completed by global stakeholders and by health care workers in three high-burden countries. We also analyzed direct observations of clinical practice from those countries to see how bottlenecks affected practice. An a priori interpretive threshold of 75% was selected to indicate a bottleneck was not a severe impediment to implementation. Surveys from 102 global stakeholders and 246 health care workers, as well as 2039 direct observations of clinical practice revealed variation in adherence to WHO recommendations, with some through-lines. Oxytocin for PPH prevention and treatment was perceived to have national policy support (> 75% for inclusion in national guidelines and Essential Medicines Lists, regulatory approval, and support from national champions) but other uterotonics were not. Tranexamic acid for PPH treatment was found to be underutilized, likely due to compounding bottlenecks. Respondents reported extensive bottlenecks to refractory PPH interventions (< 75% across nearly all bottlenecks). The most substantial bottlenecks were availability/procurement of medicines and devices, affordability and quality of medicines and devices, presence of job aids, and availability of qualified staff. Observed practice generally aligned with stakeholder perceptions. National policy bottlenecks strongly mediated implementation in clinical practice. Policy change addressing gaps in commodity procurement and availability of trained clinicians is critical. Efforts addressing only one part of the implementation ecosystem are unlikely to drive transformative change.