Shared decision making (SDM) is guideline-recommended for primary prevention of cardiovascular (CV) disease, but there are barriers to routine adoption of tools to promote SDM. This pragmatic trial evaluated the effect of tailored strategies on implementation of an SDM tool (CV Prevention Choice) used during clinical encounters. Fifteen primary care and preventive cardiology sites within three U.S. healthcare systems participated. Outcomes were organized using the RE-AIM evaluation framework and included reach (number, proportion and characteristics of patient encounters), adoption (clinician uptake), implementation (fidelity), and maintenance (sustained use). Effectiveness is not reported here. Data included electronic health record (EHR) encounter data, surveys and interviews with clinicians and administrators, periodic reflections with implementation facilitators, and site visits. Surveys and EHR data were analyzed descriptively. Qualitative data were analyzed using content analysis and the Consolidated Framework for Implementation Research. We explored fidelity by reviewing a sample of video-recorded encounters. Between May 2021 and January 2025, 136 surveys, 38 interviews, 65 periodic reflections, and 6 site visits were completed. CV Prevention Choice was used with 3031 patients. The 76 clinicians (43
Advances in cancer treatment have improved patient survival, but treatment-related toxicities commonly impair patient quality of life and contribute to emergency department visits and hospitalizations. Electronic patient-reported outcomes (ePRO) systems have demonstrated benefits for symptom control, quality of life, and reduced acute healthcare utilization. However, evidence of large-scale implementation within routine oncology care remains limited. We describe a protocol to implement, track adaptations, and evaluate a system-wide ePRO program across 17 diverse oncology settings. This single-arm, phased implementation initiative, supported through the Patient-Centered Outcomes Research Institute (PCORI) Health Systems Implementation Initiative, aims to implement an ePRO program across 17 oncology sites, including an academic medical center and community oncology practices. The project includes a one-year planning phase, two-year implementation period, and a maintenance phase. All adults age 21 + initiating a new non-hormonal systemic cancer treatment will receive weekly symptom surveys via text message and/or email for six months, with a pivot to interactive voice response if three consecutive weeks are not completed. Symptoms identified as warranting clinical attention will be sent to oncology care teams, who will respond within two business days. Evaluation is framed by the Reach, Effectiveness (healthcare utilization with propensity-score-matched controls), Adoption, Implementation, and Maintenance (RE-AIM) Framework. Implementation strategies and adaptations will be documented in a modified FRAME-IS tracker. We will track adaptations in implementation of an Evidence-Based ePRO intervention within a large, mid-Atlantic healthcare system. Anticipated challenges include a pending electronic health record transition, workforce turnover, and sustained engagement among clinical teams. We will give special consideration to implementation strategies to track our implementation decisions and outcomes. Findings will contribute to implementation science by identifying pragmatic strategies for scaling and sustaining ePRO programs in cancer care and may contribute to the broader adoption of symptom monitoring interventions in clinical practice.
Abstract Background Approximately 14.9% of medications prescribed during hospital care in low- and middle-income countries (LMICs) contain errors, with neonates who experience high morbidity and mortality in these settings being particularly vulnerable. Gentamicin, a common first-line antibiotic for treating neonatal infections in LMICs including Kenya, is similarly prone to frequent prescribing errors. Nevertheless, evidence on effective interventions to improve prescribing practices in such contexts remains limited. Objective Our objective was to evaluate a theory-informed, pharmacist-supported audit and feedback (A&F) intervention aimed at improving routine prescribing practices, with an initial focus on reducing gentamicin prescribing errors in neonatal care. Methods We used interrupted time series analysis to model fluctuations in prescribing errors for neonates ≤ 28 days admitted to newborn units (NBU) in 22 hospitals in Kenya between July 2021 to June 2024 and explored intervention effects in a feedback meeting at the end of the study. The study had three phases, pre-intervention period (July 2021 to June 2022), intervention period (July 2022 to June 2023), and post-intervention period (July 2023 to June 2024). The primary study was a standard single-group interrupted time-series study (ITS) design to evaluate the comparative effectiveness of enhanced A&F in reducing prescribing error trends after its introduction in sixteen hospitals. Secondary analysis included comparison to prescribing error outcomes in an additional six hospitals in a contemporaneous comparison group that received basic A&F reports without pharmacist involvement in the NBU prescribing practices. Results Between July 2021 and June 2024, the sixteen hospitals in the primary outcome analysis and the six additional hospitals for the secondary outcome analysis had 36,668 and 8,943 neonates with Gentamicin prescriptions at admission retrospectively. From the incidence rate ratios (IRR) of incorrect prescribing at admission, there was no step change (IRR 1.115, 95% CI: 0.920 to 1.352, p-value = 0.265) or trend change (IRR 1.014, 95% CI: 0.986 to 1.042, p-value = 0.344) due to the enhanced pharmacist-supported A&F intervention in the sixteen hospitals in the primary study. From the secondary study, change in the trend post-intervention in the sixteen primary study hospitals in the primary study relative to the six hospitals acting as a contemporaneous comparison group was positive (IRR 0.933, 95% CI: 0.878 to 0.985, p-value = 0.014), despite no step change due to the enhanced A&F intervention. Conclusion We found no statistically significant effect of the team-based pharmacist-supported A&F intervention on reducing gentamicin medication errors in neonatal care. Prescribing errors during intervention and post-intervention periods were increasing across all hospitals in both arms of the study during and post-intervention periods. However, relative to comparison hospitals sites receiving routine feedback but without pharmacist involvement or pharmacist-supported CMEs, the primary study sites had a positive trend in reducing Gentamicin prescription error rates at admission during and post-introduction of the pharmacist-supported A&F intervention. Trial registration PACTR , PACTR202203869312307. Registered 17th March 2022, https://pactr.samrc.ac.za/Search.aspx?TrialID=PACTR202203869312307 .
Variations in implementation success across sites are common when introducing complex health interventions; however, such variations are rarely examined systematically, particularly for family-focused interventions in intensive care units (ICUs). As part of a clinical trial, a nurse-led, multicomponent family support intervention (FSI) was implemented in eight Swiss ICUs using a tailored implementation approach. Understanding site-specific differences and contextual determinants that influence implementation success is essential to inform future scale-up and sustainability of the FSI across diverse ICU settings. A Matrixed Multiple Case Study (MMCS) design was used to examine multilevel implementation determinants across ICUs with 228 ICU staff members. Implementation success was assessed using three global items from the Normalization Measure Development questionnaire (Global-NoMAD). Data were collected at four time points over an 25-month period (03/2022–04/2024). Prior to the implementation, a contextual analysis assessed baseline determinants (T0). During active implementation, a process evaluation examined implementation progress (T1–T2), followed by a summative evaluation to assess overall implementation success (T3). MMCS steps 1–4 were conducted retrospectively to define the research focus, identify key determinants, and prepare site-specific data, while steps 5–9 were applied prospectively to construct the cross-case matrix, compare implementation patterns and to identify contextual and phase-related configurations. Implementation success ranged from 60 to 80
Active surveillance (AS) offers an option for managing low- and favorable intermediate-risk prostate cancer without unwanted, deleterious urinary and sexual side effects commonly seen with curative treatment options. However, the adoption of AS remains deficient in community urological practice and its quality is not always optimal. We aimed to understand the factors that influence urologists’ perceptions of using AS, including their use of confirmatory testing, an important initial step in providing high quality AS. We conducted a qualitative sub-study using semi-structured interviews with 14 urologists and five practice managers from the Michigan Urological Surgery Improvement Collaborative and the Pennsylvania Urology Regional Collaborative. Interviews were guided by the Tailored Implementation for Chronic Diseases (TICD) framework. We analyzed narrative data using a rapid analytic approach and identified barriers and facilitators by TICD domains. Three facilitators and two barriers were identified. Facilitators included strong urologist support for AS, perceptions of adequate reimbursement for AS, and adherence to confirmatory testing guideline recommendations. Barriers included challenges with patient understanding of AS as an important option in low- and favorable intermediate-risk prostate cancer and difficulty in obtaining insurance reimbursement for confirmatory testing. Urologists generally described support and use of AS for men with low- and favorable intermediate-risk prostate cancer. However, to increase the adoption of high quality AS, it will be crucial to address identified barriers. Next steps include designing implementation strategies, based on the barriers and facilitators identified, and planning for implementation.
Polygenic risk scores (PRS) have emerged as a promising tool for assessing the genetic risk of complex diseases. However, the lack of standardized workflows to guide multidisciplinary teams in deploying PRS analyses poses a barrier to their clinical adoption. In addition, persistent methodological, technical, and knowledge barriers must be addressed. Bridging this research–practice gap therefore requires explicit modeling of current PRS implementation processes, but also modeling idealized workflows that incorporate mitigations for existing barriers. Following a Business Process Model and Notation (BPMN) lifecycle approach, our methodology proceeds in two stages: characterizing current practices and defining a future, improved state. First, we conduct a targeted literature search and thematic synthesis of articles describing PRS analysis implementation examples, extracting procedural information and translating it into an AS-IS diagram representing current practices. Second, building on prior research on barriers to translating PRSs into clinical practice, we derive an idealized OUGHT-TO-BE diagram incorporating literature-informed process improvements, accompanied by an actionable checklist to guide organizations in developing intermediate, context-specific TO-BE workflows. Of approximately one hundred screened articles, only four provided sufficient procedural detail. The thematic synthesis resulted in 49 actions, 18 tasks and three core sub-processes: creation, validation and execution of a PRS analysis pipeline. This formed the basis of the AS-IS diagram, which formalizes tasks, stakeholder roles, and data flows. The OUGHT-TO-BE diagram addresses the identified barriers with targeted process improvements, introducing 17 modifications. The accompanying 27-item checklist operationalizes these improvements, providing actionable guidance for transitioning toward intermediate TO-BE workflows. In this work we standardized current practices and proposed structured pathways for improvement, providing a foundational roadmap for integrating PRS analyses into clinical practice. The BPMN diagrams together with the actionable checklist allow for implementation and iterative improvement of workflows, aligning with specific purposes of implementation science frameworks.
Cervical cancer disproportionately affects vulnerable women due to their low participation in cervical screening. Tailored strategies were co-designed to address context-specific barriers to screening participation among vulnerable women in Estonia, Portugal, and Romania using principles of implementation research. This descriptive study applied the Integrative Systems Praxis for Implementation Research (INSPIRE) framework, a four-phase dynamic learning process designated to promote the adoption of evidence-based interventions to improve participation in cervical screening, within the CBIG-SCREEN project. It focuses on how Phases I and II of the framework, which involved conducting a scoping review of barriers and facilitators to screening participation, engaging in discussions with local stakeholders, and performing a structured capacity assessment of cervical cancer screening in the three countries, led to the co-designing of context-specific strategies for implementation in Phase III. Crucial barriers identified in Phase I included stigma, ineffective communication and invitations, appointment scheduling problems, transport challenges for women in remote areas, and time constraints, affecting both screening and follow up. Through deliberative dialogues with stakeholders (in Phase II) and focusing on the barriers and leverage points we co-designed strategies for each intervention country to be implemented and evaluated in Phase III. The strategies that were co-designed and prioritized by stakeholders included using clearer, more easily understandable language in invitations and educational materials (in Estonia and Portugal), sending prepaid HPV self-sampling kits to women’s homes (in Estonia and Portugal), and improving communication methods (in Estonia). Other strategies were supporting patient navigation, such as offering a helpline or support service for scheduling appointments and addressing concerns that may arise along the screening pathway (in Portugal), and innovative solutions for ensuring access to self-collection kits through pharmacies (in Romania). These strategies were incorporated in a country-specific protocol for implementation and evaluation in Phase III. The INSPIRE approach has facilitated the workflow designing and planning implementation strategies for the three intervention countries. The strategies have been implemented and evaluation is ongoing and will be reported in our future communications. Phases I, II and III (partially completed) results highlight the value of implementation science in understanding barriers to cervical cancer screening and selecting tailored strategies to address them in close collaboration with stakeholders.
Implementation science has developed sophisticated frameworks for studying how evidence-based practices succeed or fail in real-world settings. However, the direction of knowledge flow has remained largely unchanged: frameworks are delivered to practitioners as tools for understanding their context, while the knowledge practitioners generate through their daily work has no systematic methods for entering the science. This paper argues that the field’s primary challenge is not accessibility but knowledge generation: not how to make implementation science more usable for practitioners, but how to treat what practitioners already know as a primary scientific input. This paper introduces Practice-Driven Implementation Science (PDIS), a complementary model for how the field generates and formalizes implementation knowledge, one that extends existing participatory and practice-based traditions rather than displacing them. PDIS is not an argument against frameworks. It is an argument about sequencing. In a practice-driven approach, frameworks arrive second, as naming tools applied to knowledge that practitioners have already generated. The starting point is not what the framework says about the context. Rather, it is what the context tells us that the framework does not yet know. PDIS is operationalized through five steps: Surface, Name, Align, Test, and Embed Equity. Equity is not a final check, but a question returned to at every step. The model also introduces the epistemic broker, a person or structured function that carries practitioner knowledge into the science and bears the labor of formalizing it, so that entering the scientific record does not depend on a practitioner’s capacity to produce research. The steps are recursive rather than linear and can be entered at any point in the implementation process. Two illustrative applications show how PDIS operates across contexts: state-funded tobacco-free initiatives training with 55 community and health systems practitioners, and a sustained community health center research partnership that is now in its sixth year. Together, they show that PDIS is not a training design philosophy but an orientation toward implementation science work across settings. The paper concludes with implications for research, training, funders, and public health departments and calls for the development of systematic methods for eliciting, naming, and formalizing practitioner-generated implementation strategies.
Implementation science has long emphasised interactive strategies in advancing knowledge translation in healthcare organisations. Various types of meetings, for example, are widely used to share information and align professionals’ views with recommendations. Yet there is limited empirical understanding of how translation of evidence is accomplished in such settings at the level of social interaction. This study addresses the gap by analysing how updated clinical practice guidelines (CPGs) were negotiated in Finnish primary care meetings. A video-based microethnographic approach was employed to examine eight routine meetings (4–43 participants) across five Finnish primary care organisations, where recently updated national CPGs were discussed. The dataset comprised video recordings of routine organisational meetings (not researcher-initiated), supported by ethnographic background data. Analytic tools from Conversation Analysis were applied to identify recurring interactional activities through which recommendations were translated. We identified four recurring interactional activities through which healthcare professionals collaboratively worked to translate CPGs into local practices: (1) identifying revisions, (2) assessing those revisions, (3) negotiating their meaning, and (4) adapting them to the local context. Through these activities, professionals build shared understanding of revisions and their implications to local practice. However, difficulties in these activities often resulted in stalled translation work. The findings illustrate how routine interactions shape the emergence of local applications of guidelines, and how difficulties observable at the level of interaction may contribute to unwarranted outcomes, such as practice variation. The study demonstrates how guideline translation is accomplished through situated interactional activities in routine healthcare meetings. By making micro-level interactional processes visible, it provides insights into features of meeting interaction that may support or hinder the translation of guidelines into local practice. Methodologically, the study highlights the value of combining video-recorded data from naturally occurring institutional settings with EM/CA-informed microanalytic methods to examine the often implicit layer of interaction through which implementation efforts are accomplished in practice.
Understanding and managing intervention adaptations during implementation is critical to maintaining fidelity to evidence while improving intervention fit in context. Implementation science faces a challenge in creating pragmatic methods to track and guide adaptations during implementations. In this study we demonstrate a pragmatic intervention documentation and tracking tool: the intervention menu. This tool allowed practice facilitators to track adaptations throughout implementation, and we collected and analyzed additional qualitative meeting data to characterize relationships between adaptations and context. We conducted a qualitative descriptive study embedded within an EvidenceNOW cluster randomized hybrid implementation-effectiveness trial (NCT05664451). Data were collected from facilitated implementation meetings with clinicians and staff from 15 primary care clinics. Practice facilitators completed intervention menus after each meeting to document interventions and adaptations over time. Analysis proceeded in three stages. First, we identified intervention adaptations by comparing intervention menu entries across implementation timepoints. Second, guided by the Consolidated Framework for Implementation Research (CFIR) 2.0, we used deductive content analysis of mid-implementation meeting transcripts to identify contextual determinants relevant to adaptations. Third, we used inductive code mapping to integrate adaptation and contextual determinant data and characterize relationships between context and intervention adaptations. We identified two types of contextual influences on adaptations: (1) context drives adaptations and (2) context shapes the process of adaptation. The first captures how contextual factors (e.g., clinical workflows, patient population, information technology limitations) initially motivated, necessitated, or blocked specific adaptations. The second type captured how context continuously shaped the process of adapting interventions, influencing iterative refinements and maintenance of adaptations. Further, we demonstrated the utility of intervention menus, capturing 52 intervention adaptations total across 15 participating clinics. This study identified two distinct types of relationships between adaptations and contextual determinants of implementation, using intervention menus as a pragmatic tool for intervention adaptation tracking. The themes identified in this study capture relationships between context and adaptations, going beyond initial drivers of adaptations to characterize how context continually influences adaptation processes. This work underscores the value of integrating diverse data sources to understand adaptations during implementation. Future studies will continue to evaluate the dynamic and complex relationships between context and adaptations.
A typology of approaches used by external agencies to evaluate the sustainment of evidence-based intervention/initiatives (EBIs) was recently proposed. As the typology was initially developed by a single research group, further refinement was warranted to ensure its validity. Drawing on expert insights and real-world examples of program sustainment, this study aimed to: (1) refine the typology and (2) identify key research efforts to improve its utility and application. We used a multi-method design with a purposeful sample of international experts in public health and implementation science. Qualitative data from a one-day workshop were synthesized using rapid analysis. A proof-of-concept case study analysis was conducted with 22 health EBIs described in peer review papers, independently classified by typology approach. Final typology revisions combined insights from both analyses. A three-round modified Delphi technique was used to identify research priorities aligned with the typology to advance sustainment research. Seventeen experts across three countries participated and agreed that the approaches in the initial typology ‘Self-Sustainment’, ‘Static Sustainment’, and ‘Dynamic Sustainment’ reflected practice. Three refinements were recommended: (1) Characterise external sustainment support as a continuum (static to dynamic) to capture the complexity of sustaining EBIs in real-world settings; (2) reflect the temporal nature of support by grounding classifications to a ‘defined period of time’; and (3) clarify typology language to improve usability. The revised typology now includes: ‘Independent Sustainment’ where no active external support is provided to sustain the EBI; ‘Static Sustainment’ where fixed (static) active external support is provided; and ‘Dynamic Sustainment’ where active external support adapts over time in response to changes. The highest priority research needs to advance typology were: trials that test the effectiveness of sustainment approaches (mean = 8.6 SD = 0.7), mapping and case study analysis to explore typology transferability (mean = 8.2, SD = 1.1), and practitioner feedback to assess typology utility (mean = 7.2 SD = 1.1). This study provides a refined and more transferable typology of approaches external agencies use to support EBIs to sustain. Selecting an approach early can guide agencies to plan for the lifecycle of an EBI and may improve the likelihood it continues in practice.
South Korea faces a growing population of homebound older adults, yet structured home-based primary care (HBPC) infrastructure remains underdeveloped. Although Korean medicine (KM) doctors participate in the government-led long-term care home medical center pilot, evidence on their systematic integration into interprofessional teams remains limited. This study aims to evaluate preliminary clinical signals and implementation outcomes of a KM-based interprofessional collaborative care model. This protocol describes a type 2 hybrid effectiveness–implementation study using a single-group pre–post design. The study will be conducted at a social cooperative in Daejeon, Republic of Korea, evaluating an innovation codesigned with local stakeholders. The model uses a dual-team structure: a core team (KM doctor, nurse, social worker) provides routine care through seven standardized pathways adapted from the WHO Integrated Care for Older People guidelines, while an extended team (medical doctor and allied health professionals) addresses complex needs via standardized closed-loop referrals. The target sample includes 100 homebound innovation recipients and all eligible innovation deliverers. The primary clinical outcome is the change in systolic blood pressure from baseline to 4-month follow-up; secondary clinical indicators include diastolic blood pressure, random blood glucose, and glycated hemoglobin (HbA1c), among others. Implementation outcomes will be evaluated using the RE-AIM framework, with the primary implementation outcome being collaboration execution, defined as the proportion of completed collaborative referrals and replies among identified collaboration needs in recipients requiring collaboration. A mixed-methods approach will be used: quantitative analyses will assess pre–post changes in clinical and implementation indicators, and qualitative analyses of focus group interviews and field logs will examine implementation determinants and adaptations using CFIR-informed directed content analysis. Findings will be integrated using a joint display matrix. This study will generate practice-relevant evidence on optimizing bidirectional collaboration between KM and medical services in HBPC. By clarifying role delineation and referral mechanisms, the findings will inform refinement and potential scale-up of integrated HBPC models for frail, homebound older adults. Clinical Research Information Service (KCT0011285; registered December 9, 2025; URL: https://cris.nih.go.kr/cris/search/detailSearch.do?seq=31890
Up to 4 in 5 adults seeking treatment for substance use disorders (SUDs) have sustained at least one traumatic brain injury (TBI) in their lifetime. TBIs can lead to cognitive impairments that can affect a person’s perceptions of their ability to attain goals, diminish self-efficacy, and reduce cognitive engagement in SUD treatment. Although screening for and accommodating the effects of TBI are widely recognized in the brain injury research and practice community, these interventions are not widely adopted in SUD treatment organizations. This study protocol describes a hybrid type 2 effectiveness-implementation pilot trial designed to investigate the effectiveness and implementation of the novel TBI-RECOVER intervention model (i.e., TBI screening, cognitive/behavioral challenges screening, and cognitive compensatory strategies) in a hospital-based outpatient SUD treatment program. Guided by the Theory of Implementation Effectiveness and Organizational Learning Theory, we will investigate multilevel mechanisms associated with the provider-focused implementation strategies on implementation outcomes, as well as intervention mechanisms associated with TBI-RECOVER on patient treatment outcomes. Aim 1 will evaluate the effectiveness of provider-focused implementation strategies (e.g., training/education, champions, external facilitation, and audit and feedback) on the adoption, reach, implementation fidelity, and maintenance of TBI-RECOVER. Hypothesized implementation strategy mechanisms are provider/facilitator working alliance, provider self-efficacy, implementation readiness, leadership support, and implementation climate. Aim 2 will enroll up to 300 patients in the Control/Pre-Implementation Phase to receive TBI screening and education, 300 patients in the Treatment/Implementation Phase to receive the TBI-RECOVER intervention, and 300 patients in the Sustainment Phase to receive TBI-RECOVER. Primary treatment effectiveness outcomes are treatment retention and symptom reduction. Hypothesized treatment mechanisms are patient self-efficacy, cognitive engagement, and treatment satisfaction. Aim 3 will qualitatively assess patient and provider acceptability and satisfaction with the TBI-RECOVER intervention, and provider perceptions of the utility of the implementation strategies in supporting implementation and sustainment of TBI-RECOVER. This pilot trial contributes to the implementation literature by examining potential multilevel mechanisms of provider-focused implementation strategies on implementation outcomes, as well as mechanisms through which TBI-RECOVER may improve patient treatment outcomes. Results will inform a subsequent multiphase optimization strategy to scale out TBI-RECOVER in a future cluster randomized controlled trial. Clinicaltrials.gov NCT07215221, registered October 9, 2025.
Theories, models, and frameworks (TMFs) are frequently used to facilitate rigorous qualitative data collection and analysis of context in dissemination and implementation (D I) science. The Practical, Robust Implementation and Sustainability Model (PRISM), which includes contextual determinants of Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) dimensions, is one of the most widely used TMFs. Yet, missing from the literature is an assessment of how PRISM can inform the collection of qualitative data across implementation phases (i.e., pre-implementation, implementation, and post-implementation). The purpose of this study was to curate a collection of PRISM-informed qualitative data collection guides and assess how questions relate to PRISM domains and RE-AIM dimensions. In this retrospective observational study, exemplar interview and focus group guides were collected from a group of D I science experts to assess how PRISM constructs were operationalized. All guides were compiled into a database, and each question and sub-question were labelled with one or more relevant PRISM domains and RE-AIM dimensions. We calculated descriptive characteristics of all interview guides included in the database. The frequency of each PRISM domain was calculated across all interview guides, by implementation phase and by participant role. Guides (n=31) were collected from 13 research studies and were primarily used in individual interviews (n=30) and across pre-implementation (n=8), implementation (n=8), and post-implementation (n=15) phases. Research settings included the Veterans Health Administration (n=16), community health settings (n=10), schools (n=4), and an academic health center (n=1). Questions and sub-questions were more commonly labelled with PRISM domains (n=667) than RE-AIM dimensions (n=303). The Perspectives of Implementers (n=201), Perspectives of Recipients (n=152) and Implementation and Sustainability Infrastructure (n=103) were the most frequently used PRISM domains and Implementation (n=113) was the most frequent RE-AIM dimension. Our findings demonstrate that PRISM has valuable applications in qualitative data collection with recipients and implementers across all implementation phases and highlights how PRISM can be adapted for different topics and settings. The database of qualitative guides is publicly available and can be used as a resource for D I investigators using PRISM to guide their qualitative contextual assessment.
Human papillomavirus (HPV) self-sampling can increase screening uptake among women not engaged in clinic-based screening, but evidence remains limited on how implementation strategies can be developed and integrated into routine screening workflows in low-resource rural settings. We aimed to develop and specify implementation strategies for integrating HPV self-sampling into a rural screening system using a rapid stakeholder-engaged application of the Implementation Research Logic Model (IRLM). We conducted a pre-implementation study in two rural counties of China. The existing organized cervical cancer screening program provided clinic-based, clinician-collected screening. The planned intervention was a “mobilization plus self-sampling option”, in which village doctors would offer HPV self-sampling to hard-to-reach women who declined the routine screening. Using the IRLM, we organized determinants, implementation strategies, hypothesized mechanisms, and planned outcomes along a prospective pathway. Stakeholder interviews were guided by the Consolidated Framework for Implementation Research (CFIR). Barriers were matched to candidate strategies through the CFIR-ERIC (Expert Recommendations for Implementing Change) matching tool. In a co-design workshop, stakeholders prioritized strategies by discussion and dot voting, specified them using Proctor’s categories, and linked them to hypothesized mechanisms. Outcomes were organized using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A pilot pretest checked the intervention delivery workflow and data capture procedures. The study was conducted from March 23 to April 21, 2025, covering 26 activity days and 331.6 person-hours. CFIR-based interviews included 43 stakeholders, 25 of whom joined the co-design workshop. Three major barriers were identified: insufficient legitimacy of village doctor-led mobilization, gaps between initial agreement and correct self-sampling completion, and poor alignment between the self-sampling workflow and existing service responsibilities and incentives. CFIR-ERIC matching generated 46 candidate strategies; nine received at least 60
Abstract Background During 2024 and 2025, an adapted version of the World Health Organization’s Labour Care Guide was implemented in approximately half of Sweden’s labor wards within the PICRINO trial. Organizational readiness is widely regarded as a key determinant of successful implementation, however, empirical evidence linking organizational readiness to implementation outcomes remain limited. This study aimed to examine the association between organizational readiness for implementing the Labour Care Guide in Sweden and implementation fidelity, to explore variations in readiness and fidelity across organizational and individual factors and to assess changes in fidelity over time. Methods The study included the implementation of the Labour Care Guide at ten labor wards in Sweden. Organizational readiness was measured among health care staff ( n = 282) using the E-Ready 2.0 questionnaire before implementation was launched. Fidelity was assessed by analyzing degree of documentation within the Labour Care Guide tool at 3, 6, and 9 months ( n = 750). A coding protocol including all seven sections of the tool, in which two sections were considered core components, was used to systematically analyze fidelity. Fidelity was then compared between wards with the aggregated highest, intermediate, and lowest levels of readiness at ward level. Results The three wards reporting the aggregated highest levels of organizational readiness also demonstrated the highest implementation fidelity, while the three wards with the lowest reported aggregated readiness showed the lowest fidelity. In addition, staff at smaller labor wards reported greater readiness than staff at larger wards, and readiness was higher in non-university hospitals compared with university hospitals. Physicians reported higher readiness than midwives. Overall fidelity to the Labour Care Guide declined over time, however, this trend was not observed among core components. Conclusions This study provides empirical support for an association between organizational readiness and implementation fidelity when introducing the Labour Care Guide in Sweden. Fidelity to core components remained stable, suggesting that essential elements were more resilient to implementation challenges. Findings highlight the importance of assessing and strengthening organizational readiness prior to implementation and of providing sustained support over time to maintain fidelity, particularly for non-core components. Trial registration www.clinicaltrials.gov NCT05560802, 2022-09-17.
Multiple U.S. states have recently enacted laws enabling pharmacists to independently prescribe HIV pre-exposure prophylaxis (PrEP). These laws differ by state with different combinations of legal conditions, restrictions, and enablers. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, we conducted a real-world implementation evaluation to assess state adoption, pharmacist adoption, and patient reach of pharmacist-prescribed PrEP in the United States. We developed and applied a legal epidemiological coding framework to assess state adoption by characterizing pharmacist PrEP prescribing laws across 14 purposively sampled states, generating a longitudinal dataset describing monthly law status from January 2020 through April 2024. To measure pharmacist adoption and patient reach, we obtained anonymized PrEP prescription claims from IQVIA (2020–2023) and classified prescriptions as pharmacist-prescribed or not based on the prescriber’s primary taxonomy data from the Centers for Medicare and Medicaid Services National Plan and Provider Enumeration System National Provider Identifier Registry. Ten of the 14 states permitted pharmacists to use non-patient-specific collaborative practice agreements that could support PrEP prescribing. Ten states required pharmacists to complete PrEP-specific training, six imposed limits on the number of days for which pharmacists could prescribe PrEP, and eight states required private health plans to cover pharmacist-prescribed PrEP. From 2020 to 2023, approximately 88
Sustainability is a key focus in implementation science given the global challenge of ensuring evidence-based practices (EBPs) deliver long-term benefits across community, public health, and clinical settings. We conducted a portfolio analysis of NCI-funded implementation science grants to describe the characteristics of funded applications that proposed to study the sustainability of cancer control EBPs and identify opportunities to advance the field. A systematic search using the National Institutes of Health (NIH) Query View Report tool identified NCI-funded implementation science grants with sustainability-focused aims awarded between fiscal years 2017 and 2023. Two coders independently reviewed full grant application materials to determine eligibility and extract information using a structured codebook developed, pilot-tested, and iteratively revised prior to full coding. Variables captured study objectives, proposed designs, sustainability measurement approaches, outcomes, implementation strategies, how sustainability was defined, and theories, models, or frameworks proposed. Of 351 implementation science grants identified through the search strategy, 72 included at least one sustainability-focused aim and were included in the analysis. Most funded applications (n = 58, 81
Despite the availability of evidence-based clinical guidelines for type 2 diabetes mellitus (T2DM), their implementation in primary healthcare remains inconsistent across low- and middle-income countries (LMICs), particularly in Sub-Saharan Africa (SSA) and Southeast Asia (SEA). Implementation efforts frequently fail to account for the structural realities of health systems, resulting in limited sustainability and suboptimal patient outcomes. To develop an empirically grounded taxonomy of implementation strategies for T2DM care in the SSA and SEA countries represented in this review, and to propose a design-oriented conceptual framework, Systems Congruence complementing existing diagnostic frameworks (CFIR, PARIHS) by specifying structural alignment principles for resource-constrained healthcare settings. Following PRISMA 2020 guidelines, we systematically searched PubMed, Embase, CINAHL, Scopus, and Google Scholar for studies published between 2000 and 2024. Eligible studies reported implementation strategies for T2DM guidelines in primary healthcare settings in SSA or SEA. Data were extracted and study quality was appraised using Cochrane RoB 2, ROBINS-I, and MMAT tools. An inductive thematic synthesis was conducted to construct an implementation strategy taxonomy and derived an explanatory conceptual framework. Twenty-one studies from SSA and SEA (n = 14,281 participants) met the inclusion criteria. Nine distinct categories of implementation strategies were identified, including educational interventions, task-shifting, digital health, and culturally integrated approaches. Strategies demonstrating Systems Congruence, defined as intentional alignment with workforce capacity, the resource ecosystem, and patient context, were associated with substantial retention and adherence, reaching up to 94–100
