Implementation science communications最新文献

Background: Incarcerated individuals have high rates of chronic disease, which will likely increase as the prison population ages. Despite this, prison healthcare services primarily focus on infectious diseases, mental illness, and substance abuse, largely neglecting chronic physical health conditions. The Chronic Disease Self-Management Program (CDSMP) is an evidence-based program that supports self-management for people with chronic illnesses. Although numerous pilot studies of CDSMP have been conducted in correctional settings, there has been little research into efficient and effective strategies for scaling up the intervention within state corrections systems. The purpose of this project is to evaluate and develop an implementation approach to maximize the scalability of CDSMP among older adults in state correctional systems.

Methods: Guided by the Scaling up Management Framework, we will use a mixed-methods approach to assess scalability, utilizing both quantitative survey data and qualitative interviews. Study participants will include external agency leaders (n = 20), prison staff (n = 20), and incarcerated individuals (n = 20) who have been involved in CDSMP implementation within a U.S. state prison system. Data from this study will be used to develop a scale-up manual to be tested in a subsequent randomized trial. This study does not meet the World Health Organization (WHO) definition of a clinical trial.

Discussion: As the prison population continues to age, the burden of chronic disease within correctional systems will continue to increase, which contributes to skyrocketing correctional costs. Understanding how to expand evidence-based chronic disease programs within correctional systems is crucial for reducing disease-related morbidity and mortality among incarcerated individuals and for reducing costs. This line of research will identify and test scale-up strategies for chronic disease management in prisons.

Background: The field of implementation research has recently seen much interest in equity, with a strong emphasis on recognising and responding to disparities in care. Recent studies highlight the role of macro-level processes that translate meso-level institutional behaviours to micro-level healthcare practices, and that are generative of health and care inequities. They emphasise challenges patient-centredness and underscore the need for justice-oriented intervention design to address disparities and promote equitable care.

Aim: To develop a patient-centred and justice-informed approach to the design of complex healthcare interventions and innovations in service delivery.

Method: Patient-centred Equity Design was developed in five stages. Sociological, public health, and implementation science theories explaining the generation of modifiable inequities were identified, and relevant explanatory constructs were extracted from them and organised into a determinant framework. Framework elements were then translated into (a) process models characterizing causal mechanisms of systemic inequities; (b) generative principles to guide equity- and patient-centred interventions and services; and (c) critical design questions to appraise the ways that inequities are embedded in healthcare interventions and services.

Results: Development work led to a determinant framework linking macro-level processes to meso- and micro-level healthcare inequities, and these were visualized in process models. The framework informed principles for the promotion of equitable, patient-centred interventions: fostering civility and dependability, ensuring clarity and continuity, and reducing workload and complexity. Four critical questions address relational inequalities, participation barriers, role expectations, and restitution for inequities. These were translated into proposed content for a simple appraisal tool to support the equitable design and evaluation of healthcare interventions and services.

Conclusion: Patient-centred Equity Design integrates sociology, social justice, and implementation science to create equity-focused healthcare interventions. It offers a determinant framework, process models, generative principles, and critical questions to guide design. While not a validated tool, it enhances intervention development and service delivery, with potential for future Medical Research Council Framework integration. Patient- centred Equity Design provides actionable generative design principles to centre patient and caregiver experiences within intervention development, emphasizing restitution for inequities.

Background: Integrating mental health services into primary health care (PHC) in low- and middle-income countries (LMICs) is a complex systems-change challenge that requires robust, contextually adapted frameworks. The Mental Health in Primary Care (MeHPriC) initiative in Lagos, Nigeria, aimed to scale up Mental Health Gap Action Programme (mhGAP) based task-sharing for depression, psychosis, and epilepsy. To guide this complex intervention, a participatory Theory of Change (ToC) approach was adopted as a planning, implementation, and governance tool.

Methods: Using a participatory action research design guided by the Consolidated Framework for Implementation Research (CFIR), the MeHPriC ToC was co-created over an 18-month period (2013-2014). The process involved three structured workshops, 36 stakeholder-specific consultations, and four technical working groups with over 150 participants from government, health facilities, and communities. A Community Knowledge, Attitudes, and Practices survey assessed community-level changes in mental health literacy and stigma. A mixed-methods evaluation was conducted (2014-2017) to assess implementation and clinical outcomes using the ToC as an analytical framework, with operational definitions established for key indicators.

Results: The participatory process produced a comprehensive, co-owned ToC map detailing causal pathways, assumptions, and indicators across community, facility, administrative, and state levels. Implementation outcomes included training 320 PHC workers, achieving 69.1% practice adoption and 79.6% fidelity to core protocols. This resulted in a 58.7% increase in mental health consultations and a 60.3% clinical recovery rate for depression. Community stigma remained at 20% post-intervention. A systematic analysis of implementation barriers and facilitators through CFIR domains showed distinct patterns within each domain, such as the need for cultural adaptations, involvement of religious leaders, and the use of hybrid supervision models. Key policy wins included integration of mental health indicators into the state Health Management Information System and establishment of dedicated budget lines for supervision.

Conclusion: A participatory and empirically-refined ToC approach can serve as an effective governance and implementation framework for complex health system interventions in LMIC settings. The MeHPriC experience demonstrates that this methodology guides implementation to achieve positive clinical outcomes while fostering stakeholder alignment necessary for policy integration and long-term sustainability.

Nilsen et al.'s (Implement Sci Commun 6:90, 2025) proposal to distinguish between implementation efficacy and effectiveness, and to situate implementation studies along a continuum from ideal to real-world conditions, offers a valuable conceptual advance. In this commentary, we acknowledge the contribution of their debate while highlighting potential limitations of applying a single-axis continuum to a field heavily characterized by contextual complexity. Drawing from decades of healthcare quality improvement, we argue that implementation interventions often blend efficacy-like and effectiveness-like elements, making neat classification difficult. We further suggest that oversimplification risks obscuring the realities of organizational change. Instead, we propose a double-axis model that considers both the implementation intervention and the context in which it unfolds. Economic evaluation likewise requires nuanced approaches that go beyond their proposed continuum indicator tool ("Implementation PRECIS"). To constructively extend Nilsen et al.'s contribution, we advocate for integration of the tool with existing approaches to evaluation, co-production with stakeholders, and empirical validation across diverse settings. While no implementation endeavor is ideal, advancing discourse around how efficacy and effectiveness are conceptualized can support more pragmatic, context-responsive, and sustainable improvements in healthcare.

Introduction: Out-of-hospital cardiac arrest (OHCA) poses a critical public health challenge globally, with survival rates in China being significantly lower than that in high-income countries. Delayed emergency response, low bystander Cardio Pulmonary Resuscitation (CPR) rates, and limited AED accessibility contribute to poor outcomes. Leveraging smart technology to mobilize trained volunteers via mobile applications has emerged as a promising strategy to bridge these gaps. However, in urban contexts within China, there remains a scarcity of implementation evidence encompassing aspects such as adoption, contextual barriers, and sustainability. This shortage of evidence hinders the integration of policies and systems at the policy and system levels. This study aims to improve the survival rates of OHCA patients in China, by designing, implementing and evaluating the effectiveness of an optimized "Interconnected First-Aid App" dispatching EMS volunteers through a stepped-wedge cluster randomized trial.

Methods and analysis: A stepped-wedge cluster randomized controlled trial will be conducted in 24 streets/townships across three districts in Shaoguan, China. The 24 streets/townships will be randomly assigned to four clusters, and each cluster will receive staggered interventions over 18 months, including volunteer recruitment/training, app-AED-EMS integration, and community education step by step. The trial adopts the PEDALS framework (Problem, Evidence-based Practice, Determinants, Action, Long-term, Scale) to assess both implementation processes and clinical outcomes. Primary outcomes include survival rates, bystander CPR/AED utilization, and response times. Implementation outcomes will evaluate adoption, feasibility, and sustainability through surveys, interviews, and health system data analysis. Findings will inform scalable, context-adapted implementation strategies for community-based OHCA response, particularly leveraging digital health innovations to address inequities in emergency care access in low- and middle-income settings.

Ethics and dissemination: This protocol was approved by the Biomedical Research Ethics Committee of Peking University First Hospital (2025R0017-0001). Findings will be disseminated through traditional academic pathways, including peer-reviewed publications and conference presentations, with policy briefings prepared for stakeholders and leaders at the local, provincial and national levels.

Trial registration: The study is registered with the Chinese Clinical Trial Registry under the ID ChiCTR2500101187, registered on April 21, 2025.

Background: Community-clinical linkage models (CCLM) display significant potential to address the unique, multi-level type 2 diabetes risk factors facing minoritized communities, such as South Asian Americans. However, there lacks a systematic, longitudinal evaluation of how such tailored CCLMs can be better implemented in dynamic, real-world settings. This study aims to leverage multi-partner insights, collected in real time, to explore the barriers and facilitators to implement a South Asian American diabetes management and prevention intervention (the DREAM intervention).

Methods: The DREAM intervention, a two-arm randomized controlled trial, was implemented from 2019-2022; partners involved in its implementation were interviewed annually to understand their experiences of the program. Implementation partners included community health workers (CHWs), participating healthcare providers, community advisory board (CAB) partners, and research staff. The interview guide and subsequent deductive qualitative analysis was informed by the Consolidated Framework for Implementation Research (CFIR).

Results: Overall, 78 interviews were conducted across four waves (2019-2022) with 5 research staff, 8 CHWs, 18 providers/clinic staff, and 12 CAB partners. CHWs adapted intervention characteristics by tailoring curriculum and implementation to patient needs, including personalized goal setting and shifting to remote delivery with COVID-19-related content. At the individual level, participants' occupations, family dynamics, and technological capacity shaped engagement, while changing social, financial, and health contexts over time required CHWs to continually adjust support. Within the inner setting, partner roles and resource availability fluctuated, yet structured and consistent meetings facilitated communication and problem-solving. Outer setting influences, including shifting government and universities policies and the COVID-19 pandemic, required repeated adaptations, while CAB partnerships expanded community connections and services over time. Process-related findings underscored the evolving role of CHWs and research staff in planning and fidelity, with training shifting toward peer mentorship to build capacity.

Conclusion: Findings revealed the pivotal role of programmatic adaptability and robust partner engagement in navigating dynamic contexts to support the diabetes needs of minoritized communities. The real-time, longitudinal approach taken for data collection and analysis was crucial in understanding how intervention changes were implemented and experienced, providing a model for similar implementation assessments.

Background: Clinical treatment guidelines are designed to improve quality of care by offering clear recommendations for health workers; however, across many settings, implementing guidelines is a challenge. For over 20 years, comprehensive World Health Organization guidelines for care of hospitalized children have provided guidance for treating the primary causes of childhood death. These recommendations were adapted in Kenya and codified in the Basic Paediatric Protocol; however, adherence to these evidence-based interventions remains suboptimal.

Methods: This qualitative study identified the barriers and facilitators of providing guideline-adherent care to children admitted to two hospitals in Kenya. The semi-structured question guide was informed by the Theoretical Domains Framework (TDF). Three focus group discussions and 16 in-depth interviews were conducted with 35 health workers. Participants were nurses, doctors, clinical officers, or nutritionists (including in-charges and clinical supervisors). Interviews were audio recorded and transcribed. Transcripts were coded using a TDF-based codebook, validated, and analyzed for themes.

Results: TDF domains with the greatest influence on the thematic findings were environmental context and resources, social influences, beliefs about consequences, and beliefs about capabilities. Health workers were knowledgeable about guidelines and felt strongly that adherence to them was beneficial; however, they also faced barriers implementing them. Challenges related to the environmental context were pervasive, including shortages of staff and supplies. Participants praised the simplicity of guidelines but also noted that simplified diagnostic criteria don't align with complex patient presentations. While guidelines empowered some nurses to make clinical decisions, respondents reported that strict professional roles sometimes delayed diagnosis and treatment. Further, health workers reported some deviations were intentional (ex. when guidelines were not aligned to their beliefs) and other times they were unintentional (ex. when complex patient presentations make guideline adherence difficult).

Conclusions: Knowledge of guidelines and motivation to use them were not major determinants in this analysis. Rather, human and material resource shortages presented the greatest barrier to guideline adherence in this setting. Improving guidelines by involving health workers in participatory development of guidelines would improve both clarity and feasibility. Health workers are well-versed in guideline recommendations, so educational strategies should focus on knowledge gaps or changes in the latest version of guidelines.

Background: HIV pre-exposure prophylaxis (PrEP) remains underutilized in communities over-burdened by HIV. Same-day PrEP, prescribing and starting PrEP at the initial visit, may be an implementation strategy to address this gap. Federally qualified health centers (FQHC) and community-based organizations (CBO) provide healthcare to un- and under-insured populations and have the potential to increase PrEP services via same-day PrEP. This exploratory mixed methods study explored same-day PrEP program implementation strategies and determinants.

Methods: Key stakeholders, recruited from FQHC and CBO in Georgia, Texas, and Illinois, participated in virtual interviews (qualitative strand) grounded in the Consolidated Framework for Implementation Science. Thematic analysis in NVivo identified implementation strategies. Purposively sampled FQHC and CBO stakeholder focus groups (FG) rank-ordered same-day PrEP implementation strategies (quantitative strand) based on perceived effectiveness and feasibility to create meta-inferences. N = 5 individuals participated in both interviews and FG. We then calculated the mean rank order score for each implementation strategy (range = 1-12), within each state and across all three states. We calculated these mean scores separately for both perceived strategy effectiveness/impact and perceived feasibility within their respective settings.

Results: Twenty-four stakeholders completed interviews. 46% (N = 11) were clinic directors/managers, 63% (N = 15) were affiliated with a CBO, 71% (N = 17) worked in settings where same-day oral PrEP was offered. Theme 1) Medicaid expansion is a useful resource for same-day PrEP implementation; however, same-day PrEP is feasible in non-Medicaid expansion states by leveraging additional financial resources. Theme 2) Leadership buy-in and PrEP champions spearhead programs. Theme 3) Intercommunity relationships and formal evaluation are needed. The three most highly ranked strategies in terms of perceived effectiveness were: 1. Leadership buy-in (mean ranking = 2.51); 2. PrEP champion (mean ranking = 3.62); and 3. PrEP navigators (mean ranking = 4.68). Leadership buy-in first (mean ranking = 2.91), followed by the use of a PrEP champion second (mean ranking = 3.91) and consumer outreach (mean ranking = 4.81) were ranked highest in terms of perceived feasibility.

Conclusions: Diversification of funding, support from leaders, and customization of implementation strategies are consistent factors necessary for same-day PrEP programs.

Background: Better understanding of how deliverers use research and select interventions can further reduce the gap between developing and delivering effective intervention and implementation strategies, especially in the field of HIV.

Methods: We interviewed a convenience sample of Midwest health organizations and health departments who are involved with HIV treatment and/or prevention services. Using an iterative, rapid qualitative analysis, we identified key steps in the process of prioritizing health needs, selecting interventions, and disseminating or receiving information about interventions.

Results: In order to prioritize areas for interventions, organizations used community assessments, developing leaderships buy-in, considered staff capacity, accessed funding, and created partnerships. Once a priority areas was developed, interventions were usually developed by the organization or adapted from pre-existing interventions to meet local needs. Organizations preferred to receive information from trusted broker agencies or from peer organizations. There was a strong desire to evaluate and share results from home-grown interventions but evaluation capacity and funding were limiting factors.

Conclusions: There are several ways to improve dissemination and knowledge sharing between researchers and practitioners. Researchers can design flexible and adaptable interventions, with a range of dissemination materials available to broker agencies. Deliverers can partner with researchers for evaluation, while funders can specifically support evaluation and dissemination, including peer-to-peer learning.

Background: In the emergency department (ED), clinicians often make challenging, high-pressure decisions within a short time frame. Clinical decision support (CDS) tools integrated into the electronic health record can provide evidence-based support. Yet, numerous implementation barriers limit the broad use of such tools in ED settings. CDS tools could be particularly helpful for patients presenting to the ED with an acute exacerbation of heart failure (AHF), a common and costly medical condition for which patients are typically admitted to the hospital. We developed and implemented STRATIFY, a validated risk prediction model that effectively identifies AHF patients at low risk of 30-day adverse events who could potentially be discharged home from the ED.

Methods: This article describes a multi-center study to 1) develop a stakeholder-informed CDS-based implementation process for STRATIFY, 2) use novel statistical methods to overcome data integration challenges to the real-world implementation of predictive models in the ED, and 3) evaluate the implementation and effectiveness of the newly developed STRATIFY CDS at 7 EDs to guide decision-making to admit or discharge patients with AHF. The study's multi-level implementation strategy is tailored to each site and informed by site assessments (including pre-visit surveys, on-site ED visits, and virtual interviews), small group discussions with patients and caregivers, and iterative user-centered design to develop and refine the STRATIFY CDS. Overcoming data challenges for real-time predictive models involves accommodating missing risk factor data while still generating valid predictions of risk. In the evaluation of effectiveness, we will evaluate ED disposition (admit/discharge) for patients with AHF, as well as potential adverse outcomes, using an interrupted time-series design at 7 participating EDs. The study will evaluate implementation outcomes ranging from acceptability to sustainability using electronic health record data and surveys of clinicians and patients.

Discussion: This study uses a stakeholder-informed, iterative design approach to develop a tailored CDS-based process supported by a multi-level implementation strategy to incorporate a validated risk prediction tool into the care of patients with AHF in the ED. The study will advance methods to close the evidence-practice gap in the care of emergency department patients.