Implementation Science最新文献

Background: Theories, models, and frameworks (TMFs) are central to implementation practice and research. Selecting one or more TMF(s) for a project remains challenging due to numerous options and limited guidance. This study aimed to (1) identify and categorize the reported purposes and attributes of TMFs, as well as the practical considerations of TMF users, and (2) synthesize these findings into a meta-framework that supports implementation practitioners and researchers in selecting TMFs.

Methods: A scoping review was conducted using Joanna Briggs Institute guidelines. Medline, Embase, and CINAHL were searched to identify articles on the selection of TMFs. Articles were selected and data extracted using Covidence. Inductive thematic analysis was used to refine and categorize purposes, attributes and practical considerations. The meta-framework was developed by mapping these categories onto a sequential process, pilot-testing through case studies, and iteratively refining it based on team feedback.

Results: Of 9,276 records, 43 articles (2005-2024) were included. Most articles reported TMF purposes (41 articles), followed by attributes (30) and practical considerations (13). Seven distinct purposes were identified: (1) enhancing conceptual clarity, (2) anticipating change and guiding inquiry, (3) guiding the implementation process, (4) guiding identification of determinants, (5) guiding design and adaptation of strategies, (6) guiding evaluation and causal explanation, and (7) guiding interpretation and dissemination. Additionally, 24 TMF attributes were grouped into five domains: clarity and structure, scientific strength and evidence, applicability and usability, equity and sociocultural responsiveness, and system and partner integration. Ten practical considerations were grouped into three domains: team expertise and readiness, resource availability, and project fit. These findings informed the development of the Systematic Evaluation and Selection of Implementation Science Theories, Models and Frameworks (SELECT-IT) meta-framework, comprising four steps: (1) determine the purpose(s) of using TMF(s); (2) identify potential TMFs; (3) evaluate short-listed TMFs against attributes; and (4) assess practical considerations of using TMF(s) within the project context. A worked example and two user-friendly worksheets illustrate its utility.

Conclusions: This study advances understanding of the selection of implementation science TMFs by distinguishing inherent TMF attributes from practical considerations. The SELECT-IT meta-framework offers a structured, context-sensitive approach for selecting appropriate TMFs. Future research should evaluate its validity and utility across diverse contexts.

Background: Hybrid type 1 effectiveness-implementation randomised controlled trials (RCTs) aim to accelerate the translation of proven clinical interventions into routine care by concurrently investigating the effectiveness of clinical interventions and the context for real-world implementation. Hybrid type 1 RCTs can make use of implementation science theoretical approaches (i.e., theories, models, and frameworks) to understand barriers and facilitators to sustainable implementation of clinical interventions; however, the extent to which these approaches have been used in hybrid type 1 RCTs has not been systematically investigated. This scoping review aimed to investigate the extent to which implementation science theoretical approaches have been used in hybrid type 1 RCTs of healthcare interventions and describe which approaches have been reported and how they have been used.

Methods: The review was conducted in accordance with the pre-registered protocol ( https://doi.org/10.17605/OSF.IO/CJ8A7 ). Searches of six electronic databases were conducted for published hybrid type 1 RCTs evaluating any clinical intervention in any healthcare setting. The included trials were full-text, peer-reviewed primary research articles written in English, and reporting the findings of hybrid type 1 RCTs of healthcare interventions. Non-English language reports, reviews, protocols without a linked trial results report, methodological papers, opinion pieces, commentaries, books/book chapters, dissertations, and conference abstracts were excluded. Two reviewers independently selected studies, extracted data, and assessed use of theoretical approach/es.

Results: We identified 8,878 citations, screened 673 full-text records, and included 37 trials. Most trials were conducted in North America (68%), investigating clinical interventions for mental health problems (32%) in adults (43%). Twenty-eight (76%) trials cited use of at least one theoretical approach. The most common was the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework (43%). Theoretical approaches were most often applied (62%) to justify the implementation study design, guide selection of study materials or analyse implementation outcomes.

Conclusion: The majority of published hybrid type 1 effectiveness-implementation RCTs of healthcare interventions report using at least one theoretical approach to explore the context for implementation. Use of implementation science theories, models, and/or frameworks to understand the barriers and facilitators to implementation and sustainability of proven clinical interventions is likely to accelerate future translation of evidence-based practices into routine care and thus optimise patient outcomes.

Background: Does the importance of context in implementation imply that generalizing about the effects of strategies is ultimately limited? Conceptual approaches for generalizing in the presence of significant contextual heterogeneity could advance implementation research but require novel perspectives.

Main body: Drawing from perspectives from Realist approaches, Pearl's transportability framework and philosophy of science, this paper outlines a mechanism-based approach to generalizing about the effects of implementation strategies. We suggest that understanding mechanisms creates a conceptual bridge between the effects of a strategy and the influence of the implementation context. Using directed acyclic graphs to represent the mechanisms of strategies, we show how conceptualizing mediators of overall effects offer a basis for considering the effects of context. Hence, theorizing and testing a mechanistic understanding enriches the ways in which we can consider how context could change those effects. Such an approach allows us to understand how a strategy works within a given implementation context, determine what information from new contexts are needed to infer across contexts, and if that information is available, what those effects would be - thereby advancing generalizing in implementation research. We consider particular implementation strategies (e.g., Community Adherence Groups and practice facilitation) as examples to illustrate generalizing into different contexts.

Conclusion: Mechanisms can help implementation research by simultaneously accommodating the importance of context as well as the imperative to generalize. A shift towards a mechanism-focused approach that goes beyond identifying barriers and facilitators can enhance the value of implementation research.

Background: Hypertension affects nearly half of adults in the U.S., with African American and Black (AA/B) adults experiencing some of the highest rates domestically and globally. Despite improvements in blood pressure control in the general population, rates of control among AA/B adults have stagnated, contributing to significant health disparities in the prevalence of hypertension and its long-term health impacts. Systemic barriers, including poverty and historically earned distrust in healthcare, hinder patient and clinician adherence to best practices for hypertension management. Community-based interventions, particularly those involving faith-based organizations, show promise in improving blood pressure control among AA/B adults.

Methods: The CIRCL-Chicago Implementation Research Center will test the effectiveness of a community-adapted hypertension control program, a "bundled" intervention developed by and tested in the Kaiser Permanente system, in South Side Chicago community health centers. A key partner for this trial, the Total Resource Community Development Organization, isa faith-based community outreach hub networked with faith-based organizations throughout Chicago's South Side community. The study employs a type 3 hybrid effectiveness-implementation approach with a parallel cluster-randomized trial. Sixteen clinics will be randomized to implement a community-adapted Kaiser bundle with or without practice facilitation. We will recruit adults who live, work, or practice their faith in Chicago's South Side community to populate a community-based hypertension registry (target n = 5,760 participants). The primary implementation outcome is the reach of the intervention, measured by the proportion of eligible patients in the registry who receive the adapted Kaiser bundle. Secondary outcomes include blood pressure control rates, assessed at 12 months post-enrollment. The study will use community-engaged adaptation, practice facilitation, and education and training strategies to support implementation.

Discussion: The CIRCL-Chicago study aims to address cardiovascular health disparities by integrating clinical and community-based approaches to hypertension management. By leveraging trusted community settings and engaging local partners, the study seeks to enhance the reach and effectiveness of evidence-based hypertension interventions. The findings could inform scalable models for hypertension control in diverse urban communities, potentially reducing health disparities for AA/B adults.

Trial registration: Clinicaltrials.gov NCT04755153 on 24 August 2023, https://www.centerwatch.com/clinical-trials/listings/NCT04755153/community-intervention-to-reduce-cardiovascular-disease-in-chicago.

Background: Expanding human papillomavirus (HPV) vaccination for girls and HPV self-collection for women can reduce the global burden of cervical cancer. However, HPV vaccination and self-collection services are rarely implemented simultaneously in mother-daughter dyads, leaving a critical gap in cervical cancer prevention. From 2023 to 2024, a community-engaged model for combined HPV vaccination and screening was co-designed using crowdsourcing open calls and designathons with mother-daughter teams and pilot-tested by trained research facilitators. This study explores the impact of this crowdsourced, community-engaged mother-daughter campaign and implementation strategy bundle on HPV vaccination among girls and HPV screening among their mothers in Nigeria over 6 months in 18 Nigerian local government areas (LGAs).

Methods: A hybrid effectiveness-implementation type II pragmatic stepped-wedge cluster randomized control trial has been employed to the effectiveness of an implementation strategy bundle; a crowdsourced, tailored, community-engaged, mother-daughter HPV campaign on increasing uptake of HPV vaccination among girls aged 9-14 and HPV screening uptake among women aged 30-49 in Nigeria. The mother-daughter campaign will be tailored to local sites and conducted among 612 mother-daughter dyads (1,224 participants) recruited from 18 LGAs in six geopolitical zones of Nigeria. Trained community health workers will collect baseline data and implement a mother-daughter campaign that will provide education on cervical cancer control and access to onsite services for HPV vaccination and screening in a private area while engaging mothers and daughters simultaneously to increase uptake of the services. A mixed-methods evaluative and iterative assessment will be conducted using Proctor's Implementation Outcomes Framework and the PEN- 3 cultural model. The primary outcomes are the uptake of HPV preventive measures-HPV vaccination (one dose) among girls (ascertained by onsite clinical records of vaccine uptake) and HPV self-collection completion among mothers (ascertained by laboratory receipt of self-collected specimens) within six months of trial enrollment. Pre-post effectiveness and cost of study components are embedded in the implementation and sustainment phases, compared to pre-implementation data assessed for each LGA.

Discussion: This study is a unique dyadic intervention focused on both girls and their mothers or female caregivers to drive cervical cancer control in Africa. Findings have the potential to inform local and global policies aimed at reducing the cervical cancer burden in African countries like Nigeria, eliminating missed opportunities by closing the research-to-translation gap. The protocol was registered with clinicaltrials.gov under registration NCT06728085.

Background: Schools need to implement universal student supports that prevent social, emotional, and behavioral difficulties; minimize associated risks; and promote social, emotional, and behavioral competencies. The purpose of this study is to examine the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy for promoting school-level implementation leadership, implementation climate, and high-fidelity delivery of an evidence-based practice. We will test HELM with an exemplar EBP, Positive Behavioral Interventions and Supports (PBIS). The specific aims of the study are to: 1) experimentally evaluate the effects of HELM versus PBIS training and technical assistance only (control condition); and 2) explore for whom, under what conditions, how equitably, and through which processes HELM works to improve outcomes, as well as its cost-effectiveness.

Methods: This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools. Schools will be randomly assigned to HELM + PBIS training and technical assistance (n = 21 schools; n = 210 educators) or PBIS training and technical assistance only (n = 21 schools; n = 210 educators) in a 1:1 ratio within cohorts using covariate constrained randomization that accounts for degree of prior PBIS exposure (measured using the Tiered Fidelity Inventory at baseline) and school size. A series of mixed effects models (time within educator, educator within school) will test within-subject/between-subject interactions across three timepoints (12 months total) to examine whether HELM will show steeper gains than the control on implementation leadership (primary outcome), implementation climate, PBIS fidelity, and student outcomes. Mediational analyses will test hypothesized mechanisms of change (i.e., implementation leadership and climate) of HELM on PBIS fidelity. Sequential mixed-methods data collection and analyses will further explore how organizational mechanisms are linked to implementation outcomes. Cost-effectiveness analyses will compare costs and outcomes of PBIS training and technical assistance only versus PBIS implementation with HELM.

Discussion: The nature of leadership support in schools can make the difference between successful and unsuccessful EBP implementation. Testing HELM within the context of PBIS implementation will provide rigorous evidence about whether and how HELM can equitably address important EBP and student outcomes. NAME OF THE REGISTRY: clinicaltrials.gov.

Trial registration: Clinical Trials ID: NCT06586723. Date of Registration: August 27, 2024. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06586723?intr=helm&rank=1.

Background: Dashboards-tools that compile and summarize key performance data-have become increasingly utilized for supporting data organization and decision-making processes across various fields, such as business, economics, healthcare, and policy. The dashboard's impact is dependent on its use by the individuals for whom it was designed. Yet, few studies measure dashboard use, and of those that do, their utility is limited. When dashboards go unused, they provide little value and impact. We argue that successful and long-term use of dashboards can be achieved using human-centered design and implementation science methods.

Main body: In this article, we describe the characteristics of dashboards and provide examples of existing dashboards. We discuss the common pitfalls of dashboards that result in their limited use. Next, we proffer how human-centered design and implementation science can improve dashboard relevance. We provide eight recommendations from across the design to the sustainment phase. To guide dashboard developers and implementers, we organize our recommendations using the Exploration, Preparation, Implementation, and Sustainment (EPIS) Framework. Lastly, we raise several cautions when using human-centered design and implementation science methods in dashboard development and implementation.

Conclusion: There is a need for more effective, sustainable, and impactful dashboards. We suggest that incorporating human-centered design and implementation science methods can facilitate achieving this goal.