BACKGROUND: Persons with diabetes have 27% elevated risk of developing colorectal cancer (CRC) and are disproportionately from priority health disparities populations. Federally qualified health centers (FQHCs) struggle to implement CRC screening programs for average risk patients. Strategies to effectively prioritize and optimize CRC screening for patients with diabetes in the primary care safety-net are needed.
METHODS: Guided by the Exploration, Preparation, Implementation and Sustainment Framework, we conducted a stakeholder-engaged process to identify multi-level change objectives for implementing optimized CRC screening for patients with diabetes in FQHCs. To identify change objectives, an implementation planning group of stakeholders from FQHCs, safety-net screening programs, and policy implementers were assembled and met over a 7-month period. Depth interviews (n = 18-20) with key implementation actors were conducted to identify and refine the materials, methods and strategies needed to support an implementation plan across different FQHC contexts. The planning group endorsed the following multi-component implementation strategies: identifying clinic champions, development/distribution of patient educational materials, developing and implementing quality monitoring systems, and convening clinical meetings. To support clinic champions during the initial implementation phase, two learning collaboratives and bi-weekly virtual facilitation will be provided. In single group, hybrid type 2 effectiveness-implementation trial, we will implement and evaluate these strategies in a in six safety net clinics (n = 30 patients with diabetes per site). The primary clinical outcomes are: (1) clinic-level colonoscopy uptake and (2) overall CRC screening rates for patients with diabetes assessed at baseline and 12-months post-implementation. Implementation outcomes include provider and staff fidelity to the implementation plan, patient acceptability, and feasibility will be assessed at baseline and 12-months post-implementation.
CONCLUSIONS: Study findings are poised to inform development of evidence-based implementation strategies to be tested for scalability and sustainability in a future hybrid 2 effectiveness-implementation clinical trial. The research protocol can be adapted as a model to investigate the development of targeted cancer prevention strategies in additional chronically ill priority populations.
BACKGROUND: This study was registered in ClinicalTrials.gov (NCT05785780) on March 27, 2023 (last updated October 21, 2023).

BACKGROUND: Norwegian school health services received a national best-practice guideline in 2017. To promote healthy life skills and identify adolescents needing support, the guideline includes strong recommendations for individual consultations with all 8th graders and increased collaboration with schools. To help implement the recommendations, a blended implementation strategy (SchoolHealth) was co-created with school nurses, students, and stakeholders. SchoolHealth consists of three implementation elements: Digital dialog and administration tool (audit and feedback +), Dialog support (external consultation), and Collaboration materials (targeted dissemination). This hybrid study will test the main and combined effects of the elements on guideline fidelity and effectiveness.
METHODS: The GuideMe study is a factorial cluster randomized controlled trial examining SchoolHealth\'s effectiveness on guideline fidelity and guideline effectiveness goals. Forty Norwegian secondary schools will be randomized to eight different combinations of the elements in SchoolHealth. Participants will include school nurses and school personnel from these schools, and 8th grade students (n = 1200). Primary outcomes are school nurses\' fidelity to the guidelines and student\'s ability to cope with their life (i.e., health literacy, positive health behaviors and self-efficacy). Quantitative methods will be used to test effects and mechanisms, while mixed- and qualitative methods will be used to explore mechanisms, experiences, and other phenomena in depth. Participants will complete digital questionnaires at the start and end of the schoolyear, and after the consultation during the schoolyear. The study will run in two waves, each lasting for one school year. The multifactorial design allows testing of interactions and main effects due to equal distribution of all factors within each main effect. Sustainment and scale-up of optimized SchoolHealth elements using national infrastructure are simultaneously prepared.
CONCLUSIONS: The study will investigate possible effects of the implementation elements in isolation and in combination, and hypothesized implementation mechanisms. In-depth study of user experiences will inform improvements to elements in SchoolHealth. The results will yield causal knowledge about implementation strategies and the mechanisms through which they assert effects. Mixed-methods will provide insights into how and when the elements work. Optimizing guideline implementation elements can support adolescents in a crucial life phase.
BACKGROUND: ISRCTN24173836. Registration date 8 August 2022.

Advances in detection and treatment for breast cancer have led to an increase in the number of individuals managing significant late and long-term treatment effects. Primary care has a role in caring for patients with a history of cancer, yet there is little guidance on how to effectively implement survivorship care evidence into primary care delivery.
This protocol describes a multi-phase, mixed methods, stakeholder-driven research process that prioritizes actionable, evidence-based primary care improvements to enhance breast cancer survivorship care by integrating implementation and primary care transformation frameworks: the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and the Practice Change Model (PCM). Informed by depth interviews and a four round Delphi panel with diverse stakeholders from primary care and oncology, we will implement and evaluate an iterative clinical intervention in a hybrid type 1 effectiveness-implementation cluster randomized design in twenty-six primary care practices. Multi-component implementation strategies will include facilitation, audit and feedback, and learning collaboratives. Ongoing data collection and analysis will be performed to optimize adoption of the intervention. The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using mixed methods to explore how organizational and contextual variables affect adoption, implementation, and early sustainability for provision of follow-up care, symptom, and risk management activities at six- and 12-months post implementation.
Study findings are poised to inform development of scalable, high impact intervention processes to enhance long-term follow-up care for patients with a history of breast cancer in primary care. If successful, next steps would include working with a national primary care practice-based research network to implement a national dissemination study. Actionable activities and processes identified could also be applied to development of organizational and care delivery interventions for follow-up care for other cancer sites.
Registered with ClinicalTrials.gov on June 2, 2022: NCT05400941.

BACKGROUND: Most justice-involved youth are supervised in community settings, where assessment and linkage to substance use (SU) treatment services are inconsistent and fragmented. Only 1/3 of youth with an identified SU need receive a treatment referral and even fewer initiate services. Thus, improving identification and linkage to treatment requires coordination across juvenile justice (JJ) and behavioral health (BH) agencies. The current study examines the comparative effectiveness of two bundled implementation intervention strategies for improving SU treatment initiation, engagement, and continuing care among justice-involved youth supervised in community settings. Exploration, Preparation, Implementation, Sustainment (EPIS) served as the conceptual framework for study design and selection/timing of implementation intervention components, and the BH Services Cascade served as the conceptual and measurement framework for identifying and addressing gaps in service receipt.
METHODS: Part of a larger Juvenile-Justice Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) Cooperative, this study involved a multisite, cluster-randomized control trial where sites were paired then randomly assigned to receive Core (training teams on the BH Services Cascade and data-driven decision making; supporting goal selection) or Core+Enhanced (external facilitation of implementation teams) intervention components. Youth service records were collected from 20 JJ community supervision agencies (in five states) across five study phases (baseline, pre-randomization, early experiment, late experiment, maintenance). Implementation teams comprised of JJ and BH staff collaboratively identified goals along the BH Cascade and used data-driven decision-making to implement change.
RESULTS: Results suggest that Core intervention components were effective at increasing service receipt over time relative to baseline, but differences between Core and Core+Enhanced conditions were non-significant. Time to service initiation was shorter among Core+Enhanced sites, and deeper Cascade penetration occurred when external facilitation (of implementation teams) was provided. Wide variation existed in the degree and nature of change across service systems.
CONCLUSIONS: Findings demonstrate the criticality of early EPIS phases, demonstrating that strategies provided during the formative exploration and preparation phases produced some improvement in service receipt, whereas implementation-focused activities produced incremental improvement in moving youth farther along the Cascade.

BACKGROUND: Evidence from previous pandemics as well as early evidence from COVID-19 suggests risk of adverse mental health and wellbeing outcomes for healthcare workers. In response to these concerns, healthcare systems and organisations rapidly established staff support and wellbeing programmes. While there is emerging literature related to the effectiveness of such interventions, what is less well understood and evaluated is the evidence base regarding how such programmes are implemented; what supports and hinders their implementation; and how or if they are maintained following the initial acute phase of the pandemic. This study addresses this gap by studying the implementation process of COVID-19-related staff wellbeing programmes in the three UK NHS Trusts that make up one of Europe\'s largest academic health sciences centres, King\'s Health Partners.
METHODS: We will conduct a prospective, cross-sectional descriptive study using qualitative research methods and non-probability purposive sampling to identify a study participant group representative of the population and implementation activity of interest. We will conduct semi-structured interviews of between 30 min and 1 h. We will identify theory-driven elements in the dataset using the Consolidated Framework for Implementation Research (barriers and drivers), Exploration, Preparation, Implementation, Sustainment Framework (timeline/chronology/evolution of the implementation and different issues at different times) and Expert Recommendations for Implementing Change (implementation strategies). We will then identify indicators of these constructs within the dataset and report them, as well as their inter-relationships.
CONCLUSIONS: Through this study, we hope to better understand what factors hindered and enabled the implementation of three inter-linked staff support and wellbeing programmes and how/to what extent have these programmes been sustained. We will also explore whether implementation science frameworks are applicable and beneficial in conceptualising and understanding crisis driven and rapidly implemented interventions and in what ways, if any, they need to be adjusted when used in unprecedented circumstances such as the COVID-19 pandemic.

Youth involved in the juvenile justice system (YIJJ) have high rates of substance use problems; however, rates of YIJJ engagement in substance use services is low. Barriers to service engagement include lack of appropriate screening and connection to services by the juvenile justice system, as well as lack of resources for delivering evidence-based treatment in community-based settings. To address these barriers, this paper describes a protocol for a type 1 hybrid design to (1) implement universal substance use screening for YIJJ; (2) implement and evaluate the feasibility and effectiveness of a brief, three-session substance use interventions based in motivational interviewing for youth with mild/moderate substance use: Teen Intervene (an individual-based intervention); (3) implement ENCOMPASS, an evidence-based substance use intervention based in motivational enhancement and cognitive behavioral therapy for youth with severe substance use; and (4) evaluate facilitators and barriers to implementing these interventions for mild to severe substance use among YIJJ in community mental health centers (CMHC).
Using a hybrid type 1 clinical effectiveness-implementation design, we will collaborate with CMHCs and juvenile justice in two rural Indiana counties. Guided by the EPIS (exploration, preparation, implementation, sustainability) framework, we will measure factors that affect implementation of substance use screening in juvenile justice and implementation of substance use interventions in CMHCs utilizing self-reports and qualitative interviews with juvenile justice and CMHC staff pre- and post-implementation. YIJJ with mild/moderate substance use will receive a brief interventions and YIJJ with severe substance use will receive ENCOMPASS. We will measure the effectiveness of a brief and comprehensive intervention by assessing changes in substance use across treatment. We anticipate recruiting 160 YIJJ and their caregivers into the study. We will assess intervention outcomes utilizing baseline, 3-, and 6-month assessments.
Findings have the potential to improve screening and intervention services for YIJJ.

If evidence-based interventions (EBIs) are not sustained, investments are wasted and public health impact is limited. Leadership has been suggested as a key determinant of implementation and sustainment; however, little empirical work has examined this factor. This mixed-methods study framed using the Exploration, Preparation, Implementation, Sustainment (EPIS) conceptual framework examines leadership in both the outer service system context and inner organizational context in eleven system-wide implementations of the same EBI across two U.S. states and 87 counties. Quantitative data at the outer context (i.e., system) and inner context (i.e., team) levels demonstrated that leadership predicted future sustainment and differentiated between sites with full, partial, or no sustainment. In the outer context positive sustainment leadership was characterized as establishing a project\'s mission and vision, early and continued planning for sustainment, realistic project plans, and having alternative strategies for project survival. Inner context frontline transformational leadership predicted sustainment while passive-avoidant leadership predicted non-sustainment. Qualitative results found that sustainment was associated with outer context leadership characterized by engagement in ongoing supportive EBI championing, marketing to stakeholders; persevering in these activities; taking action to institutionalize the EBI with funding, contracting, and system improvement plans; and fostering ongoing collaboration between stakeholders at state and county, and community stakeholder levels. For frontline leadership the most important activities included championing the EBI and providing practical support for service providers. There was both convergence and expansion that identified unique contributions of the quantitative and qualitative methods. Greater attention to leadership in both the outer system and inner organizational contexts is warranted to enhance EBI implementation and sustainment.