BACKGROUND: Multiple evidence-based strategies (EBS) for promoting HPV vaccination exist. However, adolescent HPV vaccination rates remain below target levels in communities at high risk for HPV-associated cancers and served by safety-net clinics. Participatory engaged approaches are needed to leverage the expertise of community and clinical partners in selecting EBS relevant to their local context. We engaged concept mapping as a method to inform the adoption and adaptation of EBS that seeks to empower implementation partners to prioritize, select, and ultimately implement context-relevant EBS for HPV vaccination.
METHODS: Using 38 EBS statements generated from qualitative interviews and national HPV vaccine advocacy sources, we conducted a modified concept mapping activity with partners internal to safety-net clinics and external community members in two study sites of a larger implementation study (Greater Los Angeles and New Jersey), to sort EBS into clusters and rate each EBS by importance and feasibility for increasing HPV vaccination within safety-net clinics. Concept mapping findings (EBS statement ratings, ladder graphs and go-zones) were shared with leaders from a large federally qualified health center (FQHC) system (focusing on three clinic sites), to select and implement EBS over 12 months.
RESULTS: Concept mapping participants (n=23) sorted and rated statements, resulting in an eight-cluster solution: 1) Community education and outreach; 2) Advocacy and policy; 3) Data access/quality improvement monitoring; 4) Provider tracking/audit and feedback; 5) Provider recommendation/communication; 6) Expanding vaccine access; 7) Reducing missed opportunities; and 8) Nurse/staff workflow and training. The FQHC partner then selected to intervene on eight of 17 EBS statements in the \"go-zone\" for action, with three from \"reducing missed opportunities,\" two from \"nurse/staff workflow and training,\" and one each from \"provider tracking/audit and feedback,\" \"provider recommendation/communication,\" and \"expanding vaccine access,\" which the research team addressed through the implementation of three multi-level intervention strategies (e.g., physician communication training, staff training and workflow assessment, audit and feedback of clinic processes).
CONCLUSIONS: Concept mapping provided a powerful participatory approach to identify multilevel EBS for HPV vaccination relevant to the local safety-net clinic context, particularly when several strategies exist, and prioritization is necessary. This study demonstrates how a clinic system benefited directly from the ratings and prioritization of EBS by multilevel clinic and community partners within the broader safety-net clinic context to identify and adapt prioritized solutions needed to advance HPV vaccine equity.

The COVID-19 pandemic not only led to drastic changes in the implementation context for early intervention and early childhood special education services in 2020, but has had an enduring effect on the organizations, educators, families, and children with developmental delays and disorders. Through secondary data analysis, characteristics of toddlers with autism being served in a publicly funded center-based early intervention program as well as the characteristics of their educators are examined, comparing those who were enrolled in (a) two randomized trials conducted prior to the pandemic and (b) one ongoing randomized trial that launched in return to in-person educational services after the pandemic shutdown. Significant demographic differences are found for toddlers, where the current study includes more girls (p = 0.002), who are younger (p < .001) than the prior studies. Further, toddlers enrolled in the current trial are entering with significantly younger receptive (p < .001) and expressive language age-equivalent scores (p < .001) than toddlers from the prior studies. In addition, significant differences are also found for teaching assistants (TAs), who are younger (p < .001), less experienced supporting children with autism (p < .001), have spent less time in this position (p < .001), and who are still working toward college degrees (p < .001) than TAs in the prior studies. Implications of these changes for both intervention strategies to support the strengths and needs of the toddlers (e.g., reduce frequency of TA-child pairing changes to build rapport, increase time in adult-child JASPER before adding peers) as well as implementation strategies (e.g., increase foundational content, TA teaming) to support the training and retention of the TAs are discussed. Clinical Trials Registry number: NCT04283045.

BACKGROUND: There is noted increase in attention towards implementation of evidence-based interventions in response to the stillbirth burden in low- and middle-income countries including Uganda. Recent results reporting some of the strategies adopted have tended to focus much attention towards their overall effect on the stillbirth burden. More is needed regarding stakeholder reflections on priorities and opportunities for delivering quality services within a limited resource setting like Uganda. This paper bridges this knowledge gap.
METHODS: Data collection occurred between March and June 2019 at the national level. Qualitative interviews were analysed using a thematic analysis technique.
RESULTS: Identified priorities included; a focus on supportive functions such as the referral system, attention to the demand side component of maternal health services, and improvements in the support supervision particularly focusing on empowering subnational level actors. The need to strengthen the learning for better implementation of strategies which are compatible with context was also reported. A comprehensive and favourable policy environment with the potential to direct implementation of strategies, harnessing the private sector contribution as well as the role of national level champions and patient advocates to amplify national stillbirth reduction efforts for continued visibility and impact were recommended.
CONCLUSIONS: Great potential exists within the current strategies to address the national stillbirth burden. However, priorities such as improving the supportive functions of MCH service delivery and attention to the demand side need to be pursued more for better service delivery with opportunities including a favourable policy environment primed to better serve the current strategies. This calls for dedicated efforts targeted at addressing gaps within the existing priorities and opportunities for better delivery of national strategies to address the stillbirth burden in Uganda.

BACKGROUND: Integrated care involves care provided by a team of professionals, often in non-traditional settings. A common example worldwide is integrated school-based mental health (SBMH), which involves externally employed clinicians providing care at schools. Integrated mental healthcare can improve the accessibility and efficiency of evidence-based practices (EBPs) for vulnerable populations suffering from fragmented traditional care. However, integration can complicate EBP implementation due to overlapping organizational contexts, diminishing the public health impact. Emerging literature suggests that EBP implementation may benefit from the similarities in the implementation context factors between the different organizations in integrated care, which we termed inter-organizational alignment (IOA). This study quantitatively explored whether and how IOA in general and implementation context factors are associated with implementation outcomes in integrated SBMH.
METHODS: SBMH clinicians from community-based organizations (CBOs; nclinician = 27) and their proximal student-support school staff (nschool = 99) rated their schools and CBOs (clinician only) regarding general (organizational culture and molar climate) and implementation context factors (Implementation Climate and Leadership), and nine common implementation outcomes (e.g., treatment integrity, service access, acceptability). The levels of IOA were estimated by intra-class correlations (ICCs). We fitted multilevel models to estimate the standalone effects of context factors from CBOs and schools on implementation outcomes. We also estimated the 2-way interaction effects between CBO and school context factors (i.e., between-setting interdependence) on implementation outcomes.
RESULTS: The IOA in general context factors exceeded those of implementation context factors. The standalone effects of implementation context factors on most implementation outcomes were larger than those of general context factors. Similarly, implementation context factors between CBOs and schools showed larger 2-way interaction effects on implementation outcomes than general context factors.
CONCLUSIONS: This study preliminarily supported the importance of IOA in context factors for integrated SBMH. The findings shed light on how IOA in implementation and general context factors may be differentially associated with implementation outcomes across a broad array of integrated mental healthcare settings.

UNASSIGNED: Integrated care involves care provided by a team of professionals, often in non-traditional settings. A common example worldwide is integrated school-based mental health (SBMH), which involves externally employed clinicians providing care at schools. Integrated mental healthcare can improve the accessibility and efficiency of evidence-based practices (EBPs) for vulnerable populations suffering from fragmented traditional care. However, integration can complicate EBP implementation due to overlapping organizational contexts, diminishing the public health impact. Emerging literature suggests that EBP implementation may benefit from the similarities in the implementation context factors between the different organizations in integrated care, which we termed inter-organizational alignment (IOA). This study quantitatively explored whether and how IOAs in general and implementation context factors are associated with implementation outcomes in integrated SBMH.
UNASSIGNED: SBMH clinicians from community-based organizations (CBOs; nclinician=27) and their proximal student-support school staff (nschool=99) rated their schools and CBOs (clinician only) regarding general (organizational culture and molar climate) and implementation context factors (Implementation Climate and Leadership), and nine common implementation outcomes (e.g., treatment integrity, service access, acceptability). The levels of IOA were estimated by intra-class correlations (ICCs). We fitted multilevel models to estimate the standalone effects of context factors from CBOs and schools on implementation outcomes. We also estimated the 2-way interaction effects between CBO and school context factors (i.e., between-setting interdependence) on implementation outcomes.
UNASSIGNED: The IOA in general context factors exceeded those of implementation context factors. The standalone effects of implementation context factors on most implementation outcomes were larger than those of general context factors. Similarly, implementation context factors between CBOs and schools showed larger 2-way interaction effects on implementation outcomes than general context factors.
UNASSIGNED: This study preliminarily supported the importance of IOA in context factors for integrated SBMH. The findings shed light on how IOA in implementation and general context factors may be differentially associated with implementation outcomes across a broad array of integrated mental healthcare settings.

BACKGROUND: Hypertension (HTN) control among Blacks in the USA has become a major public health challenge. Barriers to HTN control exist at multiple levels including patient, physician, and the health system. Patients also encounter significant community-level barriers, such as poor linkage to social services that impact health (unstable housing, food access, transportation). We describe a multi-component needs assessment to inform the development, implementation, and evaluation of a program to improve HTN management within a large healthcare system in New York City (NYC).
METHODS: Guided by the Community-Based Participatory Research (CBPR) and Consolidated Framework for Implementation Research (CFIR) frameworks, data will be collected from four main sources: (1) quantitative surveys with health systems leadership, providers, and staff and with community-based organizations (CBOs) and faith-based organizations (FBOs); (2) qualitative interviews and focus groups with health systems leadership, providers, and staff and with CBOs and FBOs; (3) NYC Community Health Survey (CHS); and (4) New York University (NYU) Health system Epic Electronic Health Record (EHR) system. The data sources will allow for triangulation and synthesis of findings.
CONCLUSIONS: Findings from this comprehensive needs assessment will inform the development of a clinic-community-based practice facilitation program utilizing three multi-level evidence-based interventions (nurse case management, remote blood pressure (BP) monitoring, and social determinants of health (SDoH) support) integrated as a community-clinic linkage model for improved HTN control in Black patients. Integration of stakeholders\' priorities, perspectives, and practices into the development of the program will improve adoption, sustainability, and the potential for scale-up.
BACKGROUND: NCT05208450; registered on January 26, 2022.

In an effort to address the current opioid epidemic, a number of hospitals across the United States have implemented emergency department-based interventions for engaging patients presenting with opioid use disorder. The current study seeks to address gaps in knowledge regarding implementation of a sub-type of such interventions, emergency department-based peer support services, in rural areas by comparing implementation of rural and urban programs that participated in Indiana\'s Recovery Coach and Peer Support Initiative (RCPSI).
We conducted a secondary analysis of qualitative semi-structured implementation interviews collected as part of an evaluation of 10 programs (4 rural and 6 urban) participating in the RCPSI. We conducted interviews with representatives from each program at 3 time points over the course of the first year of implementation. Our deductive coding process was guided by the Consolidated Framework for Implementation Research (CFIR) and an external context taxonomy.
We identified key differences for rural programs corresponding to each of the 5 primary constructs in the coding scheme. (1) Intervention characteristics: rural sites questioned intervention fit with their context, required more adaptations, and encountered unexpected costs. (2) External context: rural sites were not appropriately staffed to meet patient needs, encountered logistical and legal barriers regarding patient privacy, and had limited patient transportation options. (3) Inner setting: rural sites lacked strong mechanisms for internal communication and difficulties integrating with pre-existing culture and climate. (4) Characteristics of individuals: some rural providers resisted working with peers due to pre-existing attitudes and beliefs. (5) Implementation process: rural sites spent more time identifying external partners and abandoned more components of their initial implementation plans.
Findings demonstrate how rural programs faced greater challenges implementing emergency department-based peer services over time. These challenges required flexible adaptations to originally intended plans. Rural programs likely require flexibility to adapt interventions that were developed in urban settings to ensure success considering local contextual constraints that were identified by our analysis.

BACKGROUND: For successful implementation of an innovation within a complex adaptive system, we need to understand the ways that implementation processes and their contexts shape each other. To do this, we need to explore the work people do to make sense of an innovation and integrate it into their workflow and the contextual elements that impact implementation. Combining Normalization Process Theory (NPT) with the Consolidated Framework for Implementation Research (CFIR) offers an approach to achieve this. NPT is an implementation process theory that explains how changes in the way people think about and use an innovation occurs, while CFIR is a framework that categorizes and describes contextual determinants across five domains that influence implementation. We demonstrate through a case example from our prior research how we integrated NPT and CFIR to inform the development of the interview guide, coding manual, and analysis of the findings.
METHODS: In collaboration with our stakeholders, we selected NPT and CFIR to study the implementation process and co-developed an interview guide to elicit responses that would illuminate concepts from both. We conducted, audio-recorded, and transcribed 28 interviews with various professionals involved with the implementation. Based on independent coding of select transcripts and team discussion comparing, clarifying, and crystallizing codes, we developed a coding manual integrating CFIR and NPT constructs. We applied the integrated codes to all interview transcripts.
RESULTS: Our findings highlight how integrating CFIR domains with NPT mechanisms adds explanatory strength to the analysis of implementation processes, with particular implications for practical strategies to facilitate implementation. Multiple coding across both theoretical frames captured the entanglement of process and context. Integrating NPT and CFIR enriched understandings of how interactions between implementation processes and contextual determinants shaped each other during implementation.
CONCLUSIONS: The integration of NPT and CFIR provides guidance to identify and explore complex entangled interactions between agents, processes, and contextual conditions within and beyond organizations to embed innovations into routine practices. Nuanced understandings gained through this approach moves understandings beyond descriptions of determinants to explain how change occurs or not during implementation. Mechanism-based explanations illuminate concrete practical strategies to support implementation.

In implementation science, contextual inquiry guides the implementation process for successful uptake of evidence-based practices. However, the conceptualization and measurement of context varies across frameworks and stakeholders. To move the field forward, future efforts to advance the understanding of context should incorporate input from implementation stakeholders through co-creation, elicit stakeholders\' perspectives in low- and middle-income countries (LMICs) to generate a more comprehensive list of determinants, and refine inconsistencies in terminology to promote research synthesis. Greater conceptual clarity and generalizability in contextual inquiry will enable improved communication and collaboration, thus facilitating a shift in focus to development and evaluation of implementation strategies to improve healthcare and health outcomes.

Developing effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for describing how strategies are adapted and modified in practice. We built on existing implementation science methods to provide novel methods for tracking strategy modifications.
These methods were developed within a stepped-wedge trial of an implementation strategy package designed to help community clinics adopt social determinants of health-related activities: in brief, an \'Implementation Support Team\' supports clinics through a multi-step process. These methods involve five components: 1) describe planned strategy; 2) track its use; 3) monitor barriers; 4) describe modifications; and 5) identify / describe new strategies. We used the Expert Recommendations for Implementing Change taxonomy to categorize strategies, Proctor et al.\'s reporting framework to describe them, the Consolidated Framework for Implementation Research to code barriers / contextual factors necessitating modifications, and elements of the Framework for Reporting Adaptations and Modifications-Enhanced to describe strategy modifications.
We present three examples of the use of these methods: 1) modifications made to a facilitation-focused strategy (clinics reported that certain meetings were too frequent, so their frequency was reduced in subsequent wedges); 2) a clinic-level strategy addition which involved connecting one study clinic seeking help with community health worker-related workflows to another that already had such a workflow in place; 3) a study-level strategy addition which involved providing assistance in overcoming previously encountered (rather than de novo) challenges.
These methods for tracking modifications made to implementation strategies build on existing methods, frameworks, and guidelines; however, as none of these were a perfect fit, we made additions to several frameworks as indicated, and used certain frameworks\' components selectively. While these methods are time-intensive, and more work is needed to streamline them, they are among the first such methods presented to implementation science. As such, they may be used in research on assessing effective strategy modifications and for replication and scale-up of effective strategies. We present these methods to guide others seeking to document implementation strategies and modifications to their studies.
clinicaltrials.gov ID: NCT03607617 (first posted 31/07/2018).