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Abstract Background Understanding how and when a new evidence-based clinical intervention becomes standard practice is crucial to ensure that healthcare is delivered in alignment with the most up-to-date knowledge. However, rigorous methods are needed to determine when a new clinical practice becomes normalized to the standard of care. To address this gap, this study qualitatively explores how, when, and why a clinical practice change becomes normalized within healthcare organizations. Methods We used purposive sampling to recruit clinical leaders who worked in quality improvement and/or implementation science in diverse health contexts. Enrolled participants completed semi-structured interviews around implementing evidence-based practices. Qualitative data was inductively and deductively analyzed, and was guided by a modified version of the Normalization Process Theory (NPT) framework to identify salient themes. Additionally, identified normalization strategies were mapped to the Expert Recommendations for Implementation Change (ERIC) project. Results A total of 17 individuals were interviewed. Two categories of themes emerged: 1) signals of when a new clinical practice is considered to be normalized within clinical care; and 2) strategies utilized to normalize new clinical innovations. Participants described four key signals for identifying when a novel clinical practice becomes the new normal: 1) integrated seamlessly into existing workflows; 2) scaled across the entire organizational unit; 3) has strong staff buy-in and ownership; and 4) no longer needs monitoring and evaluation to be sustained. Major strategies to normalize new clinical interventions included: 1) taking a patient approach that starts slow and gains momentum; 2) identifying and using methods to gain staff buy-in and ownership; and 3) conducting ongoing measurement of progress towards normalization. Conclusions The results offer valuable insight into the indicators that signify when a novel clinical practice becomes normalized, and the strategies employed to facilitate this transition. These findings can inform future research to develop instruments that implementation leaders can use to systematically measure the clinical change process.

Abstract Background Xylazine is an increasingly common adulterant in the North American unregulated drug supply that is associated with adverse health outcomes (e.g., skin infections, overdose). However, there are significant knowledge gaps regarding how xylazine was initially identified and how syringe services program (SSP) staff and clients (people who use drugs) responded to its emergence. Methods From June–July 2023, we conducted qualitative interviews with medical (e.g., clinicians) and frontline SSP staff (e.g., outreach workers) and adult clients with a history of injection drug use at a Miami-based SSP. Inductive memos identified emergent codes; thematic analysis involving team consensus established final themes. Results From interviews with SSP staff (n = 8) and clients (n = 17), xylazine emergence was identified at different times, in various ways. Initially, during summer 2022, clients identified a “tranquilizer-like substance” that worsened sedation and withdrawal and caused wounds. SSP medical staff later identified this adulterant as xylazine by treating new medical cases and through diverse information-sharing networks that included professional societies and news sources; however, frontline SSP staff and clients needed additional educational resources about xylazine and its side effects. With limited guidance on how to reduce harm from xylazine, SSP clients altered their drug consumption routes, reduced drug use, and relied on peers’ experiences with the drug supply to protect themselves. Some individuals also reported preferring xylazine-adulterated opioids and increasing their drug use, including the use of stimulants to avoid over sedation. Conclusions Xylazine’s emergence characterizes the current era of unprecedented shifts in the unregulated drug supply. We found that xylazine spurred important behavioral changes among people who use drugs (e.g., transitioning from injecting to smoking). Incorporating these experiences into early drug warning surveillance systems and scaling up drug-checking services and safer smoking supply distribution could help mitigate significant health harms caused by xylazine and other emergent adulterants.

The Medicaid Inmate Exclusion Policy (MIEP) prohibits using federal funds for ambulatory care services and medications (including for infectious diseases) for incarcerated persons. More than one quarter of states, including California and Massachusetts, have asked the federal government for authority to waive the MIEP. To improve health outcomes and continuation of care, those states seek to cover transitional care services provided to persons in the period before release from incarceration. The Massachusetts Sheriffs’ Association, Massachusetts Department of Correction, Executive Office of Health and Human Services, and University of Massachusetts Chan Medical School have collaborated to improve infectious disease healthcare service provision before and after release from incarceration. They seek to provide stakeholders working at the intersection of criminal justice and healthcare with tools to advance Medicaid policy and improve treatment and prevention of infectious diseases for persons in jails and prisons by removing MIEP barriers through Section 1115 waivers.

Abstract Background A myriad of federal, state, and organizational policies are designed to improve access to evidence-based healthcare, but the impact of these policies likely varies due to contextual determinants of, reinterpretations of, and poor compliance with policy requirements throughout implementation. Strategies enhancing implementation and compliance with policy intent can improve population health. Critically assessing the multi-level environments where health policies and their related health services are implemented is essential to designing effective policy-level implementation strategies. California passed a 2019 health insurance benefit mandate requiring coverage of fertility preservation services for individuals at risk of infertility due to medical treatments, in order to improve access to services that are otherwise cost prohibitive. Our objective was to document and understand the multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to fertility preservation services. Methods We conducted a mixed-methods study and used the policy-optimized exploration, preparation, implementation, and sustainment (EPIS) framework to analyze the implementation of California’s fertility preservation benefit mandate (SB 600) at and between the state insurance regulator, insurer, and clinic levels. Results Seventeen publicly available fertility preservation benefit mandate-relevant documents were reviewed. Interviews were conducted with four insurers; 25 financial, administrative, and provider participants from 16 oncology and fertility clinics; three fertility pharmaceutical representatives; and two patient advocates. The mandate and insurance regulator guidance represented two “Big P” (system level) policies that gave rise to a host of “little p” (organizational) policies by and between the regulator, insurers, clinics, and patients. Many little p policies were bridging factors to support implementation across levels and fertility preservation service access. Characterizing the mandate’s functions (i.e., policy goals) and forms (i.e., ways that policies were enacted) led to identification of (1) intended and unintended implementation, service, and patient outcomes, (2) implementation processes by level and EPIS phase, (3) actor-delineated key processes and heterogeneity among them, and (4) inner and outer context determinants that drove adaptations. Conclusions Following the midstream and downstream implementation of a state health insurance benefit mandate, data generated will enable development of policy-level implementation strategies, evaluation of determinants and important outcomes of effective implementation, and design of future mandates to improve fit and fidelity.

Abstract Background Improving access to high-quality healthcare for individuals in correctional settings is critical to advancing health equity in the United States. Compared to the general population, criminal-legal involved individuals experience higher rates of chronic health conditions and poorer health outcomes. Implementation science frameworks and strategies offer useful tools to integrate health interventions into criminal-legal settings and to improve care. A review of implementation science in criminal-legal settings to date is necessary to advance future applications. This systematic review summarizes research that has harnessed implementation science to promote the uptake of effective health interventions in adult criminal-legal settings. Methods A systematic review of seven databases (Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Social Work Abstracts, ProQuest Criminal Justice Database, ProQuest Sociological Abstracts, MEDLINE/PubMed) was conducted. Eligible studies used an implementation science framework to assess implementation outcomes, determinants, and/or implementation strategies in adult criminal-legal settings. Qualitative synthesis was used to extract and summarize settings, study designs, sample characteristics, methods, and application of implementation science methods. Implementation strategies were further analyzed using the Pragmatic Implementation Reporting Tool. Results Twenty-four studies met inclusion criteria. Studies implemented interventions to address infectious diseases (n=9), substance use (n=6), mental health (n=5), co-occurring substance use and mental health (n=2), or other health conditions (n=2). Studies varied in their operationalization and description of guiding implementation frameworks/taxonomies. Sixteen studies reported implementation determinants and 12 studies measured implementation outcomes, with acceptability (n=5), feasibility (n=3), and reach (n=2) commonly assessed. Six studies tested implementation strategies. Systematic review results were used to generate recommendations for improving implementation success in criminal-legal contexts. Conclusions The focus on implementation determinants in correctional health studies reflects the need to tailor implementation efforts to complex organizational and inter-agency contexts. Future studies should investigate policy factors that influence implementation success, design, and test implementation strategies tailored to determinants, and investigate a wider array of implementation outcomes relevant to criminal-legal settings, health interventions relevant to adult and juvenile populations, and health equity outcomes. Trial registration A study protocol (CRD42020114111) was registered with Prospero.

Abstract Background It is challenging to identify and understand the specific mechanisms through which an implementation strategy affects implementation outcomes, as implementation happens in the context of complex, multi-level systems. These systems and the mechanisms within each level have their own dynamic environments that change frequently. For instance, sequencing may matter in that a mechanism may only be activated indirectly by a strategy through another mechanism. The dosage or strength of a mechanism may vary over time or across different health care system levels. To elucidate the mechanisms relevant to successful implementation amidst this complexity, systems analysis methods are needed to model and manage complexity. Methods The fields of systems engineering and systems science offer methods—which we refer to as systems analysis methods—to help explain the interdependent relationships between and within systems, as well as dynamic changes to systems over time. When applied to studying implementation mechanisms, systems analysis methods can help (i) better identify and manage unknown conditions that may or may not activate mechanisms (both expected mechanisms targeted by a strategy and unexpected mechanisms that the methods help detect) and (ii) flexibly guide strategy adaptations to address contextual influences that emerge after the strategy is selected and used. Results In this paper, we delineate a structured approach to applying systems analysis methods for examining implementation mechanisms. The approach includes explicit steps for selecting, tailoring, and evaluating an implementation strategy regarding the mechanisms that the strategy is initially hypothesized to activate, as well as additional mechanisms that are identified through the steps. We illustrate the approach using a case example. We then discuss the strengths and limitations of this approach, as well as when these steps might be most appropriate, and suggest work to further the contributions of systems analysis methods to implementation mechanisms research. Conclusions Our approach to applying systems analysis methods can encourage more mechanisms research efforts to consider these methods and in turn fuel both (i) rigorous comparisons of these methods to alternative mechanisms research approaches and (ii) an active discourse across the field to better delineate when these methods are appropriate for advancing mechanisms-related knowledge.

Abstract Background Engaging policy actors in research design and execution is critical to increasing the practical relevance and real-world impact of policy-focused dissemination and implementation science. Identifying and selecting which policy actors to engage, particularly actors involved in “Big P” public policies such as laws, is distinct from traditional engaged research methods. This current study aimed to develop a transparent, structured method for iteratively identifying policy actors involved in key policy decisions—such as adopting evidence-based interventions at systems-scale—and to guide implementation study sampling and engagement approaches. A flexible policy actor taxonomy was developed to supplement existing methods and help identify policy developers, disseminators, implementers, enforcers, and influencers. Methods A five-step methodology for identifying policy actors to potentially engage in policy dissemination and implementation research was developed. Leveraging a recent federal policy as a case study—The Family First Prevention Services Act (FFPSA)—publicly available documentation (e.g., websites, reports) were searched, retrieved, and coded using content analysis to characterize the organizations and individual policy actors in the “room” during policy decisions. Results The five steps are as follows: (1) clarify the policy implementation phase(s) of interest, (2) identify relevant proverbial or actual policymaking “rooms,” (3) identify and characterize organizations in the room, (4) identify and characterize policy actors in the “room,” and (5) quantify (e.g., count actors across groups), summarize, and compare “rooms” to develop or select engagement approaches aligned with the “room” and actors. The use and outcomes of each step are exemplified through the FFPSA case study. Conclusions The pragmatic and transparent policy actor identification steps presented here can guide researchers’ methods for continuous sampling and successful policy actor engagement. Future work should explore the utility of the proposed methods for guiding selection and tailoring of engagement and implementation strategies (e.g., research-policy actor partnerships) to improve both “Big P” and “little p” (administrative guidelines, procedures) policymaking and implementation in global contexts.

Abstract Background The existing grant review criteria do not consider unique methods and priorities of Dissemination and Implementation Science (DIS). The ImplemeNtation and Improvement Science Proposals Evaluation CriTeria (INSPECT) scoring system includes 10 criteria based on Proctor et al.’s “ten key ingredients” and was developed to support the assessment of DIS research proposals. We describe how we adapted INSPECT and used it in combination with the NIH scoring system to evaluate pilot DIS study proposals through our DIS Center. Methods We adapted INSPECT to broaden considerations for diverse DIS settings and concepts (e.g., explicitly including dissemination and implementation methods). Five PhD-level researchers with intermediate to advanced DIS knowledge were trained to conduct reviews of seven grant applications using both the INSPECT and NIH criteria. The INSPECT overall scores range from 0 to 30 (higher scores are better), and the NIH overall scores range from 1 to 9 (lower scores are better). Each grant was independently reviewed by two reviewers, then discussed in a group meeting to compare the experiences using both criteria to evaluate the proposal and to finalize scoring decisions. A follow-up survey was sent to grant reviewers to solicit further reflections on each scoring criterion. Results Averaged across reviewers, the INSPECT overall scores ranged from 13 to 24, while the NIH overall scores ranged from 2 to 5. Reviewer reflections highlighted the unique value and utility for each scoring criterion. The NIH criteria had a broad scientific purview and were better suited to evaluate more effectiveness-focused and pre-implementation proposals not testing implementation strategies. The INSPECT criteria were easier to rate in terms of the quality of integrating DIS considerations into the proposal and to assess the potential for generalizability, real-world feasibility, and impact. Overall, reviewers noted that INSPECT was a helpful tool to guide DIS research proposal writing. Conclusions We confirmed complementarity in using both scoring criteria in our pilot study grant proposal review and highlighted the utility of INSPECT as a potential DIS resource for training and capacity building. Possible refinements to INSPECT include more explicit reviewer guidance on assessing pre-implementation proposals, providing reviewers with the opportunity to submit written commentary with each numerical rating, and greater clarity on rating criteria with overlapping descriptions.

Abstract Background Policy is a powerful tool for systematically altering healthcare access and quality, but the research to policy gap impedes translating evidence-based practices into public policy and limits widespread improvements in service and population health outcomes. The US opioid epidemic disproportionately impacts Medicaid members who rely on publicly funded benefits to access evidence-based treatment including medications for opioid use disorder (MOUD). A myriad of misaligned policies and evidence-use behaviors by policymakers across federal agencies, state Medicaid agencies, and managed care organizations limit coverage of and access to MOUD for Medicaid members. Dissemination strategies that improve policymakers’ use of current evidence are critical to improving MOUD benefits and reducing health disparities. However, no research describes key determinants of Medicaid policymakers’ evidence use behaviors or preferences, and few studies have examined data-driven approaches to developing dissemination strategies to enhance evidence-informed policymaking. This study aims to identify determinants and intermediaries that influence policymakers’ evidence use behaviors, then develop and test data-driven tailored dissemination strategies that promote MOUD coverage in benefit arrays. Methods Guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, we will conduct a national survey of state Medicaid agency and managed care organization policymakers to identify determinants and intermediaries that influence how they seek, receive, and use research in their decision-making processes. We will use latent class methods to empirically identify subgroups of agencies with distinct evidence use behaviors. A 10-step dissemination strategy development and specification process will be used to tailor strategies to significant predictors identified for each latent class. Tailored dissemination strategies will be deployed to each class of policymakers and assessed for their acceptability, appropriateness, and feasibility for delivering evidence about MOUD benefit design. Discussion This study will illuminate key determinants and intermediaries that influence policymakers’ evidence use behaviors when designing benefits for MOUD. This study will produce a critically needed set of data-driven, tailored policy dissemination strategies. Study results will inform a subsequent multi-site trial measuring the effectiveness of tailored dissemination strategies on MOUD benefit design and implementation. Lessons from dissemination strategy development will inform future research about policymakers’ evidence use preferences and offer a replicable process for tailoring dissemination strategies.

Abstract Background Implementation science aims to accelerate the public health impact of evidence-based interventions. However, implementation science has had too little focus on the role of health policy — and its inseparable politics, polity structures, and policymakers — in the implementation and sustainment of evidence-based healthcare. Policies can serve as determinants, implementation strategies, the evidence-based “thing” to be implemented, or another variable in the causal pathway to healthcare access, quality, and patient outcomes. Research describing the roles of policy in dissemination and implementation (D&I) efforts is needed to resolve persistent knowledge gaps about policymakers’ evidence use, how evidence-based policies are implemented and sustained, and methods to de-implement policies that are ineffective or cause harm. Few D&I theories, models, or frameworks (TMF) explicitly guide researchers in conceptualizing where, how, and when policy should be empirically investigated. We conducted and reflected on the results of a scoping review to identify gaps of existing Exploration, Preparation, Implementation, and Sustainment (EPIS) framework-guided policy D&I studies. We argue that rather than creating new TMF, researchers should optimize existing TMF to examine policy’s role in D&I. We describe six recommendations to help researchers optimize existing D&I TMF. Recommendations are applied to EPIS, as one example for advancing TMF for policy D&I. Recommendations (1) Specify dimensions of a policy’s function (policy goals, type, contexts, capital exchanged). (2) Specify dimensions of a policy’s form (origin, structure, dynamism, outcomes). (3) Identify and define the nonlinear phases of policy D&I across outer and inner contexts. (4) Describe the temporal roles that stakeholders play in policy D&I over time. (5) Consider policy-relevant outer and inner context adaptations. (6) Identify and describe bridging factors necessary for policy D&I success. Conclusion Researchers should use TMF to meaningfully conceptualize policy’s role in D&I efforts to accelerate the public health impact of evidence-based policies or practices and de-implement ineffective and harmful policies. Applying these six recommendations to existing D&I TMF advances existing theoretical knowledge, especially EPIS application, rather than introducing new models. Using these recommendations will sensitize researchers to help them investigate the multifaceted roles policy can play within a causal pathway leading to D&I success.

Background: A major part of the HEALing Communities Study (HCS), launched in 2019 to address the growing opioid epidemic, is evaluating the study’s intervention implementation process through an implementation science (IS) approach. One component of the IS approach involves teams with more than 20 researchers collaborating across four research sites to conduct in-depth qualitative interviews with over 300 participants at four time points. After completion of the first two rounds of data collection, we reflect upon our qualitative data collection and analysis approach. We aim to share our lessons learned about designing and applying qualitative methods within an implementation science framework. Methods: The HCS evaluation is based on the RE-AIM/PRISM framework and incorporates interviews at four timepoints. At each timepoint, the core qualitative team of the Intervention Work Group drafts an interview guide based on the framework and insights from previous round(s) of data collection. Researchers then conduct interviews with key informants and coalition members within their respective states. Data analysis involves drafting, iteratively refining, and finalizing a codebook in a cross-site and within-site consensus processes. Interview transcripts are then individually coded by researchers within their respective states. Results: Successes in the evaluation process include having structured procedures for communication, data collection, and analysis, all of which are critical for ensuring consistent data collection and for achieving consensus during data analysis. Challenges include recognizing and accommodating the diversity of training and knowledge among researchers, as well as establishing reliable ways to securely store, manage, and share the large volumes of data. Conclusion: Qualitative methods using a Team Science approach have been limited in their application in large, multi-site randomized controlled trials of health interventions. Our experience provides practical guidance for future studies with large teams that are experientially and disciplinarily diverse and that are seeking to incorporate qualitative or mixed-methods components for their evaluations.

Abstract Background Despite the important upstream impact policy has on population health outcomes, few studies in implementation science in health have examined implementation processes and strategies used to translate state and federal policies into accessible services in the community. This study examines the policy implementation strategies and experiences of Medicaid programs in three US states that responded to a federal prompt to improve access to evidence-based practice (EBP) substance use disorder (SUD) treatment. Methods Three US state Medicaid programs implementing American Society of Addiction Medicine (ASAM) Criteria-driven SUD services under Section 1115 waiver authority were used as cases. We conducted 44 semi-structured interviews with Medicaid staff, providers and health systems partners in California, Virginia, and West Virginia. Interviews were triangulated with document review of state readiness and implementation plans. The Exploration, Preparation, Implementation, Sustainment Framework (EPIS) guided qualitative theme analysis. The Expert Recommendations for Implementing Change and Specify It criteria were used to create a taxonomy of policy implementation strategies used by policymakers to promote providers’ uptake of statewide EBP SUD care continuums. Results Four themes describe states’ experiences and outcomes implementing a complex EBP SUD treatment policy directive: (1) Medicaid agencies adapted their inner/outer contexts to align with EBPs and adapted EBPs to fit their local context; (2) enhanced financial reimbursement arrangements were inadequate bridging factors to achieve statewide adoption of new SUD services; (3) despite trainings, service providers and managed care organizations demonstrated poor fidelity to the ASAM Criteria; and (4) successful policy adoption at the state level did not guarantee service providers’ uptake of EBPs. States used 29 implementation strategies to implement EBP SUD care continuums. Implementation strategies were used in the Exploration (n=6), Preparation (n=10), Implementation (n=19), and Sustainment (n=6) phases, and primarily focused on developing stakeholder interrelationships, evaluative and iterative approaches, and financing. Conclusions This study enhances our understanding of statewide policy implementation outcomes in low-resource, public healthcare settings. Themes highlight the need for additional pre-implementation and sustainment focused implementation strategies. The taxonomy of detailed policy implementation strategies employed by policymakers across states should be tested in future policy implementation research.

Background In 2016, the California Department of Healthcare Services (DHCS) released an “All Plan Letter” (APL 16-014) to its Medicaid managed care plans (MCPs) providing guidance on implementing tobacco-cessation coverage among Medicaid beneficiaries. However, implementation remains poor. We apply the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to identify barriers and facilitators to fidelity to APL 16-014 across California Medicaid MCPs. Methods We assessed fidelity through semi-structured interviews with MCP health educators ( N = 24). Interviews were recorded, transcribed, and reviewed to develop initial themes regarding barriers and facilitators to implementation. Initial thematic summaries were discussed and mapped onto EPIS constructs. Results The APL (Innovation) was described as lacking clarity and specificity in its guidelines, hindering implementation. Related to the Inner Context, MCPs described the APL as beyond the scope of their resources, pointing to their own lack of educational materials, human resources, and poor technological infrastructure as implementation barriers. In the Outer Context, MCPs identified a lack of incentives for providers and beneficiaries to offer and participate in tobacco-cessation programs, respectively. A lack of communication, educational materials, and training resources between the state and MCPs (missing Bridging Factors) were barriers to preventing MCPs from identifying smoking rates or gauging success of tobacco-cessation efforts. Facilitators included several MCPs collaborating with each other and using external resources to promote tobacco cessation. Additionally, a few MCPs used fidelity monitoring staff as Bridging Factors to facilitate provider training, track providers’ identification of smokers, and follow-up with beneficiaries participating in tobacco-cessation programs. Conclusions The release of the evidence-based APL 16-014 by California's DHCS was an important step forward in promoting tobacco-cessation services for Medicaid MCP beneficiaries. Improved communication on implementation in different environments and improved Bridging Factors such as incentives for providers and patients are needed to fully realize policy goals. Plan Language Summary In 2016, the California Department of Healthcare Services (DHCS) in California released an “All Plan Letter” (APL 16-014) to its Medicaid managed care plans (MCPs) providing guidance on implementing tobacco-cessation coverage to address tobacco use among Medicaid beneficiaries. We conducted semi-structured interviews with health educators in California Medicaid MCPs to explore the barriers and facilitators to implementing the APL using the Exploration, Preparation, Implementation, Sustainment framework. According to MCPs, barriers included a lack of clarity in the APL guidelines; a lack of resources, including educational materials, infrastructure to identify smokers, and human resources; and a lack of incentives or penalties for providers to provide tobacco-cessation materials to beneficiaries. Facilitators included collaboration between MCPs and state and/or national public health programs. Overall, our findings can provide avenues for improving the implementation of tobacco-cessation services within Medicaid MCPs.