Understanding implementation research collaborations from a co-creation lens: recommendations for a path forward

Increasing calls within the field of implementation science (IS) research seek to promote active engagement of diverse and often disenfranchised stakeholder voices to increase buy-in, fidelity, outcome relevance, and sustainment of evidence-based practices (EBPs). Including such voices requires cultural humility and the integration of multiple perspectives and values among organizations, groups, and individuals. However, the IS field lacks guidance for researchers on structuring collaborative approaches to promote a co-created process (i.e., synergistic approach to goal attainment). We contend that improved operationalization of co-created implementation collaborations is critical to sparking synergy and addressing differentials based on power, privilege, knowledge, and access to resources among stakeholders. These differentials can undermine future implementation and sustainment efforts if not addressed early in the research effort. An insufficient understanding of the guiding principles of co-created implementation collaborations may limit the scientific value of evaluation processes, and researchers' ability to replicate outcomes. We propose a perspective foregrounded in the concept of co-creation to guide the structuring of implementation collaboratives through five principles. We offer three case examples informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework to illustrate the application of these co-creation principles. Lastly, we offer recommendations for promoting co-creation in IS research moving forward

Who’s “in the room where it happens”? A taxonomy and five-step methodology for identifying and characterizing policy actors

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

Tailoring dissemination strategies to increase evidence-informed policymaking for opioid use disorder treatment: study protocol.

BackgroundPolicy 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.MethodsGuided 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.DiscussionThis 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

Tailoring dissemination strategies to increase evidence-informed policymaking for opioid use disorder treatment: Study protocol

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.</p

Where is “policy” in dissemination and implementation science? Recommendations to advance theories, models, and frameworks: EPIS as a case example

BackgroundImplementation 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&amp;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&amp;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&amp;I studies. We argue that rather than creating new TMF, researchers should optimize existing TMF to examine policy's role in D&amp;I. We describe six recommendations to help researchers optimize existing D&amp;I TMF. Recommendations are applied to EPIS, as one example for advancing TMF for policy D&amp;I.Recommendations(1)&nbsp;Specify dimensions of a policy's function (policy goals, type, contexts, capital exchanged). (2)&nbsp;Specify dimensions of a policy's form (origin, structure, dynamism, outcomes). (3)&nbsp;Identify and define the nonlinear phases of policy D&amp;I across outer and inner contexts. (4)&nbsp;Describe the temporal roles that stakeholders play in policy D&amp;I over time. (5)&nbsp;Consider policy-relevant outer and inner context adaptations. (6) Identify and describe bridging factors necessary for policy D&amp;I success.ConclusionResearchers should use TMF to meaningfully conceptualize policy's role in D&amp;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&amp;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&amp;I success

Applying the EPIS framework to policy-level considerations: Tobacco cessation policy implementation among California Medicaid managed care plans.

BackgroundIn 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.MethodsWe 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.ResultsThe 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.ConclusionsThe 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 summaryIn 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

Enhancing review criteria for dissemination and implementation science grants.

BackgroundThe 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.MethodsWe 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.ResultsAveraged 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.ConclusionsWe 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

A structured approach to applying systems analysis methods for examining implementation mechanisms

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

The application of implementation science methods in correctional health intervention research: a systematic review

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

Standardizing an approach to the evaluation of implementation science proposals

Abstract Background The fields of implementation and improvement sciences have experienced rapid growth in recent years. However, research that seeks to inform health care change may have difficulty translating core components of implementation and improvement sciences within the traditional paradigms used to evaluate efficacy and effectiveness research. A review of implementation and improvement sciences grant proposals within an academic medical center using a traditional National Institutes of Health framework highlighted the need for tools that could assist investigators and reviewers in describing and evaluating proposed implementation and improvement sciences research. Methods We operationalized existing recommendations for writing implementation science proposals as the ImplemeNtation and Improvement Science Proposals Evaluation CriTeria (INSPECT) scoring system. The resulting system was applied to pilot grants submitted to a call for implementation and improvement science proposals at an academic medical center. We evaluated the reliability of the INSPECT system using Krippendorff’s alpha coefficients and explored the utility of the INSPECT system to characterize common deficiencies in implementation research proposals. Results We scored 30 research proposals using the INSPECT system. Proposals received a median cumulative score of 7 out of a possible score of 30. Across individual elements of INSPECT, proposals scored highest for criteria rating evidence of a care or quality gap. Proposals generally performed poorly on all other criteria. Most proposals received scores of 0 for criteria identifying an evidence-based practice or treatment (50%), conceptual model and theoretical justification (70%), setting’s readiness to adopt new services/treatment/programs (54%), implementation strategy/process (67%), and measurement and analysis (70%). Inter-coder reliability testing showed excellent reliability (Krippendorff’s alpha coefficient 0.88) for the application of the scoring system overall and demonstrated reliability scores ranging from 0.77 to 0.99 for individual elements. Conclusions The INSPECT scoring system presents a new scoring criteria with a high degree of inter-rater reliability and utility for evaluating the quality of implementation and improvement sciences grant proposals