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      Integrated Smoking Cessation for Smokers With Serious Mental Illness: Protocol for a Convergent Mixed Methods Implementation Evaluation Study


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          Tobacco smoking is associated with significant morbidity and premature mortality in individuals with serious mental illness. A 2-year pragmatic clinical trial (PCORI PCS-1504-30472) that enrolled 1100 individuals with serious mental illness in the greater Boston area was conducted to test 2 interventions for tobacco cessation for individuals with serious mental illness: (1) academic detailing, which delivers education to primary care providers and highlights first-line pharmacotherapy for smoking cessation, and (2) provision of community health worker support to smoker participants. Implementing and scaling this intervention in other settings will require the systematic identification of barriers and facilitators, as well as the identification of relevant subgroups, effective and unique components, and setting-specific factors.


          This protocol outlines the proposed mixed methods evaluation of the pragmatic clinical trial to (1) identify barriers and facilitators to effective implementation of the interventions, (2) examine group differences among primary care physicians, and (3) identify barriers that stakeholders such as clinical, payor, and policy leaders would anticipate to impact the implementation of effective components of the intervention.


          Qualitative interviews will be conducted with all study community health workers and selected smoker participants, primary care providers, and other stakeholders. Measures of performance and engagement will guide purposive sampling. The Consolidated Framework for Implementation Research will guide qualitative data collection and analysis in accordance with the following framework approach: (1) familiarization, (2) identifying a thematic framework, (3) indexing, (4) charting, and (5) mapping and interpretation. Joint display analyses will be constructed to analyze and draw conclusions across the quantitative and qualitative data.


          The 3-year cluster-randomized trial has concluded, and the analysis of primary outcomes is underway. Results from the pragmatic trial and this mixed methods implementation evaluation will be used to help disseminate, scale, and expand a systems intervention.


          The results of this mixed methods implementation evaluation will inform strategies for dissemination and solutions to potential barriers to the implementation of interventions from a smoking cessation trial for individuals with serious mental illness.

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          Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

          Background Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. Methods We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. Results The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. Conclusion The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
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            Making sense of implementation theories, models and frameworks

            Background Implementation science has progressed towards increased use of theoretical approaches to provide better understanding and explanation of how and why implementation succeeds or fails. The aim of this article is to propose a taxonomy that distinguishes between different categories of theories, models and frameworks in implementation science, to facilitate appropriate selection and application of relevant approaches in implementation research and practice and to foster cross-disciplinary dialogue among implementation researchers. Discussion Theoretical approaches used in implementation science have three overarching aims: describing and/or guiding the process of translating research into practice (process models); understanding and/or explaining what influences implementation outcomes (determinant frameworks, classic theories, implementation theories); and evaluating implementation (evaluation frameworks). Summary This article proposes five categories of theoretical approaches to achieve three overarching aims. These categories are not always recognized as separate types of approaches in the literature. While there is overlap between some of the theories, models and frameworks, awareness of the differences is important to facilitate the selection of relevant approaches. Most determinant frameworks provide limited “how-to” support for carrying out implementation endeavours since the determinants usually are too generic to provide sufficient detail for guiding an implementation process. And while the relevance of addressing barriers and enablers to translating research into practice is mentioned in many process models, these models do not identify or systematically structure specific determinants associated with implementation success. Furthermore, process models recognize a temporal sequence of implementation endeavours, whereas determinant frameworks do not explicitly take a process perspective of implementation.
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              Achieving integration in mixed methods designs-principles and practices.

              Mixed methods research offers powerful tools for investigating complex processes and systems in health and health care. This article describes integration principles and practices at three levels in mixed methods research and provides illustrative examples. Integration at the study design level occurs through three basic mixed method designs-exploratory sequential, explanatory sequential, and convergent-and through four advanced frameworks-multistage, intervention, case study, and participatory. Integration at the methods level occurs through four approaches. In connecting, one database links to the other through sampling. With building, one database informs the data collection approach of the other. When merging, the two databases are brought together for analysis. With embedding, data collection and analysis link at multiple points. Integration at the interpretation and reporting level occurs through narrative, data transformation, and joint display. The fit of integration describes the extent the qualitative and quantitative findings cohere. Understanding these principles and practices of integration can help health services researchers leverage the strengths of mixed methods. © Health Research and Educational Trust.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                July 2021
                27 July 2021
                : 10
                : 7
                : e25390
                [1 ] Center for Addiction Medicine Massachusetts General Hospital Boston, MA United States
                [2 ] Harvard Medical School Boston, MA United States
                [3 ] Mixed Methods Program University of Michigan Ann Arbor, MI United States
                [4 ] Department of Family Medicine University of Michigan Ann Arbor, MI United States
                Author notes
                Corresponding Author: Kristina Schnitzer kschnitzer@ 123456partners.org
                Author information
                ©Kristina Schnitzer, Melissa Culhane Maravić, Diana Arntz, Nathaniel L Phillips, Gladys Pachas, A Eden Evins, Michael Fetters. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.07.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 30 October 2020
                : 1 March 2021
                : 25 March 2021
                : 26 April 2021

                mixed methods implementation evaluation,pharmacotherapeutic smoking cessation aids,serious mental illness,smoking cessation,tobacco


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