Implementation science in community pharmacy : development of frameworks, models and tools for introducing and integrating professional services

University of Technology Sydney. Graduate School of Health.Background: Internationally, professional pharmacy services are being remunerated and community pharmacies are beginning to implement, however there appears to be a pervasive challenge to achieving widespread support and integration into routine practice. The use of implementation science to conduct implementation studies and evaluate implementation efforts may assist community pharmacy move towards the ultimate goal of sustained service provision and improved health outcomes for the communities they serve. Objectives: To synthesise, analyse and progress knowledge concerning implementation science, then contextualise and apply this knowledge for the implementation of professional services in community pharmacy internationally. The research aims to conceptualise and define the process, influences and indicators for the implementation of professional services in community pharmacy. Methodology: Mixed methodologies were employed. Two theoretical works were conducted to develop definitions and models based on reviews of pharmacy practice, health services and implementation science literature (chapters 3 and 6). A systematic review methodology was used to investigate implementation frameworks of innovations in healthcare (chapter 4). A qualitative study involving semi‐structured interviews examined the implementation process and influences in community pharmacies across Australia. Thematic framework analysis of the data was performed (chapter 5). In Spain, both qualitative and quantitative approaches were applied to develop and test two tools, for the medication review with follow‐up service being implemented in Spain, as measures of the implementation outcome, fidelity (chapter 7). Results: Professional pharmacy services were defined and placed within a model of the overall service offering of a pharmacy (chapter 3). The core concepts across implementation frameworks (i.e. (i) an innovation, (ii) a multi-level context, (iii) a complex multi‐stage process, influenced by a range of (iv) factors, (v) strategies and (vi) evaluations), were collated in a cross‐disciplinary, overarching Generic Implementation Framework (GIF) (chapter 4). The concepts were contextualised for community pharmacy as the Framework for the Implementation of Services in Pharmacy (FISpH) (chapter 5). A model for the evaluation of implementation programs and professional pharmacy services was designed to include implementation impact, process and outcome indicators (chapter 6). Two implementation tools were developed and tested: a 39 item adherence index and a 12 item, 2‐factor patient responsiveness scale (chapter 7). Conclusion: Implementation science provides a base for community pharmacy as they move towards the introduction and integration of professional pharmacy service. The incorporated definitions, models and tools of the framework have been applied in practice to develop implementation programs and implementation research protocols, both in Australia and Spain. [Español] Antecedentes: A nivel internacional, los servicios profesionales farmacéuticos están siendo remunerados y las farmacias comunitarias están empezando a implantarlos; sin embargo, lograr su integración generalizada en la práctica rutinaria está resultando un importante desafío. El uso de la ciencia de implantación para desarrollar estudios de implantación y medir indicadores de implantación de servicios puede ayudar a la farmacia comunitaria a avanzar hacia el objetivo final de la prestación sostenible de servicios y la mejora de los resultados de salud para las comunidades que atienden. Objetivos: Sintetizar, analizar y avanzar el conocimiento relativo a la ciencia de implantación para su posterior contextualización y aplicación en la implantación de servicios profesionales en farmacia comunitaria. Más concretamente, la investigación pretende conceptualizar y definir los procesos, influencias e indicadores para la implantación de dichos servicios profesionales. Metodología: Se emplearon metodologías mixtas. Se realizaron dos trabajos teóricos basados en la literatura científica del ámbito de la práctica de farmacia, los servicios de salud y la ciencia de implantación para desarrollar definiciones y modelos que contextualizaran el trabajo a realizar (capítulos 3 y 6). Se realizó una revisión sistemática para investigar los marcos teóricos para la implantación de innovaciones en el área de la asistencia sanitaria (capitulo 4). Tambien se llevó a cabo un estudio cualitativo con entrevistas semi‐estructuradas que examinó el proceso de implantación y los factores que lo influyen en las farmacias comunitarias en Australia (capitulo 5). En España, se aplicaron metodologías cualitativas y cuantitativas para desarrollar y testar dos herramientas que permitieran medir los resultados de la implantación del servicio de Seguimiento Farmacoterapéutico; concretamente la fidelidad (capitulo 7). Resultados: Los servicios profesionales de la farmacia fueron definidos y contextualizados dentro de la oferta global de servicios que puede realizar una farmacia comunitaria (capitulo 3). Los conceptos fundamentales incluidos en los marcos de implantación (es decir, (i) una innovación, (ii) un contexto multinivel, (iii) un proceso complejo de varias etapas, influido por una serie de (iv) factores, (v) estrategias y (vi) evaluaciones), se recopilaron en un marco interdisciplinario general, el Marco Genérico de la Implantación (capitulo 4). Estos conceptos fueron contextualizados para la farmacia comunitaria en una nueva versión adaptada del mencionado marco (Marco para la Implantación de Servicios en la Farmacia) (capitulo 5). Se desarrolló un modelo para la evaluación de los programas de implantación y los servicios profesionales farmacéuticos, incluyendo indicadores de impacto, proceso y resultados de la implantación (capitulo 6). Finalmente, se desarrollaron y testaron dos herramientas de para medir la implantación de servicios profesionales: un índice de adherencia de 39 ítems y una escala de receptividad del paciente de 12 ítems en 2 factores (capitulo 7). Conclusiones: La ciencia de la implantación proporciona una base para la introducción e integración de los servicios profesionales en la farmacia comunitaria. Las definiciones, modelos y herramientas incorporadas en el marco genérico de la implantación derivado de esta tesis, se han aplicado en la práctica para el desarrollo de protocolos de investigación y programas de implantación, tanto en Australia y España

The value of implementation science in bridging the evidence gap in bereavement care

There is a gap in the use of evidence in bereavement care. Implementation science is a field focused on moving evidence into practice and therefore may help close the gap. Implementation science advances the design, relevance, and dissemination of research and the adoption, implementation, and maintenance of evidence-based practices. We provide an overview of implementation science, describe five implementation frameworks (Knowledge to Action; Behavior Change Wheel; Exploration Preparation Implementation Sustainment; Interactive Systems Framework; and Reach, Adoption, Implementation, Maintenance), and illustrate their application in bereavement care. These advancements will promote high-quality bereavement care that improves the lives of bereaved people

Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework

Background: Effective implementation of evidence-based practices (EBPs) remains a significant challenge. Numerous existing models and frameworks identify key factors and processes to facilitate implementation. However, there is a need to better understand how individual models and frameworks are applied in research projects, how they can support the implementation process, and how they might advance implementation science. This systematic review examines and describes the research application of a widely used implementation framework, the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Methods: A systematic literature review was performed to identify and evaluate the use of the EPIS framework in implementation efforts. Citation searches in PubMed, Scopus, PsycINFO, ERIC, Web of Science, Social Sciences Index, and Google Scholar databases were undertaken. Data extraction included the objective, language, country, setting, sector, EBP, study design, methodology, level(s) of data collection, unit(s) of analysis, use of EPIS (i.e., purpose), implementation factors and processes, EPIS stages, implementation strategy, implementation outcomes, and overall depth of EPIS use (rated on a 1-5 scale). Results: In total, 762 full-text articles were screened by four reviewers, resulting in inclusion of 67 articles, representing 49 unique research projects. All included projects were conducted in public sector settings. The majority of projects (73%) investigated the implementation of a specific EBP. The majority of projects (90%) examined inner context factors, 57% examined outer context factors, 37% examined innovation factors, and 31% bridging factors (i.e., factors that cross or link the outer system and inner organizational context). On average, projects measured EPIS factors across two of the EPIS phases (M = 2.02), with the most frequent phase being Implementation (73%). On average, the overall depth of EPIS inclusion was moderate (2.8 out of 5). Conclusion: This systematic review enumerated multiple settings and ways the EPIS framework has been applied in implementation research projects, and summarized promising characteristics and strengths of the framework, illustrated with examples. Recommendations for future use include more precise operationalization of factors, increased depth and breadth of application, development of aligned measures, and broadening of user networks. Additional resources supporting the operationalization of EPIS are available

Leading for the long haul: A mixed-method evaluation of the Sustainment Leadership Scale (SLS)

© 2018 The Author(s). Background: Despite our progress in understanding the organizational context for implementation and specifically the role of leadership in implementation, its role in sustainment has received little attention. This paper took a mixed-method approach to examine leadership during the sustainment phase of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Utilizing the Implementation Leadership Scale as a foundation, we sought to develop a short, practical measure of sustainment leadership that can be used for both applied and research purposes. Methods: Data for this study were collected as a part of a larger mixed-method study of evidence-based intervention, SafeCare®, sustainment. Quantitative data were collected from 157 providers using web-based surveys. Confirmatory factor analysis was used to examine the factor structure of the Sustainment Leadership Scale (SLS). Qualitative data were collected from 95 providers who participated in one of 15 focus groups. A framework approach guided qualitative data analysis. Mixed-method integration was also utilized to examine convergence of quantitative and qualitative findings. Results: Confirmatory factor analysis supported the a priori higher order factor structure of the SLS with subscales indicating a single higher order sustainment leadership factor. The SLS demonstrated excellent internal consistency reliability. Qualitative analyses offered support for the dimensions of sustainment leadership captured by the quantitative measure, in addition to uncovering a fifth possible factor, available leadership. Conclusions: This study found qualitative and quantitative support for the pragmatic SLS measure. The SLS can be used for assessing leadership of first-level leaders to understand how staff perceive leadership during sustainment and to suggest areas where leaders could direct more attention in order to increase the likelihood that EBIs are institutionalized into the normal functioning of the organization

Implementing a case management intervention for frequent users of the emergency department (I-CaM): An effectiveness-implementation hybrid trial study protocol

Background: ED overcrowding represents a significant public health problem in developed countries. Frequent users of the emergency departments (FUEDs; reporting 5 or more ED visits in the past year) are often affected by medical, psychological, social, and substance use problems and account for a disproportionately high number of ED visits. Past research indicates that case management (CM) interventions are a promising way to reduce ED overcrowding and improve FUEDs' quality of life. There is, however, very limited knowledge about how to disseminate and implement this intervention on a large scale to diverse clinical settings, including community hospitals and non-academic centers. This paper describes the protocol of a research project aiming to implement a CM intervention tailored to FUEDs in the public hospitals with ED in the French-speaking region of Switzerland and evaluate both the implementation process and effectiveness of the CM intervention. Methods: This research project uses a hybrid study design assessing both implementation and clinical outcomes. The implementation part of the study uses mixed methods a) to describe quantitatively and qualitatively factors that influence the implementation process, and b) to examine implementation effectiveness. The clinical part of the study uses a within-subject design (pre-post intervention) to evaluate participants' trajectories on clinical variables (e.g., quality of life, ED use) after receiving the CM intervention. We designed the study based on two implementation science frameworks. The Generic Implementation Framework guided the overall research protocol design, whereas the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework guided the implementation and effectiveness evaluations. Discussion: This research project will contribute to implementation science by providing key insights into the processes of implementing CM into broader practice. This research project is also likely to have both clinical and public health implications. Trial registration: NCT03641274, Registered 20 August 2018

A systematic review examining socioeconomic factors in trials of interventions for men that report weight as an outcome.

Funder: Australian Government Research Training Program ScholarshipWeight management interventions designed specifically for men have become more common, but the extent to which socioeconomic factors are considered in trials of these interventions is unclear. We synthesized study characteristics, methods, and reporting of interventions with a behavioral component for men that report weight as an outcome, to establish the extent to which socioeconomic factors are considered during intervention design, conduct, and reporting. A comprehensive search was conducted on Medline, Embase, PsycINFO, and CENTRAL for studies published from January 2000 to July 2021. Thirty-six trials were included. Educational attainment (n = 24) was the most frequently reported socioeconomic characteristic, followed by working status (n = 14) and area level deprivation (n = 12). Seven studies did not report any socioeconomic characteristics. Most studies (n = 20) did not mention the socioeconomic profile of their samples in relation to study strengths or limitations. Few (n = 4) consulted with men from lower socioeconomic groups during intervention design. One study examined potential differential intervention effects across socioeconomic groups, with most not powered to do so. Recent feasibility trials (n = 3) targeting specific socioeconomic groups suggest a potential nascent towards a greater consideration of factors related to equity. To best inform public health policy related to health inequalities, greater consideration of socioeconomic factors is required in trials of men's weight management interventions

Qualitative study on the implementation of professional pharmacy services in Australian community pharmacies using framework analysis

Abbreviations: BCT, Behavioural change techniques taxonomy; BCW, Behavioural change wheel; CFIR, Consolidated framework for implementation research; EPOC, Cochrane effective practice and organisation of care; FISpH, Framework for the implementation of services in pharmacy; GIF, Generic implementation framework; KPI, Key performance indicator; TDF, Theoretical domains frameworkBackground: Multiple studies have explored the implementation process and influences, however it appears there is no study investigating these influences across the stages of implementation. Community pharmacy is attempting to implement professional services (pharmaceutical care and other health services). The use of implementation theory may assist the achievement of widespread provision, support and integration. The objective was to investigate professional service implementation in community pharmacy to contextualise and advance the concepts of a generic implementation framework previously published. Methods: Purposeful sampling was used to investigate implementation across a range of levels of implementation in community pharmacies in Australia. Twenty-five semi-structured interviews were conducted and analysed using a framework methodology. Data was charted using implementation stages as overarching themes and each stage was thematically analysed, to investigate the implementation process, the influences and their relationships. Secondary analyses were performed of the factors (barriers and facilitators) using an adapted version of the Consolidated Framework for Implementation Research (CFIR), and implementation strategies and interventions, using the Expert Recommendations for Implementing Change (ERIC) discrete implementation strategy compilation. Results: Six stages emerged, labelled as development or discovery, exploration, preparation, testing, operation and sustainability. Within the stages, a range of implementation activities/steps and five overarching influences (pharmacys' direction and impetus, internal communication, staffing, community fit and support) were identified. The stages and activities were not applied strictly in a linear fashion. There was a trend towards the greater the number of activities considered, the greater the apparent integration into the pharmacy organization. Implementation factors varied over the implementation stages, and additional factors were added to the CFIR list and definitions modified/contextualised for pharmacy. Implementation strategies employed by pharmacies varied widely. Evaluations were lacking. Conclusions: The process of implementation and five overarching influences of professional services implementation in community pharmacy have been outlined. Framework analysis revealed, outside of the five overarching influences, factors influencing implementation varied across the implementation stages. It is proposed at each stage, for each domain, the factors, strategies and evaluations should be considered. The Framework for the Implementation of Services in Pharmacy incorporates the contextualisation of implementation science for pharmacy.The study was funded as part of a University of Technology Sydney (UTS) Research Excellence Scholarship (RES), comprising of an Australian Postgraduate Award (APA) Scholarship funded by the Australian Government, plus a Top-up funded by the University of Technology Sydney, received from the primary author (JCM)

Development and testing of the Measure of Innovation-Specific Implementation Intentions (MISII) using Rasch measurement theory

© 2018 The Author(s). Background: Implementation is proposed to be a multiphase, multilevel process. After a period of exploration, an adoption decision is made, typically at the upper management or policy level. Nevertheless, movement through each of the subsequent phases of the implementation process involves clinicians or providers at the individual level to adopt the innovation and then change their behavior to use/deliver the innovation. Multiple behavioral change theories propose that intentions are a critical determinant of implementation behavior. However, there is a need for the development and testing of pragmatic measures of providers' intentions to use a specific innovation or evidence-based practice (EBP). Methods: Nine items were developed to assess providers' intentions to use a specific innovation or EBP. Motivational interviewing was the EBP in the study. Items were administered, as part of larger survey, to 179 providers across 38 substance use disorder treatment (SUDT) programs within five agencies in California, USA. Rasch analysis was conducted using RUMM2030 software to assess the items, their overall fit to the Rasch model, the response scale used, individual item fit, differential item functioning (DIF), and person separation. Results: Following a stepwise process, the scale was reduced from nine items to three items to increase the feasibility and acceptability of the scale while maintaining suitable psychometric properties. The three-item unidimensional scale showed good person separation (PSI =.872), no disordering of thresholds, and no evidence of uniform or non-uniform DIF. Rasch analysis supported the viability of the scale as a measure of implementation intentions. Conclusions: The Measure of Innovation-Specific Implementation Intentions (MISII) is a sound measure of providers' intentions to use a specific innovation or EBP. Future evaluation of convergent, divergent, and predictive validity are needed. The study also demonstrates the value of Rasch analysis for testing the psychometric properties of pragmatic implementation measures

Testing the leadership and organizational change for implementation (LOCI) intervention in substance abuse treatment: A cluster randomized trial study protocol

© 2017 The Author(s). Background: Evidence-based practice (EBP) implementation represents a strategic change in organizations that requires effective leadership and alignment of leadership and organizational support across organizational levels. As such, there is a need for combining leadership development with organizational strategies to support organizational climate conducive to EBP implementation. The leadership and organizational change for implementation (LOCI) intervention includes leadership training for workgroup leaders, ongoing implementation leadership coaching, 360° assessment, and strategic planning with top and middle management regarding how they can support workgroup leaders in developing a positive EBP implementation climate. Methods: This test of the LOCI intervention will take place in conjunction with the implementation of motivational interviewing (MI) in 60 substance use disorder treatment programs in California, USA. Participants will include agency executives, 60 program leaders, and approximately 360 treatment staff. LOCI will be tested using a multiple cohort, cluster randomized trial that randomizes workgroups (i.e., programs) within agency to either LOCI or a webinar leadership training control condition in three consecutive cohorts. The LOCI intervention is 12months, and the webinar control intervention takes place in months 1, 5, and 8, for each cohort. Web-based surveys of staff and supervisors will be used to collect data on leadership, implementation climate, provider attitudes, and citizenship. Audio recordings of counseling sessions will be coded for MI fidelity. The unit of analysis will be the workgroup, randomized by site within agency and with care taken that co-located workgroups are assigned to the same condition to avoid contamination. Hierarchical linear modeling (HLM) will be used to analyze the data to account for the nested data structure. Discussion: LOCI has been developed to be a feasible and effective approach for organizations to create a positive climate and fertile context for EBP implementation. The approach seeks to cultivate and sustain both effective general and implementation leadership as well as organizational strategies and support that will remain after the study has ended. Development of a positive implementation climate for MI should result in more positive service provider attitudes and behaviors related to the use of MI and, ultimately, higher fidelity in the use of MI. Trial registration: This study is registered with Clinicaltrials.gov ( NCT03042832 ), 2 February 2017, retrospectively registered