How does the external context affect an implementation processes? A qualitative study investigating the impact of macro-level variables on the implementation of goal-oriented primary care.

BACKGROUND: Although the importance of context in implementation science is not disputed, knowledge about the actual impact of external context variables on implementation processes remains rather fragmented. Current frameworks, models, and studies merely describe macro-level barriers and facilitators, without acknowledging their dynamic character and how they impact and steer implementation. Including organizational theories in implementation frameworks could be a way of tackling this problem. In this study, we therefore investigate how organizational theories can contribute to our understanding of the ways in which external context variables shape implementation processes. We use the implementation process of goal-oriented primary care in Belgium as a case. METHODS: A qualitative study using in-depth semi-structured interviews was conducted with actors from a variety of primary care organizations. Data was collected and analyzed with an iterative approach. We assessed the potential of four organizational theories to enrich our understanding of the impact of external context variables on implementation processes. The organizational theories assessed are as follows: institutional theory, resource dependency theory, network theory, and contingency theory. Data analysis was based on a combination of inductive and deductive thematic analysis techniques using NVivo 12. RESULTS: Institutional theory helps to understand mechanisms that steer and facilitate the implementation of goal-oriented care through regulatory and policy measures. For example, the Flemish government issued policy for facilitating more integrated, person-centered care by means of newly created institutions, incentives, expectations, and other regulatory factors. The three other organizational theories describe both counteracting or reinforcing mechanisms. The financial system hampers interprofessional collaboration, which is key for GOC. Networks between primary care providers and health and/or social care organizations on the one hand facilitate GOC, while on the other hand, technology to support interprofessional collaboration is lacking. Contingent variables such as the aging population and increasing workload and complexity within primary care create circumstances in which GOC is presented as a possible answer. CONCLUSIONS: Insights and propositions that derive from organizational theories can be utilized to expand our knowledge on how external context variables affect implementation processes. These insights can be combined with or integrated into existing implementation frameworks and models to increase their explanatory power.

[Design and practice of biological reaction engineering flipped classroom in applied undergraduate colleges].

This study aims to explore and refine the teaching aspects of a flipped classroom approach for biological reaction engineering. The study encompasses three iterations of teaching practice, focusing on key elements such as theme content selection, implementation process, evaluation and effectiveness. By integrating relevant industry and societal topics with course's professional knowledge, students are encouraged to independently collect data, analyze and discuss findings, and present their work in group. Comprehensive literacy of students is assessed through discussion reports, defense reports, utilization of new tools, and team cooperation. Analysis of student performance reveals that the design and implementation of the flipped classroom approach significantly enhances student motivation to learn, improves scores, and supports the achievement of course objectives. Therefore, the methodology presented in this study may serve as a reference for implementing teaching reforms in core courses in applied undergraduate colleges, thereby fostering well-round individuals with strong theoretical foundation, innovative analytical skills, and excellent teamwork abilities.

Dilemma and promotion strategy of “dual channel”management policy for China’s medical insurance negotiated drugs / 中国药房

OBJECTIVE To provide reference for the smooth implementation of the “dual channel” management policy for China’s medical insurance negotiated drugs. METHODS Based on Smith policy implementation process model， the dilemmas for the implementation of “dual channel” policy for medical insurance negotiated drugs were analyzed from four aspects： implementation details and regulatory system， drug selection， drug provision and quality control， the situation of medical insurance funds and information technology capabilities. The corresponding promotion strategies were put forward. RESULTS & CONCLUSIONS The “dual channel” policy for medical insurance negotiated drugs in China might face implementation difficulties such as a lack of clear implementation rules and a full process supervision system， the suitability and operability of some medical insurance negotiated drugs need to be considered in the “dual channel” management， difficulties in drug allocation and quality control， differences in the management and operation of medical insurance funds in different regions， and insufficient informatization capability. In this regard， this study suggests that measures， such as improving the implementation rules of the “dual channel” policy， enhancing the rationality of the “dual channel” drug catalog， establishing a dynamic exit mechanism for “dual channel” pharmacies， promoting professional delivery services， and improving the electronic prescription circulation platform， which can be taken to enhance the implementation effect of the “dual channel” policy.

Fostering Excellence in Obstetrical Surgery.

Introduction: This obstetric surgery review is directed toward the common obstetrical surgeries (caesarean delivery, VBAC/TOLAC, operative vaginal delivery, placenta accreta spectrum) with evidence for quality and safety to allow for obstetrical outcome excellence. Materials and Methods: This focused scoping review has used a structured process for article identification and inclusion for each of the focused surgeries. Results: The review results provide an obstetrical surgery (OS) overview for caesarean delivery, vaginal birth after caesarean delivery and/or trial of labor after caesarean delivery, operative vaginal delivery, placenta accreta spectrum; considerations for quality and safety variance due to non-clinical human factors; quality improvement (QI) tools; OS QI implementation cohorts; implementation considering certain barriers and solutions. Conclusion: Administrative health care systems and obstetrical surgery care providers cannot afford, not to consider and implement, certain evidenced-based "bottom-up/top-down" processes for quality and safety, as the patients will demand the quality and the safety, but the lawyers should not have to enforce it.

Perspectives of researchers with lived experience in implementation science research: Opportunities to close the research-to-practice gap in substance use systems of care.

Background: The field of implementation science acknowledges the importance of diversity within research teams including members from diverse disciplines and with lived expertise in practical implementation (e.g., administrators, front-line workers, patients/clients). Gaps remain in the successful implementation of proven substance use treatment interventions. Methods: This paper will outline the rationale for the purposeful inclusion of researchers with lived experience (RLE) related to substance use disorder (SUD) within implementation science research studies focused on improving SUD services. Results: We posit that researchers with such experience can help address research-to-practice gaps by (1) building strong community partnerships, (2) engaging in conversations around effective interventions through knowledge translation, (3) providing community-congruent approaches to evaluation, and (4) aiding in dissemination and sustainability efforts. Conclusions: We end by offering recommendations for researchers without lived experience as they intentionally collaborate with RLE.

Implementation science usually involves and prioritizes community collaboration; however, there are often barriers to community collaboration because the community may not trust researcher intentions or there might be challenges to identifying shared language. Researchers who have lived experience with substance use disorders might be able to make community collaborations between researchers and community members easier through shared knowledge of both research and lived experience. The involvement of researchers with lived experience may also help community-based organizations find the best ways to use evidence-based practices. We describe ways that the intentional involvement of researchers with lived experience may improve implementation outcomes and ultimately improve the services received and experiences of community members.

A Systematic Review of the Implementation and Effectiveness of 'The Daily Mile' on Markers of Children's Health.

Currently, a high percentage of children globally fail to meet the World Health Organisation's (WHO) recommended daily physical activity (PA) guidelines. The Daily Mile (TDM) is a school-based PA initiative, designed to improve primary school children's PA behaviour. The purpose of this review was to evaluate the extant TDM implementation process and identify its impact on health-related metrics. Three databases were used to search for articles from the time TDM originated in 2012 until February 2022. The identification and screening process of articles for their ability to meet this review's eligibility criteria were facilitated by use of PRISMA and Rayyan. Sixteen articles from the initial search (n = 202) were deemed eligible for inclusion. An analysis of these articles identified five common outcome categories that permeated throughout the research articles: (1) cardiorespiratory fitness (CRF); (2) anthropometry and body composition; (3) PA; (4) cognition; and (5) process evaluation. Results presented from the included articles suggests TDM positively impacts markers of a variety of health-related metrics, namely CRF and PA. However, implementation barriers including TDM's repetitive nature, time constraints associated with competing curriculum demands and inadequate facilities regularly necessitate the adaptation and development of the original TDM format by schools and teachers.

Will the implementation process for goal-oriented primary care succeed? A qualitative study investigating five perceived attributes of goal-oriented care.

Throughout the western world, goal oriented care (GOC) is increasingly promoted as a strategy towards more person-centered, integrated care. The implementation of goal-oriented care not only takes place at the micro-level with individual primary care providers (PCPs) changing their approach, but also requires meso- and macro-level investment. In this study, we zoom in on experiences and actions of various meso- and macro-level actors that are actively engaged with implementing GOC, both within their organization or at the policy level. In-depth interviews were conducted with n = 23 actors from a variety of different organizations (governmental institutions, provider organizations, patient organizations, health/social care organizations, primary care zones/care councils, etc.), using a semi- interview guide inspired by realist interviewing. Three main drivers for implementation were identified: recognition, commitment and coordination. On top of that, results were interpreted through Rogers' Diffusion of Innovations (Dol) theory in which five attributes are discussed that contribute to or hinder implementation success. Our findings can help define actions to support and facilitate the implementation process of an innovation such as GOC.

Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.

RESEARCH QUESTION AND AIM: Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC's implementation, to increase knowledge about CEC's implementation strategy. RESEARCH DESIGN: We collected quantitative data related to number and characteristics of CEC activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC's development and implementation process. PARTICIPANTS AND RESEARCH CONTEXT: The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. ETHICAL CONSIDERATIONS: The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. FINDINGS: In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC's impact on clinical practice. CONCLUSION: Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially.

Mothers In Motion Program: Implementation Process and Acceptability by Community.

BACKGROUND: Implementing lifestyle behavior programs in real-world settings challenges researchers. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) has implemented and sustained Mothers In Motion (MIM)'s client videos for clients to promote healthy lifestyle behaviors, and train-the-trainer videos, for personnel to enhance motivational interviewing techniques since 2015 and 2016, respectively. This paper describes the implementation processes and the results of client video implementation acceptability by WIC personnel. METHODS: To document the implementation process, we applied the Framework for Adaptation and Modifications to Evidence-Based Implementation Strategies (FRAME-IS). To evaluate implementation acceptability, we conducted semi-structured interviews with 15 WIC personnel. A qualitative analysis was conducted to identify the common themes. RESULTS: The facilitators for client video implementation were the inclusion of the target audience and family members addressing daily challenges, easy implementation, and compatibility with daily practice. While videos online facilitated implementation, videos in DVD format could challenge implementation. CONCLUSIONS: Future lifestyle intervention programs aimed for future implementation in community settings may consider the inclusion of the target audience and their family members and take into consideration easy implementation and compatibility.

Implementing a Text Messaging Intervention to Engage Fathers in Home Visiting.

PURPOSE: This "From the Field" article reports on the Text4Dad text messaging intervention designed to engage fathers in home visiting. We introduce implementation process components from our pilot study across three Healthy Start home visitation sites. DESCRIPTION: Three Fatherhood Community Health Workers (F-CHWs) and three fathers from one Text4Dad site were interviewed. Using content analysis, we examined the experiences of F-CHWs who implemented Text4Dad and program participants who used Text4Dad. ASSESSMENT: Results highlighted five implementation process components related to: (1) F-CHWs' use of Text4Dad and enrolling fathers; (2) F-CHWs' interactions with fathers, perceptions of Text4Dad content, and integration of Text4Dad into home visits with fathers; (3) training and technical assistance for F-CHWs; (4) father program participants' acceptability and usability of Text4Dad; and (5) fathers' barriers to interactive use of Text4Dad. CONCLUSION: The F-CHWs were able to successfully enroll fathers into Text4Dad. F-CHWs and fathers found Text4Dad content acceptable to their circumstances. Text4Dad technology was viewed as usable, with some limitations. F-CHWs experienced challenges accessing the Text4Dad platform while on home visits. Results suggested that F-CHWs did not use Text4Dad to facilitate interaction, and accordingly, fathers had a lower than anticipated response rate to texts sent by their F-CHWs. We conclude with future directions for improving the implementation of text messaging programs in community-based fatherhood programs.

Fidelity to the ACT SMART Toolkit: an instrumental case study of implementation strategy fidelity.

BACKGROUND: Evidence-based practices (EBPs) are shown to improve a variety of outcomes for autistic children. However, EBPs often are mis-implemented or not implemented in community-based settings where many autistic children receive usual care services. A blended implementation process and capacity-building implementation strategy, developed to facilitate the adoption and implementation of EBPs for autism spectrum disorder (ASD) in community-based settings, is the Autism Community Toolkit: Systems to Measure and Adopt Research-based Treatments (ACT SMART Toolkit). Based on an adapted Exploration, Adoption decision, Preparation, Implementation, Sustainment (EPIS) Framework, the multi-phased ACT SMART Toolkit is comprised of (a) implementation facilitation, (b) agency-based implementation teams, and (c) a web-based interface. In this instrumental case study, we developed and utilized a method to evaluate fidelity to the ACT SMART Toolkit. This study responds to the need for implementation strategy fidelity evaluation methods and may provide evidence supporting the use of the ACT SMART Toolkit. METHODS: We used an instrumental case study approach to assess fidelity to the ACT SMART Toolkit during its pilot study with six ASD community agencies located in southern California. We assessed adherence, dose, and implementation team responsiveness for each phase and activity of the toolkit at both an aggregate and individual agency level. RESULTS: Overall, we found that adherence, dose, and implementation team responsiveness to the ACT SMART Toolkit were high, with some variability by EPIS phase and specific activity as well as by ASD community agency. At the aggregate level, adherence and dose were rated notably lowest during the preparation phase of the toolkit, which is a more activity-intensive phase of the toolkit. CONCLUSIONS: This evaluation of fidelity to the ACT SMART Toolkit, utilizing an instrumental case study design, demonstrated the potential for the strategy to be used with fidelity in ASD community-based agencies. Findings related to the variability of implementation strategy fidelity in the present study may also inform future adaptations to the toolkit and point to broader trends of how implementation strategy fidelity may vary by content and context.

Implementation process evaluation of an ergonomic train the trainer program: How to learn from mechanisms and the temporal structure of processes?

In implementation process evaluation, the analysis of the temporal structure of processes is key for understanding the successive interactions between the flow of practitioners' actions and evolving workplace reactions and context. However, capturing the temporal structure of processes in data analysis is a methodological challenge, and available literature to overcome this challenge is scarce, especially for workplace ergonomic interventions. The aim of this paper was to perform an implementation process evaluation of an ergonomic train the trainer program taking into account the temporal structure of processes. We provided a method for qualitative data analysis based on a three-stage strategy: 1) producing the timeline of the implemented intervention, 2) identifying influential factors, 3) identifying determinant mechanisms (sequence of influential factors that intervened in the implementation process). This method allowed us to identify six determinant mechanisms positioned on the timeline of the intervention. Obstacles and levers were identified as a sequence of interrelated causes and consequences rather than isolated factors. We recommended success strategies for practitioners, while also shedding light on how organizations can better be prepared to undertake the intervention and their required actions to attain targeted intervention objectives.

Theory-based implementation of physical activity programs in worksite health promotion settings: a systematic review.

Worksites are important settings for implementing health promotion programs. Evidence for sustainable upscaling of physical activity (PA) programs and critical evaluation of the implementation process are scarce. In this article, we address the following research questions: (i) To what extent is the implementation process of PA programs theoretically informed? (ii) What characterizes the implementation process of PA programs in theory driven studies? (iii) Which facilitators and barriers are identified in the implementation process and at what level? We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The databases Medline (Ovid) and Sportdiscuss (Ebsco) were searched for peer-reviewed original articles published in English (2000-2020), from a European, North American, New Zealand and Australian context. Reported implementation components and facilitators/barriers (F/Bs) were detected, interpreted and analyzed according to implementation theory. Appraisal of methodological quality on included studies was executed. Of 767 eligible studies, 17 studies were included, 11 of which conducted a theory-based process evaluation of the implementation. They implemented composite PA programs, at two or more levels with internal or mixed implementation teams. F/Bs were most frequently related to the implementation component 'fidelity', corresponding to organizational and implementer level, and the component 'reach' corresponding to program and participant level. Notably, only one study reported F/Bs on the socio-political level. Despite more frequent use in recent years of theory-based implementation, few studies reported implementation effectiveness. Major challenges regarding incoherent use of theoretical concepts and scarcity of empirically tested frameworks are discussed.

Physical activity (PA) programs are popular health promotion initiatives in worksites. However, most PA programs are difficult to maintain and upscale, leading to misachievement of expected results. In this study, we address what drives or hampers the implementation of PA programs in a worksite health promotion setting. We specifically address how current theoretical frameworks add value to the implementation processes. The databases Medline (Ovid) and Sportdiscuss (Ebsco) were searched for peer-reviewed original articles. Reported implementation components and facilitators/barriers were detected, interpreted and analyzed according to implementation theory. Of 767 eligible studies, 17 studies were included for investigation. The World Health Organization has long called for more theory-based implementation of health promotion programs. Eleven studies explicitly invoked current theories in describing program implementation strategies. We find those implementing PA programs showing greater theoretical engagement compared to a sample from prior years, while nonetheless few recent studies reported overall implementation effectiveness. Implications for stakeholders of our results are discussed.

Introduction and enlightenment of foreign remote inspection mode of pharmaceutical production / 中国药房

OBJECTIVE To provide reference for the construction of remote inspection mode of pharmaceutical production in China. METHODS By combing the guidance documents of remote inspection and related pilots issued abroad， the experience of constructing remote inspection mode of pharmaceutical production was summarized. RESULTS & CONCLUSIONS Typical foreign countries and regions have carried out remote inspection pilots all over the world， and clearly defined the application situation， implementation process， inspection techniques and related points for attention of remote inspection of pharmaceutical production. In terms of application， the European Union pointed out four specific applicable situations， including travel restrictions， while the United States stipulated that remote inspection was applicable to pre-approved inspection and so on. In terms of the implementation process， the United States developed a four-step method of remote inspection， while the European Union has defined the specific implementation process of remote inspection in more detail. In comparison， Japan paid more attention to the remote inspection process of production documents. In terms of inspection techniques， the European Union used 360° cameras， Matterport 3D technology and document review software to realize the remote inspection of production sites and production documents. In terms of attention points for remote inspection， the United States required that access rights should be set for information sharing to avoid information disclosure. Both the European Union and the United States required inspectors to be trained and equipment inspected before remote inspection. It is suggested that China should formulate unified guidelines for remote inspection of pharmaceutical production， clarify the applicable situations， and formulate the implementation process of remote inspection of pharmaceutical production with reference to the opinions of drug manufacturers. In addition， intelligent remote inspection technology can be used in combination with the information construction level of drug manufacturers， and remote inspection training program can be formulated to cultivate professional remote inspection team.

Discussion of the process of conducting an investigator-initiated research / 中国胸心血管外科临床杂志

@#The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.

Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial.

BACKGROUND: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support. METHODS: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis. RESULTS: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028). CONCLUSIONS: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017).

Clinical implementation of routine diagnostic laparoscopy to guide initial treatment in patients with advanced-stage epithelial ovarian cancer in Dutch clinical practice: Evaluation of support and a budget impact analysis.

OBJECTIVE: In patients with advanced-stage epithelial ovarian cancer (EOC), a diagnostic laparoscopy (DLS) to determine treatment regime prevents futile laparotomies and seems cost-neutral. The uptake of DLS in current practice is unknown. We evaluated the clinical application of routine DLS in treatment planning in patients with advanced-stage EOC in the Netherlands. METHODS: The implementation was evaluated over the period 2017-2019, using a health technology assessment including clinical, organizational, and economic factors. Barriers for implementation were identified and DLS use was assessed using semi-structured surveys with healthcare professionals. Data from the Dutch Gynecological Oncology Audit were used to determine (un)successful CRS rates. To assess the economic impact, we performed a budget impact analysis (BIA) of the combined interventions of DLS and primary CRS. RESULTS: The DLS use to guide treatment planning increased from 16% to 20%. The majority of the centers did not support routine DLS implementation, mainly because of logistic barriers and its invasive nature. The primary CRS rate of all CRS decreased from 44% to 36%, in favor of interval CRS. The unsuccessful primary CRS rate decreased from 15% to 9% resulting in fewer patients needed a second interval CRS. Consequently, total health care costs decreased from €4.457.496 to €4.274.751. CONCLUSIONS: The implementation of routine DLS for guiding treatment planning in patients with advanced-stage EOC has limited support in the Netherlands. Over the years, total health care costs decreased. For current practice, it is advised that a DLS is useful in case it is uncertain whether a successful primary CRS is feasible based on conventional work-up.

Sugar-sweetened beverage tax implementation processes: results of a scoping review.

Taxing sugar-sweetened beverages (SSB) is seen as a win-win situation for governments. It is argued that SSB taxes are relatively easy to implement from a practical perspective compared to for example other nutrition policies. However, the implementation of SSB taxation laws does not happen by itself. Therefore, this work examines implementation processes for SSB taxation in terms of (1) pre-implementation context, (2) taxation instruments used and (3) interactions in the implementation process. Ten databases and grey literature were systematically searched for studies reporting on SSB taxation implementation processes up to February 2020. All studies (N = 1248) were screened independently by two reviewers according to predefined criteria. The selection of variables to be extracted was based on the policy cycle heuristic and informed by intervention implementation research. Information on the process of implementing SSB taxation is limited. Only six cases based on three publications were identified, indicating a gap in this research area. SSB taxation implementation was accomplished by hiring a subcontractor for the implementation or using pre-existing tax collection structures. Political and public support within the implementation process seems to be supportive for the city of Berkeley and for Portugal but was not reported for the Pacific Islands. However, the existing data are very limited, and further research on SSB taxation implementation processes is needed to determine whether the aim of the policy and the envisaged outcome are linked in practice. Registration The protocol was registered with the Open Science Framework (OSF) (osf.io/7w84q/).

Understanding implementation context and social processes through integrating Normalization Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR).

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

Augmenting systems-level implementation of patient-reported outcomes for depression care through the use of structured analysis and design technique.

Background: Health systems increasingly need to implement complex practice changes such as the routine capture of patient-reported outcome (PRO) measures. Yet, health systems have met challenges when trying to bring practice change to scale across systems at large. While implementation science can guide the evaluation of implementation determinants, teams first need tools to systematically understand and compare workflow activities across practice sites. Structured analysis and design technique (SADT), a system engineering method of workflow modeling, may offer an opportunity to enhance the scalability of implementation evaluation for complex practice change like PROs. Method: We utilized SADT to identify the core workflow activities needed to implement PROs across diverse settings and goals for use, establishing a generalizable PRO workflow diagram. We then used the PRO workflow diagram to guide implementation monitoring and evaluation for a 1-year pilot implementation of the electronic Patient Health Questionnaire-9 (ePHQ). The pilot occurred across multiple clinical settings and for two clinical use cases: depression screening and depression management. Results: SADT identified five activities central to the use of PROs in clinical care: deploying PRO measures, collecting PRO data, tracking PRO completion, reviewing PRO results, and documenting PRO data for future use. During the 1-year pilot, 8,596 patients received the ePHQ for depression screening via the patient portal, of which 1,719 (21%) submitted the ePHQ; 367 patients received the ePHQ for depression management, of which 174 (47%) submitted the ePHQ. We present three case examples of how the SADT PRO workflow diagram augmented implementation monitoring, tailoring, and evaluation activities. Conclusions: Use of a generalizable PRO workflow diagram aided the ability to systematically assess barriers and facilitators to fidelity and identify needed adaptations. The use of SADT offers an opportunity to align systems science and implementation science approaches, augmenting the capacity for health systems to advance system-level implementation. Plain Language Summary: Health systems increasingly need to implement complex practice changes such as the routine capture of patient-reported outcome (PRO) measures. Yet these system-level changes can be challenging to manage given the variability in practice sites and implementation context across the system at large. We utilized a systems engineering method-structured analysis and design technique-to develop a generalizable diagram of PRO workflow that captures five common workflow activities: deploying PRO measures, collecting PRO data, tracking PRO completion, reviewing PRO results, and documenting PRO data for future use. Next, we used the PRO workflow diagram to guide our implementation of PROs for depression care in multiple clinics. Our experience showed that use of a standard workflow diagram supported our implementation evaluation activities in a systematic way. The use of structured analysis and design technique may enhance future implementation efforts in complex health settings.