Ethnography and user-centered design to inform context-driven implementation.

Despite pervasive findings pointing to its inextricable role in intervention implementation, context remains poorly understood in implementation science. Existing approaches for describing context (e.g., surveys, interviews) may be narrow in scope or superficial in their elicitation of contextual data. Thus, in-depth and multilevel approaches are needed to meaningfully describe the contexts into which interventions will be implemented. Moreover, many studies assess context without subsequently using contextual information to enhance implementation. To be useful for improving implementation, though, methods are needed to apply contextual information during implementation. In the case example presented in this paper, we embedded an ethnographic assessment of context within a user-centered design approach to describe implementation context and apply that information to promote implementation. We developed a patient-reported outcome measure-based clinical intervention to assess and address the pervasive unmet needs of young adults with cancer: the Needs Assessment & Service Bridge (NA-SB). In this paper, we describe the user-centered design process that we used to anticipate context modifications needed to deliver NA-SB and implementation strategies needed to facilitate its implementation. Our ethnographic contextual inquiry yielded a rich understanding of local implementation context and contextual variation across potential scale-up contexts. Other methods from user-centered design (i.e., translation tables and a design team prototyping workshop) allowed us to translate that information into specifications for NA-SB delivery and a plan for implementation. Embedding ethnographic methods within a user-centered design approach can help us to tailor interventions and implementation strategies to their contexts of use to promote implementation.

The field of implementation science studies how to better integrate research evidence into practice. To accomplish this integration, it is important to understand the contexts into which interventions are being implemented. For example, implementation may be influenced by contextual factors such as patient/provider beliefs about an intervention, budget constraints, leadership buy-in, an organization's readiness to change, and many others. Understanding these factors upfront can allow us to adapt interventions to better suit context (e.g., tailoring intervention content to patients' needs), change context to make it more ready for implementation (e.g., changing provider workflow to accommodate an intervention), and anticipate strategies that may be needed to implement an intervention (e.g., delivering training on the intervention to providers). To do this, the field of implementation science is in need of methods for assessing context and using that information to improve implementation. In this paper, we present several methods, including ethnography and methods from user-centered design, for using context to inform implementation efforts.

A case study of a theory-based method for identifying and reporting core functions and forms of evidence-based interventions.

Adaptation of existing evidence-based interventions (EBIs) to improve their fit in new contexts is common. A critical first step in adaptation is to identify core functions (purposes) and forms (activities) of EBIs. Core functions should not be adapted as they are what account for the efficacy of EBIs. Despite their importance, core functions are rarely identified by EBI developers; methods for identifying them post hoc are lacking. We present a case study of theory-based methods for identifying core functions and forms post hoc. We developed these methods as the first step in a larger effort to adapt an existing EBI to improve the timeliness of referrals to hospice to a new patient population and care setting. Our methods were rooted in the Planned Adaptation Model (PAM). Through our case study, we developed six steps for identifying core functions and forms, as well as accompanying tools and methods. Our case study further operationalized PAM in several ways. Where PAM offered guiding tenets for identifying core functions and forms (review existing EBI materials, conduct primary data collection, and identify the theory of change), we produced specific tools (interview guides and codebooks) and methods (sampling approaches and analytic methods). Our case study extended PAM with the addition of two steps in the process of identifying core functions and forms: (a) identifying the usual care pathway, including barriers to the outcome of interest encountered in usual care, and (b) mapping EBI core functions onto an extant theory. Identifying core functions and forms is a critical first step in the adaptation process to ensure adaptations do not inadvertently compromise the efficacy or effectiveness of the EBI by compromising core functions. Our case study presents step-by-step methods that could be used by researchers or practitioners to identify core functions and forms post hoc.

Priority domains, aims, and testable hypotheses for implementation research: Protocol for a scoping review and evidence map.

BACKGROUND: The challenge of implementing evidence-based innovations within practice settings is a significant public health issue that the field of implementation research (IR) is focused on addressing. Significant amounts of funding, time, and effort have been invested in IR to date, yet there remains significant room for advancement, especially regarding IR's development of scientific theories as defined by the National Academy of Sciences (i.e., a comprehensive explanation of the relationship between variables that is supported by a vast body of evidence). Research priority setting (i.e., promoting consensus about areas where research effort will have wide benefits to society) is a key approach to helping accelerate research advancements. Thus, building upon existing IR, general principles of data reduction, and a general framework for moderated mediation, this article identifies four priority domains, three priority aims, and four testable hypotheses for IR, which we organize in the priority aims and testable hypotheses (PATH) diagram. METHODS: The objective of this scoping review is to map the extent to which IR has examined the identified PATH priorities to date. Our sample will include IR published in leading implementation-focused journals (i.e., Implementation Science, Implementation Science Communications, and Implementation Research and Practice) between their inception and December 2020. The protocol for the current scoping review and evidence map has been developed in accordance with the approach developed by Arksey and O'Malley and advanced by Levac, Colquhoun, and O'Brien. Because scoping reviews seek to provide an overview of the identified evidence base rather than synthesize findings from across studies, we plan to use our data-charting form to provide a descriptive overview of implementation research to date and summarize the research via one or more summary tables. We will use the PATH diagram to organize a map of the evidence to date. DISCUSSION: This scoping review and evidence map is intended to help accelerate IR focused on suggested priority aims and testable hypotheses, which in turn will accelerate IR's development of National Academy of Sciences-defined scientific theories and, subsequently, improvements in public health. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework https://osf.io/3vhuj/.

Towards a comprehensive model for understanding adaptations' impact: the model for adaptation design and impact (MADI).

BACKGROUND: Implementation science is shifting from qualifying adaptations as good or bad towards understanding adaptations and their impact. Existing adaptation classification frameworks are largely descriptive (e.g., who made the adaptation) and geared towards researchers. They do not help practitioners in decision-making around adaptations (e.g., is an adaptation likely to have negative impacts? Should it be pursued?). Moreover, they lack constructs to consider "ripple effects" of adaptations (i.e., both intended and unintended impacts on outcomes, recognizing that an adaptation designed to have a positive impact on one outcome may have unintended impacts on other outcomes). Finally, they do not specify relationships between adaptations and outcomes, including mediating and moderating relationships. The objective of our research was to promote systematic assessment of intended and unintended impacts of adaptations by using existing frameworks to create a model that proposes relationships among constructs. MATERIALS AND METHODS: We reviewed, consolidated, and refined constructs from two adaptation frameworks and one intervention-implementation outcome framework. Using the consolidated and refined constructs, we coded qualitative descriptions of 14 adaptations made to an existing evidence-based intervention; the 14 adaptations were designed in prior research by a stakeholder panel using a modified Delphi approach. Each of the 14 adaptations had detailed descriptions, including the nature of the adaptation, who made it, and its goal and reason. Using coded data, we arranged constructs from existing frameworks into a model, the Model for Adaptation Design and Impact (MADI), that identifies adaptation characteristics, their intended and unintended impacts (i.e., ripple effects), and potential mediators and moderators of adaptations' impact on outcomes. We also developed a decision aid and website ( MADIguide.org ) to help implementation scientists apply MADI in their work. RESULTS AND CONCLUSIONS: Our model and associated decision aids build on existing frameworks by comprehensively characterizing adaptations, proposing how adaptations impact outcomes, and offering practical guidance for designing adaptations. MADI encourages researchers to think about potential causal pathways of adaptations (e.g., mediators and moderators) and adaptations' intended and unintended impacts on outcomes. MADI encourages practitioners to design adaptations in a way that anticipates intended and unintended impacts and leverages best practice from research.

Pilot Test of an Adapted Intervention to Improve Timeliness of Referrals to Hospice and Palliative Care for Eligible Home Health Patients.

Background: Casarett et al. tested an intervention to improve timeliness of referrals to hospice. Although efficacious in the nursing home setting, it was not tested in other settings of care for seriously ill patients. We, therefore, adapted Casarett's intervention for use in home health (HH). Objective: To assess feasibility, acceptability, and patient outcomes of the adapted intervention. Design: We conducted a nine-week observational pilot test. Setting/Subjects: We conducted our pilot study with two HH agencies. Eligible patients included those who were high risk or frail (identified by the agencies' analytic software as being moderate to high risk for hospitalization or a candidate for hospice referral). Clinical managers identified eligible patients and registered nurses then delivered the intervention, screening patients for hospice appropriateness by asking about care goals, needs, and preferences and initiating appropriate follow-up for patients who screened positive. Measurements: We collected quantitative data on patient enrollment rates and outcomes (election of hospice and/or palliative care). We collected qualitative data on pilot staff experience with the intervention and suggestions for improvement. Results: Pilot HH agencies were able to implement the intervention with high fidelity with minimal restructuring of workflows; 14% of patients who screened positive for hospice appropriateness elected hospice or palliative care. Conclusions: Our findings suggest the adapted intervention was feasible and acceptable to enhance timeliness of hospice and palliative care referral in the HH setting. Additional adaptations suggested by pilot participants could improve impact of the intervention.

Nationwide Quality of Hospice Care: Findings From the Centers for Medicare & Medicaid Services Hospice Quality Reporting Program.

CONTEXT: With increasing use of the Medicare hospice benefit, policymakers recognize the need for quality measurement to assure that terminally ill patients receive high-quality care and have the information they need when selecting a hospice. Toward these goals, Centers for Medicare & Medicaid Services has been collecting standardized patient-level quality data via the Hospice Item Set (HIS) since July 1, 2014. OBJECTIVE: This article presents a first look at the national hospice HIS quality data. METHODS: We calculated seven quality measures using the HIS data. These measures are endorsed by the National Quality Forum and focus on important care processes hospice providers are required to perform at admission, including discussion of patient preferences regarding life-sustaining treatments, care for spiritual and existential concerns, and symptom management (pain, opioid-induced constipation, and dyspnea). RESULTS: Our sample included 1,218,786 hospice patients discharged from 3922 hospices from October 1, 2014 to September 30, 2015. More than 90% of patients received screenings and assessments captured by six of the seven quality measures. The only exception was pain assessment, for which the national mean score was 78.2%. A small number of hospices (156, 4.0%) had perfect scores for all seven quality measures. CONCLUSIONS: Most hospices conduct critical assessments and discuss treatment preferences with patients at admission, although few hospices have perfect scores.

Organizational theory for dissemination and implementation research.

BACKGROUND: Even under optimal internal organizational conditions, implementation can be undermined by changes in organizations' external environments, such as fluctuations in funding, adjustments in contracting practices, new technology, new legislation, changes in clinical practice guidelines and recommendations, or other environmental shifts. Internal organizational conditions are increasingly reflected in implementation frameworks, but nuanced explanations of how organizations' external environments influence implementation success are lacking in implementation research. Organizational theories offer implementation researchers a host of existing, highly relevant, and heretofore largely untapped explanations of the complex interaction between organizations and their environment. In this paper, we demonstrate the utility of organizational theories for implementation research. DISCUSSION: We applied four well-known organizational theories (institutional theory, transaction cost economics, contingency theories, and resource dependency theory) to published descriptions of efforts to implement SafeCare, an evidence-based practice for preventing child abuse and neglect. Transaction cost economics theory explained how frequent, uncertain processes for contracting for SafeCare may have generated inefficiencies and thus compromised implementation among private child welfare organizations. Institutional theory explained how child welfare systems may have been motivated to implement SafeCare because doing so aligned with expectations of key stakeholders within child welfare systems' professional communities. Contingency theories explained how efforts such as interagency collaborative teams promoted SafeCare implementation by facilitating adaptation to child welfare agencies' internal and external contexts. Resource dependency theory (RDT) explained how interagency relationships, supported by contracts, memoranda of understanding, and negotiations, facilitated SafeCare implementation by balancing autonomy and dependence on funding agencies and SafeCare developers. In addition to the retrospective application of organizational theories demonstrated above, we advocate for the proactive use of organizational theories to design implementation research. For example, implementation strategies should be selected to minimize transaction costs, promote and maintain congruence between organizations' dynamic internal and external contexts over time, and simultaneously attend to organizations' financial needs while preserving their autonomy. We describe implications of applying organizational theory in implementation research for implementation strategies, the evaluation of implementation efforts, measurement, research design, theory, and practice. We also offer guidance to implementation researchers for applying organizational theory.

Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review.

BACKGROUND: Over 60 implementation frameworks exist. Using multiple frameworks may help researchers to address multiple study purposes, levels, and degrees of theoretical heritage and operationalizability; however, using multiple frameworks may result in unnecessary complexity and redundancy if doing so does not address study needs. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) are both well-operationalized, multi-level implementation determinant frameworks derived from theory. As such, the rationale for using the frameworks in combination (i.e., CFIR + TDF) is unclear. The objective of this systematic review was to elucidate the rationale for using CFIR + TDF by (1) describing studies that have used CFIR + TDF, (2) how they used CFIR + TDF, and (2) their stated rationale for using CFIR + TDF. METHODS: We undertook a systematic review to identify studies that mentioned both the CFIR and the TDF, were written in English, were peer-reviewed, and reported either a protocol or results of an empirical study in MEDLINE/PubMed, PsycInfo, Web of Science, or Google Scholar. We then abstracted data into a matrix and analyzed it qualitatively, identifying salient themes. FINDINGS: We identified five protocols and seven completed studies that used CFIR + TDF. CFIR + TDF was applied to studies in several countries, to a range of healthcare interventions, and at multiple intervention phases; used many designs, methods, and units of analysis; and assessed a variety of outcomes. Three studies indicated that using CFIR + TDF addressed multiple study purposes. Six studies indicated that using CFIR + TDF addressed multiple conceptual levels. Four studies did not explicitly state their rationale for using CFIR + TDF. CONCLUSIONS: Differences in the purposes that authors of the CFIR (e.g., comprehensive set of implementation determinants) and the TDF (e.g., intervention development) propose help to justify the use of CFIR + TDF. Given that the CFIR and the TDF are both multi-level frameworks, the rationale that using CFIR + TDF is needed to address multiple conceptual levels may reflect potentially misleading conventional wisdom. On the other hand, using CFIR + TDF may more fully define the multi-level nature of implementation. To avoid concerns about unnecessary complexity and redundancy, scholars who use CFIR + TDF and combinations of other frameworks should specify how the frameworks contribute to their study. TRIAL REGISTRATION: PROSPERO CRD42015027615.

A systematic review of the use of the Consolidated Framework for Implementation Research.

BACKGROUND: In 2009, Damschroder et al. developed the Consolidated Framework for Implementation Research (CFIR), which provides a comprehensive listing of constructs thought to influence implementation. This systematic review assesses the extent to which the CFIR's use in implementation research fulfills goals set forth by Damschroder et al. in terms of breadth of use, depth of application, and contribution to implementation research. METHODS: We searched Scopus and Web of Science for publications that cited the original CFIR publication by Damschroder et al. (Implement Sci 4:50, 2009) and downloaded each unique result for review. After applying exclusion criteria, the final articles were empirical studies published in peer-review journals that used the CFIR in a meaningful way (i.e., used the CFIR to guide data collection, measurement, coding, analysis, and/or reporting). A framework analysis approach was used to guide abstraction and synthesis of the included articles. RESULTS: Twenty-six of 429 unique articles (6 %) met inclusion criteria. We found great breadth in CFIR application; the CFIR was applied across a wide variety of study objectives, settings, and units of analysis. There was also variation in the method of included studies (mixed methods (n = 13); qualitative (n = 10); quantitative (n = 3)). Depth of CFIR application revealed some areas for improvement. Few studies (n = 3) reported justification for selection of CFIR constructs used; the majority of studies (n = 14) used the CFIR to guide data analysis only; and few studies investigated any outcomes (n = 11). Finally, reflections on the contribution of the CFIR to implementation research were scarce. CONCLUSIONS: Our results indicate that the CFIR has been used across a wide range of studies, though more in-depth use of the CFIR may help advance implementation science. To harness its potential, researchers should consider how to most meaningfully use the CFIR. Specific recommendations for applying the CFIR include explicitly justifying selection of CFIR constructs; integrating the CFIR throughout the research process (in study design, data collection, and analysis); and appropriately using the CFIR given the phase of implementation of the research (e.g., if the research is post-implementation, using the CFIR to link determinants of implementation to outcomes).

Hospices' use of electronic medical records for quality assessment and performance improvement programs.

CONTEXT: Electronic medical records (EMRs) are increasingly viewed as essential tools for quality assurance and improvement in many care settings, but little is known about the use of EMRs by hospices in their quality assessment and performance improvement (QAPI) programs. OBJECTIVES: To examine the data sources hospices use to create quality indicators (QIs) used in their QAPI programs and to examine the domains of EMR-based QIs. METHODS: We used self-reported QIs (description, numerator, and denominator) from 911 hospices nationwide that participated in the Centers for Medicare & Medicaid Services nationwide hospice voluntary reporting period. The data reflected QIs that hospices used for their internal QAPI programs between October 1 and December 31, 2011. We used the primary data sources for QIs reported by hospices and analyzed EMR-based QIs in terms of the quality domains and themes addressed. RESULTS: EMRs were the most frequent data source for the QIs reported, followed by family survey and paper medical record. Physical symptom management was the largest quality domain--included in 51.5% of the reported EMR-based QIs--followed by patient safety and structure and process of care. CONCLUSION: Most participating hospices use EMRs for retrieving items needed for QI calculations. EMR-based QIs address various quality domains and themes. Our findings present opportunities for potential future reporting of EMR-based quality data.

Achieving benchmark financial performance in CAHs: lessons from high performers.

CEOs and CFOs of 19 critical access hospitals (CAHs) that achieved benchmark financial performance over three years were interviewed regarding the strategies they use. The interviews identified nine success factors for exemplary financial performance that were common to all or most of the 19 hospitals. All of the participating executives agreed that other CAHs would likely benefit from applying these nine success factors.