Trust in the Transplant Team Associated With the Level of Chronic Illness Management-A Secondary Data Analysis of the International BRIGHT Study.

A trustful relationship between transplant patients and their transplant team (interpersonal trust) is essential in order to achieve positive health outcomes and behaviors. We aimed to 1) explore variability of trust in transplant teams; 2) explore the association between the level of chronic illness management and trust; 3) investigate the relationship of trust on behavioral outcomes. A secondary data analysis of the BRIGHT study (ID: NCT01608477; https://clinicaltrials.gov/ct2/show/NCT01608477?id=NCT01608477&rank=1) was conducted, including multicenter data from 36 heart transplant centers from 11 countries across four different continents. A total of 1,397 heart transplant recipients and 100 clinicians were enrolled. Trust significantly varied among the transplant centers. Higher levels of chronic illness management were significantly associated with greater trust in the transplant team (patients: AOR= 1.85, 95% CI = 1.47-2.33, p < 0.001; clinicians: AOR = 1.35, 95% CI = 1.07-1.71, p = 0.012). Consultation time significantly moderated the relationship between chronic illness management levels and trust only when clinicians spent ≥30 min with patients. Trust was significantly associated with better diet adherence (OR = 1.34, 95%CI = 1.01-1.77, p = 0.040). Findings indicate the relevance of trust and chronic illness management in the transplant ecosystem to achieve improved transplant outcomes. Thus, further investment in re-engineering of transplant follow-up toward chronic illness management, and sufficient time for consultations is required.

Methodological approaches to study context in intervention implementation studies: an evidence gap map.

BACKGROUND: Within implementation science studies, contextual analysis is increasingly recognized as foundational to interventions' successful and sustainable implementation. However, inconsistencies between methodological approaches currently limit progress in studying context and guidance to standardize the use of those approaches is scant. Therefore, this study's objective was to systematically review and map current methodological approaches to contextual analysis in intervention implementation studies. The results would help us both to systematize the process of contextual analysis and identify gaps in the current evidence. METHODS: We conducted an evidence gap map (EGM) based on literature data via a stepwise approach. First, using an empirically developed search string, we randomly sampled 20% of all intervention implementation studies available from PubMed per year (2015-2020). Second, we assessed included studies that conducted a contextual analysis. Data extraction and evaluation followed the Basel Approach for CoNtextual ANAlysis (BANANA), using a color-coded rating scheme. Also based on BANANA and on the Context and Implementation of Complex Interventions (CICI) framework-an implementation framework that pays ample attention to context- we created visual maps of various approaches to contextual analysis. RESULTS: Of 15, 286 identified intervention implementation studies and study protocols, 3017 were screened for inclusion. Of those, 110 warranted close examination, revealing 22% that reported on contextual analysis. Only one study explicitly applied a framework for contextual analysis. Data were most commonly collected via surveys (n = 15) and individual interviews (n = 13). Ten studies reported mixed-methods analyses. Twenty-two assessed meso-level contextual and setting factors, with socio-cultural aspects most commonly studied. Eighteen described the use of contextual information for subsequent project phases (e.g., intervention development/adaption, selecting implementation strategies). Nine reported contextual factors' influences on implementation and/or effectiveness outcomes. CONCLUSIONS: This study describes current approaches to contextual analysis in implementation science and provides a novel framework for evaluating and mapping it. By synthesizing our findings graphically in figures, we provide an initial evidence base framework that can incorporate new findings as necessary. We strongly recommend further development of methodological approaches both to conduct contextual analysis and to systematize the reporting of it. These actions will increase the quality and consistency of implementation science research.

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial.

BACKGROUND: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders). METHODS: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods). DISCUSSION: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021.

Development of an integrated model of care for allogeneic stem cell transplantation facilitated by eHealth-the SMILe study.

PURPOSE: Allogeneic stem cell transplantation would benefit from re-engineering care towards an integrated eHealth-facilitated care model. With this paper we aim to: (1) describe the development of an integrated care model (ICM) in allogeneic SteM-cell-transplantatIon faciLitated by eHealth (SMILe) by combining implementation, behavioral, and computer science methods (e.g., contextual analysis, Behavior Change Wheel, and user-centered design combined with agile software development); and (2) describe that model's characteristics and its application in clinical practice. METHODS: The SMILe intervention's development consisted of four steps, with implementation science methods informing each: (1) planning its set-up within a theoretical foundation; (2) using behavioral science methods to develop the content; (3) choosing and developing its delivery method (human/technology) using behavioral and computer science methods; and (4) describing its characteristics and application in clinical practice. RESULTS: The SMILe intervention is embedded within the eHealth enhanced Chronic Care Model, entailing four self-management intervention modules, targeting monitoring and follow-up of important medical and symptom-related parameters, infection prevention, medication adherence, and physical activity. Interventions are delivered partly face-to-face by a care coordinator embedded within the transplant team, and partly via the SMILeApp that connects patients to the transplant team, who can monitor and rapidly respond to any relevant changes within 1 year post-transplant. CONCLUSION: This paper provides stepwise guidance on how implementation, behavioral, and computer science methods can be used to develop interventions aiming to improve care for stem cell transplant patients in real-world clinical settings. This new care model is currently being tested in a hybrid I effectiveness-implementation trial.

The German version of the high-performance work systems questionnaire (HPWS-G) in the context of patient safety: a validation study in a Swiss university hospital.

BACKGROUND: High performance work systems (HPWSs) are successful work systems in the context of safety climate and patient safety. The 10-item HPWS questionnaire is a validated instrument developed to assess existing HPWS structures in hospitals. The objectives of this cross-sectional study were to translate the English HPWS questionnaire into German (HPWS-G), to rate its content validity, and to examine its psychometric properties. METHODS: Content validity was examined by a panel of 12 physicians and nurses, and I-CVI and S-CVI calculated. For internal consistency, Cronbach's α and item-scale correlations were determined. Construct validity was measured via confirmatory factor analysis. A convenience sample of 782 nurses and physicians in a University hospital setting in Switzerland's German-speaking region was surveyed. Four inclusion criteria were applied: working in intensive care, emergency department or operating room; having daily patient contact; having worked in the current clinical area for more than three months; and more than 40% employment. RESULTS: A total of 281 questionnaires were completed (response rate: 35.9%). Overall, the 10-item HPWS-G questionnaire showed good content validity (I-CVI = .83-1; S-CVI = .86) and internal consistency (Cronbach's α = .853). HPWS-G scores correlated significantly with safety climate (rs = .657, p < .01) and teamwork climate (rs = .615, p < .01). The proposed 1-factor model was accepted considering results of applied minimum rank factor analysis; a confirmatory factor analysis indicated an acceptable to good model fit (GFI = .968; CFI = .902; RMSEA = .043). CONCLUSIONS: The HPWS-G showed good psychometric properties. In clinical practice it can be used to assess HPWS practices and for intra- and inter-hospital benchmarking. Some minor adaptions to the wording could be made as well as reassessing the psychometric properties at other clinical sites.

Unraveling implementation context: the Basel Approach for coNtextual ANAlysis (BANANA) in implementation science and its application in the SMILe project.

BACKGROUND: Designing intervention and implementation strategies with careful consideration of context is essential for successful implementation science projects. Although the importance of context has been emphasized and methodology for its analysis is emerging, researchers have little guidance on how to plan, perform, and report contextual analysis. Therefore, our aim was to describe the Basel Approach for coNtextual ANAlysis (BANANA) and to demonstrate its application on an ongoing multi-site, multiphase implementation science project to develop/adapt, implement, and evaluate an integrated care model in allogeneic SteM cell transplantatIon facILitated by eHealth (the SMILe project). METHODS: BANANA builds on guidance for assessing context by Stange and Glasgow (Contextual factors: the importance of considering and reporting on context in research on the patient-centered medical home, 2013). Based on a literature review, BANANA was developed in ten discussion sessions with implementation science experts and a medical anthropologist to guide the SMILe project's contextual analysis. BANANA's theoretical basis is the Context and Implementation of Complex Interventions (CICI) framework. Working from an ecological perspective, CICI acknowledges contextual dynamics and distinguishes between context and setting (the implementation's physical location). RESULTS: BANANA entails six components: (1) choose a theory, model, or framework (TMF) to guide the contextual analysis; (2) use empirical evidence derived from primary and/or secondary data to identify relevant contextual factors; (3) involve stakeholders throughout contextual analysis; (4) choose a study design to assess context; (5) determine contextual factors' relevance to implementation strategies/outcomes and intervention co-design; and (6) report findings of contextual analysis following appropriate reporting guidelines. Partly run simultaneously, the first three components form a basis both for the identification of relevant contextual factors and for the next components of the BANANA approach. DISCUSSION: Understanding of context is indispensable for a successful implementation science project. BANANA provides much-needed methodological guidance for contextual analysis. In subsequent phases, it helps researchers apply the results to intervention development/adaption and choices of contextually tailored implementation strategies. For future implementation science projects, BANANA's principles will guide researchers first to gather relevant information on their target context, then to inform all subsequent phases of their implementation science project to strengthen every part of their work and fulfill their implementation goals.

Context-specific adaptation of an eHealth-facilitated, integrated care model and tailoring its implementation strategies-A mixed-methods study as a part of the SMILe implementation science project.

Background: Contextually adapting complex interventions and tailoring their implementation strategies is key to a successful and sustainable implementation. While reporting guidelines for adaptations and tailoring exist, less is known about how to conduct context-specific adaptations of complex health care interventions. Aims: To describe in methodological terms how the merging of contextual analysis results (step 1) with stakeholder involvement, and considering overarching regulations (step 2) informed our adaptation of an Integrated Care Model (ICM) for SteM cell transplantatIon faciLitated by eHealth (SMILe) and the tailoring of its implementation strategies (step 3). Methods: Step 1: We used a mixed-methods design at University Hospital Basel, guided by the Basel Approach for coNtextual ANAlysis (BANANA). Step 2: Adaptations of the SMILe-ICM and tailoring of implementation strategies were discussed with an interdisciplinary team (n = 28) by considering setting specific and higher-level regulatory scenarios. Usability tests were conducted with patients (n = 5) and clinicians (n = 4). Step 3: Adaptations were conducted by merging our results from steps 1 and 2 using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME). We tailored implementation strategies according to the Expert Recommendations for Implementing Change (ERIC) compilation. Results: Step 1: Current clinical practice was mostly acute-care-driven. Patients and clinicians valued eHealth-facilitated ICMs to support trustful patient-clinician relationships and the fitting of eHealth components to context-specific needs. Step 2: Based on information from project group meetings, adaptations were necessary on the organizational level (e.g., delivery of self-management information). Regulations informed the tailoring of SMILe-ICM`s visit timepoints and content; data protection management was adapted following Swiss regulations; and steering group meetings supported infrastructure access. The usability tests informed further adaptation of technology components. Step 3: Following FRAME and ERIC, SMILe-ICM and its implementation strategies were contextually adapted and tailored to setting-specific needs. Discussion: This study provides a context-driven methodological approach on how to conduct intervention adaptation including the tailoring of its implementation strategies. The revealed meso-, and macro-level differences of the contextual analysis suggest a more targeted approach to enable an in-depth adaptation process. A theory-guided adaptation phase is an important first step and should be sufficiently incorporated and budgeted in implementation science projects.

Understanding dynamic complexity in context-Enriching contextual analysis in implementation science from a constructivist perspective.

Context in implementation science includes not only characteristics of a setting in which an intervention will be delivered, but also social systems (e.g., interrelationships). Context is dynamic and interacts with both, the intervention and its implementation. Therefore, contextual analysis is recognized as an indispensable part of implementation science methodology: it provides the foundation for successful and sustainable implementation projects. Yet, driven by the prevailing post-positivist understanding of context, contextual analysis typically focuses on individual characteristics of context i.e., contextual dynamics and interactions go unnoticed. Conducting contextual analysis from a constructivist perspective promotes a multilayered approach, building a more comprehensive understanding of context, and thus facilitating successful implementation. In this article, we highlight the limitations of prevailing perspectives on context and approaches to contextual analysis. We then describe how contextual analysis can be enriched by working from a constructivist perspective. We finish with a discussion of the methodological and practical implications the proposed changes would entail. Emerging literature attempts to address both the concept of context and methods for contextual analysis. Various theories, models and frameworks consider context, however, many of these are reductionistic and do not acknowledge the dynamic nature of context or interactions within it. To complement recent conceptualizations of context, we suggest consider the following five constructivist concepts: 1) social space; 2) social place; 3) agency; 4) sensation; and 5) embodiment. We demonstrate the value of these concepts using COVID-19 vaccination uptake as an example and integrate the concepts in the Context and Implementation of Complex Interventions (CICI) framework-an implementation science framework that pays ample attention to context. To study context from a constructivist perspective, we also suggest additional considerations in view of methodologies for data collection and analysis, e.g., rapid ethnographic methods. A constructivist perspective contributes to a stronger conceptualization of contextual analysis. Considering the five constructivist concepts helps to overcome contextual analysis' current shortcomings, while revealing complex dynamics that usually go unnoticed. Thus, more comprehensive understanding of context can be developed to inform subsequent phases of an implementation project, thereby maximizing an intervention's uptake and sustainability.

Multi-level correlates of received social support among heart transplant recipients in the international BRIGHT Study: a secondary analysis.

AIMS: Social support is critical in follow-up of patients after heart transplant (HTx) and positively influences well-being and clinical outcomes such as medication adherence. The purpose of this study was to (i) explore received social support variation (emotional and practical) in HTx recipients at country and centre level and (ii) to assess multi-level correlates. METHODS AND RESULTS: Secondary data analysis of the multi-level cross-sectional BRIGHT study was conducted in 36 HTx centres in 11 countries. Received social support related to medication adherence was measured with emotional and practical sub-scales. The Conceptual Model of Social Networks and Health guided selection of patient, micro (interpersonal and psychosocial), meso (HTx centre) and macro-level (country health system) factors. Descriptive statistics, intraclass correlations, and sequential multiple ordinal mixed logistic regression analysis were used. A total of 1379 adult HTx recipients were included. Patient level correlates (female sex, living alone, and fewer depressive symptoms) and micro-level correlates (higher level of chronic disease management and trust in the healthcare team) were associated with better emotional social support. Similarly, patient level (living alone, younger age, and male sex), micro-level and meso-level (patient and clinician-rated higher level of chronic disease management) were associated with better practical social support. Social support varied at country and centre levels for emotional and practical dimensions. CONCLUSIONS: Social support in HTx recipients varies by country, centre, and was associated with multi-level correlates. Qualitative and longitudinal studies are needed to understand influencing factors of social support for intervention development, improvement of social support, and clinical outcomes.

Relevant Journals for Identifying Implementation Science Articles: Results of an International Implementation Science Expert Survey.

In implementation science (IS), conducting well-targeted and reproducible literature searches is challenging due to non-specific and varying terminology that is fragmented over multiple disciplines. A list of journals that publish IS-relevant content for use in search strings can support this process. We conducted a cross-sectional online survey of 56 Australian, European, and North American IS experts to identify and prioritize relevant journals that publish IS articles. Journals' relevance was assessed by providing each with a list of 12 journals, to which they were encouraged to add additional journal names and comments as free text. We also assessed which journals had published special IS-focused issues-identified via PubMed and Google searches-over the last 20 years. Data were analyzed descriptively. Between February 28 and March 15, 2020, a purposive sample of 34/56 experts participated in the survey (response rate: 60.7%). Implementation Science and BMC Health Services Research were perceived as relevant by 97.1% of participants; other journals' relevance varied internationally. Experts proposed 50 additional journals from various clinical fields and health science disciplines. We identified 12 calls and 53 special issues on IS published within various journals and research fields. Experts' comments confirmed the described challenges in identifying IS literature. This report presents experts' ratings of IS journals, which can be included in strategies supporting searches of IS evidence. However, challenges in identifying IS evidence remain geographically and interdisciplinary. Further investment is needed to develop reproducible search strings to capture IS evidence as an important step in improving IS research quality.

Clinicians and patients perspectives on follow-up care and eHealth support after allogeneic hematopoietic stem cell transplantation: A mixed-methods contextual analysis as part of the SMILe study.

PURPOSE: We report on our contextual analysis's methodology, as a first step of an implementation science project aiming to develop, implement, and test the effectiveness of an integrated model of care in SteM-cell transplantatIon faciLitated by eHealth (SMILe). METHODS: We applied an explanatory sequential mixed-methods design including clinicians and patients of the University Hospital Freiburg, Germany. Data were collected from 3/2017 to 1/2018 via surveys in 5 clinicians and 60 adult allogeneic stem-cell transplantation patients. Subsequently, we conducted 3 clinician focus groups and 10 patient interviews. Data analysis followed a 3-step process: (1) creating narrative descriptions, tables, and maps; (2) mapping key observational findings per dimension of the eHealth-enhanced Chronic-Care Model; (3) reflecting on how findings affect our choice of implementation strategies. RESULTS: Current clinical practice is mostly acute care driven, with no interdisciplinarity and weak chronic illness management. Gaps were apparent in the dimensions of self-management support and delivery-system design. Health behaviors that would profit from support include medication adherence, physical activity and infection prevention. The theme "being alone and becoming an expert" underpinned patients need to increase support in hospital-to-home transitions. Patients reported insecurity about recognizing, judging and acting upon symptoms. The theme "eHealth as connection not replacement" underscores the importance of eHealth augmenting, not supplanting human contact. Synthesis of our key observational findings informed eight implementation strategies. CONCLUSION: Stakeholders are willing towards a chronic care-focused approach and open for eHealth support. The contextual information provides a basis for the SMILe model's development and implementation.