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.

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.

Exploring Stem Cell Transplanted Patients' Perspectives on Medication Self-Management and Electronic Monitoring Devices Measuring Medication Adherence: A Qualitative Sub-Study of the Swiss SMILe Implementation Science Project.

PURPOSE: Little is known about allogeneic stem cell transplant (alloSCT) patients' medication adherence strategies. Acceptability and preferences regarding electronic monitoring (EM) systems to assess all three phases of medication adherence (ie, initiation, implementation, persistence) are crucial to allow their successful implementation in clinical or research settings but have not yet been evaluated. We therefore aimed to explore: 1) alloSCT patients' medication adherence and self-management strategies; and 2) their acceptability and preferences of three different EM systems (MEMS Cap, Helping Hand, Button) as part of the Swiss SMILe study. PATIENTS AND METHODS: Respecting anti-pandemic measures, we used a purposive sample of six adult alloSCT patients from the University Hospital Basel, Switzerland (USB)-6 weeks to 2 years post-alloSCT-to conduct three focus group sessions with two patients each. Using a semi-structured outline, we explored 1) patients' medication adherence strategies and medication self-management; and 2) their acceptance and preferences regarding EM use. The three tested EM systems were available for testing during each session. Discussions were audio-recorded, visualized using mind-mapping and analyzed using Mayring's qualitative content analysis. RESULTS: Patients (33% females; mean age 54.6±16.3 years; 10.4±8.4 months post-alloSCT) used medication adherence enhancing strategies (eg, preparing pillbox, linking intake to a habit). Still, they indicated that post-alloSCT medication management was challenging (eg, frequent schedule changes). All participants preferred the MEMS Button. Participants said its small size and the possibility to combine it with existing pillboxes (eg, putting it into/next to them) made them more confident about implementing it in their daily lives. CONCLUSION: Regarding EM systems for medication adherence, end-user preferences and acceptability influence adoption and fidelity. Of the three systems tested, our sample found the MEMS Button most acceptable and most preferable. Therefore, we will use it for our USB SMILe study.

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.

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.

Implementation Science Meets Software Development to Create eHealth Components for an Integrated Care Model for Allogeneic Stem Cell Transplantation Facilitated by eHealth: The SMILe Study as an Example.

PURPOSE: To describe a process of creating eHealth components for an integrated care model using an agile software development approach, user-centered design and, via the Behavior Change Wheel, behavior theory-guided content development. Following the principles of implementation science and using the SMILe project (integrated care model for allogeneic stem cell transplantation facilitated by eHealth) as an example, this study demonstrates how to narrow the research-to-practice gap often encountered in eHealth projects. METHODS: We followed a four-step process: (a) formation of an interdisciplinary team; (b) a contextual analysis to drive the development process via behavioral theory; (c) transfer of content to software following agile software development principles; and (d) frequent stakeholder and end user involvement following user-centered design principles. FINDINGS: Our newly developed comprehensive development approach allowed us to create a running eHealth component and embed it in an integrated care model. An interdisciplinary team's collaboration at specified interaction points supported clear, timely communication and interactions between the specialists. Because behavioral theory drove the content development process, we formulated user stories to define the software features, which were prioritized and iteratively developed using agile software development principles. A prototype intervention module has now been developed and received high ratings on the System Usability Scale after two rounds of usability testing. CONCLUSIONS: Following an agile software development process, structured collaboration between nursing scientists and software specialists allowed our interdisciplinary team to develop meaningful, theory-based eHealth components adapted to context-specific needs. CLINICAL RELEVANCE: The creation of high-quality, accurately fitting eHealth components specifically to be embedded in integrated care models should increase the chances of uptake, adoption, and sustainable implementation in clinical practice.

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project.

BACKGROUND: Medication adherence to immunosuppressants in allogeneic stem cell transplantation (alloSCT) is essential to achieve favorable clinical outcomes (e.g. control of Graft-versus-Host Disease). Over 600 apps supporting medication adherence exist, yet they lack successful implementation and sustainable use likely because of lack of end-user involvement and theoretical underpinnings in their development and insufficient attention to implementation methods to support their use in real-life settings. Medication adherence has three phases: initiation, implementation and persistence. We report the theory-driven development of an intervention module to support medication adherence (implementation and persistence phase) in alloSCT outpatients as a first step for future digitization and implementation in clinical setting within the SMILe project (Development, implementation and testing of an integrated care model in allogeneic SteM cell transplantatIon faciLitated by eHealth). METHODS: We applied Michie's Behavior Change Wheel (BCW) and the Capability-Opportunity-Motivation and Behavior (COM-B) model using three suggested stages followed by one stage added by our team regarding preparation for digitization of the intervention: (I) Defining the problem in behavioral terms; (II) Identifying intervention options; (III) Identifying content and implementation options; (IV) SMILe Care Model Prototype Development. Scientific evidence, data from a contextual analysis and patients'/caregivers' and clinical experts' inputs were compiled to work through these steps. RESULTS: (I) Correct immunosuppressant taking and timing were defined as target behaviors. The intervention's focus was determined within the COM-B dimensions Capability (lack of knowledge, lack of routine), Opportunity (lack of cues, interruptions in daily routine) and Motivation (lack of problem solving, trivialization). (II) Five intervention functions were chosen, i.e. education, training, modelling, persuasion and enablement. (III) Twenty-four behavior change techniques were selected, e.g., goal setting, action planning and problem solving. (IV) Finally, seventeen user stories were developed to guide the SMILeApp's software development process. CONCLUSION: Our example on the theory-driven development of an intervention module in alloSCT delivered by eHealth and transplant team using a rigorous 3 + 1-stage approach based on BCW, COM-B and agile software development techniques, can be used as methodological guidance for other eHealth intervention developers. Our approach has the potential to enhance successful implementation and sustained use of eHealth solutions in real-life settings.

A self-management support intervention for patients with atrial fibrillation: a randomized controlled pilot trial.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia worldwide. Despite effective treatment, it is characterized by frequent recurrences. Optimal therapeutic management of AF requires active participation and self-management from patients. Two major components of self-management are self-monitoring and sign-and-symptom management. Pulse self-palpation (PSP) is a method of self-monitoring; however, not all AF patients are capable of successfully performing PSP. Due to a lack of interventions on this topic, a nurse-led intervention for patients with AF (PSPAF intervention) was developed to foster self-monitoring and to enhance self-management through PSP. The purpose of this pilot study was to test the acceptability, feasibility, and potential effects of this intervention on the capability of patients' PSP and sign-and-symptom management. Moreover, we aimed at gathering data on the feasibility of applied research methods to aid in the design of future studies. METHODS: The pilot trial involved 20 adult patients with AF, randomized to an intervention or usual care group. At baseline and during a home visit 3-5 weeks later, we collected data using questionnaires, checklists, field notes, a mobile ECG device, and a diary. Acceptability and feasibility measures were validated through predefined cut-off points. Effect size estimates were expressed as relative risks (RR) and the number needed to treat (NNT). RESULTS: The PSPAF intervention seemed feasible, but only partly acceptable. There were limitations in terms of potential effectiveness, suitability, addressing participants' willingness to implement its content in daily life, and adherence. Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0). The feasibility of applied research methods showed minor limitations on recruitment and participant burden. CONCLUSIONS: Despite some limitations, the intervention seemed to be applicable and promising. Taking into account the suggestions and amendments we have made, we recommend conducting a full-scale trial to examine the efficacy of the PSPAF intervention. TRIAL REGISTRATION: This pilot study was registered in the German Clinical Trials Register at September 4, 2017 (Main ID: DRKS00012808).

The home care work environment's relationships with work engagement and burnout: A cross-sectional multi-centre study in Switzerland.

This study aimed to investigate the levels of burnout and work engagement among home care workers in Switzerland and to test their association with job demands and job resources. We conducted a multi-centre, cross-sectional survey in the German-speaking part of Switzerland with a convenience sample of seven home care agencies. Data were collected between September 2017 and January 2018. We assessed burnout with the Maslach Burnout Inventory (MBI) and work engagement with the Utrecht Work Engagement Scale (UWES) as well as job demands (overtime, work-family conflicts, experienced aggression and work stressors) and job resources (predictability, staffing, teamwork, leadership, collaboration, social support, sense of community, feedback). To investigate the levels of burnout and work engagement, we applied descriptive statistics. Based on Bakker and colleagues' Job Demands-Resources model, we used a path analysis to test the associations of job demands and job resources with burnout and work engagement. We analysed data from 448 home care workers (response rate 61.8%, mean age 44 years (SD 13.2), 96% female). The frequency of burnout in our sample was low, while that of work engagement was high. Job demands correlated positively with emotional exhaustion (ß = .54, p < .001) and negatively with work engagement (ß = -.25, p < .001). Job resources correlated negatively with emotional exhaustion (ß = -.28, p < .001) and positively with work engagement (ß = .41, p < .001). Work-family conflicts and work stressors correlated strongest with emotional exhaustion, whereas social support and feedback were found to correlate strongest with work engagement. Improvements to the home care work environment might enhance work engagement and reduce burnout. Corrective interventions could focus on reducing specific aspects of job demands, such as work-family conflicts and work stressors, as well as on increasing aspects of job resources, especially social support and feedback.

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.

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.

An oral care self-management support protocol (OrCaSS) to reduce oral mucositis in hospitalized patients with acute myeloid leukemia and allogeneic hematopoietic stem cell transplantation: a randomized controlled pilot study.

INTRODUCTION: Oral mucositis (OM) is a common and debilitating side effect of chemoradiotherapy in patients awaiting allogeneic hematopoietic stem cell transplantation (aHSCT). PURPOSE: The aim of this pilot RCT was to compare an oral care self-management support protocol (OrCaSS) to usual pre-aHSCT care. Feasibility was tested, effect sizes calculated for OM (primary outcome), and patient adherence was measured (secondary outcome). METHODS: Eighteen AML patients awaiting aHSCT and hospitalized between August 2012 and April 2013 were randomized 1:1 to usual care (UCG) and intervention (IG) groups. The OrCaSS protocol consisted of two sessions of educational and behavioral interventions, the first delivered 1 week pre-admission (T1), the second on admission day (T2). Via field notes, practicability and acceptability were evaluated to explore the feasibility of intervention and study procedures. OM data were collected at T1, T2, and daily for 28 days using the WHO scale. The effect size r was calculated (r less than -0.1 ≙ small and greater than or equal to -0.3 ≙ medium). Patients' adherence to the protocol was assessed at T1, T2, and 8-10 days post-HSCT (T3). RESULTS: Research and intervention procedures were feasible. OM incidence was 100 %. The IG's median highest OM grade was 2.0 (IQR = 2); the UCGs was 3.0 (IQR = 2; r = -0.1). Median OM durations were 12 days in the IG and 14 days in the UCG (r = -0.1). OM onset was 2 days later in the IG than in the UCG (r = -0.1). Over the course of the study, patient adherence decreased in both groups. CONCLUSIONS: OrCaSS is a promising intervention to delay and reduce OM. These results can serve to plan a larger RCT.