BackgroundEvaluation of an implementation process and its fidelity can give insight into the 'black box' of interventions. However, a lack of standardized methods for studying fidelity and implementation process have been reported, which might be one reason for the fact that few prior studies in the field of health service research have systematically evaluated interventions' implementation processes.The aim of this project is to systematically evaluate implementation fidelity and possible factors influencing fidelity of complex interventions in health and social care.MethodsA modified version of The Conceptual Framework for Implementation Fidelity will be used as a conceptual model for the evaluation. The modification implies two additional moderating factors: context and recruitment. A systematic evaluation process was developed. Multiple case study method is used to investigate implementation of three complex health service interventions. Each case will be investigated in depth and longitudinally, using both quantitative and qualitative methods.DiscussionThis study is the first attempt to empirically test The Conceptual Framework for Implementation Fidelity. The study can highlight mechanism and factors of importance when implementing complex interventions. Especially the role of the moderating factors on implementation fidelity can be clarified.Trial RegistrationSupported Employment, SE, among people with severe mental illness -- a randomized controlled trial: NCT00960024.

BackgroundPrior studies measuring fidelity of complex interventions have mainly evaluated adherence, and not taken factors affecting adherence into consideration. A need for studies that clarify the concept of fidelity and the function of factors moderating fidelity has been emphasized. The aim of the study was to systematically evaluate implementation fidelity and possible factors influencing fidelity of a complex care continuum intervention for frail elderly people.MethodsThe intervention was a systematization of the collaboration between a nurse with geriatric expertise situated at the emergency department, the hospital ward staff, and a multi-professional team with a case manager in the municipal care services for older people. Implementation was evaluated between September 2008 and May 2010 with observations of work practices, stakeholder interviews, and document analysis according to a modified version of The Conceptual Framework for Implementation Fidelity.ResultsA total of 16 of the 18 intervention components were to a great extent delivered as planned, while some new components were added to the model. No changes in the frequency or duration of the 18 components were observed, but the dose of the added components varied over time. Changes in fidelity were caused in a complex, interrelated fashion by all the moderating factors in the framework, i.e., context, staff and participant responsiveness, facilitation, recruitment, and complexity.DiscussionThe Conceptual Framework for Implementation Fidelity was empirically useful and included comprehensive measures of factors affecting fidelity. Future studies should focus on developing the framework with regard to how to investigate relationships between the moderating factors and fidelity over time.Trial registrationClinicalTrials.gov, NCT01260493.

Future interventions should focus on counteracting work-related exhaustion and improving competence development to improve work satisfaction among older people care nursing staff in both care settings. Relevance to clinical practice. Work-related exhaustion and lack of competence development may have significant negative implications for work satisfaction among older people care nursing staff in both home care and nursing homes.

BackgroundFrail elderly people need an integrated and coordinated care. The two-armed study "Continuum of care for frail elderly people" is a multi-professional and multidimensional intervention for frail community-dwelling elderly people. It was designed to evaluate whether the intervention programme for frail elderly people can reduce the number of visits to hospital, increase satisfaction with health and social care and maintain functional abilities. The implementation process is explored and analysed along with the intervention. In this paper we present the study design, the intervention and the outcome measures as well as the baseline characteristics of the study participants.Methods/designThe study is a randomised two-armed controlled trial with follow ups at 3, 6 and 12 months. The study group includes elderly people who sought care at the emergency ward and discharged to their own homes in the community. Inclusion criteria were 80 years and older or 65 to 79 years with at least one chronic disease and dependent in at least one activity of daily living. Exclusion criteria were acute severely illness with an immediate need of the assessment and treatment by a physician, severe cognitive impairment and palliative care. The intention was that the study group should comprise a representative sample of frail elderly people at a high risk of future health care consumption. The intervention includes an early geriatric assessment, early family support, a case manager in the community with a multi-professional team and the involvement of the elderly people and their relatives in the planning process.DiscussionThe design of the study, the randomisation procedure and the protocol meetings were intended to ensure the quality of the study. The implementation of the intervention programme is followed and analysed throughout the whole study, which enables us to generate knowledge on the process of implementing complex interventions. The intervention contributes to early recognition of both the elderly peoples' needs of information, care and rehabilitation and of informal caregivers' need of support and information. This study is expected to show positive effects on frail elderly peoples' health care consumption, functional abilities and satisfaction with health and social care.Trial registrationClinicalTrials.gov: NCT01260493

Background A considerable proportion of interventions provided to patients lack evidence of their effectiveness. This implies that patients may receive ineffective, unnecessary or even harmful care. However, despite some empirical studies in the field, there has been no synthesis of determinants impacting the use of low-value care (LVC) and the process of de-implementing LVC. Aim The aim was to identify determinants influencing the use of LVC, as well as determinants for de-implementation of LVC practices in health care. Methods A scoping review was performed based on the framework by Arksey and O’Malley. We searched four scientific databases, conducted snowball searches of relevant articles and hand searched the journal Implementation Science for peer-reviewed journal articles in English. Articles were included if they were empirical studies reporting on determinants for the use of LVC or de-implementation of LVC. The abstract review and the full-text review were conducted in duplicate and conflicting decisions were discussed until consensus was reached. Data were charted using a piloted data charting form and the determinants were inductively coded and categorised in an iterative process conducted by the project group. Results In total, 101 citations were included in the review. Of these, 92 reported on determinants for the use of LVC and nine on determinants for de-implementation. The studies were conducted in a range of health care settings and investigated a variety of LVC practices with LVC medication prescriptions, imaging and screening procedures being the most common. The identified determinants for the use of LVC as well as for de-implementation of LVC practices broadly concerned: patients, professionals, outer context, inner context, process and evidence and LVC practice. The results were discussed in relation to the Consolidated Framework for Implementation Research. Conclusion The identified determinants largely overlap with existing implementation frameworks, although patient expectations and professionals’ fear of malpractice appear to be more prominent determinants for the use and de-implementation of LVC. Thus, existing implementation determinant frameworks may require adaptation to be transferable to de-implementation. Strategies to reduce the use of LVC should specifically consider determinants for the use and de-implementation of LVC. Registration The review has not been registered.

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Participatory intervention approaches that are embedded in existing organizational structures may improve the efficiency and effectiveness of organizational interventions, but concrete tools are lacking. In the present article, we use a realist evaluation approach to explore the role of kaizen, a lean tool for participatory continuous improvement, in improving employee well-being in two cluster-randomized, controlled participatory intervention studies. Case 1 is from the Danish Postal Service, where kaizen boards were used to implement action plans. The results of multi-group structural equation modeling showed that kaizen served as a mechanism that increased the level of awareness of and capacity to manage psychosocial issues, which, in turn, predicted increased job satisfaction and mental health. Case 2 is from a regional hospital in Sweden that integrated occupational health processes with a pre-existing kaizen system. Multi-group structural equation modeling revealed that, in the intervention group, kaizen work predicted better integration of organizational and employee objectives after 12 months, which, in turn, predicted increased job satisfaction and decreased discomfort at 24 months. The findings suggest that participatory and structured problem-solving approaches that are familiar and visual to employees can facilitate organizational interventions.

BackgroundThere has long been debate about the balance between fidelity to evidence-based interventions (EBIs) and the need for adaptation for specific contexts or particular patients. The debate is relevant to virtually all clinical areas. This paper synthesises arguments from both fidelity and adaptation perspectives to provide a comprehensive understanding of the challenges involved, and proposes a theoretical and practical approach for how fidelity and adaptation can optimally be managed.DiscussionThere are convincing arguments in support of both fidelity and adaptations, representing the perspectives of intervention developers and internal validity on the one hand and users and external validity on the other. Instead of characterizing fidelity and adaptation as mutually exclusive, we propose that they may better be conceptualized as complimentary, representing two synergistic perspectives that can increase the relevance of research, and provide a practical way to approach the goal of optimizing patient outcomes. The theoretical approach proposed, the “Value Equation,” provides a method for reconciling the fidelity and adaptation debate by putting it in relation to the value (V) that is produced. The equation involves three terms: intervention (IN), context (C), and implementation strategies (IS). Fidelity and adaptation determine how these terms are balanced and, in turn, the end product – the value it produces for patients, providers, organizations, and systems. The Value Equation summarizes three central propositions: 1) The end product of implementation efforts should emphasize overall value rather than only the intervention effects, 2) implementation strategies can be construed as a method to create fit between EBIs and context, and 3) transparency is vital; not only for the intervention but for all of the four terms of the equation.SummaryThere are merits to arguments for both fidelity and adaptation. We propose a theoretical approach, a Value Equation, to reconciling the fidelity and adaptation debate. Although there are complexities in the equation and the propositions, we suggest that the Value Equation be used in developing and testing hypotheses that can help implementation science move toward a more granular understanding of the roles of fidelity and adaptation in the implementation process, and ultimately sustainability of practices that provide value to stakeholders.