In this study, we refer to implementation within the context of an RCT which was conducted as part of development and testing of a complex intervention. The concept of implementation can refer to implementation within clinical practice, which may only be endeavored when the intervention has shown effectiveness in outcomes evaluation, or it may refer to the implementation within the context of an effectiveness evaluation (RCT). The key questions in process evaluations are concerned with the implementation of the intervention: What was implemented, and how was the intervention implemented?. A clear description of the intervention and its causal assumptions is a prerequisite for conducting a process evaluation and to be able to interpret an intervention’s outcomes. The concept of process evaluation has become an essential part of designing and testing complex interventions in health and rehabilitation. Description of the intervention and its theoretical and empirical underpinnings as well as the content and structure of the intervention will be included as background. In the following, we will present the concept of process evaluation and the conceptual framework chosen to guide the analysis of implementation fidelity in the present study. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. Thus, successful evaluations of complex interventions should go beyond the traditional outcome evaluation and include a process evaluation. Furthermore, there is the risk of evaluating an intervention without knowing if it has been delivered as intended. However, critics argue that the RCT design oversimplifies cause and effect in complex interventions and that the context of delivering the intervention and the influence exerted by implementers and participants may be ignored in such a study design.
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A randomized controlled trial (RCT) design is generally the preferred design for evaluating the effect of interventions. In complex interventions in health and rehabilitation, the complexity lies not only within the several interacting components within the intervention itself, but also in the way these components may interact with the context during intervention delivery. Trial registrationĬ, NCT02338869 registered.
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The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity. This evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. The results show that the core components of the intervention were delivered although the intervention trajectories were individualized. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. Qualitative process data were collected after the last data collection point of the RCT. Quantitative process data were collected longitudinally along with data collection in the RCT. This study has an explanatory, sequential two-phase mixed methods design.
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A modified conceptual framework for implementation fidelity was used to guide the analysis. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs.