Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study

Abstract

BackgroundEvaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis.MethodsThis study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. 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. 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.ResultsThe results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. 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.ConclusionsThis 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. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity.Trial registrationClinicalTrials.gov, NCT02338869; registered 10/04/2014.Electronic supplementary materialThe online version of this article (10.1186/s12874-019-0694-z) contains supplementary material, which is available to authorized users.

Effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke in Norway: A randomized controlled trial

“…Analysis of the implementation fidelity showed that the intervention's core components were delivered according to protocol, although the intervention trajectories were individualized (32). Based on a composite score of the adherence measures (number of sessions, timeliness of starting, and duration of intervention), 80% of the intervention programmes were implemented with high fidelity.…”

The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial

“…In addition, the comprehensive process evaluation, including the evaluation of implementation fidelity that was conducted alongside the trial, 32 was an important advantage in documenting the trial implementation and in understanding trial outcomes.…”

“…15 Implementation fidelity was assessed and previously published as part of the process evaluation of this RCT. 32 The assessment of implementation fidelity included a separate analysis of intervention adherence. The composite adherence score showed that 117 (80.1%) of the intervention trajectories satisfied the criteria for high-fidelity intervention adherence.…”

“…It lasted 17 weeks, and the last session was completed within six months post-stroke. 15 , 32 A guide of stroke-related topics and work-sheets for each session were supplied as part of the intervention. 15 The intervention provider and the participant were encouraged to individually adapt the order of topics and the time in-between sessions to suit the needs of the participants.…”

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

“…A process evaluation alongside the trial was conducted to gain an in-depth understanding of the participants' experiences of being in the control group and of their adjustment process after stroke (9). Substantial psychosocial problems following stroke are common (1,9,(12)(13)(14)(15), and adjustment involves hard psychosocial and physical work. Mental strategies, cognitive adjustment and meaning making are key elements (16), and include plans, tasks, actions and coping efforts initiated by stroke survivors to manage their illness (17).…”