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

Line Kildal Bragstad, Berit Arnesveen Bronken, Unni Sveen, Ellen Gabrielsen Hjelle, Gabriele Kitzmüller, Randi Martinsen, Kari J Kvigne, Margrete Mangset, Marit Kirkevold, Line Kildal Bragstad, Berit Arnesveen Bronken, Unni Sveen, Ellen Gabrielsen Hjelle, Gabriele Kitzmüller, Randi Martinsen, Kari J Kvigne, Margrete Mangset, Marit Kirkevold

Abstract

Background: Evaluation 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.

Methods: This 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.

Results: The 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.

Conclusions: 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. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity.

Trial registration: ClinicalTrials.gov , NCT02338869; registered 10/04/2014.

Keywords: Implementation fidelity; Mixed methods; Process evaluation; Psychosocial intervention; Stroke.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this study, including the process evaluation, was granted by REC South East (Case number: 2013/2047) and by the Data Protection Official responsible for all participating hospitals (Case number: 2014/1026). Written informed consent, adjusted for stroke survivors with aphasia [31], was collected from all patients participating in the RCT and the process evaluation. Written informed consent was collected from the IP prior to conducting focus group interviews.

Consent for publication

The written consent forms contain information about scientific publication of results from the study in anonymous form and all participants and IP have given their written consent.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The modified conceptual framework for implementation fidelity [4]
Fig. 2
Fig. 2
Theoretical structure of the intervention [12]
Fig. 3
Fig. 3
Content and suggested structure of the intervention trajectory [6]
Fig. 4
Fig. 4
RCT enrolment, group allocation and follow-up at 6 and 12 months
Fig. 5
Fig. 5
Data collection timeline for RCT and process evaluation

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