Abstract
BackgroundUnderstanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used. This study aimed to use these methods to explore the quality of implementation of a complex intervention (Safewards) on mental health wards during a cluster randomised controlled trial. Specific aims were firstly to describe the different ways in which the intervention was implemented, and secondly to explore the contextual factors moderating the quality of intervention delivery, in order to inform ‘real world’ implementation of the intervention.MethodsSafewards was implemented on 16 mental health wards in England. We used Research Assistants (RAs) trained in participant observation to record qualitative observational data on the quality of intervention delivery (n = 565 observations). At the end of the trial, two focus groups were conducted with RAs, which were used to develop the coding framework. Data were analysed using thematic analysis.ResultsThere was substantial variation in intervention delivery between wards. We observed modifications to the intervention which were both fidelity consistent and inconsistent, and could enhance or dilute the intervention effects. We used these data to develop a typology which describes the different ways in which the intervention was delivered. This typology could be used as a tool to collect qualitative observational data about fidelity during trials. Moderators of Safewards implementation included systemic, interpersonal, and individual factors and patient responses to the intervention.ConclusionsOur study demonstrates how, with appropriate training in participant observation, RAs can collect high-quality observational data about the quality of intervention delivery during a trial, giving a more complete picture of ‘fidelity’ than measurements of adherence alone.Trial registrationISRCTN registry; IRSCTN38001825. Registered 29 August 2012
Highlights
Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity affects the validity of trial findings, and because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice
Understanding intervention fidelity is an essential part of the evaluation of complex interventions because it is central to the validity, reliability and so generalisability of trial findings, and because studies can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of an effective intervention into routine clinical practice [2]
The results of the qualitative observational study are presented in two parts: first, we outline a typology of implementation quality for the Safewards randomised controlled trial (RCT), and second, describe moderators of the quality of implementation of Safewards observed by Research assistant (RA) during the trial
Summary
Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity affects the validity of trial findings, and because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Understanding intervention fidelity is an essential part of the evaluation of complex interventions because it is central to the validity, reliability and so generalisability of trial findings, and because studies can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of an effective intervention into routine clinical practice [2]. Approaches to measuring theoretical fidelity include the use of standardised tools which record the extent to which the ‘essential elements’ of an intervention are delivered [3], or frameworks which support differentiation of fidelity-consistent, or fidelity-inconsistent, adaptations to an intervention [8]
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call