Background: Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation of a study as well as the analysis of the results and interpretation of the findings. The objectives of this study are (a) to describe the methods of assessing the intervention fidelity used in the peer-led chronic pain management program (PAP) and (b) to report the findings on the PAP's intervention fidelity.
Methods: To optimize fidelity to the intervention, we used various strategies and measured them in a continuous process using several different approaches: (a) peer volunteer (PV) training workshop, (b) biweekly meetings with the research team, (c) a detailed teaching manual, (d) a fidelity checklist, (e) on-site visits and direct observations, and (f) semi-structured interview.
Results: The PVs' attendance was high, and most of them achieved a high level of implementation in following the fidelity checklist. As part of a large clustered RCT, the fidelity assessment was carried out to help determine the effectiveness of the intervention.
Conclusions: Overall, the PVs successfully delivered the intervention, and the results of the study indicate the effectiveness of the PAP.
Trial registration: ClinicalTrials.gov NCT03823495 . Registered on 30 January 2019.
Keywords: Clustered randomized controlled trial; Intervention fidelity; Peer volunteer (PV); Peer-led pain management program (PAP).
© 2021. The Author(s).