Intervention Fidelity

Abstract

Background Measurement of intervention fidelity is an essential component of any scientifically sound intervention trial. However, few papers have proposed ways to integrate intervention fidelity data into the execution of these trials. Objective The purpose of this paper is to describe the intervention fidelity process used in a randomized controlled trial of a human patient simulator intervention and how these data were used to monitor drift and provide feedback to improve the consistency of both intervention and control delivery over time in a multisite education intervention for parents of children with newly diagnosed type 1 diabetes. Methods Intervention fidelity was measured for both the intervention and control condition by direct observation, self-report of interventionist delivery, and parent participant receipt of educational information. Intervention fidelity data were analyzed after 50%, 75% and 100% of the participants had been recruited and compared by group (treatment and control) and research site. Results The sample included 191 parents of young children newly diagnosed with type 1 diabetes. Observations scores in both intervention and control groups indicated a high level of intervention fidelity. Treatment receipt was also high and did not differ by treatment group. The teaching session attendance rates by site and session were significantly different at time point 1 (50% enrollment); following study staff retraining and reinforcement, there were no significant differences at time point 3 (100% enrollment). Implications Results demonstrate the importance of monitoring intervention fidelity in both the intervention and control condition over time and using these data to correct drift during the course of a multi-site clinical trial.

Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions

“…to prevent intervention drift over time), and when they are conducted in relation to the main trial results, for example, without knowledge of trial findings, or subsequently integrated to illuminate the findings. Bova et al ( 2017 ) provide an example of how fidelity of intervention delivery was monitored over time, and data were subsequently used to correct drift in both the intervention and comparator conditions during the course of a complex clinical trial (Bova et al, 2017 ). They also explicitly report using fidelity of delivery data within their main trial analysis to examine the effect of fidelity variability on treatment outcomes (Sullivan-Bolyai et al, 2015 ).…”

Factors Influencing Fidelity to a Calorie Posting Policy in Public Hospitals: A Mixed Methods Study

“…To maximise fidelity and reduce "intervention drift", implementation needs to be adequately and continuously monitored via internal and external sources (68,77,104,109,110). A feedback loop is also required along with encouragement, reward or recognition for implementation efforts (104).…”

Impact of a work-based feedback intervention on student performance during clinical placements in acute-care healthcare settings: a quasi-experimental protocol for the REMARK programme

“…in which the intervention is delivered as planned and accepted by the study participants. [33][34][35] Strategies to enhance protocol adherence-and therefore reliability and validity of the study-include: ► Work-based intervention congruent with underpinning theory and current evidence; ► Use of validated measurement tools to evaluate study outcomes; ► REMARK programme lead researcher's experience with intervention studies and individual/group facilitation and coaching; ► Pre-engagement with key stakeholders and gatekeepers; ► Delivery of sessions by the REMARK programme lead researcher; ► Visibility of REMARK programme lead researcher in intervention units throughout study; and ► Comparable content and session length for all units at the intervention site.…”