Simulation Training to Improve Informed Consent and Pharmacokinetic/Pharmacodynamic Sampling in Pediatric Trials

Abstract

Background: Pediatric trials to add missing data for evidence-based pharmacotherapy are still scarce. A tailored training concept appears to be a promising tool to cope with critical and complex situations before enrolling the very first patient and subsequently to ensure high-quality study conduct. The aim was to facilitate study success by optimizing the preparedness of the study staff shift. Method: An interdisciplinary faculty developed a simulation training focusing on the communication within the informed consent procedure and the conduct of the complex pharmacokinetic/pharmacodynamic (PK/PD) sampling within a simulation facility. Scenarios were video-debriefed by an audio-video system and manikins with artificial blood simulating patients were used. The training was evaluated by participants' self-assessment before and during trial recruitment. Results: The simulation training identified different optimization potentials for improved informed consent process and study conduct. It facilitated the reduction of avoidable errors, especially in the early phase of a clinical study. The knowledge gained through the intervention was used to train the study teams, improve the team composition and optimize the on-ward setting for the FP-7 funded "LENA" project (grant agreement no. 602295). Self-perceived ability to communicate core elements of the trial as well as its correct performance of sample preparation increased significantly (mean, 95% CI, p ≤ 0.0001) from 3 (2.5-3.5) to four points (4.0-4.5), and from 2 (1.5-2.5) to five points (4.0-5.0). Conclusion: An innovative training concept to optimize the informed consent process and study conduct was successfully developed and enabled high-quality conduct of the pediatric trials as of the very first patient visit.

Keywords: clinical study; communication; patient recruitment; pediatrics; pharmacokinetic/pharmacodynamic; simulation training; study conduct.

FIGURE 1

Results of the conducted self-assessment survey. Panel (A) depicts the participants rating on their competencies before and two days after the training concerning communication and PK/PD sampling. Results are depicted as Hodges Lehmann Estimator (HLE) with corresponding CI using a 5-point Likert-scale (1 = very poor, 5 = very good, *p < 0.0001, **p = 0.0001, p = 0.0002). Panel (B) illustrates the perceived long-term effects on attitude, knowledge, and working practice. Time points of determination were immediately after the simulation training (“after the training”), short before individual study start at each site (“before starting the study”) and at time point of 70% of anticipated study-wide patient recruitment (“during recruitment”).

FIGURE 2

Recruitment rates per site. Both panels show the recruited patients per study site over the total study period. In panel (A) each patient is represented by one symbol, patients of one site are connected by lines. Panel (B) shows normalized data, the percentage of patients recruited over the percentage of each site’s recruitment time. The dashed line is a non-linear curve fit of all curves indicating that the mean recruitment rate is highest at recruitment start.