233 The Use of High-Fidelity Simulation to Identify Potential Protocol Violations and Latent Risk Threats During Standardized Protocol Training in a Large, Multicenter Study

Abstract

High-fidelity simulation (HF-SIM) has been used extensively in medical education and quality improvement; however, its role in protocol training for large clinical research trials is not well described. We sought to utilize HF-SIM for protocol training for a large multicenter clinical trial in order to standardize training and identify potential protocol violations (PPVs) or study-related latent risk threats (LRTs) prior to enrolling patients in the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial. LRTs are elements of the health care system that make patient care errors more likely. In addition to having over a dozen study sites, the enrollment and treatment protocols for the HOBIT trial are complex, including interdisciplinary critical care transfers between multiple units and patient care areas. This makes a standardized approach to protocol training critical to success. This was a feasibility study of the use of HF-SIM for standardized protocol training in a large, multicenter study. Prior to onboarding individual study sites, 4 HF-SIM patient care scenarios were developed and run in active patient care areas at the primary study site. The scenarios included: 1) a standard, uncomplicated enrollment process with patient transport through all clinical areas, 2) a ventilator circuit kinking during transport requiring troubleshooting, 3) a pneumothorax during HBO therapy requiring urgent decompression, and 4) a ventilator disconnection during HBO therapy, requiring emergent decompression. The scenarios were thought to represent conditions most likely to result in PPVs or LRTs. After each scenario, PPVs and LRTs discovered during the scenario were documented. The primary site’s HF-SIMs were video recorded as examples, and all other participating sites were required to watch the scenarios and reproduce 2 HF-SIM cases at their individual institutions, including one uncomplicated enrollment case and one complication case. Individual sites were required to submit a recorded video of their simulations and a tracking document that listed any PPVs or LRTs discovered, along with potential solutions, in order to determine site readiness for active enrollment of patients. The PPVs and LRTs discovered were coded by 2 independent raters. Items lacking initial agreement were discussed and subsequently agreed upon. Use of HF-SIM was feasible for protocol training at the initial 2 study sites, as both had in-house simulation centers. One center was forced to run a portion of their scenario in the simulation center instead of the ICU due to hospital census, but was able to run the remainder of their HF-SIMs in patient care areas. No other financial or logistical barriers were reported. Aggregate data from these sites reveals that 34 unique PPVs or LRTs were discovered. Themes included: need for additional medical training n=7 (20.6%), protocol clarifications n=4 (11.8%), equipment issues n=8 (23.5%), and systems issues n=15 (44.1%). Some issues were found in multiple care areas, but only included once in the analysis. HF-SIM can be used as part of a standardized protocol training program for clinical trials. The use of HF-SIM identified multiple training and process deficiencies prior to enrolling patients, and could lead to decreased protocol violations as well as decreased patient safety threats during the actual study period.