James S. Todd Memorial Award for Patient Safety Research

Improving Patient Safety in Cardiac Surgery via Prospective Use of the Cumulative Sum (CUSUM) Failure Method

Investigators: Richard J. Novick, MD (PI), Douglas Bloyd, MD, John Lee, MD, Mckenzie Quantz, MD

Using a statistical methodology known as CUSUM, this two-year study analyzed the learning curves of new surgical consultants and surgeons engaged in minimally invasive cardiac surgery. The investigators anticipated that the CUSUM method would enable prospective analysis of the learning curves of new surgical consultants and of surgeons engaging in innovative, minimally invasive procedures. The goal of this study was to incorporate the CUSUM technique into standard methods of surgical audit to improve patient safety and outcomes after
cardiac surgery.

The results of this study illustrate that prospective use of the CUSUM method can alert surgeons to suboptimal results and the need for prompt remedial action in advance of standard comparative analyses.

In a highly innovative field such as cardiac surgery where techniques are changing weekly, an “online” sequential probability assessment of patient outcomes is obligatory. The researchers have already noted significant interest in CUSUM analysis among the cardiac surgical community in North America and
Europe and believe that it will have a significant impact on future outcome assessment in cardiac surgery.

Pediatric Sedation: a Safety and Efficacy Problem for Children Requiring Diagnostic and Therapeutic Procedures in the Hospital Setting; A Human Factors Opportunity for Improvement

George T. Blike, MD (PI), Joseph Cravero, MD, Gene Nelson, PhD, Kate Whalen, RN

This research involved extensive video observation of pediatric procedural sedation in the hospital setting. The study sought to shift how medical practitioners viewed the concepts of safety and efficacy to all aspects of the sociotechnical system that impacts outcome. Specifically, this research aimed to characterize performance in a state-feedback control model that would allow critical factors affecting control to be identified and then utilized for system redesign.

The results of this research have led to a shift in our understanding regarding the undertreatment of pain and anxiety. Undertreatment errors should be viewed as a safety failure and are related to control failures in managing overdose events.
Practitioners with unreliable systems for managing overdose states in patients routinely tolerate underdose states to create a margin of safety. These data fostered subsequent research focused on rescue systems and distributed teams. The initial study funded by NPSF was pivotal in allowing our research team to secure funding from the National Institute of Child Health and Human Development to use simulation to identify latent conditions preventing optimal rescue and control of rare but potentially lethal overdose events.

Ultimately, this project impacted the provision of sedation to pediatric patients at our hospital, resulting in improved safety and reliability for children who require painful and/or stressful procedures. We have implemented a sedation program that has now been in place for over eight years that was designed to optimize control.

Error Detection and Recovery: Fixation vs. Adaptability

Investigators: William R. Torbert, PhD, Jenny Rudolph, PhD, John S. Carroll, PhD, Daniel Ramer, PhD

The goal of this project was to help medical trainees understand and transcend their internal barriers in identifying, discussing, and recovering from error. The study focused on the debriefing of trainees who have been challenged with responding to critical events during training sessions in a realistic simulator. Study aim was to better understand the process of fixation error, revise the debriefing sessions to reduce fixation and improve hypothesis generation, and then retest performance in a subsequent event to assess the efficacy of the intervention.

Serious Medication Errors: Evaluation of Prevention Strategies in Pediatrics

Donald Goldmann, MD, Rainu Kaushal, MD, David W. Bates, MD, Margaret D. Clapp, MS

The team of this project is studying the effectiveness of two interventions, pharmacist involvement on inpatient pediatric wards plus CQI teams and a physician order system, on the rate of serious medication errors at two academic pediatric institutions. This project follows a study that has been examining adverse events and medications errors in a fashion similar to that of studies in adult populations. While these interventions have been studied in adult populations, the investigators have identified unique qualities of errors and sequelae in children that justify examination in this setting.