Prior to the finalization of a complex protocol and/or during the start up of a study that has unique training needs, we will institute the use of the Duke Human Simulation and Patient Safety Center (HSPSC) for two distinct purposes; protocol “usability”/design, and immersive training of research personnel.
Researchers in the HSPSC have demonstrated phenomenon consistent with learning curves in the data record of several clinical trials1 and have described the benefits of applying simulation techniques in the development and start-up of clinical trials.2,3 There is emerging evidence that learning curves may negatively influence the outcome of large multicenter clinical trials4 and the frequency of adverse events.5 The HSPSC is pioneering the use of human factors methods and simulation to mitigate learning curves in clinical trials. The application of our methods provide long term benefits to patients, trainees, and sponsors, including protection of the sponsors investment in their drug or device, the reduction of research cost and most importantly, reducing the potential risks to real patients. Simulation (mannequin-based or actor-based) is typically used in two ways: 1) protocol walk-throughs and 2) research personnel training.
Walkthroughs are used to assess protocol design. Protocol developers observe their study performed by research personnel in a high-fidelity simulated clinical setting prior to subject enrollment. Viewing (and reviewing) walkthroughs of clinical protocols helps uncover issues with design, timing, complexity, and practicality. Potential protocol errors and inefficiencies are highlighted and can be corrected before the protocol is implemented, thereby minimizing subject exposure and the number of protocol amendments—ultimately impacting both safety and cost.
In addition, skill acquisition of the research personnel is a key factor in the safe and effective deployment of a clinical research protocol. Proper performance of a clinical trial depends on complex behaviors. Complex human behaviors demonstrate ‘learning curves’, where performance improves with repetition. Just like a sports team, proficiency is gained through practical experience. Interactive training in a simulated environment provides the opportunity for Investigators, coordinators, and monitors to ‘practice’ without placing subjects or data at risk. Following simulation training, research personnel are closer to optimal performance at the time subject enrollment begins.
Ultimately, we believe our methods improve the chances of a successful trial (through better design and enhanced research personnel performance) while minimizing cost, improving efficiency, and enhancing safety.
Two examples of protocols using the simulation training are:
A Phase II multicenter, randomized, double-blind, parallel group, dose-ranging, effect-controlled study to determine the pharmacokinetics and pharmacodynamics of Sodium Nitroprusside in pediatric patients, sponsored by the NIH.
A Phase III, multicenter, randomized study of the safety and efficacy of Heparinase I versus Protamine in patients undergoing CABG with and without cardiopulmonary bypass/ sponsor by sponsored by an industry pharmaceutical company.
1. Taekman JM, Stafford-Smith M, Velazquez EJ, Wright MC, Phillips-Bute BG, Pfeffer MA, et al. Departures from the protocol during conduct of a clinical trial: A pattern from the data record consistent with a learning curve. Qual Saf Health Care 2010, Aug 10.
2. Wright MC, Taekman JM, Barber L, Hobbs G, Newman MF, Stafford-Smith M. The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures. Contemp Clin Trials. 2005;26:646-659.
3. Taekman JM, Hobbs G, Barber L, et al. Preliminary Report on the Use of High-Fidelity Simulation in the Training of Study Coordinators Conducting a Clinical Research Protocol. Anesth Analg. 2004;99:521-527.
The Anesthesia Cash Register - authored this award-winning program that calculates the cost of an anesthetic in real and compressed time. Received a Meritorious Award in Stuart Pharmaceutical’s Cost-Effectiveness Awards. 1992–1993.
The Penn State Anesthesia Content Outline and Keyword Review - designed and implemented this interactive teaching tool which reviews and tests essential topics in anesthesia. Part of the 1994 ASA Annual Meeting’s First Place Scientific Exhibit. 1994–1995.
Penn State Anesthesia Home Page - designed, programmed and maintained the Penn State / Geisinger Anesthesia World Wide web Home Page and internet serving computer. 1995–1999.
Penn State Anesthesia Electronic Case Conference - peer-reviewed educational publication on the internet dedicated to the discussion of perioperative management issues in anesthesia. Chosen as charter program for Penn State’s World Campus, a global distance education initiative. 1995–1999.
Penn State Anesthesia Recruitment Kiosk - designed and programmed this computer kiosk authored to convey information on the Penn State Anesthesia Residency Program. 1995–1996.
Applied Research Ethics National Association Home Page – designed, implemented, and maintained home page for this national organization (www.aamc.org/research/primr/arena/)1995.
Anesthesia Employment Archive - designed, programmed, and maintain the original internet resource enabling position matching in anesthesia (www.anes.hmc.psu.edu/employmentfolder/AEAhome.html). 1996–1999.
Pennsylvania Society of Anesthesiologist’s Home Page - designed and programmed the Society’s World Wide web Page. 1996.
The Ontology Mine - invented this computer-based medical education and reference tool. PSU Software Disclosure No. SW-97 031. 1997–1999.
The Penn State Anesthesia Intranet – programmed, designed, and maintained this internal departmental resource. Includes database/web integration for tracking clinical time, educational time, and resident evaluations. 1997–1999.
Penn State College of Medicine Faculty Discussion Site - designed and maintained this institution-wide internet resource to disseminate and discuss issues of importance to the clinical and research faculty. 1998–1999.
ResEval - A web-Based Resident Evaluation System. 1999–2004.
Academic Relative Value Unit Project (AcademicRVU)-A web-based system to monitor faculty productivity and resources. 1999–2001.
The Comparison Matrix (CompMatrix)-A web-based decision making tool to help resident applicants compare and rank disparate anesthesiology residency programs. Software disclosure: Patent Pending. 2000–2007.
MedicalSim-L Human Simulation Discussion List– founded an international internet discussion group focusing on human simulation. Ultimately folded into the Society for Simulation in Healthcare. 2001–2006.
Simulation Scripting Template – a method for “story-boarding” simulation exercises prior to formal simulator programming. 2001–present.
Medical Student Surgical Core Palm Project – A Palm/web based tool to aid in point-of-care education for medical students and residents. 2001–2002.
Duke Anesthesiology Didactics Course Site - A web-based didactic archiving project. 2001–2003.
Faculty Profiling System/web - A web-based tool which automates the classification and identification of research interests of the Duke University School of Medicine Faculty. 2001–2002.
SimDot – A multidisciplinary, peer-reviewed, web-based community to facilitate collaboration in simulation patient and scenario development., 2002–2006.
Simulation Management Interface – designed and implemented this system used to manage the Duke University Human Simulation and Patient Safety Center. (http://dukesimcenter.org/calendar/) 2002–2008.
ACGME-Compliant PDA Case Log – designed the application framework and oversaw the development of this handheld application used to track resident cases and procedures. 2003–2004.
Peripheral Nerve Block PDA Log Book – designed the application shell and served as advisor for development of this handheld application to track regional anesthesia procedures. 2003–2004.
Medical Student Procedure PDA Log Book – designed the application shell and serve as advisor for development of this handheld application to track medical student patient and procedure encounters. 2003–2005.