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Patient Simulator Improves Performance Of Clinical Trial Coordinators

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Duke Health News 919-660-1306

SAN FRANCISCO – Duke University Medical Center researchers have demonstrated that training research coordinators on a human simulator prior to a complex clinical trial can significantly improve the coordinators' confidence in their abilities.

Since the researchers believe that confidence is a central element in competence, they said that the routine use of such simulators could not only lead to the collection of higher quality data during a trial, but can also have an important impact on improving patient safety.

Clinical trial coordinators are health care workers who collect data at the research sites. They tend to have the most contact with patients or participants in the trial.

The simulator is a life-sized human model that can be programmed to react physiologically to different scenarios, such as the administration of drugs or the placement of intravenous lines. The researchers can control the reactions of the simulated patients to allow learners to experience a variety of situations that may occur.

"While traditional methods of teaching new material involve reading and lectures, the simulator provides a hands-on experience that greatly improves the learning experience," said anesthesiologist Jeffrey Taekman, M.D., director of the Duke Human Simulation and Patient Safety Center. "The process is analogous to pilots who can train under all sorts of conditions without flying. After going through the simulations, the coordinators in our study saw a dramatic and statistically significant increase in their confidence levels."

Taekman, who is also assistant dean for educational technology at the Duke School of Medicine, presented the results of the Duke study today (Oct. 14, 2003) at the annual meeting of the American Society of Anesthesiologists.

For their study, the Duke team trained 29 coordinators who were about to be involved in a complex clinical trial that would take place in an operating room setting. Before and after the training, the coordinators took standardized tests that measure confidence.

The responses to the questions were categorized according to Bloom's taxonomy of learning, which describes three aspects of learning:

--affective: how the learner feels about what is being learned

--cognitive: actual knowledge and intellectual skills, and

--psychomotor: physical skills and movement.

"All three of these areas are integral to effective learning," Taekman said. "This particular trial would take place in the complex setting of the operating room, where action is occurring all around and information is constantly being generated that must be analyzed and acted upon. The trial also involved a lot of hands-on activity."

According to Taekman, when ranked on a scale of one to 10, with 10 being the most confident, the coordinators who participated saw their overall average confidence score increase from 5.7 to 8.12.

While all three domains of learning saw dramatic increases after simulator training, the psychomotor area saw the greatest relative improvement, from 4.83 to 8.1. The affective domain increased from 6.13 to 8.17 and the cognitive domain increased from 6.17 to 8.03.

"We fully believe that simulation training could be the wave of the future, especially after seeing the results of this study," Taekman said. "The current approach to training coordinators fails to take advantage of adult learning theory, which has shown that interactivity is a superior method for teaching medical professionals.

"In terms of the learning process, the simulator provides the next best thing than actually being at the bedside." Taekman continued. "The simulator allows learners to hone their skills before coming in contact with patients, thereby shortening the learning curve."

The Duke team has completed an analysis of whether or not simulator training actually leads to better trial data and improved patient safety – the results will be published at a later date.

Taekman's study was supported by the Department of Anesthesiology. The Simulation Center is a joint effort of Duke's School of Medicine, School of Nursing and Department of Anesthesiology.

Other Duke team members were Barbara Phillips-Bute, Ph.D., Eugene Hobbs, Linda Barber, M.S.N., Mark Newman, M.D., and Mark Stafford-Smith, M.D.

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