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DURHAM, N.C. – Duke University Medical Center researchers have gathered evidence that training clinical trial coordinators on computer-controlled simulated patients before the beginning of a trial could reduce the potential risks to real patients.

The researchers said their findings indicate that the use of human simulators provides a key element of effective learning – interactivity – that traditional training programs can lack. For this reason, they argue that human simulation training should be an integral part of any complex clinical trial.

The results of their latest study involving human simulation, published July 22, 2004, in the online edition of the journal Anesthesia and Analgesia, showed a significant increase in the level of confidence of trial coordinators after their simulation experience.

Clinical trial coordinators are health care workers who are responsible for collecting 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.

"In any complex behavior, such as a clinical trial, there is always a learning curve," said anesthesiologist Jeffrey Taekman, M.D., director of the Duke Human Simulation and Patient Safety Center. "With human simulation, we can give coordinators hands-on experience even before they see a living patient at the bedside.

"Simulation has proven to be quite effective in the aviation and nuclear power industries to shorten the learning curve without any adverse effects on humans," Taekman continued. "We believe that simulation can perform the same role for making clinical trials a safer experience for patients."

To test their hypothesis, the researchers put 18 clinical trial coordinators through training at the Duke Human Simulation and Patient Safety Center. The clinical trial they were to conduct involved administering anesthetics during an open heart procedure. The procedure required constant monitoring of the patients' vital signs, as well as interacting with other members of the surgical and anesthesia team.

As a measure of the coordinators' competence in their knowledge of the study protocol, the researchers measured the coordinator's confidence in their knowledge of the trial and their ability to react appropriately to changing conditions in the operating room. Researchers tested 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).

According to Taekman, who is also assistant dean for educational technology at the Duke School of Medicine, the coordinators who participated saw their overall average confidence score increase from 5.77 to 8.64, when ranked on a scale of one to 10, with ten being the most confident.

In the three domains of learning, the increases were 4.89 to 8.24 in the affective, 6.42 to 8.75 in the cognitive, and 5.26 to 8.63 in the psychomotor.

"Traditional methods of teaching new procedures can be very static, involving written materials, didactic lectures and small group discussions," Taekman said. "In terms of the learning process, the simulator provides the next best thing to actually being at the bedside. 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."

Taekman said that human simulation laboratories could also be used by the investigators involved in clinical trials to work out protocol details in the earliest phases of design. Simulation might also be used to screen potential coordinators for competence, although Taekman said that this prospect needs further study.

The researcher team plans to conduct an analysis of the quality of the data collected by coordinators who have had simulator training. They will compare that data to that collected by coordinators who received the more traditional method of training to see if human simulation training can improve trial outcomes.

Taekman's study was supported by Duke's Department of Anesthesiology. The clinical trial was supported by the Global Perioperative Research Organization, a joint effort of the International Anesthesia Research Society, the Duke Clinical Research Institute and Duke's Department of Anesthesiology to improve outcomes of patients during surgery.

The Simulation Center is a joint effort of Duke's School of Medicine, School of Nursing and Department of Anesthesiology.

Other Duke researchers involved were team members were Eugene Hobbs, Linda Barber, Barbara Phillips-Bute, Ph.D., Melanie Wright, Ph.D., Mark Newman, M.D., and Mark Stafford-Smith, M.D.