Development of standardized simulated patients for quality control of the clinical interview.

The evaluation and training of clinical trial staff who counsel patients in lifestyle changes for disease prevention is aided by a review of videorecorded interviews conducted with a simulated patient. This report describes the Inventory of Simulated Patient Characteristics, a listing of 34 generic parameters for developing a simulated patient for use in staff training and evaluation in counseling. The Inventory creates a complete person in all critical aspects of counseling for lifestyle change (e.g., daily routines, family, job). The Inventory was used in the Lipid Research Clinics' Coronary Primary Prevention Trial (CPPT) to examine the trial staff's skills in counseling for regimen adherence. In 1979 and 1980, 85 and 52 clinic staff, respectively, conducted a total of 548 interviews with four different simulated patients developed using the Inventory, and rated the portrayals as highly realistic. The Inventory also was used to verify that the simulated patient portrayals were greater than 90% faithful to their characterizations. While simulated patients limited to specific clinical syndromes have been used widely in medical education, no guidelines exist for their use in training trial staff in regimen counseling. The Inventory provides a simple template for creating simulated patients with broad characterizations that closely mimic actual trial participants.