A voice information system supporting compliance in the Aviron FluMistTM vaccine trial

Describes a voice information system (VIS) which is used to encourage compliance during pharmaceutical trials. Our VIS was developed to support a research trial conducted by Aviron to assess the safety, tolerability and effectiveness of the FluMist^TM influenza virus vaccine. The role of the VIS was to contact the trial participants during the effectiveness phase to communicate information and to ensure compliance in completing and returning their diaries. We describe the architecture and functionality of the VIS and we report results from using the system throughout the trial. The VIS is a Windows NT application, running on a Compaq platform with a multichannel Dialogic telephony subsystem. The application was developed in Visual Basic and linked with a Microsoft Access database. We designed the system to make a high volume of calls during a short time window and to track call progress information and user behavior for each call. The message pragmatics of the calls varied during the trial and included reminders, confirmations, instructions and news. We based the dialog on simple dialog prototypes and we varied message delivery as a function of the mode of answering the call. With regard to system performance, we assess the system in terms of reliability, flexibility and effectiveness of call completion. With regard to user behavior, we report objective measures reflecting the willingness of participants to receive information transmitted via automated outbound calls. We draw descriptive statistics from our call sample that may be useful for establishing design parameters of future voice-interactive applications