Interactive Voice Technology for Telecommunications Applications (IVTTA'98)

Torino, Italy
September 29-30, 1998

A Voice Information System Supporting Compliance in the Aviron FluMist (TM) Vaccine Trial

Bonnie L. Zeigler (1), Nick Bulley (2)

(1) PAREXEL International, Waltham, MA, USA
(2) Aviron, Mountain View, CA, USA

We describe a Voice Information System (VIS) used to encourage compliance during pharmaceutical trials. Our VIS was developed to support a research trial conducted by Aviron (Mountain View, California, USA) to assess the safety, tolerability, and effectiveness of FluMist (TM) (Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted). The trial was conducted in the U.S. during the '97-'98 flu season. The 4561 participants in the trial received intranasal administration of either the vaccine or a placebo, and subsequently filled out detailed monthly diaries to chronicle their health histories during the effectiveness phase of the trial. The role of our automated voice system was to contact the participants twice a month during the effectiveness phase to communicate information and to ensure compliance in completing and returning the diaries. In the present paper, we describe the architecture and functionality of the VIS, and we report results from using the system throughout the trial. The VIS is a custom-developed Windows NT application, running on a Compaq platform with a multichannel Dialogic telephony subsystem. The application was developed in Visual Basic and linked with an MS/Access database used to set application parameters, store participant information, and record data during system use. We designed the system to make a high volume of calls during a short time window (required by other aspects of the trial process) 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 (i.e., human, answering machine, modem).

Our results pertain to system performance, user behavior, and diary compliance during the 5-month effectiveness phase of the trial. 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. Finally, we draw from our large-scale call sample to provide descriptive statistics that may be useful for establishing design parameters of future voice-interactive applications.

Full Paper

Bibliographic reference.  Zeigler, Bonnie L. / Bulley, Nick (1998): "A voice information system supporting compliance in the aviron flumist (TM) vaccine trial", In IVTTA'98, 215-218.