Association between interactive voice response adherence and subject retention in a randomized controlled trial

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• 作者：Christopher S. Gatehouse^a ; Howard A. Tennen^b ; Richard S. Feinn^c ; Khamis S. Abu-Hasaballah^d ; Rajesh V. Lalla^e ; ^{lalla@uchc.edu}
• 关键词：Interactive voice response ; IVR ; Interactive voice response systems ; IVRS ; Retention ; Compliance ; Clinical research
• 刊名：Contemporary Clinical Trials
• 出版年：2012
• 期刊代码：63_15517144
• 类别：med
• 出版时间：July, 2012
• 卷：33
• 期：4
• 页码：589-592
• 文件大小：129 K

摘要

Introduction

Interactive voice response (IVR) technology uses the telephone to collect patient reports. This study examined whether IVR adherence during a year-long clinical trial was related to subject retention in the trial.

Methods

As part of a randomized, double-blind, placebo-controlled study of daily multivitamin supplementation for recurrent aphthous stomatitis, 160 study participants were asked to make 1 weekly IVR call for the one-year study duration.

Results

The 114 subjects who completed the study made 90.5%of their expected number of IVR calls, as compared to 55.7%of expected calls made by the 46 subjects who withdrew prematurely (p < 0.001). Subjects who successfully completed the study were also more likely to initiate their IVR calls as compared to subjects who withdrew from the study (p < 0.001). A multivariable model incorporating different adherence variables was able to successfully predict retention status of more than 80%of subjects. IVR adherence during the first few weeks of study participation was strongly predictive of subsequent retention and successful completion of this one-year study.

Discussion

Subjects who withdrew prematurely had more missing data than study completers, even after accounting for period of study participation, potentially introducing bias into IVR results. Sub-optimal adherence to weekly IVR might provide an early signal of subsequent premature withdrawal in clinical trials. IVR adherence could be used as a screening tool during a trial period, to identify subjects most likely to stay on long clinical trials.

Conclusion

IVR adherence may be useful in anticipating retention in long-term clinical studies.