W-16: Patient Understanding of Rescue Medication: Value of Patient Training on Reporting Rescue Medication Use

Poster Presenter

Kelly M. Dumais

Director, eCOA Science and Consulting
Clario
United States

Objectives

Self-reported rescue medication use is frequently used as evidence to support drug efficacy in clinical trials, yet the concept of rescue medication may not be well understood by patients.

Method

933 participants were surveyed regarding their understanding of rescue medication. Subjects were then given a written 1 sentence instruction on the meaning of rescue medication to examine whether a brief training would improve their understanding.

Results

When asked to imagine being in a clinical trial for pain, 39% of participants incorrectly thought that taking a dose of the investigational drug given to them by their doctor meant that they were taking rescue medication. In a multiple choice question, most participants did not chose the correct definition of rescue medication, with about a third of participants (32%) thinking rescue medication was a medication used to rescue you from a dangerous situation, and 15% thinking it was any medication taken to treat your pain. Only 22% correctly identified rescue medication as any medication taken to treat your pain other than the investigational medication. A brief written training on the meaning of rescue medication significantly increased the percentage of participants who correctly defined rescue medication from 22% to 66%. Because rescue medication often supports key endpoints in clinical trials in migraine, we also stratified the data by those participants who report experiencing migraines. Similarly, only 21% of participants with migraines correctly defined rescue medication, with training statistically increasing this percentage to 68%.

Conclusion

Accurate reporting of rescue medication by clinical trial subjects is imperative for identifying investigational drug efficacy. A misunderstanding of how to report rescue medication may introduce noise and false data. Our findings show that most participants surveyed did not understand the meaning of the term rescue medication, and that a brief 1 sentence training instruction significantly increased participants’ understanding. We would expect that a more thorough training developed for a clinical trial could even further improve patients’ understanding of rescue medication. These findings should encourage the use of subject training in clinical trials in order to optimize patients’ understanding and increase accurate self-reporting of rescue medication.