Generating a New Outcome Variable Using Mixed Methods in a Randomized Controlled Trial: The Caregiver Study—An Advance Care Planning Investigation

The use of mixed methods research in intervention trials mostly centers around using quantitative data to assess primary outcomes and qualitative data primarily for exploratory purposes, to supplement, and/or explain quantitative findings. We describe a novel mixed methods procedure that generates an integrated outcome variable used to reexamine unexpected findings that resulted from an advance care planning interventional randomized controlled trial. The integrated outcome variable helped explain apparent anomalies in study data that resulted from analyzing quantitative or qualitative data independently. The methodology outlined in this article provides a useful mixed methodological contribution by illustrating steps that may be taken by researchers seeking a more meaningful way to integrate qualitative and quantitative data to form intervention variables in trials.