Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: A randomized controlled trial

Abstract Objective To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund. Methods Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence. Results Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p < 0.001). Conclusion PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account. Practice implications This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.