Introduction: The Institute of Medicine reports and recently published studies indicate that mortality associated with medication errors is on the rise, mainly because of the poor understanding of drug-related information. In current practice, patients receive dense information from a combination of Food and Drug Administration (FDA) mandated patient package inserts, medication guides, and pharmacy’s voluntary consumer medication information sheets. Further, the prescription information leaflets are lengthy, have small fonts, unorganized and often have difficult terminology. The Risk Communication and Advisory Committee in 2009 recommended that the FDA adopt a standard single-page document to improve patient comprehension of prescription drug information. The objective of this study was to develop a patient friendly one-page prescription drug information leaflet (PILs) and empirically test impact of cognitive effort exerted and patient involvement level on information processing variables and comprehension. In summary, this study tested a comprehensive model of describing how consumers evaluate information on prescription information leaflets.

Methods: One-page PILs were developed using cognitive principles and graphics to exert lower mental effort. A 3x2 repeated measures study was conducted. Each participant was exposed to 3 types of leaflets specifically, the current practice (obtained from a community pharmacy), pre-existing one page text-only and PILs. Adults (≥18 years) in a university setting evaluated the leaflets after reading a scenario to simulate high and low involvement. A pre-validated, survey instrument was then used to measure information load, information anxiety, product knowledge, attitude towards leaflet and intention to read. Data collected was coded and entered into Microsoft Excel. Reliability analysis, descriptive statistics, and MANCOVA were performed using SAS® version 9.2 at a priori significance level of 0.05. Post hoc analyses were conducted to determine which of the k means in a one-way ANOVA are significantly different. Comprehensive model testing was conducted using structural equation modeling (SEM) technique. Mplus was used to test the model.

Results: Response rate of 61.96% was obtained (n=360). Multivariate analysis of variance test indicated significant positive effect of leaflet type, involvement and interaction effect on all measured variables (Wilk’s lambda, p<0.001). Individual analysis of variance tests on mean scores for leaflets followed by post-hoc Scheffe test revealed that PILs had the lowest scores on information load and information anxiety (p<0.001). The product knowledge, attitude towards leaflet and intention to read scores were highest for PILs (p<0.001). Interaction analyses revealed that for one-page formats; the information load reduces, information anxiety reduces and product knowledge increases to a greater extent in high involvement scenario. The results of structural equation modeling indicated that the proposed model had an acceptable fit. All the proposed paths were significant except the direct association of cognitive effort with product knowledge. In other words, reducing cognitive effort would not directly increase product knowledge. The SRMR value for the proposed model was 0.07 indicating a goof fit.

Conclusion/Implication: The PILs had significantly higher patient comprehension as compared to the current practice and text-only prototypes. Increasing involvement further improves product knowledge, intention to read and attitude towards leaflet. The FDA could consider these findings and provide guidelines to design a concise prescription drug information leaflet to eventually improve the expected outcomes associated with these information sources.