A randomised controlled trial of patient information leaflets as a medication counselling aid

Abstract

Background: Medication counselling improves patient safety, adherence and satisfaction but is poorly done in clinical practice. Written aids further improve outcomes when used with verbal counselling. No studies have previously compared two types of written counselling aid. Aim: To compare the utility of a patient information leaflet (PIL) with a drug monograph as a medication counselling tool for patients starting a new medicine. Methods: A single-blinded randomised controlled trial of medical students counselling simulated patients during a clinical examination. The PIL was compared with the drug monographs as counselling aids by assessing information transfer and aid usage. Results: A total of 96 students was recruited. The PIL was superior to the drug monograph for counselling relating to missed doses (P = 0.02), and non-inferior for other domains of information transfer. The aid was used more frequently in the PIL arm (91% vs 77%, P = 0.09) and for longer (4.6 min vs 2.9 min, P < 0.01). Conclusions: The PIL was non-inferior to the drug monograph for overall information transfer, but superior for contingency planning. Aid usage was greater in the PIL arm, which may reflect greater student satisfaction with the tool.