Objective : To evaluate communication effects of the intervention by written risk information on prescribed drugs and explore the influencing factors.
Design : A randomized prospective controlled trial.
Setting : An outpatient unit in a medical center.
Patients : 243 outpatients prescribed antihypertensive drugs.
Intervention : Patients were randomized into either the study or control group. The study group received sheets showing risk information in addition to drug's name and efficacy while the control group received those without risk information. Patients were requested to complete a questionnaire before and 1 month after receiving information.
Main outcome measures : The communication effects, defined in terms of patient satisfaction, helpfulness of the sheets, reassurance about taking drugs and compliance evaluated by himself.
Results : Of 243 patients, 123 completed the second questionnaire. Of those 123, the study group patients were significantly more satisfied (p=0.035). For other 3 measures, there were no significant differences between the study and control groups. But almost all patients regarded the sheets helpful. After receiving the sheets with or without risk information, 67 (61.5%, 109 answered) were reassured and the compliance was said to be improved with 32 (28.1%, 114 answered).
From the exploratory analysis of 112 patients having completed both questionnaires, patients who evaluated the sheets helpful tended to be more reassured. The compliance of patients who were reassured tended to be better.
Conclusion : Patients regarded the written drug information as a helpful medium and were more satisfied with risk information. Irrespective of whether risk information was included, reassurance and better compliance were attained by the written drug information.