46775
document
Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use . BACKGROUND Medication errors are an important public health concern , and poor understanding of medication labels are a root cause . Research shows that labels are variable , of poor quality , and not patient-centered . No real-world trials have evaluated whether improved medication labels can affect appropriate medication use , adherence or health outcomes . TRIAL DESIGN We developed an evidence-based prescription label that addresses both content and format . The enhanced label includes a universal medication schedule ( UMS ) that standardizes the directions for use incorporating 1 ) standard time periods for administration ( morning , noon , evening , and bedtime ) , 2 ) numeric vs. alpha characters , 3 ) 'carriage returns ' to separate daily dose and 4 ) a graphic aid to visually depict dose and frequency . We will evaluate the effect of providing this label to randomly sampled patients who receive their care from free clinics , mobile vans and federally qualified health centers ( FQHCs ) in Northern Virginia . We will recruit patients with diabetes or hypertension ; these patients will be randomly assigned to receive all of their medications with improved labels or to receive prescriptions with standard labels . The primary outcome will be the patient 's ability to correctly demonstrate dosing instructions . Other outcomes include adherence , error rates and health outcomes . CONCLUSION To our knowledge , this trial is the first to evaluate the effect of prescription label improvement on understanding , medication use and outcomes in a clinical setting . If successful , these findings could be implemented broadly to promote safe and appropriate medication use and to support evidence-based standards in the development of labels .
46776
Intervention_Educational
evidence-based prescription drug label
46777
Intervention_Educational
evidence-based prescription label
46778
Intervention_Educational
enhanced label
46779
Intervention_Educational
label
46780
Outcome_Mental
patient 's ability to correctly demonstrate dosing instructions
46781
Outcome_Mental
adherence
46782
Outcome_Other
error rates
46783
Outcome_Physical
health outcomes
46784
Outcome_Mental
understanding
46785
Outcome_Mental
medication use
46786
Participant_Condition
patients who receive their care from free clinics , mobile vans and federally qualified health centers
46787
Participant_Condition
patients with diabetes or hypertension