Improving Prescription Drug Warning Labels

Completed · Phase 4

Conditions studied: Enhanced Text, Enhanced Text + Icon

In brief

Prior studies have documented a high prevalence of patients misunderstanding prescription drug warning labels, placing them at risk for medication error. We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient comprehension beyond a current standard.A three-arm, controlled clinical trial was conducted. Patients were assigned to receive 1) current standard drug warning labels on prescription containers (standard), 2) 'enhanced' drug warnings with text rewritten in plain language (enhanced text), or 3) enhanced language and icons developed with patient feedback (enhanced text + icon). Setting: Two academic and two community health primary care clinics in Chicago, IL and Shreveport, LA. Patients: 500 adult patients consecutively recruited at each clinic. Main Outcome Measure: Rates of correct interpretation of nine drug warning labels as determined by a blinded panel review of patients' verbatim responses.

Key facts

Study ID

NCT00846209

Run by

Northwestern University

People needed

500

Starts

2007-06-01

Expected to finish

2009-02-01

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• > 18 years old

You may not qualify if…

• cognitive impairment
• vision or hearing impairment
• non-English speaking
• severely ill

Where it is running

• Northwestern Memorial Faculty Foundation — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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