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Improving Prescription Drug Warning Labels

NCT00846209 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Enhanced Text
  • Enhanced Text + Icon

Interventions

OTHER

Enhanced drug labeling

use of clear concise text and icons on drug warning labels

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center Shreveport

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Northwestern University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-08-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846209 on ClinicalTrials.gov