Improving Prescription Drug Warning Labels

This study has been completed.
Sponsor:
Collaborators:
Louisiana State University Health Sciences Center Shreveport
Emory University
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00846209
First received: February 13, 2009
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Enhanced Text
Enhanced Text + Icon
Other: Enhanced drug labeling
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research

Further study details as provided by Northwestern University:

Enrollment: 500
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Enhanced drug labeling
    use of clear concise text and icons on drug warning labels
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > 18 years old

Exclusion Criteria:

  • cognitive impairment
  • vision or hearing impairment
  • non-English speaking
  • severely ill
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00846209

Locations
United States, Illinois
Northwestern Memorial Faculty Foundation
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Louisiana State University Health Sciences Center Shreveport
Emory University
  More Information

No publications provided

Responsible Party: Michael Wolf, PhD MPH, Northwestern University
ClinicalTrials.gov Identifier: NCT00846209     History of Changes
Other Study ID Numbers: 0923-010
Study First Received: February 13, 2009
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
prescription drug
warnings
health literacy
enhanced language

ClinicalTrials.gov processed this record on August 28, 2014