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Improving Prescription Drug Warning Labels

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846209
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Louisiana State University Health Sciences Center Shreveport
Emory University
Information provided by:
Northwestern University
  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
Intervention Model: Parallel Assignment
Masking: Single (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Wolf, PhD MPH, Northwestern University
ClinicalTrials.gov Identifier: NCT00846209     History of Changes
Other Study ID Numbers: 0923-010
First Submitted: February 13, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

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