NCT00846209

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

February 13, 2009

Last Update Submit

November 10, 2023

Conditions

Enhanced TextEnhanced Text + Icon

Keywords

prescription drugwarningshealth literacyenhanced language

Interventions

Enhanced drug labelingOTHER

use of clear concise text and icons on drug warning labels

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 18, 2009

Study Start

June 1, 2007

Primary Completion

August 1, 2008

Study Completion

February 1, 2009

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

US(1)