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Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

This study has been completed.
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University Identifier:
First received: September 2, 2010
Last updated: November 17, 2014
Last verified: November 2014
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use.

Condition Intervention
Medication Understanding Diabetes Hypertension Other: Enhanced Label

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

Further study details as provided by Michael S. Wolf, Northwestern University:

Primary Outcome Measures:
  • Understanding of prescription medication [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ]
    Difference in understanding and comprehension of medication use as compared to control.

Secondary Outcome Measures:
  • Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ]

Enrollment: 420
Study Start Date: October 2010
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Label
Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label.
Other: Enhanced Label
A prescription drug label that has simplified text, more white space and overall is more patient-friendly.
No Intervention: Standard Label
Subjects in this arm will receive their prescriptions labeled with a standard label.

Detailed Description:
The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. Spanish-speaking patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive all their prescribed medicines from this location. Recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. We anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Type II diabetes or hypertension in their medical chart
  • Spanish speaking
  • 30 years or older

Exclusion Criteria:

  • Uncorrectable hearing or visual impairment.
  • Too ill to participate
  Contacts and Locations
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Please refer to this study by its identifier: NCT01200849

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Michael Wolf, Phd, MPH Northwestern University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael S. Wolf, Professor, Northwestern University Identifier: NCT01200849     History of Changes
Other Study ID Numbers: STU00005495
Study First Received: September 2, 2010
Last Updated: November 17, 2014 processed this record on June 23, 2017