Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Medication Understanding; Diabetes; Hypertension	Other: Enhanced Label	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	420 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use
Study Start Date :	October 2010
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:	Michael Wolf, Phd, MPH	Northwestern University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016 Dec;31(12):1482-1489. Epub 2016 Aug 19.

Responsible Party:	Michael S. Wolf, Professor, Northwestern University
ClinicalTrials.gov Identifier:	NCT01200849 History of Changes
Other Study ID Numbers:	STU00005495
First Posted:	September 14, 2010
Last Update Posted:	November 18, 2014
Last Verified:	November 2014