Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

Northwestern University

Status: Completed

Conditions: Hypertension; Diabetes; Medication Understanding

Treatments: Other: Enhanced Label

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01200849

STU00005495

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Enhanced Label

Experimental group

Description:

Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label.

Treatment:

Other: Enhanced Label

Standard Label

No Intervention group

Description:

Subjects in this arm will receive their prescriptions labeled with a standard label.