Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
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|
- Understanding of prescription medication [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ] [ Designated as safety issue: No ]Difference in understanding and comprehension of medication use as compared to control.
- Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200849
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Michael Wolf, Phd, MPH||Northwestern University|