Enhanced Prescription Drug Label to Improve 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 patients' understanding of instructions for use.
The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve patients' understanding of actual prescribed medicines, compared to a standard label format. Patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive their prescribed medicines from this location. Recruited 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. Other exploratory outcome measures will also be measured, including 1) adverse effects associated with medication use defined by a) the rate of physician visits, b) the rate of emergency room visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure measurements. 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Enhanced Prescription Drug Label to Improve Patient Understanding and Use|
- Understanding of prescription medication [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
- Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||November 2012 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973180
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Michael S. Wolf, PhD, MPH||Northwestern University|