Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

Study Overview
=================
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.

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.

Official Title
-----------------
Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

Conditions
-----------------
Medication Understanding, Diabetes, Hypertension

Intervention / Treatment
-----------------
* Other: Enhanced Label


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Label<br>Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label. | Other: Enhanced Label<br>* A prescription drug label that has simplified text, more white space and overall is more patient-friendly.<br>|
| No Intervention: Standard Label<br>Subjects in this arm will receive their prescriptions labeled with a standard label. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding of prescription medication | Difference in understanding and comprehension of medication use as compared to control. | Baseline, 3 month follow-up, 9 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c or blood pressure readings |  | Baseline, 3 month follow-up, 9 month follow-up |