(provided by the applicant): The objective of this study is to test the effectiveness of an evidence-based, Spanish language prescription drug (Rx) labeling strategy to improve patient understanding and use. The primary aims of this study are to: 1) Test the efficacy of enhanced Spanish Rx labeling (container label, leaflet) to improve Spanish-speaking patients'understanding of instructions compared to two current standard labeling strategies, and 2) Evaluate the effectiveness of the enhanced Rx labeling to improve Spanish-speaking patients'understanding and actual use of their own medicine compared to a current labeling standard. Research activities will be conducted in three phases: i) Preparation, ii) Comprehension Testing, and iii) "Actual Use" Assessment. During a brief Preparation phase, an evidence-based Spanish language Rx container label prototype and accompanying 'enhanced print'leaflets will be refined and pilot tested among Spanish-speaking adults recruited from three diverse settings. In the Comprehension Testing phase, Spanish-speaking patients'ability to comprehend the instructions for use on the enhanced Rx labeling will be compared against two standard labeling practices representing current pharmacy practices.
For Aim 2, the proposed research study takes advantage of a rare opportunity within a pharmacy practice to evaluate the effectiveness of this evidence-based, Spanish Rx labeling strategy in actual use. A randomized trial will be conducted among diabetic Spanish-speaking patients at safety-net clinics affiliated with a central-fill pharmacy. Correct understanding and self-reported adherence (3-month follow-up) will be compared between Spanish-speaking patients who receive the enhanced Rx labeling and those receiving current standard labeling for all of their prescribed medicines. Pharmacy and medical records data will be used in exploratory analyses to examine label differences in adherence (refill), health care use, and outcome (HBA1C) at one year. We will also conduct a 'post-use'formative assessment of patients'perspectives regarding the clarity and utility of enhanced Rx labeling, and gather patient data pertaining to specific cultural factors to examine the association between health beliefs and practices on medication understanding and use. Findings gathered will inform anticipated next steps for a dissemination strategy.

Public Health Relevance

Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use NARRATIVE Nearly half of Latino adults in the U.S. have limited English proficiency, increasing the need for pharmacy practices to offer language concordant care to support safe and appropriate medication use. Our research team has developed a comprehensive, Spanish language prescription drug (Rx) labeling strategy utilizing 'best practices'to optimize comprehension of Rx medication instructions. The proposed intervention will: 1) test the efficacy of enhanced Spanish Rx labeling strategy to improve Spanish-speaking patients'understanding of instructions compared to two current standard labeling strategies and 2) evaluate the effectiveness of the enhanced Rx labeling to improve Spanish-speaking patients'understanding and actual use of their own medicine compared to a current labeling standard.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS019435-03
Application #
8222816
Study Section
Special Emphasis Panel (ZMD1-PA (R4))
Program Officer
Brach, Cindy
Project Start
2010-04-01
Project End
2013-10-31
Budget Start
2012-02-01
Budget End
2013-10-31
Support Year
3
Fiscal Year
2012
Total Cost
Indirect Cost
Name
Northwestern University at Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
Wolf, Michael S; Davis, Terry C; Curtis, Laura M et al. (2011) Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use. Med Care 49:96-100