PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

Study Overview
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Brief Summary
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This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. English and Spanish speaking patients are eligible, with a planned sample size of up to 500 adults.

Official Title
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PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

Conditions
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Health Behavior, Medication Adherence

Intervention / Treatment
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* Behavioral: PictureRx medication label


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years old, Fluency in English or Spanish Manage their own prescription medicines, and Have recently filled at least 1 new prescription medication (e.g, a medicine or medication dose that they have not taken before) and have their new prescription bottle information with them. Exclusion Criteria: Excludes health professionals (such as a doctor, nurse or pharmacist) Too ill to participate in an interview Do not have a telephone Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart) Persons picking up new medicines for others Inability to communicate in either Spanish or English Overt psychiatric illnesses, overt delirium or dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional prescription drug labels<br>Routine drug labels provided by the participating pharmacies | |
| Experimental: Reformatted medication labels<br>Prescription drug container labels that follow a new format and also include illustrations | Behavioral: PictureRx medication label<br>* Reformatted medication labels that adhere to current best practices for label design and also include illustrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient understanding of their medication regimen. | Patient understanding of the instructions for taking their medications correctly. | Approximately 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | Patients' confidence in being able to follow their medication regimen. | Approximately 7 days | 
| Self-reported adherence | Patient self-reported adherence to the medications filled. | Approximately 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prescription Labels, Low Health Literacy, Limited English Proficiency, Spanish