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Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

NCT ID: NCT01200849

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Medication Understanding Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Enhanced Label

Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label.

Group Type EXPERIMENTAL

Enhanced Label

Intervention Type OTHER

A prescription drug label that has simplified text, more white space and overall is more patient-friendly.

Standard Label

Subjects in this arm will receive their prescriptions labeled with a standard label.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Label

A prescription drug label that has simplified text, more white space and overall is more patient-friendly.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Michael S. Wolf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Wolf, Phd, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016 Dec;31(12):1482-1489. doi: 10.1007/s11606-016-3816-x. Epub 2016 Aug 19.

Reference Type DERIVED
PMID: 27542666 (View on PubMed)

Other Identifiers

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STU00005495

Identifier Type: -

Identifier Source: org_study_id