Enhanced Prescription Drug Label to Improve Patient Understanding and Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University
ClinicalTrials.gov Identifier:
NCT00973180
First received: September 8, 2009
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Prescription Medication Understanding
Other: Enhanced Label

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Enhanced Prescription Drug Label to Improve Patient Understanding and Use

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Understanding of prescription medication [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]

Enrollment: 850
Study Start Date: May 2009
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type II diabetes or hypertension in their medical chart.
  • 30 years or older.
  • Fluent in English.

Exclusion Criteria:

  • Uncorrectable hearing or visual impairment.
  • Too ill to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973180

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Michael S. Wolf, PhD, MPH Northwestern University
  More Information

No publications provided

Responsible Party: Michael S. Wolf, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00973180     History of Changes
Other Study ID Numbers: NU-0923017
Study First Received: September 8, 2009
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Prescription medication understanding among diabetic and hypertension patients.
Prescription medication use among diabetic and hypertension patients.
Hemoglobin A1c changes among diabetic patients.
Blood pressure changes among hypertension patients.

ClinicalTrials.gov processed this record on October 19, 2014