NCT06320808

Evaluating FDA's Proposed Patient Medication Information Handout

Evaluating FDA's Proposed Patient Medication Information Handout: A Randomized Trial Measuring Perceived Usefulness and Comprehension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Carnegie Mellon University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users. The main questions it aims to answer are: How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension? and How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information? Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension.

Detailed description

The US Food and Drug Administration (FDA) has proposed a new one-page 'patient medication information (PMI) handout that can be provided with every prescription medication, in order to provide patients with the information they need to use their medications safely and effectively. The current proposal omits some decision-critical benefit information and had not been tested with potential users, potentially undermining its effectiveness. The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users, compared with a revision adding drug benefit information and with the current drug information insert. A randomized trial will be conducted with U.S. female adults 18-45 years, recruited in March, 2024. Participants will complete an online survey after being randomized to view 1 of the 3 information formats. Participants will be paid $10. Surveys are expected to take no more than 30 minutes to complete. Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information) for the drug, Mifeprex. All individuals will complete knowledge and usability questions and provide demographic information. The main outcomes measured will be perceived usefulness and comprehension of the patient medication information.

Conditions

• Knowledge
• Attitude

Interventions

Type	Name	Description
OTHER	FDA template PMI	Intervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention.
OTHER	Decision Critical PMI	Intervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template and modified, according to decision science principles, to include benefit information, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention.
OTHER	Standard Information	The intervention is an information format viewed by participants. This patient medication information format is the current standard of care patient medication information that is included with the drug. No drug or device is included as part of this intervention.

Timeline

• Start date: 2024-03-03
• Primary completion: 2024-03-04
• Completion: 2025-02-06
• First posted: 2024-03-20
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States