Evaluating FDA's Proposed Patient Medication Information Handout

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06320808
Study type	Interventional
Source	Carnegie Mellon University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 3, 2024
Completion date	March 3, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.