Evaluating FDA's Proposed Patient Medication Information Handout
NCT ID: NCT06320808
Last Updated: 2025-11-10
Study Results
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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COMPLETED
NA
330 participants
INTERVENTIONAL
2024-03-03
2025-02-06
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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FDA-template PMI
Patient medication information designed according to FDA template
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.
Decision Critical PMI
Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information
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.
Standard Information
Standard of care patient medication information
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 18-45 years of age
* assigned female sex at birth
Exclusion Criteria
* \> 45 years of age
* assigned a sex other than female at birth
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Pittsburgh
OTHER
Carnegie Mellon University
OTHER
Responsible Party
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Baruch Fischhoff
University Professor
Locations
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Carnegie Mellon University
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY2023_00000449
Identifier Type: -
Identifier Source: org_study_id