An interventional study of FDA template PMI and Decision Critical PMI in Knowledge and Attitude, sponsored by Carnegie Mellon University. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Carnegie Mellon University · Not applicable, Interventional, and Other
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.
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.
371 studies on the registry are indexed under Behavior; 158 are open to participants now.
This study's enrollment of 330 is above the median of 120 across 295 interventional studies indexed under Behavior.
Browse Behavior studies →Carnegie Mellon University is the lead sponsor of 46 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Patient medication information designed according to FDA template
Other: FDA template PMI
Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information
Other: Decision Critical PMI
Standard of care patient medication information
Other: Standard Information
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.
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.
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.
Perceived difficulty or ease in reading information
Single question with a 5-point likert scale response for "How easy or difficult was it to read the medication information guide about \[drug\]?" Minimum score is 1; Maximum score is 5. A higher score represents higher perceived usefulness.
Time frame: day 1
Perceived usefulness of the medication information guide in making a use decision
Single question with a 5-point likert scale response for "For someone who had not yet decided to use \[drug\], how useful would the medication information guide be in helping them to make that decision?" Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Time frame: day 1
Perceived usefulness of the medication information guide in taking the medication properly
Single question with a 5-point likert scale response for "If someone had decided to use \[drug\], how useful would the medication information guide about \[drug\] be in helping them use the drug properly? " Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Time frame: day 1
Comprehension
10 newly-constructed questions designed to measure the comprehension of the following information from the medication information guide: 1) Analysis of condition (1 question) 2) Risks (3 questions) 3)Risk Management (3 questions), and 5) Benefits (3 questions). Participants can score from 0-10 with 10 representing full comprehension of the information and 0 representing no comprehension of the information.
Time frame: day 1
Strength of Evidence
3 questions measuring strength of evidence. One asking about perceived strength of evidence, one about safety, and one about effectiveness of the medication. Each measured on a 5-point likert scale. The question text for each question, respectively, is "how strong is the scientific evidence that \[drug\], when taken correctly, helps patients \[purpose of drug\]?" "how safe is \[drug\], when taken correctly, for \[purpose of drug\]? "how effective is \[drug\], when taken correctly, for \[purpose of drug\]?"
Time frame: day 1
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Carnegie Mellon University