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Completed

NCT Number: NCT06320808

Evaluating FDA's Proposed Patient Medication Information Handout

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.

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Key information

Conditions

Knowledge Attitude Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • US geographic location
  • 18-45 years of age
  • assigned female sex at birth

Exclusion criteria

  • <18 years of age
  • > 45 years of age
  • assigned a sex other than female at birth

Treatment and study plan

FDA template PMI

Other

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

Other

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

Other

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.

Primary outcomes

  1. Perceived difficulty or ease in reading information

    Time frame: day 1

    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.

  2. Perceived usefulness of the medication information guide in making a use decision

    Time frame: day 1

    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.

  3. Perceived usefulness of the medication information guide in taking the medication properly

    Time frame: day 1

    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.

  4. Comprehension

    Time frame: day 1

    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.

Secondary outcomes

  1. Strength of Evidence

    Time frame: day 1

    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]?"

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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