Evaluating FDA's Proposed Patient Medication Information Handout

Knowledge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06320808
• Other study ID #: STUDY2023_00000449
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: March 3, 2025

Study information

• Verified date: June 2024
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: March 3, 2025
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Attitude
• Knowledge

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Carnegie Mellon University	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 1
Primary	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.	day 1
Primary	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.	day 1
Primary	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.	day 1
Secondary	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]?"	day 1