Evaluating FDA's Proposed Patient Medication Information Handout

Carnegie Mellon University

Status: Completed

Conditions: Attitude; Knowledge

Treatments: Other: FDA template PMI; Other: Standard Information; Other: Decision Critical PMI

Study type: Interventional

Funder types: Other

Identifiers

NCT06320808

STUDY2023_00000449

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 3 patient groups

FDA-template PMI

Experimental group

Description:

Patient medication information designed according to FDA template

Treatment:

Other: FDA template PMI

Decision Critical PMI

Experimental group

Description:

Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information

Treatment:

Other: Decision Critical PMI

Standard Information

Experimental group

Description:

Standard of care patient medication information

Treatment:

Other: Standard Information