Clinical trial NCT06320808: Evaluating FDA's Proposed Patient Medication Information Handout
Official title: Evaluating FDA's Proposed Patient Medication Information Handout: A Randomized Trial Measuring Perceived Usefulness and Comprehension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knowledge
Attitude
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2024-03-20
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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). Participants will complete the same survey questions measuring perceived usefulness and comprehension of the information.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived difficulty or ease in reading information
timeFrame: day 1
measure: Perceived usefulness of the medication information guide in making a use decision
timeFrame: day 1
measure: Perceived usefulness of the medication information guide in taking the medication properly
timeFrame: day 1
measure: Comprehension
timeFrame: day 1
Secondary outcomes:
measure: Strength of Evidence
timeFrame: day 1
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
References: