FDA Medication Information Handout for Patient Understanding

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Carnegie Mellon University

Disqualifiers: Age, Sex assigned at birth

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

330 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals in the US, aged 18-45, who were assigned female at birth. It's not open to those over 45 years old, under 18, or assigned a different sex at birth.

Inclusion Criteria

US geographic location

I was assigned female at birth.

Exclusion Criteria

I am under 18 years old.

I was assigned a sex other than female at birth.

I am older than 45 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Survey Completion

Participants are randomized to review one of three patient medication information sheets and complete an online survey

1 day

1 virtual visit

Follow-up

Participants are monitored for comprehension and perceived usefulness of the medication information

1 day

Treatment Details

Interventions

• Decision Critical PMI
• FDA template PMI
• Standard Information

Trial Overview The study is testing three types of patient medication information sheets: one based on the FDA's proposed template, another with standard info, and a third that adds drug benefit details. Participants will be randomly given one sheet to review for usefulness and comprehension.

Participant Groups

Group I: Standard Information Experimental Treatment 1 Intervention

Standard of care patient medication information

Group II: FDA-template PMI Experimental Treatment 1 Intervention

Patient medication information designed according to FDA template

Group III: Decision Critical PMI Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Carnegie Mellon University

Lead Sponsor

Trials

80

Recruited

540,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+