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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness of different types of patient medication information (PMI) in conveying drug details. Participants will review one of three PMI formats: the standard information sheet, an FDA-template sheet, or an FDA-template sheet with added drug benefit details. The study compares which format is easiest to understand and most useful. Individuals assigned female at birth, aged 18-45, and living in the US may be suitable for this trial. As an unphased trial, it offers participants the chance to help improve how medication information is communicated to patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these patient medication information sheets are safe for use?

Research has shown that patient medication information (PMI) created using the FDA template clearly presents safety details. This format includes sections on the drug's name, important safety information, common side effects, and instructions for use. This standardized approach helps patients use their medications safely and effectively.

Similarly, the Decision Critical PMI incorporates information about the drug's benefits, applying principles from decision science. This aids patients in making informed choices about their medication.

Both types of PMI aim to improve understanding and safe use of medications. They are not treatments themselves but serve as tools designed to effectively communicate safety information, which has been a key focus in their design and testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FDA Medication Information Handout trial because it aims to improve how patients understand their medications. Unlike traditional medication guides, which can be dense and hard to follow, this trial is testing three different types of patient medication information (PMI). The "Decision Critical PMI" integrates decision science principles to make benefits clearer, potentially helping patients make more informed choices. The "FDA-template PMI" is designed to be straightforward and user-friendly, aligning with the FDA's guidelines. By comparing these new methods with standard information, researchers hope to find out which format best helps patients understand their medications and make better health decisions.

What evidence suggests that this trial's treatments could be effective for improving patient understanding of medication information?

Research has shown that clear and simple information about medications helps people use their medicines correctly. This trial will compare different types of patient medication information (PMI). The FDA's proposed PMI provides easy-to-understand details about prescription drugs. Studies have found that better PMI reduces medication mistakes and improves treatment results by ensuring patients know how to use their medicines safely. Additionally, "Decision Critical PMI," which includes information about a medication's benefits, has been linked to better patient understanding. In one study, participants who received this type of PMI had a clearer understanding of their medication's risks and benefits. Overall, these methods aim to improve patient knowledge and lead to healthier outcomes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12098189/

Evidence-Based Design of Prescription Medication ... Poor PMI increases risk for negative outcomes such as ineffective treatment, medication errors, adverse drug events, and increasing morbidity [1]. ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/10901981251377723

Evaluating Information on Medication Abortion In the randomized controlled trial with 311 participants, we found the “Decision Critical Handout” was associated with better comprehension, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829916

Public Understanding of Risk and Benefit of Mifepristone This study's results suggest that succinct, readable, quantitative information can help patients understand drug risks and benefits. Such ...

4. link.springer.com link.springer.com/article/10.1007/s40264-025-01527-8

Evidence-Based Design of Prescription Medication ... Poor PMI increases risk for negative outcomes such as ineffective treatment, medication errors, adverse drug events, and increasing morbidity [1] ...

5. federalregister.gov federalregister.gov/documents/2023/05/31/2023-11354/medication-guides-patient-medication-information

Medication Guides: Patient Medication Information PMI is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0168851020301895

An overview of critical decision-points in the medical ... Technical performance includes data from Phase 2 with sufficient dose-response evidence to support Phase 3 dose-selection, safety, quality and favourable ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12098510/

Reasoning, Evidence, and Decision-Making in Drug Safety This paper examines the key sources of these divergences and presents a structured framework to enhance alignment in drug safety decision making.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1551741124000494

Decision-making about changing medications across ... To explore decision-making between health professionals, older patients and families about medication changes across transitions of care.

9. nature.com nature.com/articles/s41746-020-0221-y

An overview of clinical decision support systems: benefits ... A clinical decision support system (CDSS) is intended to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge.