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Behavioural Intervention
FDA Medication Information Handout for Patient Understanding
N/A
Waitlist Available
Research Sponsored by Carnegie Mellon University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if a new one-page FDA-template for patient medication information is helpful compared to the current drug information insert. Participants will be given one of three information sheets and asked questions about their
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves reviewing information sheets rather than taking medications or undergoing treatments, there are no direct physical side effects associated with participating.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comprehension
Perceived difficulty or ease in reading information
Perceived usefulness of the medication information guide in making a use decision
+1 moreSecondary study objectives
Strength of Evidence
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Standard InformationExperimental Treatment1 Intervention
Standard of care patient medication information
Group II: FDA-template PMIExperimental Treatment1 Intervention
Patient medication information designed according to FDA template
Group III: Decision Critical PMIExperimental Treatment1 Intervention
Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information
Find a Location
Who is running the clinical trial?
Carnegie Mellon UniversityLead Sponsor
77 Previous Clinical Trials
539,565 Total Patients Enrolled
University of PittsburghOTHER
1,792 Previous Clinical Trials
16,359,656 Total Patients Enrolled