KnowledgeNCT06320808
Evaluating FDA's Proposed Patient Medication Information Handout
A study testing FDA template PMI, Decision Critical PMI and Standard Information in people with Knowledge and Attitude, run by Carnegie Mellon University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- FDA template PMI, Decision Critical PMI and Standard Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2024to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- US geographic location
- 18-45 years of age
- assigned female sex at birth
Who cannot join
- <18 years of age
- > 45 years of age
- assigned a sex other than female at birth
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Evaluating FDA's Proposed Patient Medication Information Handout: A Randomized Trial Measuring Perceived Usefulness and Comprehension
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.
Read the 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.
- Being tested
- FDA template PMI, Decision Critical PMI, Standard Information
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDA template PMIOther
Intervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention.
Decision Critical PMIOther
Intervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template and modified, according to decision science principles, to include benefit information, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention.
Standard InformationOther
The intervention is an information format viewed by participants. This patient medication information format is the current standard of care patient medication information that is included with the drug. No drug or device is included as part of this intervention.
| Study group | Role | What they receive |
|---|---|---|
| FDA-template PMI | Experimental | Patient medication information designed according to FDA template Receives: Other: FDA template PMI |
| Decision Critical PMI | Experimental | Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information Receives: Other: Decision Critical PMI |
| Standard Information | Experimental | Standard of care patient medication information Receives: Other: Standard Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived difficulty or ease in reading information
Single question with a 5-point likert scale response for "How easy or difficult was it to read the medication information guide about [drug]?" Minimum score is 1; Maximum score is 5. A higher score represents higher perceived usefulness.
Measured: day 1
Perceived usefulness of the medication information guide in making a use decision
Single question with a 5-point likert scale response for "For someone who had not yet decided to use [drug], how useful would the medication information guide be in helping them to make that decision?" Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Measured: day 1
Perceived usefulness of the medication information guide in taking the medication properly
Single question with a 5-point likert scale response for "If someone had decided to use [drug], how useful would the medication information guide about [drug] be in helping them use the drug properly? " Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Measured: day 1
Comprehension
10 newly-constructed questions designed to measure the comprehension of the following information from the medication information guide: 1) Analysis of condition (1 question) 2) Risks (3 questions) 3)Risk Management (3 questions), and 5) Benefits (3 questions). Participants can score from 0-10 with 10 representing full comprehension of the information and 0 representing no comprehension of the information.
Measured: day 1
Secondary outcomes (1)
Strength of Evidence
3 questions measuring strength of evidence. One asking about perceived strength of evidence, one about safety, and one about effectiveness of the medication. Each measured on a 5-point likert scale. The question text for each question, respectively, is "how strong is the scientific evidence that [drug], when taken correctly, helps patients [purpose of drug]?" "how safe is [drug], when taken correctly, for [purpose of drug]? "how effective is [drug], when taken correctly, for [purpose of drug]?"
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Mar 2024
- Primary completion4 Mar 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Baruch Fischhoff, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320808
- Sponsor's protocol ID
- STUDY2023_00000449
- Status last verified
- Jun 2024
- First submitted
- 8 Mar 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating FDA's Proposed Patient Medication Information Handout: A Randomized Trial Measuring Perceived Usefulness and Comprehension
- ClinicalTrials.gov ID
- NCT06320808
- Acronym / sponsor ID
- STUDY2023_00000449
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| FDA-template PMI | Experimental | Other: FDA template PMIPatient medication information designed according to FDA template |
| Decision Critical PMI | Experimental | Other: Decision Critical PMIPatient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information |
| Standard Information | Experimental | Other: Standard InformationStandard of care patient medication information |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- US geographic location
- 18-45 years of age
- assigned female sex at birth
Key exclusion criteria (3 listed)
- <18 years of age
- > 45 years of age
- assigned a sex other than female at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDA template PMIIntervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention. | Other | FDA-template PMI |
| Decision Critical PMIIntervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template and modified, according to decision science principles, to include benefit information, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention. | Other | Decision Critical PMI |
| Standard InformationThe intervention is an information format viewed by participants. This patient medication information format is the current standard of care patient medication information that is included with the drug. No drug or device is included as part of this intervention. | Other | Standard Information |
Primary outcome
Perceived difficulty or ease in reading information
Time frame: day 1
Single question with a 5-point likert scale response for "How easy or difficult was it to read the medication information guide about [drug]?" Minimum score is 1; Maximum score is 5. A higher score represents higher perceived usefulness.
Perceived usefulness of the medication information guide in making a use decision
Time frame: day 1
Single question with a 5-point likert scale response for "For someone who had not yet decided to use [drug], how useful would the medication information guide be in helping them to make that decision?" Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Perceived usefulness of the medication information guide in taking the medication properly
Time frame: day 1
Single question with a 5-point likert scale response for "If someone had decided to use [drug], how useful would the medication information guide about [drug] be in helping them use the drug properly? " Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Comprehension
Time frame: day 1
10 newly-constructed questions designed to measure the comprehension of the following information from the medication information guide: 1) Analysis of condition (1 question) 2) Risks (3 questions) 3)Risk Management (3 questions), and 5) Benefits (3 questions). Participants can score from 0-10 with 10 representing full comprehension of the information and 0 representing no comprehension of the information.
1 secondary outcome
Strength of Evidence
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDA template PMI, Decision Critical PMI and Standard Information in people with Knowledge and Attitude, run by Carnegie Mellon University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived difficulty or ease in reading information (time frame: day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.