Over-the-counter (OTC) Labels for Older Adults

Adverse Drug Event Clinical Trial

Official title:

Over-the-counter (OTC) Labels for Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345731
• Other study ID #: STUDY00000832
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: December 16, 2023

Study information

• Verified date: April 2024
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Optimizing OTC labels for older adults: Empirical evaluation of labels designed to provide older users the information they need to to minimize adverse drug events

Description:

The overarching goal is to design and evaluate a novel front of pack label for OTC drugs that will reduce the prevalence of Adverse Drug Reactions (ADRs) in older adults. To do so the researchers will survey pharmacists to ascertain which label information is most important to the reduction of ADRs, and then will design novel OTC labels which highlight this information. To evaluate the effectiveness of these designs, the investigators propose five experiments where older adults will make judgments about OTC appropriateness.

Study 1 - Survey of Pharmacists - Overseen by University of Wisconsin - Online Survey of pharmacists to evaluate which aspects in a drug facts labels are most critical to the reduction of adverse drug events.

Experiment 2 - Change Detection- Computer screen flashes between a label and the same label which has been modify slightly. Participant is instructed to locate the change as quickly as possible. Change should be detected more quickly for labels that engage users in bottom-up processing.

Experiment 3A- Absolute Judgement- Participant is asked a yes/no question about whether a product being displayed on a computer monitor is appropriate given a scenario. Half the scenarios involve active ingredient and half warning information. Time accuracy will indicate which labels are most effective.

Experiment 3B-Cross Product Comparison-Participant is given a scenario (that requires active ingredient or warning information) and is asked to select the appropriate OTC from a set of options(both products presented in identical labeling format within a trial). Again, speed an accuracy will be used to evaluate the most effective label designs.

Experiment 4- Judging Product Appropriateness- Participants judge whether a drug is appropriate for them based on their health and current medications. Information content varies across trials to determine how much information is required to make an informed decision. Response accuracy (relative to expert pharmacists from the University of Wisconsin's evaluation) as a function of the information presented will be used to determine information that is critical to make a correct decision and how well do the participants get that information from the standard principle display panel (PDP- the front panel) and the Drug Facts Label.

Experiment 5 - Eye tracking during appropriateness judgments - Participants evaluate whether an OTC medication is appropriate for their use, given their current health status and medication intake. Label formats will include current standards and an optimized label (derived from earlier experiments). Appropriateness judgments will be evaluated by pharmacists at University of Wisconsin, and the participant's eye movements will be monitored as they inspect the drugs. Comparisons across drug label formats will allow the primary investigators at Michigan State University to evaluate whether the optimized format more effectively garners attention and improves decision making.

Experiment 6 - Will be a replication of Experiment 5's methods but will use commercial brands rather than the mock brands in Experiment 5. This will allow the primary investigators at Michigan State University to evaluate the extent to which the effects found in Experiment 5 generalize to commercial brands about which participants may have prior familiarity and which contain branding information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 16, 2023
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

Inclusion Criteria:

• participant must be 65+

• participant must be legally sighted

• participant must be able purchase and administer their own medications

• participant must be able to perform consent without assistance.

Exclusion Criteria:

• if the participant has history of seizures

• if the participant has impaired memory

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• Over the counter drug labels
A control condition based on the current standard OTC label and 3 experimental labels will be compared to identify OTC labels that more effectively communicate critical information for the reduction of adverse drug events to the consumer

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (3)

Becker MW, Kashy DA, Harben A, Venkatesan K, Rodriguez A, Kebede M, Martin B, Breslow R, Bix L. A novel strategy to optimize critical information on over the counter labels for older adults. Health Sci Rep. 2023 Jan 25;6(1):e1062. doi: 10.1002/hsr2.1062. — View Citation

Harben AL, Kashy DA, Esfahanian S, Liu L, Bix L, Becker MW. Using change detection to objectively evaluate whether novel over-the-counter drug labels can increase attention to critical health information among older adults. Cogn Res Princ Implic. 2021 May — View Citation

Martin BA, Breslow RM, Sims A, Harben AL, Bix L, Becker MW. Identifying over-the-counter information to prioritize for the purpose of reducing adverse drug reactions in older adults: A national survey of pharmacists. J Am Pharm Assoc (2003). 2022 Jan-Feb; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Detection in Over the Counter Medicine Labels	Looks at differences between two sets of images of medicine labels and locates the change between two sets of labels.	60 minutes