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OpenTrials
Completed

NCT Number: NCT04345731

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

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

Completed

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Key information

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Over the counter drug labels

Other

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

Other names: OTC drug label

Primary outcomes

  1. Change Detection in Over the Counter Medicine Labels

    Time frame: 60 minutes

    Looks at differences between two sets of images of medicine labels and locates the change between two sets of labels.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2020
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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