Clinical trial NCT04345731: Over-the-counter (OTC) Labels for Older Adults
Official title: Over-the-counter (OTC) Labels for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Event
Keywords: drug labels
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2020-04-14
Enrollment: 420
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Several different studies within one large study to explore the use of over the counter medical labels and reducing adverse side effects. Each study is a repeated subjects design, with each participant receiving all label treatments to allow a within subjects analysis of label effectiveness.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change Detection in Over the Counter Medicine Labels
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Mark W Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. eCollection 2023 Jan.
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;62(1):167-175.e1. doi: 10.1016/j.japh.2021.08.019. Epub 2021 Aug 23.
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 26;6(1):40. doi: 10.1186/s41235-021-00307-z.