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

Study Overview

• Status: Completed
• Conditions: Adverse Drug Event
• Intervention / Treatment: Other: Over the counter drug labels

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.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 110 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Condition 1 - Control; We note that our within subjects experimental design, in which each subject receives all treatments, is not well suited to this system of reporting. Thus we are defining "arms" as the label treatments we are evaluating. This label is the control label treatment which represents the current, legally required over-the-counter labeling standard.
Experimental: Condition 2 - Highlighted; This condition will involve a novel method of presenting critical active ingredient, drug/drug, and drug/diagnosis information with highlighting.	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; Other Names: OTC drug label
Experimental: Condition 3 - FOP warning label; This condition will involve presenting critical drug/drug, and drug/diagnosis information in a novel Front-of-Pack (FOP) warning label.	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; Other Names: OTC drug label
Experimental: Condition 4- FOP+Highlighting label; This condition will combine both the highlighting and FOP labeling interventions from conditions 2 and 3. Note: Across the four arms we are essentially doing a 2 (highlighting/no highlighting) by 2 (front of pack warning/ no front of pack warning) within subjects design.	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; Other Names: OTC drug label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Mark W Becker, PhD, Michigan State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 16, 2023
• Study Completion (Actual): December 16, 2023

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: drug labels
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: STUDY00000832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No