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

NCT04345731 | Completed

• 1 other identifier: STUDY00000832
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Conditions

Adverse Drug Event

Keywords

drug labels

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Condition 1 - Control

NO INTERVENTION

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.

Condition 2 - Highlighted

EXPERIMENTAL

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

Condition 3 - FOP warning label

EXPERIMENTAL

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

Condition 4- FOP+Highlighting label

EXPERIMENTAL

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

Interventions

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

Also known as: OTC drug label

Condition 2 - Highlighted; Condition 3 - FOP warning label; Condition 4- FOP+Highlighting label

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• if the participant has history of seizures
• if the participant has impaired memory

Sponsors & Collaborators

• Michigan State University: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related 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. eCollection 2023 Jan.

  PMID: 36712813 RESULT

• 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.

  PMID: 34503908 RESULT

• 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.

  PMID: 34041617 RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Mark W Becker, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 14, 2020
• Study Start: July 16, 2018
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)