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

Michigan State University

Status: Completed

Conditions: Adverse Drug Event

Treatments: Other: Over the counter drug labels

Study type: Interventional

Funder types: Other

Identifiers

NCT04345731

STUDY00000832

Details and patient eligibility

About

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

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 65 to 110 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 4 patient groups

Condition 1 - Control

No Intervention group

Description:

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 group

Description:

This condition will involve a novel method of presenting critical active ingredient, drug/drug, and drug/diagnosis information with highlighting.

Treatment:

Other: Over the counter drug labels

Condition 3 - FOP warning label

Experimental group

Description:

This condition will involve presenting critical drug/drug, and drug/diagnosis information in a novel Front-of-Pack (FOP) warning label.

Treatment:

Other: Over the counter drug labels

Condition 4- FOP+Highlighting label

Experimental group

Description:

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.

Treatment:

Other: Over the counter drug labels