Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection

Per-capita consumption of medication is higher in older adults than any other sector of the population. In fact, it has been estimated that although older adults comprise 13% of the population they take 34% of all prescriptions and 30% of the over-the-counter (OTCs) consumed in the US (National Council on Patient Information and Education, 2010). Given current trends in aging, the savings, freedom and flexibility that self-medicating provides, as well as the trends to switch prescription products to an OTC status, it is likely that older adults will increasingly turn to OTCs as part of their medical regimens for years to come (Hanlon, J et al, 2001).

In addition to the advantages that self-medicating offers, there are risks. These risks are more pronounced in older consumers, who are likely experiencing physiological changes (e.g. pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has also been suggested that low health literacy rates in older consumers detrimentally impact health and health outcomes in this population (Kutner et al., 2005 and Federman et al., 2009).

Despite the risks associated with improper OTC use, the critical importance of OTC labeling information (there is no learned intermediary), and the fact that older consumers are significantly more likely to experience an adverse drug reaction than younger adults, surprisingly little information exists about the decision making process older adults employ when selecting and using an OTC product.

We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The study has the following objectives:

1. To begin to garner insights regarding the proportion of subjects who closely examine (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or not) a drug is appropriate for them (based on their health history and current medications).
2. To quantify and compare the attentive behaviors to specific information (Specifically: name, active ingredient, symptom relief).
3. To quantify and compare the attentive behaviors to different formats of information (prominently featured information vs less prominently featured information).
4. To begin to benchmark whether or not older consumers make appropriate choices based on their current conditions and medication history.

Study Overview

• Status: Completed
• Conditions: Older Adults (65 Years and Older)

Detailed Description

Eligibility Criteria 65 or older Administer own medications Legally sighted Purchase over-the-counter medications on occasion Be willing to share complete health history and complete list of all OTC and prescription medications Have transportation to one of two test sites (MSU Campus or Lansing Ingham County Building)

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Packaging Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

65 and older self administer medication Purchase OTCs

Description

Inclusion Criteria:

• 65 or older legally sighted administer own medication purchase OTC have transportation to one of two test sites Be willing to share a complete health history and complete list of medications

Exclusion Criteria:

• Legally blind Does not use OTC medications Less than 65 Does not administer own medication

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
65 and older; No intervention will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in zone	Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present. Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye. Zones for the analysis of the data include product name, symptom relief and active ingredient. Time in zone is the amount of time a subject's eye spends on the targeted information.	Measure taken in a single session with participant
Time to first hit	Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present. Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye. Zones for the analysis of the data include product name, symptom relief and active ingredient. Time to first hit is the measure of time it takes for a subject to fixate information in the zones described above.	Measure taken in a single session with participant
Number of visual hits	Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present. Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye. Zones for the analysis of the data include product name, symptom relief and active ingredient. Number of visual hits is the number of times the eye returns to a given information zone	Measure taken in a single session with participant
Appropriate product selection	Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present. Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye. Based on the self-reported history that is provided during a guided interview, and the medications that they have brought with them, an assessment will be made regarding the "correctness" of their response to whether or not the drug is an appropriate choice for them	Measure taken in a single session with participant

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Consumer Healthcare Products Association
• Investigators: Principal Investigator: Laura Bix, PhD, Michigan State Univeristy

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: noncompliance; Adverse events,; adverse drug reactions,; medication error,
• Other Study ID Numbers: MSU14-679