Clinical trial NCT02188134: Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Official title: Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Older Adults (65 Years and Older)
Keywords: Adverse events,
adverse drug reactions,
medication error,
noncompliance
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Consumer Healthcare Products Association
First posted: 2014-07-11
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 and older self administer medication Purchase OTCs

Brief summary: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Time in zone
timeFrame: Measure taken in a single session with participant
measure: Time to first hit
timeFrame: Measure taken in a single session with participant
measure: Number of visual hits
timeFrame: Measure taken in a single session with participant
measure: Appropriate product selection
timeFrame: Measure taken in a single session with participant
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Packaging Building
state: Michigan
Study officials:
affiliation: Michigan State Univeristy
name: Laura Bix, PhD
role: PRINCIPAL_INVESTIGATOR
References: