Clinical trial NCT04729894: Evaluating the Impact of a Safe Medication Storage Device
Official title: Evaluating the Impact of a Safe Medication Storage Device on Modifiable Storage Behaviors and Pediatric Poisonings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poisoning
Safety Issues
Accidents Injury
Keywords: pediatric poisonings
medication storage
safe medication storage
Lead sponsor: Binghamton University
Sponsor class: OTHER
Collaborators: name: State University of New York - Upstate Medical University
First posted: 2021-01-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite the initial success of the 1970s Poison Prevention Packaging Act, the incidence of pediatric medication poisonings in the United States remains high. Unintentional pediatric medication ingestions result in significant morbidity and are associated with substantial healthcare use and costs. A majority of these medication poisonings involve a caregivers' medication and are caused by modifiable unsafe storage behaviors. A better understanding of factors associated with pediatric poisonings and safe medication storage behaviors is needed to inform public health policy and develop targeted educational interventions. Furthermore, low-cost, scalable interventions that improve medication storage behaviors and reduce pediatric poisonings are necessary to address this ongoing preventable public health crisis.

In preliminary experiments, a baseline evaluation of caregivers demonstrated that they are unlikely to have a locked medication storage device in their home, but would be willing to use a locked device if one was available. Additionally, a follow-up assessment indicated that a majority of caregivers had used their medication over a one-month period. The latter feasibility assessment supports both caregiver willingness to use a safe storage device and demonstrates that a storage device can improve medication storage behaviors in the short-term.

Given these findings, we hypothesize that pediatric medication poisonings are due to improper storage, that medication storage behaviors are influenced by demographic and household specific factors, and that medication lockboxes improve safe medication storage behaviors and reduce pediatric poisonings. These hypotheses will be evaluated using the studies in the following Specific Aims: (1) to identify factors associated with pediatric poisonings, (2) to identify factors associated with medication storage behaviors, (3) to evaluate the effect of lockboxes on storage behaviors and pediatric poisonings.

Should this exploratory study reveal factors associated with increased risk for pediatric poisoning or with safe medication storage, and should safe medication storage interventions improve modifiable storage behaviors or show a reduction in pediatric poisonings, the results will be used to inform targeted public health campaigns and to develop a low-cost, scalable national program for improving safe medication storage and reducing pediatric poisonings.


Eligibility criteria: Inclusion Criteria:

* Primary caregivers of pediatric patients less than 6 years of age presenting to the emergency department
* Adults (at least 18 years of age) who are responsible for supervising at least one child under the age of 6 years in their residence
* Supervision of at least one child under the age of 6 years for at least 3.5 days per week on average

Exclusion Criteria:

* pediatric patients who are critically ill or unstable
* pediatric patients presenting due to a poisoning related incident
* caregivers who are unable or unwilling to provide consent
* caregivers who are non-English speaking.

Primary outcomes:
measure: Medication Storage Behaviors
timeFrame: 1 year
Secondary outcomes:
measure: Pediatric Poisonings
timeFrame: 1 year
measure: Medication Adherence
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
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