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Evaluating the Impact of a Safe Medication Storage Device

B

Binghamton University

Status

Unknown

Conditions

Accidents Injury
Safety Issues
Poisoning

Treatments

Other: Medication Lockbox
Behavioral: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT04729894
STUDY00002619

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,000 participants in 2 patient groups

Safe Medication Storage Device + Education
Experimental group
Treatment:
Behavioral: Education
Other: Medication Lockbox
Education
Active Comparator group
Treatment:
Behavioral: Education

Trial contacts and locations

0

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Central trial contact

William Eggleston, PharmD

Data sourced from clinicaltrials.gov

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