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临床试验/NCT04729894
NCT04729894Unknown不适用

Evaluating the Impact of a Safe Medication Storage Device on Modifiable Storage Behaviors and Pediatric Poisonings

Binghamton University0 个研究点目标入组 1,000 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,000
主要终点
Medication Storage Behaviors

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Safe Medication Storage Device + Education

Experimental

干预措施: Medication Lockbox (Other)

Safe Medication Storage Device + Education

Experimental

干预措施: Education (Behavioral)

Education

Active Comparator

干预措施: Education (Behavioral)

结局指标

主要结局

Medication Storage Behaviors

时间窗: 1 year

Participants will be evaluated at regular intervals over a one year period to evaluate the impact of a medication box + education, compared to education alone, on their short and long-term medication storage behaviors. These storage behaviors include storage location in the home, storage device(s), storage location height, co-storage with non-medication items, and alternative storage locations.

次要结局

  • Pediatric Poisonings(1 year)
  • Medication Adherence(1 year)

研究者

申办方类型
Other
责任方
Sponsor

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