Evaluating the Impact of a Safe Medication Storage Device

NCT ID: NCT04729894

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-12-31

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.

Conditions

Poisoning; Safety Issues; Accidents Injury

Keywords

pediatric poisonings; medication storage; safe medication storage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Safe Medication Storage Device + Education

Group Type: EXPERIMENTAL

Medication Lockbox

Intervention Type: OTHER

Participants will receive a medication lockbox to store medications in their home.

Education

Intervention Type: BEHAVIORAL

Participants will receive information on safe medication storage practices.

Education

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

Participants will receive information on safe medication storage practices.

Interventions

Medication Lockbox

Participants will receive a medication lockbox to store medications in their home.

Intervention Type: OTHER

Education

Participants will receive information on safe medication storage practices.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: collaborator

Binghamton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

William Eggleston, PharmD

Role: CONTACT

Phone: 607-777-5848

Email: wegglest@binghamton.edu

Other Identifiers

STUDY00002619

Identifier Type: -

Identifier Source: org_study_id