Evaluating the Impact of a Safe Medication Storage Device

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04729894
• Other study ID #: STUDY00002619
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Binghamton University
• Contact: William Eggleston, PharmD
• Phone: 607-777-5848
• Email: wegglest[@]binghamton.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidents Injury
• Poisoning
• Safety Issues

Intervention

Other:
• Medication Lockbox
Participants will receive a medication lockbox to store medications in their home.

Behavioral:
• Education
Participants will receive information on safe medication storage practices.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Binghamton University	State University of New York - Upstate Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Storage Behaviors	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.	1 year
Secondary	Pediatric Poisonings	The rate of pediatric poisonings will be evaluated within each group and compared.	1 year
Secondary	Medication Adherence	Household medication adherence will be evaluated within each group and compared. Adherence will be measured using the validated eight-item Morisky Medication Adherence Scale (MMAS-8).	1 year