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Evaluating the Impact of a Safe Medication Storage Device

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ClinicalTrials.gov Identifier: NCT04729894
Recruitment Status : Not yet recruiting
First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Binghamton University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Poisoning Safety Issues Accidents Injury Other: Medication Lockbox Behavioral: Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Impact of a Safe Medication Storage Device on Modifiable Storage Behaviors and Pediatric Poisonings
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Poisoning

Arms and Interventions
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Arm Intervention/treatment
Experimental: Safe Medication Storage Device + Education 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.
Active Comparator: Education Behavioral: Education
Participants will receive information on safe medication storage practices.


Outcome Measures
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Primary Outcome Measures :
  1. Medication Storage Behaviors [ Time Frame: 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.


Secondary Outcome Measures :
  1. Pediatric Poisonings [ Time Frame: 1 year ]
    The rate of pediatric poisonings will be evaluated within each group and compared.

  2. Medication Adherence [ Time Frame: 1 year ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729894


Contacts
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Contact: William Eggleston, PharmD 607-777-5848 wegglest@binghamton.edu

Sponsors and Collaborators
Binghamton University
State University of New York - Upstate Medical University
More Information
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Responsible Party: Binghamton University
ClinicalTrials.gov Identifier: NCT04729894    
Other Study ID Numbers: STUDY00002619
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Binghamton University:
pediatric poisonings
medication storage
safe medication storage
Additional relevant MeSH terms:
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Poisoning
Accidental Injuries
Chemically-Induced Disorders
Wounds and Injuries