Evaluating the Impact of a Safe Medication Storage Device
Primary Purpose
Poisoning, Safety Issues, Accidents Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medication Lockbox
Education
Sponsored by
About this trial
This is an interventional prevention trial for Poisoning focused on measuring pediatric poisonings, medication storage, safe medication storage
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Safe Medication Storage Device + Education
Education
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pediatric Poisonings
The rate of pediatric poisonings will be evaluated within each group and compared.
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).
Full Information
NCT ID
NCT04729894
First Posted
October 14, 2020
Last Updated
January 27, 2021
Sponsor
Binghamton University
Collaborators
State University of New York - Upstate Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04729894
Brief Title
Evaluating the Impact of a Safe Medication Storage Device
Official Title
Evaluating the Impact of a Safe Medication Storage Device on Modifiable Storage Behaviors and Pediatric Poisonings
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Binghamton University
Collaborators
State University of New York - Upstate Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poisoning, Safety Issues, Accidents Injury
Keywords
pediatric poisonings, medication storage, safe medication storage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Safe Medication Storage Device + Education
Arm Type
Experimental
Arm Title
Education
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Medication Lockbox
Intervention Description
Participants will receive a medication lockbox to store medications in their home.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Participants will receive information on safe medication storage practices.
Primary Outcome Measure Information:
Title
Medication Storage Behaviors
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pediatric Poisonings
Description
The rate of pediatric poisonings will be evaluated within each group and compared.
Time Frame
1 year
Title
Medication Adherence
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Eggleston, PharmD
Phone
607-777-5848
Email
wegglest@binghamton.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluating the Impact of a Safe Medication Storage Device
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