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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
Binghamton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poisoning focused on measuring pediatric poisonings, medication storage, safe medication storage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 14, 2020
    Last Updated
    January 27, 2021
    Sponsor
    Binghamton University
    Collaborators
    State University of New York - Upstate Medical University
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    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

    Learn more about this trial

    Evaluating the Impact of a Safe Medication Storage Device

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