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PoisoningNCT04729894

Evaluating the Impact of a Safe Medication Storage Device

A study testing Medication Lockbox and Education in people with Poisoning and Safety Issues, run by Binghamton University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Poisoning, Safety Issues, Accidents Injury
What is being tested?
Medication Lockbox and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
No sites listed yet
Study dates
1 Jul 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

William Eggleston, PharmD contact

607-777-5848

wegglest@binghamton.edu

About this study

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

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.

Read more

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.

Being tested
Medication Lockbox, Education
Keywords
pediatric poisonings, medication storage, safe medication storage
Medical subject headings
Poisoning, Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication LockboxOther

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

  • EducationBehavioural

    Participants will receive information on safe medication storage practices.

Study groups in NCT04729894
Study groupRoleWhat they receive
Safe Medication Storage Device + EducationExperimentalNot described
Receives: Other: Medication Lockbox; Behavioral: Education
EducationActive comparatorNot described
Receives: Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (2)
  1. Pediatric Poisonings

    The rate of pediatric poisonings will be evaluated within each group and compared.

    Measured: 1 year

  2. 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).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04729894
Sponsor's protocol ID
STUDY00002619
Status last verified
Jan 2021
First submitted
14 Oct 2020
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Medication Lockbox and Education in people with Poisoning and Safety Issues, run by Binghamton University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact William Eggleston, PharmD (607-777-5848, wegglest@binghamton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Storage Behaviors (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.

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