NCT03894306

Brief Summary

The goal of this study is to increase safe medication storage practices in homes with young children in order to prevent unintentional childhood poisonings. As a step toward meeting this goal, this study aims to determine if an intervention to promote safe storage to patients who have young children in their home, including provision of a lock box or lock bag along with brief counseling versus brief counseling alone, results in 1) increased locked storage (and overall safe medication storage practices) of high-risk prescription medications in the home; 2) increased safe medication storage practices of other medications in the home; and 3) improved safe medication storage related knowledge and attitudes.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

March 26, 2019

Last Update Submit

December 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up.

    1 Months

Study Arms (3)

medication lock box + brief counseling

Other: Medication lock boxOther: brief counseling

medication lock bag + brief counseling

Other: medication lock bagOther: brief counseling

brief counseling alone

Other: brief counseling

Interventions

given a lock box and instructed on how to use the device.

medication lock box + brief counseling

given a lock bag and instructed on how to use the device.

medication lock bag + brief counseling

After completing the per-intervention survey, a research assistant or investigator will perform brief counseling, including educational handouts and information on safe medication storage

brief counseling alonemedication lock bag + brief counselingmedication lock box + brief counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients in the buprenorphine clinic, high A1c clinic, or palliative care clinics at NYC Health + Hospitals/Bellevue who are prescribed at least one high-risk medication and have a child less than six years old present in his/her home on average at least 8 hours per week.

You may qualify if:

  • Patient in the buprenorphine clinic, high A1c clinic, or palliative care clinic at NYC Health + Hospitals/Bellevue
  • Patient prescribed at least one high-risk mediation. A high-risk medication defined as a prescription medication that may cause significant toxicity or death with the ingestion of only one pill or a single adult dose.
  • A child less than six years old is present in the patient's home on average at least 8 hours per week.

You may not qualify if:

  • Inability to speak and read English or Spanish
  • No phone number for follow-up or unwilling to do follow-up by phone or in person
  • Prior enrollment
  • Patient was involved in pilot study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Poisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Mark K Su, MD

    NYU Langone Health - Toxicology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

December 10, 2021

Record last verified: 2021-12