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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03894306
Other study ID # 18-01297
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2021
Est. completion date June 2022

Study information

Verified date December 2021
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Medication lock box
given a lock box and instructed on how to use the device.
medication lock bag
given a lock bag and instructed on how to use the device.
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up. 1 Months
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