Understanding How Medication is Stored in the Home

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.

Study Overview

• Status: Withdrawn
• Conditions: Poisoning
• Intervention / Treatment: Other: Medication lock box; Other: brief counseling; Other: medication lock bag

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
medication lock box + brief counseling	Other: Medication lock box; given a lock box and instructed on how to use the device.; Other: 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
medication lock bag + brief counseling	Other: 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; Other: medication lock bag; given a lock bag and instructed on how to use the device.
brief counseling alone	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up.	1 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mark K Su, MD, NYU Langone Health - Toxicology

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: 18-01297

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No