PoisoningNCT03894306
Understanding How Medication is Stored in the Home
An observational study of Poisoning, run by NYU Langone Health.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poisoning
- What is being tested?
- Medication lock box, medication lock bag and brief counseling
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Poisoning
- Being tested
- Medication lock box, medication lock bag, brief counseling
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication lock boxOther
given a lock box and instructed on how to use the device.
medication lock bagOther
given a lock bag and instructed on how to use the device.
brief counselingOther
After completing the per-intervention survey, a research assistant or investigator will perform brief counseling, including educational handouts and information on safe medication storage
| Study group | Role | What they receive |
|---|---|---|
| medication lock box + brief counseling | Not described Receives: Other: Medication lock box; Other: brief counseling | |
| medication lock bag + brief counseling | Not described Receives: Other: medication lock bag; Other: brief counseling | |
| brief counseling alone | Not described Receives: Other: brief counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up.
Measured: 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study startJun 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Unable to enroll any patients due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoisoningStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark K Su, MD, Principal investigator, NYU Langone Health - Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894306
- Sponsor's protocol ID
- 18-01297
- Status last verified
- Dec 2021
- First submitted
- 26 Mar 2019
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding How Medication is Stored in the Home
- ClinicalTrials.gov ID
- NCT03894306
- Acronym / sponsor ID
- 18-01297
- Conditions
- Poisoning
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to enroll any patients due to COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medication lock box + brief counseling | – | Other: Medication lock box, Other: brief counseling |
| medication lock bag + brief counseling | – | Other: medication lock bag, Other: brief counseling |
| brief counseling alone | – | Other: brief counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication lock boxgiven a lock box and instructed on how to use the device. | Other | medication lock box + brief counseling |
| medication lock baggiven a lock bag and instructed on how to use the device. | Other | medication lock bag + brief counseling |
| brief counselingAfter completing the per-intervention survey, a research assistant or investigator will perform brief counseling, including educational handouts and information on safe medication storage | Other | brief counseling alone, medication lock bag + brief counseling, medication lock box + brief counseling |
Primary outcome
Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up.
Time frame: 1 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark K Su, MD principal investigator
NYU Langone Health - Toxicology
Questions about this trial
What is this clinical trial studying?
An observational study of Poisoning, run by NYU Langone Health.
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: withdrawn, as of the sponsor's last update on 10 Dec 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up. (time frame: 1 Months). 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 10 Dec 2021.