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Pediatric Inpatient Firearm Safety Study (IF)

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ClinicalTrials.gov Identifier: NCT03077646
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Everytown for Gun Safety
Information provided by (Responsible Party):
Alyssa Silver, Montefiore Medical Center

Brief Summary:

There is currently no available data regarding using the inpatient setting as an opportunity to talk to parents/guardians about firearm safety. The investigators will be doing a pre-/post-intervention study to investigate the effect of an intervention (a 5.5 minute Be SMART video and written materials developed by the organization Everytown for Gun Safety), on parental/legal guardian knowledge, attitudes and practices regarding firearm safety. While the American Academy of Pediatrics recommends the safest home for children is one without guns, the reality is that there are families with guns in the home. This non-political video focuses on ways to keep children safe from firearms.

The investigators will also investigate any additional effect of physician-delivered counseling on parental/guardian knowledge, attitudes and practices regarding gun safety as compared to receiving the information solely via video and written materials.

Participants will be randomized to 1 of 3 groups (intervention, intervention + MD discussion and control group). Outcomes will be assessed immediately post intervention and in a 30-day follow up phone call.


Condition or disease Intervention/treatment Phase
Firearm Safety Behavioral: Be SMART Behavioral: Control: TSE Behavioral: Be SMART + MD review Not Applicable

Detailed Description:

Eligibility:

All parents/guardians of inpatients admitted to the Children's Hospital at Montefiore.

Exclusion:

Parents/guardians whose children are in acute distress or in the Pediatric Intensive Care Unit.

Outcomes:

The primary outcome is the change in parent/legal guardian's behavior over the past 30 days with respect to how often they asked whether or not there are guns in the home when their child/children goes to play in another's person's home, as indicated by a Likert scale assignment of an ordinal value (1-5, 1= never, 2=rarely, 3=sometimes, 4=most of the time, 5=always).

Secondary outcomes will include:

  • Change in the primary outcome (intention to ask noted above) between the intervention groups (Be SMARTalone vs. Be SMART + MD)
  • Demographic factors associated with primary outcome
  • Description of general knowledge on firearm safety of parents/legal guardians of patients in our community
  • Description of attitudes about firearm safety of parents/legal guardians of patients in our community
  • Description of general practices regarding firearm safety of parents/legal guardians of patients in our community
  • Description of parents attitudes regarding physicians discussing firearm safety with them

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pediatric Inpatient Firearm Safety Study
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : August 9, 2019

Arm Intervention/treatment
Experimental: Be SMART alone
Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information.
Behavioral: Be SMART
An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART

Experimental: Be SMART + MD review
Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review).
Behavioral: Be SMART + MD review

An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART.

After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician.


Active Comparator: Control: TSE materials
Parents/guardians in this study group will watch a video "Kids and Smoke Don't Mix" and receive handouts reviewing information on tobacco smoke exposure (TSE).
Behavioral: Control: TSE
A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line.




Primary Outcome Measures :
  1. Frequency of asking about guns in the home when their child goes to spend time/play in another person's home, using Likert Scale [ Time Frame: last 30 days ]
    The primary outcome is the change in how often the parent/guardian asked whether there are guns in the home when the child went to another person's home in the last 30 days


Secondary Outcome Measures :
  1. Frequency of asking about guns in the home when their child goes to spend time/play in another person's home in the last 30 days using a likert scale, comparing BeSMART alone group to those with MD review of the information [ Time Frame: 30 days ]
    Any difference between the primary outcome between the Be SMART alone group and the Be SMART + MD group

  2. Demographic factors associated with increased frequency of asking about guns in the home when their child goes to spend time in another primary outcome, using likert scale [ Time Frame: 30 days ]
    Any demographic factors associated with the change in frequency of parents asking about guns in the homes of others when their child went to another person's home.

  3. Percentage of correct answers given by parents/guardians to factual knowledge based questions in the survey on firearm safety [ Time Frame: 30 days ]
    Description of general knowledge on firearm safety of parents/guardians of patients in our community

  4. Attitudes towards firearm safety regulations and control obtained via survey using Likert Scale [ Time Frame: 30 days ]
    Description of attitudes about firearm safety of parents/guardians of patients in our community

  5. General practices regarding firearm safety obtained via survey with frequency data [ Time Frame: 30 days ]
    Description of general practices regarding firearm safety of parents/guardians of patients in our community obtained via survey of presence of firearms in the home, method of storage of firearms in the home

  6. Attitudes regarding doctors talking to them about guns obtained via survey using Likert Scale [ Time Frame: 30 days ]
    Description of parent/guardian attitudes regarding physicians discussing firearm safety with them in our community



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • parents/guardians whose child is hospitalized in the Pediatric Intensive Care Unit
  • parents/guardians whose child is in acute distress
  • parents/guardians who have previously been in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077646


Locations
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United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Everytown for Gun Safety
Investigators
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Principal Investigator: Alyssa H Silver, MD Children's Hospital at Montefiore-Department of Pediatrics, Division of Hospital Medicine

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Responsible Party: Alyssa Silver, Assistant Professor of Pediatrics, Attending Physician Pediatric Hospital Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03077646     History of Changes
Other Study ID Numbers: 2016-6918
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data with other researchers. The data will only be available to study personnel approved on this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alyssa Silver, Montefiore Medical Center:
firearm
gun
safety
pediatric
inpatient