The Use of Public Messaging for the Promotion of Firearm Safety to Veterans

• Sponsor: Canandaigua VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03417752
• Collaborator: (none)
• Enrollment: 474
• Arms: 3
• Actual Duration (Months): 51

Study Details

Study Description

Brief Summary

This pilot study seeks to determine if exposure to the firearm safety public service announcement (PSA) developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in related beliefs and safe storage practices. Participants are randomly assigned to message exposure or control conditions. Data from this project will inform injury prevention outreach efforts targeted towards Veteran populations.

Condition or Disease	Intervention/Treatment	Phase
Injuries	Other: Exposure to firearm safety PSA; Other: Exposure to health promotion PSA	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 474 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Unlocking the Potential of VA Means Safety Programs: An Examination of the Use of Public Messaging for the Promotion of Firearm Safety to Veterans
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exposure to firearm safety Public Service Announcement (PSA) Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.	Other: Exposure to firearm safety PSA; Exposed to firearm safety PSA
Experimental: Exposure to a mix of PSAs Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization.	Other: Exposure to firearm safety PSA; Exposed to firearm safety PSA; Other: Exposure to health promotion PSA; Exposed to general health promotion PSA
Active Comparator: Active control Exposure to the general health promotion video once per week for 3 weeks.	Other: Exposure to health promotion PSA; Exposed to general health promotion PSA

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Self-reported Injury Prevention Belief [baseline]

   Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."

2. Number of Participants With Self-reported Injury Prevention Belief [3 weeks post-baseline]

   Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."

Secondary Outcome Measures

1. Number of Participants Who Self-reported Firearm Storage Behavior at Baseline [baseline]

   Number of participants at baseline with self-reported safe household firearm storage (restricted to participants with self-reported firearm access)

2. Number of Participants Who Self-reported Firearm Storage Behavior at Exit [3 weeks post-baseline]

   Number of participants at exit with self-reported safe household firearm storage (restricted to participants with self-reported firearm access)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Veterans of all gender/sex, race/ethnicities

• Living in United States

• Fluent in English language

• Capable of understanding the goals of the study

• Possess computer/internet access

Exclusion Criteria:

• Not a U.S. Veteran living in the United States

• Determined to be cognitively impaired

• Currently institutionalized (e.g., hospitalized; incarcerated, etc.)

• Do not possess computer/internet access

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Canandaigua VA Medical Center

Investigators

• Principal Investigator: Elizabeth Karras, PhD, VA Center of Excellence for Suicide Prevention

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 27, 2020

More Information

Publications

None provided.

• Responsible Party: Elizabeth Karras, Health Science Specialist, Canandaigua VA Medical Center
• ClinicalTrials.gov Identifier: NCT03417752
• Other Study ID Numbers: 910434
• First Posted: Jan 31, 2018
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Exposure to Firearm Safety PSA	Exposure to a Mix of PSAs	Active Control
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA	Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA	Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA
Period Title: Overall Study
STARTED	149	175	150
COMPLETED	115	133	110
NOT COMPLETED	34	42	40

Baseline Characteristics

Arm/Group Title	Exposure to Firearm Safety Public Service Announcement (PSA)	Exposure to a Mix of PSAs	Active Control	Total
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA	Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA	Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA	Total of all reporting groups
Overall Participants	115	133	110	358
Age, Customized (Count of Participants)
18-59 yrs old	50 43.5%	58 43.6%	48 43.6%	156 43.6%
60-69 yrs old	29 25.2%	33 24.8%	28 25.5%	90 25.1%
70+ years old	36 31.3%	42 31.6%	34 30.9%	112 31.3%
Sex/Gender, Customized (Count of Participants)
male	104 90.4%	120 90.2%	99 90%	323 90.2%
female	11 9.6%	13 9.8%	11 10%	35 9.8%
Race/Ethnicity, Customized (Count of Participants)
white	97 84.3%	113 85%	92 83.6%	302 84.4%
Non-white	18 15.7%	20 15%	18 16.4%	56 15.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Self-reported Injury Prevention Belief
Description	Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Analyses were restricted to participants that completed both baseline and exit surveys. Descriptive statistics were tabulated by frequencies and weighted percentages or mean and standard deviation, as appropriate.

Arm/Group Title	Exposure to Firearm Safety PSA	Exposure to a Mix of PSAs	Active Control
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA	Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA	Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA
Measure Participants	115	133	110
Agree	66 57.4%	73 54.9%	57 51.8%
Disagree	49 42.6%	60 45.1%	53 48.2%

2. Primary Outcome

Title	Number of Participants With Self-reported Injury Prevention Belief
Description	Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."
Time Frame	3 weeks post-baseline

Outcome Measure Data

Analysis Population Description

Analyses were restricted to participants that completed both baseline and exit surveys. Descriptive statistics were tabulated by frequencies and weighted percentages or mean and standard deviation, as appropriate.

Arm/Group Title	Exposure to Firearm Safety PSA	Exposure to a Mix of PSAs	Active Control
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA	Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA	Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA
Measure Participants	115	133	110
Agree	71 61.7%	79 59.4%	64 58.2%
Disagree	44 38.3%	54 40.6%	46 41.8%

3. Secondary Outcome

Title	Number of Participants Who Self-reported Firearm Storage Behavior at Baseline
Description	Number of participants at baseline with self-reported safe household firearm storage (restricted to participants with self-reported firearm access)
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Analyses were restricted to participants that reported firearm access. Descriptive statistics were tabulated by frequencies and weighted percentages or mean and standard deviation, as appropriate.

Arm/Group Title	Exposure to Firearm Safety PSA	Exposure to a Mix of PSAs	Active Control
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA	Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA	Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA
Measure Participants	64	71	60
Safe storage (yes)	8 7%	23 17.3%	24 21.8%
safe storage (no)	56 48.7%	48 36.1%	36 32.7%

4. Secondary Outcome

Title	Number of Participants Who Self-reported Firearm Storage Behavior at Exit
Description	Number of participants at exit with self-reported safe household firearm storage (restricted to participants with self-reported firearm access)
Time Frame	3 weeks post-baseline

Outcome Measure Data

Analysis Population Description

Analyses were restricted to participants that reported firearm access. Descriptive statistics were tabulated by frequencies and weighted percentages or mean and standard deviation, as appropriate.

Arm/Group Title	Exposure to Firearm Safety PSA	Exposure to a Mix of PSAs	Active Control
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA	Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA	Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA
Measure Participants	64	71	60
safely stored (yes)	7 6.1%	25 18.8%	23 20.9%
safely stored (no)	57 49.6%	46 34.6%	37 33.6%

Adverse Events

Time Frame	over 1 calendar year
Adverse Event Reporting Description	Adverse and serious adverse events were defined using standard definitions.
Arm/Group Title	Exposure to Firearm Safety PSA		Exposure to a Mix of PSAs		Active Control
Arm/Group Description	Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks. Exposure to firearm safety PSA: Exposed to firearm safety PSA		Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization. Exposure to firearm safety PSA: Exposed to firearm safety PSA Exposure to health promotion PSA: Exposed to general health promotion PSA		Exposure to the general health promotion video once per week for 3 weeks. Exposure to health promotion PSA: Exposed to general health promotion PSA
All Cause Mortality
	Exposure to Firearm Safety PSA		Exposure to a Mix of PSAs		Active Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/115 (0%)		0/133 (0%)		0/110 (0%)
Serious Adverse Events
	Exposure to Firearm Safety PSA		Exposure to a Mix of PSAs		Active Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/115 (0%)		0/133 (0%)		0/110 (0%)
Other (Not Including Serious) Adverse Events
	Exposure to Firearm Safety PSA		Exposure to a Mix of PSAs		Active Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/115 (0%)		0/133 (0%)		0/110 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.