Unlocking the Potential of VA Means Safety Programs: An Examination of the Use of Public Messaging for the Promotion of Firearm Safety to Veterans
Phase: NA
Conditions: Injuries
Sponsor: Canandaigua VA Medical Center

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Protocol Summary  
(IRB approved; last approved continuing review 2.27.2020) 
 
 
Study Title: The use of public messaging for the promotion of firearm safety to Veterans  
 
Clinical Trials ID: NCT03417752 
 
Clinical Trials Protocol #:  910434 
 
Research Site: VISN 2 Center of Excellence for Suicide Prevention (CoE) 
 
 
Canandaigua Veterans Affairs Medical Center 
 
 
400 Fort Hill Avenue – Bldg. 37A 
 
 
Canandaigua, NY 14424 
 
 
 
Principal Investigator: 
 
Elizabeth Karras, PhD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. OBJECTIVES 
 
Our objectives are to determine if exposure to the VA’s firearm safety messaging is associated with 
changes related to cognitive and behavioral outcomes reported below (e.g., injury; firearm safety 
practices). Comparisons of findings may be made across those exposed to the VA firearm safety 
message and those exposed to a health promotion (comparison) video. 
 
 
2. RESEARCH DESIGN & METHODS 
 
DATA 
 
Data were collected by GfK Group, a U.S. market research firm, on behalf of the VA to pilot test the 
Firearm Safety messaging with a sample of Veterans. While the majority of participants were exposed to 
the firearm safety message, subsamples were also exposed to a health promotion video to serve as a 
comparison. The survey was carried out by GfK using sample from their KnowledgePanel®, a 
probability-based web panel designed to be representative of the United States. KnowledgePanel® is the 
largest online panel that relies on probability-based sampling techniques for recruitment; hence, the 
largest national sampling frame from which fully representative samples can be generated to produce 
statistically valid inferences for study populations. GfK panel provides samples with the highest level of 
representativeness available in online research for measurement of public opinions, attitudes, and 
behaviors. The panel was first developed in 1999 by Knowledge Networks, a GfK company. Panel 
members are randomly selected so that survey results can properly represent the U.S. population with a 
measurable level of accuracy, features that are not obtainable from non-probability panels. 
 
The survey was administered online at two time points (pre/post message exposures) with a nationally 
representative sample of U.S. adult Veterans (18+, non-institutionalized) that belong to the GfK 
KnowledgePanel®. Military service status was determined using GfK’s profile data. All data are de-
identified and no personal or health information is included in the dataset. The GfK survey was designed 
to provide preliminary insights to the VA on message response. Demographic characteristics were also 
provided in the dataset. A de-identified analytic dataset has been received by the PI from GfK, and is 
currently stored in an access restricted file on the secure drive behind the VA firewall. 
 
RESEARCH DESIGN: 
 
Sampling: GfK Group uses scientific random probability-based sampling techniques for recruitment of 
U.S. households. This probability-based sampling methodology improves population coverage, and 
provides a more effective sampling infrastructure for recruitment of hard-to-reach individuals, such as 
young adults and those from various minority groups. It should be noted that under this recruitment, 
households without Internet connection are provided with a web-enabled device and free Internet 
service. Once panel members are recruited and profiled by taking the Core Profile Survey, they become 
eligible for selection for surveys. Generally, the specific survey samples represent an equal probability 
selection method (EPSEM) sample from the panel for general population surveys.  
 
Data Collection: To sample the population, GfK sampled eligible adults limited to one member per 
household. Selected panel members received an email invitation to complete the Baseline survey and 
were asked to do so at their earliest convenience. In the Baseline survey, each panel member was 
randomly assigned to one of three survey conditions. Next, panel members were then asked to view a 

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message based on the survey condition assigned. Finally, panel members were asked to complete the 
same survey 3-weeks post-baseline to determine how the video exposure may have influenced their 
opinions at exit.  
 
Data included in the analytic file were collected from 12/15/2015 through 1/5/2016. The dataset includes 
responses from 474 participants that completed the baseline survey, with 358 of these participants also 
successfully completing the subsequent message exposures and exit survey within 3 weeks post-
baseline.  
 
Waivers of Consent & HIPAA Authorization: A consent waiver has been submitted for consideration. 
We believe this waiver does not adversely affect the rights or welfare of the participants as survey topics 
are minimally invasive and do not request identifiable information. Individuals also have several 
opportunities to opt out of participation during the recruitment process. A waiver of HIPAA 
Authorization has also been submitted to the IRB as no PHI or PII is collected as part of the survey. 
Analytic data files will be limited with no PHI or PII included.  
 
Despite the request for waivers, each participant will still receive study information including a detailed 
description of purpose, procedures, risk/benefits, and voluntary nature. Prior to moving forward with 
any study procedures, participants will confirm their understanding of the study and their willingness to 
participate. 
 
ANALYSIS PLAN: 
 
All data analyses will be conducted at the VISN2 Center of Excellence for Suicide Prevention (COE) at 
the Canandaigua VAMC. All analyses will use data from the de-identified GfK dataset. The project 
under approval of this protocol will make no attempt to link data from GfK with any additional 
resources containing identifiable information. All analysis will be restricted to participants who are 18 
years or older. Statistical analysis methods will include frequencies and standard deviations to describe 
sample characteristics. Bivariate analysis will be utilized to identify potential covariates to include in the 
multivariate models.  Multivariate modeling will be used to examine hypotheses concerning the different 
effects of exposure on changes in outcomes across and within study conditions/groups. Changes in 
outcomes for each aim will be modeled over time for each condition, controlling for covariates of 
interest. Appropriate contrasts will then be used to identify significant differences in outcomes (as 
appropriate). All data management and analyses will be conducted by experienced team members listed 
on this protocol using SAS 9.4 (Cary, NC). Further ad hoc analyses may be conducted as needed. 
 
 
4. DATA MANAGEMENT & STORAGE 
 
For the purposes of this research project only a final analytic dataset was received from GfK, and will be 
user restricted with only members of the study team having access to this database. All data will be 
stored within the VA firewall. The data can only be retrieved from within the VA network and will be 
user restricted so that only members of the research team can access the data.  
 
All data is stored in ‘access restricted’ files behind the VA firewall on the VA’s secure drive and will be 
backed up at a secure VA data storage location. Access to research study data will be terminated for 
study personnel when they are no longer part of the research team. Current VA regulations require all 

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identifiable data collected and used for research be maintained as defined in the VHA Records Control 
Schedule.  Therefore, no data will be destroyed until confirmed in compliance with these regulations. 
 
VINCI 
 
Study data may also be stored on a centralized research data repository, such as the VA Informatics and 
Computing Infrastructure (VINCI).  VINCI is a partnership between the VA Office of Information 
Technology (OI&T) and the Veterans’ Health Administration Office of Research and Development 
(VHA ORD). VINCI provides the storage and server technologies to securely host suites of databases 
integrated from select national data. These servers reside at the Austin Information Technology Center 
(AITC), located in Austin, Texas. To ensure the protection of Veterans data, VINCI maintains 
compliance with the guidelines set forth by Veterans Health Administration (VHA) Handbook 1200.12, 
Use of Data and Data Repositories in VHA Research and all other applicable VA and VHA policies and 
regulations. In addition, VINCI has undergone all security certification activities in support of obtaining 
an Authorization to Operate (ATO).   
 
ADVERSE EVENT REPORTING: 
 
If any Adverse Event (AE) or Serious Adverse Event (SAE) are encountered, the research team is 
responsible for reporting such events to their IRB either as part of continuing review (AE) or within 5 
days of a SAE report. 
    
CONFIDENTIALITY: 
 
Data were de-identified and formatted by GfK before being released to the VA.  All participants of the 
GfK survey agree to have their information kept for research purposes.  In order to ensure 
confidentiality, no identifiable information is collected, and participants’ data are coded with a random 
study identification number. All participating study personnel have completed the VA’s mandatory 
ethics and research trainings and have submitted academic transcripts and currents CV’s for IRB review. 
 
CLINICAL RELATIONSHIPS: 
 
No clinical relationships will be necessary for this study. 
 
 
 

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