We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of California's Armed and Prohibited Persons System (APPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02318732
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : December 1, 2021
Sponsor:
Collaborators:
Rutgers University
Stanford University
Northeastern University
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE December 12, 2014
First Posted Date  ICMJE December 17, 2014
Last Update Posted Date December 1, 2021
Study Start Date  ICMJE February 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
Incidence of arrest for violent and firearm-related crimes [ Time Frame: Up to 3 years ]
Arrests for violent and firearm-related crimes among persons eligible for the APPS intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
  • Incidence of arrest for non-violent, non firearms-related crimes [ Time Frame: Up to 3 years ]
    Arrests for crimes not involving violence or firearms among persons eligible for the APPS intervention
  • Incidence of emergency mental health hospitalizations [ Time Frame: Up to 3 years ]
    Emergency mental health hospitalizations following a determination of dangerousness to self or others or grave disability among persons eligible for the APPS intervention
  • Incidence of domestic violence restraining orders [ Time Frame: Up to 3 years ]
    Domestic violence restraining orders among persons eligible for the APPS intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2014)
  • Community level rates of violence [ Time Frame: Up to 3 years ]
    Community-level rates of violent and firearm-related crimes
  • Cost benefit analysis [ Time Frame: Up to 3 years ]
    Assess benefits of APPS relative to costs.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of California's Armed and Prohibited Persons System
Official Title  ICMJE Prospective Evaluation of California's Armed and Prohibited Persons System
Brief Summary This study evaluates exposure to California's Armed and Prohibited Persons System (APPS) and risk of future violence and other important outcome events among individuals who legally purchased firearms in the past but have since become prohibited from owning them. The main hypothesis is that APPS will be associated with a significant reduction in risk for future violence among individuals who are directly affected.
Detailed Description

Violence remains an important public safety and public health problem. Prior research has shown that denying firearm purchases by individuals who are at high risk for committing violent crimes, thereby restricting their access to firearms, is an effective violence prevention strategy. The Armed and Prohibited Persons System (APPS) is a new violence prevention initiative undertaken by the California Department of Justice (CalDOJ). APPS is used by law enforcement to systematically identify persons who, having legally purchased firearms in the past, have become prohibited persons in the present-usually as the result of a criminal conviction. Such individuals are at increased risk for future violence.

APPS uses existing data to identify firearm owners among persons who have become prohibited from owning or possessing firearms under California or federal law. CalDOJ then uses this information to contact and attempt recovery of firearms in the possession of prohibited individuals.

This controlled prospective longitudinal evaluation of APPS relies principally on data collected by CalDOJ in the course of APPS operations or on data in the public domain, such as community characteristics published by the U.S. Census Bureau.

To maximize fairness during the implementation of APPS, approximately 1,000 California communities will be stratified by region, population, and violent crime rate and randomized into two groups that will be exposed to APPS at different times during the study period. Hierarchical analysis will examine outcomes for individuals clustered at the community level. The principal analysis will be on an intent to treat basis. A secondary per protocol analysis will also be conducted.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Violence
Intervention  ICMJE Behavioral: APPS intervention
Contact with and recovery of firearms from individuals who are prohibited from possessing them
Study Arms  ICMJE
  • Experimental: Group 1
    APPS intervention will be implemented in Group 1 communities prior to implementation in Group 2 communities.
    Intervention: Behavioral: APPS intervention
  • Active Comparator: Group 2
    APPS intervention will be implemented in Group 2 communities following implementation in Group 1 communities.
    Intervention: Behavioral: APPS intervention
Publications * Wintemute GJ, Beckett L, Kass PH, Tancredi D, Studdert D, Pierce G, Braga AA, Wright MA, Cerda M. Evaluation of California's Armed and Prohibited Persons System: study protocol for a cluster-randomised trial. Inj Prev. 2017 Oct;23(5):358. doi: 10.1136/injuryprev-2016-042194. Epub 2016 Oct 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2016)
20000
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2014)
1000
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with records of firearms ownership who have experienced a prohibiting event. Prohibiting events are based in Federal and California state law. Among others, they include criminal convictions for felonies and selected violent misdemeanors; emergency hospitalization for dangerousness associated with severe mental illness, as specified in statute; and status as respondent to a domestic violence restraining order.

Exclusion Criteria:

  • None.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02318732
Other Study ID Numbers  ICMJE 553213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of California, Davis
Original Responsible Party Garen J. Wintemute, MD, University of California, Davis, Professor, Emergency Medicine
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Rutgers University
  • Stanford University
  • Northeastern University
Investigators  ICMJE
Principal Investigator: Garen J Wintemute, MD, MPH University of California, Davis
PRS Account University of California, Davis
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP