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

• ClinicalTrials.gov Identifier: NCT02318732
• Recruitment Status: Active, not recruiting
• First Posted: December 17, 2014
• Last Update Posted: December 1, 2021
• Sponsor: University of California, Davis
• Collaborators: Rutgers University; Stanford University; Northeastern University
• Information provided by (Responsible Party): University of California, Davis

Tracking Information

• First Submitted Date: December 12, 2014
• First Posted Date: December 17, 2014
• Last Update Posted Date: December 1, 2021
• Study Start Date: February 2015
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Evaluation of California's Armed and Prohibited Persons System
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Violence

Intervention

Behavioral: APPS intervention

Contact with and recovery of firearms from individuals who are prohibited from possessing them

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 20, 2016): 20000
• Original Estimated Enrollment (submitted: December 12, 2014): 1000
• Estimated Study Completion Date: December 31, 2022
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02318732
• Other Study ID Numbers: 553213
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: University of California, Davis
• Original Study Sponsor: Same as current

Collaborators

• Rutgers University
• Stanford University
• Northeastern University

Investigators

• Principal Investigator: Garen J Wintemute, MD, MPH; University of California, Davis

• PRS Account: University of California, Davis
• Verification Date: November 2021