WrapAround Care for Youth Injured by Violence

NCT ID: NCT01895738

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-11-30

Brief Summary

Youth injured by violence is a major public health concern in Canada. It is the fourth cause of death and the leading reason for a youth to visit an emergency department (ED). In Winnipeg, 20% of youth who visit an emergency department with an injury due to violence have a second visit for a subsequent violent injury within the following year. This is consistent with studies in other jurisdictions that demonstrate that violent injury is a chronic condition. Youth injured by violence are in a reflective and receptive state of mind, rendering the emergency department setting appropriate for intervention. The investigators propose a WrapAround Care model delivered by a support worker with lived experience with violence, supported by a social worker, an addictions and mental health counsellor, a family counsellor and links to multiple community partners. Support workers will be on call 24 hours a day, 7 days a week in order to start the intervention in the ED and take advantage of the "teachable moment". The proposed study is a pilot randomized control trial to assess the feasibility of a randomized control trial designed to assess efficacy. For the pilot trial the investigators will assess recruitment, treatment fidelity, participant adherence and safety. The intervention arm will receive wraparound care initiated at the time of their visit for injury due to violence. The control arm will receive standard of care (usually a list of community contacts). The investigators will use an adapted pre-consent randomization methodology. This intervention has been developed using a community based participatory research approach. Our team includes clinicians, nurses, social workers, community youth workers, ex-gang members, elders and researchers.

Detailed Description

Youth injured by violence is a major public health concern in Canada. It is the fourth cause of death and the leading reason for a youth to visit an emergency department. In Winnipeg 20% of youth who visit an emergency department with an injury due to violence have a second visit for a subsequent violent injury within the following year. This is consistent with studies in other jurisdictions that demonstrated that violent injury is a chronic condition.

Youth injured by violence have been shown to be in a reflective and receptive state of mind, rendering the emergency department setting appropriate for intervention. There are some hospital-based intervention programs for youth injured by violence in the U.S.; however, they have not been evaluated to assess repeat injury using a randomized control trial (RCT) and given the cost of this intervention, significant equipoise exists. It is essential to evaluate this intervention rigorously using RCT methodology. A pilot RCT is prudent prior to the main RCT.

The investigators propose a WrapAround Care model delivered by a support worker with lived experience with violence, supported by a social worker, an addictions and mental health counsellor, a family counsellor and links to multiple community supports. These community supports include partnerships with aboriginal and newcomer youth cultural programs as many youth impacted by violence are aboriginal and new immigrants to Canada. Support workers will be on call 24 hours a day, 7 days a week in order to start the intervention in the ED and take advantage of the "teachable moment".

This pilot study RCT will enroll 180 youth (aged 14 - 24) over one year (90 to each arm). The treatment arm will be the WrapAround care model initiated at the time of injury (i.e. in the emergency department). The control arm will be providing youth with a list of community programs and will be a waitlist control. The primary outcomes of the pilot study will evaluate evaluate recruitment, adherence, fidelity and safety of the intervention. The primary outcome for the main trial is repeat visit to any emergency department in Winnipeg for a subsequent injury due to interpersonal violence. This will be measured using a combination of administrative data and chart review to ensure high follow-up. The secondary outcomes include measurement of counts and severity of injury and housing and education changes. This intervention has been developed using a community based participatory research approach. Our team includes clinicians, nurses, social workers, community youth workers, former gang members, elders and researchers.

Conditions

Trauma; Injuries; Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

WrapAround Care

Participants randomized to the intervention arm will be met in the emergency department by a support worker who has lived experience. They will start to build a relationship with the participant at that time (i.e. during the teachable moment) and will work with the participant for approximately one year, delivering WrapAround Care. Wraparound care is an established care model that starts with linking an individual with a support worker who works with them to address risk factors and enable the individual to make positive choices. It is hypothesized that by working with youth to address the risk factors in their control, the likelihood of future violence is reduced.

Group Type: EXPERIMENTAL

WrapAround Care

Intervention Type: BEHAVIORAL

Wraparound care is an established care model that starts with linking an individual with a support worker who works with them to address risk factors and enable the individual to make positive choices. It is hypothesized that by working with youth to address the risk factors in their control, the likelihood of future violence is reduced.

Standard of Care

Standard of Care is typically a sheet of community resources potentially handed out by the emergency physician, nurse or social worker.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

WrapAround Care

Wraparound care is an established care model that starts with linking an individual with a support worker who works with them to address risk factors and enable the individual to make positive choices. It is hypothesized that by working with youth to address the risk factors in their control, the likelihood of future violence is reduced.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 14 - 24 AND
• Presentation with an injury caused by violence (defined as an injury inflicted by someone else and one of a gunshot wound, stab wound, injury due to blunt object, or injury due to bodily force)

Exclusion Criteria

• Unable to consent due to language or brain injury
• Sexual assault (except those explicitly described as gang related - being "raped in or raped out" of a gang which is common with female gang members)
• Child Abuse
• Self-Inflicted Injury
• Transfer from a hospital > 1 hour from Winnipeg.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Carolyn Snider

Assistant Professor, Department of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Snider, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Countries

Canada

References

Snider C, Jiang D, Logsetty S, Strome T, Klassen T. Wraparound care for youth injured by violence: study protocol for a pilot randomised control trial. BMJ Open. 2015 May 19;5(5):e008088. doi: 10.1136/bmjopen-2015-008088.

Reference Type: DERIVED

PMID: 25991461 (View on PubMed)

Other Identifiers

302030

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H2013:257

Identifier Type: -

Identifier Source: org_study_id