Clinical trial NCT01895738: WrapAround Care for Youth Injured by Violence
Official title: WrapAround Care for Youth Injured by Violence: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Injuries
Violence
Keywords: Trauma
Injuries
Violence
Adolescent
WrapAround care
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 133
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Feasibility of Recruitment for Main Trial
timeFrame: One Year
measure: Fidelity to Treatment Protocol
timeFrame: Two Years
measure: Participant Adherence
timeFrame: Two Years
measure: Serious Adverse Events
timeFrame: Two Years
Secondary outcomes:
measure: To determine the cost-effectiveness of the intervention
timeFrame: Two Years
Other outcomes:
measure: To determine the impact on Visits to Hospital for Repeat Intentional Injury within one year
timeFrame: Two Years
measure: To determine the impact on # of repeat intentional injuries
timeFrame: Two Years
measure: To determine the impact on time to repeat intentional injury
timeFrame: Two Years
measure: To determine the impact on severity of repeat injury
timeFrame: Two Years
measure: To determine the impact on visits to hospital related to substance use
timeFrame: Two Years
measure: To determine the impact on visits to hospital for mental health care
timeFrame: Two Years
measure: To determine the impact on education
timeFrame: Two Years
measure: To determine the impact on housing
timeFrame: Two Years
measure: To determine the impact on criminal behaviour
timeFrame: Two Years
measure: To determine the impact on repeat injuries due to violence by self-report
timeFrame: Two Years
measure: To determine the impact on structured activity by self-report
timeFrame: Two Years
measure: To determine the impact on housing by self-report
timeFrame: Two Years
Locations:
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Carolyn Snider, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.