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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Canadian Institute of Health Research
interventional
133
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 4, 2013
Actual (reported)July 10, 2013
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 2015
Actual (reported)November 2015
Actual (reported)Feasibility of Recruitment for Main Trial
The investigators estimate that our sample size for the main trial must be 330 per arm (660 total) (Section 2.11). In order to ensure sufficient recruitment over 44 months plus 12 month follow-up for each subject and analysis time within a 5 year time frame, the investigators estimate that the investigators will need to randomize 180 youth to our pilot study in one year. This will also ensure that each support worker has an appropriate workload (approximately 2 new subjects per month with a maximum of 15 at any time). Successful Recruitment will be defined as \>180 participants in one year.
One Year
Fidelity to Treatment Protocol
The investigators have set the treatment protocol based on experience from our Proof of Concept study and our community partners. In behavioural interventions, fidelity measures are considered the quality control measure of ensuring the intervention is being implemented as intended. Fidelity preserves internal validity against type I and II errors, it improves power by decreasing the variability in treatment effect and allows replication, dissemination and implementation in practice. Successful Fidelity will be defined as \>85% of contacts (i.e. check-ins, phone calls, team meetings) attempted by the support worker.
Two Years
Participant Adherence
To determine the cost-effectiveness of the intervention
Two Years
To determine the impact on Visits to Hospital for Repeat Intentional Injury within one year
Two Years
To determine the impact on # of repeat intentional injuries
Two Years
To determine the impact on time to repeat intentional injury
Two Years
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.
Standard of Care is typically a sheet of community resources potentially handed out by the emergency physician, nurse or social worker.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R3P 3E4, Canada
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.
Carolyn Snider, MD MPH
University of Manitoba
133 participants (actual enrollment reported by the registry).
First Submitted
July 4, 2013
First Posted
July 10, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Participant adherence refers to both the receipt of the intervention (the development of a strong and effective alliance between the case manager and youth) and enacting on the intervention (accessing resources). In behavioural intervention studies it is important to demonstrate that the actual intervention is occurring as designed. If adherence to the intervention is not achieved, then our comparison of outcomes do not truly measure the difference between intervention and control. Successful Adherence will be assessed using the Working Alliance Inventory, which measures the bond between the support worker and participant and the agreement on tasks and goals set.
Two Years
Serious Adverse Events
Given youth injured by violence, especially those who are gang-involved are at high risk of retaliatory violence; investigators must ensure participants do not experience increased harm as part of the intervention. Program staff will discuss adverse events at each weekly meeting and workers and counselors will be required to fill in adverse event forms should they occur. These will be reviewed immediately with the principal investigator and if necessary the Data Safety Monitoring Board (DSMB). The DSMB will review a table of these adverse events and will review serious adverse events (e.g. death or otherwise deemed as serious) in detail. Stopping rules and guidelines are specified for the DSMB. The main stopping rule will be to stop the study if the treatment arm is significantly more likely to suffer a repeat violent injury (p\<0.05).
Two Years
Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
March 14, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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