An Evaluation of the Project CHANGE-MS Violence Intervention Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number of violent reinjuries in 12 months
研究概览
简要总结
This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case management over a one year period. Primary outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.
详细描述
Potential study participants are all adult, male survivors of community violence treated at the study site.
After a potential study participant is screened and deemed eligible for participation in the study consent will be obtained to participate in the study. At stage one a participant can either accept or refuse services and at stage two can consent or refuse to consent in the study.
If a patient consents to both receive services and participate in the study, the participant will be randomly assigned to either the "Treatment as Usual" (TAU) intervention, which receives the referral card for services, or the "Enhanced Treatment" (ET) intervention prior to assessment so that the results of the assessment do not influence program staff which group the potential study participant is assigned. At the beginning of the study, 400 identical envelopes will be created, 200 with a slip of paper labeled "Treatment as Usual" and 200 with a slip of paper labeled "Enhanced Treatment." These will be shuffled and will be used to assign the random group of those patients that consent to participate.
Those who refuse services and refuse the study will not be included in the study. Finally, those who accept services but refuse to be in the study will not be in the study.
Participation in the study will take place in five stages. At stage one, after consenting to the study and being randomly assigned to TAU or ET care groups, the patient will undergo an interview. The interview will take place at bedside granted that privacy can be guaranteed or in an office if the patient is mobile. In some cases it may be appropriate to set up an appointment after discharge to conduct the interview. Patients that agree to participate in the study will be entered into a secure Excel Database on a MedStar password protected server. Only study personnel will have access to this database, which will contain a key with patient name and a unique identifier. This database will also be used to assess study quality measures of approaches to eligible participants and percent uptake. This database and the signed consents will have identifiable patient information. An additional SpreadSheet Web tool, provided by the DC Department of Health Office of Victims Services and Justice Grants will be used to track outcomes and follow-up of participants. This will include only de-identified information. The internal secure Excel database will have a link between patient name and unique identifier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •identify as male
- •be 18 years of age or older
- •speak English
- •have experienced a violent injury in the form of a gunshot wound, stabbing, or assault within two years of first contact with the program (verified through trauma registry)
- •experienced the injury within the borders of the east coast city where the study is taking place.
排除标准
- •identifying as female
- •reporting an age ≤ 17
- •experiencing a self-inflicted violent injury
- •experiencing a traumatic brain injury
- •being under police custody
- •not being injured within the borders of the east coast city where the study is taking place
- •not being able to provide informed consent
结局指标
主要结局
Number of violent reinjuries in 12 months
时间窗: 12 months
Subsequent violent reinjury
Number of participants with death in 12 months
时间窗: 12 months
Death
次要结局
- Decreased in Frequency of Substance Abuse in past-30 days(12 months)
- Improved Life Satisfaction(12 months)
- Improvement of Level of Mastery as measured using Pearlin Mastery Scale(12 months)
- Improvement in Disposition towards Violence as measured using the Code of the Street Scale(12 months)
- Decrease in number of Medical Legal Needs screened positive(12 months)
- Decreased Post-Traumatic Stress Disorder (PTSD) Symptoms measured using PTSD-8: A Short PTSD Inventory(12 months)