Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)
2018年6月25日 更新者：McMaster University
Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
Intimate partner violence (IPV), also known as domestic abuse, is a leading cause of non-fatal injury in women worldwide.
1 in 6 women attending surgical fracture clinics have a history of IPV in the past year.
Given the high prevalence and costs associated with IPV, there is a need to identify health outcomes associated with IPV, the incidence of new and worsening cases of IPV, and resource use among IPV victims.
This prospective cohort study of women with fractures and dislocations will assess differences in injury-related outcomes (time to fracture healing, injury-related complications, and return to pre-injury function) between abused and non-abused women.
This study will also determine whether a musculoskeletal injury can lead to new or worsening abuse by an intimate partner and how patterns of IPV change over time following musculoskeletal injuries.Finally, the proposed study will also inform the feasibility of a larger multinational cohort study.
研究概览
详细说明
Number of Participants:
250
Primary Research Objectives:
Feasibility
Secondary Research Objective:
The secondary objectives are to determine:
- How a history of IPV affects injury-related complications;
- How a history of IPV affects return to pre-injury function;
- Incident cases of IPV after a musculoskeletal injury, if the injury was not the result of IPV;
- How a history of IPV affects health care and support service use after a musculoskeletal injury;
- How a history of IPV affects health-related quality of life after a musculoskeletal injury;
- How patterns of IPV change over time after a musculoskeletal injury;
- How abused women's stage of change changes over time after a musculoskeletal injury
Diagnosis and Main Inclusion Criteria:
The inclusion criteria are:
- adult females (at least 16 or 18 years of age depending on local ethics requirements);
- patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury;
- patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment.
The exclusion criteria are:
- unwilling to or unable to provide consent;
- unable to complete the study questionnaires in a private location, due to safety and confidentiality;
- unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols;
- does not speak and write in English or the dominant language of the local clinic
Study Outcomes:
The primary outcome is feasibility. Secondary outcomes are injury-related complications, return to function, incidence of IPV, quality of life, abuse type and severity, and stage of change.
Duration of Patient Follow-Up:
Study participants will be followed for 12 months
研究类型
观察性的
注册 (实际的)
250
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
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Hamilton、Ontario、加拿大、L8R 3H6
- McMaster University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Adult women presenting to participating fracture clinics with a fracture or dislocation.
描述
Inclusion Criteria:
- Adult females
- Patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury
- Patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment
Exclusion Criteria:
- Unwilling to or unable to provide consent
- Unable to complete the study questionnaires in a private location
- Unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols
- Does not speak and write in English or the dominant language of the local clinic
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Experienced abuse
Experienced IPV in the past 12 months
|
|
|
Did not experience abuse
Did not experience IPV in the past 12 months.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility - Recruitment rate
大体时间：12 months
|
Number of patients recruited at each site during a 12 month period
|
12 months
|
|
Feasibility - Proportion of Missed and/or out of window visits
大体时间：12 months
|
Proportion of missed and out of window visits
|
12 months
|
|
Feasibility - Collection of secondary outcomes (Proportion of included patients followed at 12 months for the primary and secondary outcomes)
大体时间：12 months
|
Proportion of included patients followed at 12 months for the primary and secondary outcomes
|
12 months
|
|
Feasibility - Completion of data collection (proportion of case report forms, including patient questionnaires, completed at 12 months)
大体时间：12 months
|
The proportion of case report forms, including patient questionnaires, completed at 12 months.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients with injury-related complications assessed by central adjudication
大体时间：12 months
|
Compare proportion of patients experiencing a composite of injury-related complications between patients who self-report a history of IPV and those who do not.
Injury-related complications include non-union, malunion, infection, unplanned secondary procedure, mortality, hardware failure, etc.
An independent, blinded adjudicator will determine whether the event is injury-related.
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12 months
|
|
Return to function questionnaire
大体时间：12 months
|
We will use the Return to Function Questionnaire (RTF) to compare the mean time to return to pre-injury function among women who disclose a history of IPV versus those who do not disclose IPV.
The RTF is a 4 question tool that was used in a recently completed large FDA-regulated fracture trial.
|
12 months
|
|
IPV incidence questionnaire
大体时间：12 months
|
Women's self-reported experience of IPV will be measured using a direct method of screening used by the PRAISE Investigators in 2 previous studies conducted in trauma populations.
A participant will be considered to have disclosed IPV if she answers positively to at least 1 of the 3 direct screening questions.
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12 months
|
|
Resource use questionnaire
大体时间：12 months
|
Women's access to and use of health and support services will be measured by directly asking participants to self-report if they have accessed health care services, a social worker, mental health professional, women's shelter, helpline, violence against women website, or legal assistance.
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12 months
|
|
Quality of life - EQ-5D
大体时间：12 months
|
Participants' quality of life will be measured using the EuroQol-5 Dimensions (EQ-5D), a widely used and well-validated quality of life tool.
The EQ-5D is a comprehensive, 5-item compact health status classification and health state preference questionnaire.
|
12 months
|
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IPV frequency questionnaire
大体时间：12 months
|
Using 3 questions from the Woman Abuse Screening Tool, which categorizes frequency of different types of violence, we will record and analyze changes in frequency of IPV experienced over time.
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12 months
|
|
Stage of change questionnaire
大体时间：12 months
|
Participants will complete the Domestic Violence Survivor Assessment (DVSA) Short Form questionnaire to determine her stage of change.
The stages of change are based on the transtheoretical model of health behavior change applied specifically to survivors of abuse.
We developed the DVSA Short Form for the purpose of this study, with the aim of making the self-administered form more accessible.
|
12 months
|
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IPV type questionnaire
大体时间：12 months
|
Using 3 questions from the Woman Abuse Screening Tool, which categorizes types of violence as physical, emotional, and/or sexual abuse, we will record and analyze changes in type of IPV experienced over time.
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Brad Petrisor, MD, MSc、Hamilton Health Sciences Corporation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- PRAISE Investigators; Sprague S, Bhandari M, Della Rocca GJ, Goslings JC, Poolman RW, Madden K, Simunovic N, Dosanjh S, Schemitsch EH. Prevalence of abuse and intimate partner violence surgical evaluation (PRAISE) in orthopaedic fracture clinics: a multinational prevalence study. Lancet. 2013 Sep 7;382(9895):866-76. doi: 10.1016/S0140-6736(13)61205-2. Epub 2013 Jun 12.
- Madden K; PRAISE-2 Investigators. Prospective evaluation of intimate partner violence in fracture clinics (PRAISE-2): protocol for a multicentre pilot prospective cohort study. Pilot Feasibility Stud. 2018 Jun 15;4:115. doi: 10.1186/s40814-018-0301-9. eCollection 2018.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (预期的)
2019年6月1日
研究完成 (预期的)
2019年6月1日
研究注册日期
首次提交
2015年8月7日
首先提交符合 QC 标准的
2015年8月19日
首次发布 (估计)
2015年8月20日
研究记录更新
最后更新发布 (实际的)
2018年6月26日
上次提交的符合 QC 标准的更新
2018年6月25日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.