Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)
2018년 6월 25일 업데이트: 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.
연구 개요
상태
상태
알려지지 않은
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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
연구 유형
연구 유형
관찰
등록 (실제)
등록
250
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8R 3H6
- McMaster University
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
16년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
샘플링 방법
비확률 샘플
연구 인구
Adult women presenting to participating fracture clinics with a fracture or dislocation.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
2
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Experienced abuse
Experienced IPV in the past 12 months
|
|
|
Did not experience abuse
Did not experience IPV in the past 12 months.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility - Recruitment rate
기간: 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
기간: 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)
기간: 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)
기간: 12 months
|
The proportion of case report forms, including patient questionnaires, completed at 12 months.
|
12 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients with injury-related complications assessed by central adjudication
기간: 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.
|
12 months
|
|
Return to function questionnaire
기간: 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
기간: 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.
|
12 months
|
|
Resource use questionnaire
기간: 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.
|
12 months
|
|
Quality of life - EQ-5D
기간: 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
|
|
IPV frequency questionnaire
기간: 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.
|
12 months
|
|
Stage of change questionnaire
기간: 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
|
|
IPV type questionnaire
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Brad Petrisor, MD, MSc, Hamilton Health Sciences Corporation
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
연구 시작
2015년 8월 1일
기본 완료 (예상)
기본 완료
2019년 6월 1일
연구 완료 (예상)
연구 완료
2019년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2015년 8월 7일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2015년 8월 19일
처음 게시됨 (추정)
처음 게시됨
2015년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2018년 6월 26일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 25일
마지막으로 확인됨
마지막으로 확인됨
2018년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- PRAISE-2
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .