Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02529267|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2015
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment|
|Fractures, Bone Dislocations Spouse Abuse||Other: Standard of care|
Number of Participants:
Primary Research Objectives:
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
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
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experienced IPV in the past 12 months
Other: Standard of care
Did not experience abuse
Did not experience IPV in the past 12 months.
Other: Standard of care
- Feasibility - Recruitment rate [ Time Frame: 12 months ]Number of patients recruited at each site during a 12 month period
- Feasibility - Proportion of Missed and/or out of window visits [ Time Frame: 12 months ]Proportion of missed and out of window visits
- Feasibility - Collection of secondary outcomes (Proportion of included patients followed at 12 months for the primary and secondary outcomes) [ Time Frame: 12 months ]Proportion of included patients followed at 12 months for the primary and secondary outcomes
- Feasibility - Completion of data collection (proportion of case report forms, including patient questionnaires, completed at 12 months) [ Time Frame: 12 months ]The proportion of case report forms, including patient questionnaires, completed at 12 months.
- Proportion of patients with injury-related complications assessed by central adjudication [ Time Frame: 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.
- Return to function questionnaire [ Time Frame: 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.
- IPV incidence questionnaire [ Time Frame: 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.
- Resource use questionnaire [ Time Frame: 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.
- Quality of life - EQ-5D [ Time Frame: 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.
- IPV frequency questionnaire [ Time Frame: 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.
- Stage of change questionnaire [ Time Frame: 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.
- IPV type questionnaire [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529267
|Hamilton, Ontario, Canada, L8R 3H6|
|Principal Investigator:||Brad Petrisor, MD, MSc||Hamilton Health Sciences Corporation|
|Principal Investigator:||Sheila Sprague, PhD||McMaster University|