Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fractures, Bone
- Sponsor
- McMaster University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Feasibility - Proportion of Missed and/or out of window visits
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
Number of Participants: 250 Primary Research Objectives: Feasibility Secondary Research Objective: The secondary objectives are to determine: 1. How a history of IPV affects injury-related complications; 2. How a history of IPV affects return to pre-injury function; 3. Incident cases of IPV after a musculoskeletal injury, if the injury was not the result of IPV; 4. How a history of IPV affects health care and support service use after a musculoskeletal injury; 5. How a history of IPV affects health-related quality of life after a musculoskeletal injury; 6. How patterns of IPV change over time after a musculoskeletal injury; 7. How abused women's stage of change changes over time after a musculoskeletal injury Diagnosis and Main Inclusion Criteria: The inclusion criteria are: 1. adult females (at least 16 or 18 years of age depending on local ethics requirements); 2. patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury; 3. patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment. The exclusion criteria are: 1. unwilling to or unable to provide consent; 2. unable to complete the study questionnaires in a private location, due to safety and confidentiality; 3. unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols; 4. 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Feasibility - Recruitment rate
Time Frame: 12 months
Number of patients recruited at each site during a 12 month period
Secondary Outcomes
- Proportion of patients with injury-related complications assessed by central adjudication(12 months)
- Return to function questionnaire(12 months)
- Resource use questionnaire(12 months)
- IPV incidence questionnaire(12 months)
- Quality of life - EQ-5D(12 months)
- IPV frequency questionnaire(12 months)
- Stage of change questionnaire(12 months)
- IPV type questionnaire(12 months)