Skip to content

Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) Protocol

Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) Protocol - PRAISE-2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43260
Enrollment
50
Registered
2017-04-25
Start date
2017-07-07
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal injury

Interventions

Intimate partner violence
Musculoskeletal injury

Sponsors

McMaster University
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Adult females (at least 18 years of age) 2) Patients presenting 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

Exclusion criteria

Exclusion criteria: 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 Dutch

Design outcomes

Primary

MeasureTime frame
The primary outcome of the pilot study will be a composite measure of feasibility. This will include: 1) Recruitment (number of patients recruited at each site during a 12 month period) 2) Protocol adherence (application of eligibility criteria) 3) Follow-up (proportion of included patients followed at 12 months) 4) Data quality (the proportion of case report forms, including patient questionnaires completed at 12 months)

Secondary

MeasureTime frame
Secondary objectives will be to collect data on the objectives of the definitive study. These objectives are the following: 1) To compare injury-related complications among women presenting at a fracture clinic who disclose a history of IPV versus those who do not disclose IPV over 12 months following a musculoskeletal injury 2) To determine how a history of IPV affects return to pre-injury function 3) To determine the extent to which new episodes of IPV (incident cases) occur after a musculoskeletal injury in women with no prior history of abuse over a 12 month period 4) Among women who disclose a history of IPV versus those who do not disclose IPV, what are the relative utilization and associated costs of health, legal, and social support services 5) Among women with musculoskeletal injuries who self-report a history of IPV, we aim to describe changes in abuse severity and type of abuse (physical, emotional, and/or sexual IPV) over a 12 month period 6) Among women with musculoskeletal injuries who self-report a history of IPV we aim to determine how a history of IPV affects health-related quality of life after a musculoskeletal injury 7) Among women with musculoskeletal injuries who self-report a history of IPV we aim to determine how women*s stage of change based on the Domestic Violence Survivor Assessment (DVSA) changes over time after a musculoskeletal injury.

Countries

Canada

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)