The primary objectives are to determine the feasibility of a multi-national prospective cohort study:1) Assess our ability to recruit women across clinical sites and compare actual recruitment rates to our current estimates;2) Evaluate adherence to…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
1 in 6 women in fracture clinics have experienced intimate partner violence
(IPV) in the past year, and 1 in 50 women present to fracture clinics with
IPV-related injuries. Orthopaedic health care professionals are in a good
position to identify women experiencing IPV and preventing future abuse. There
is currently no information on how IPV experiences affect orthopaedic outcomes.
Additionally, women with musculoskeletal injuries may experience changing
relationship dynamics that affect IPV patterns.
Study objective
The primary objectives are to determine the feasibility of a multi-national
prospective cohort study:
1) Assess our ability to recruit women across clinical sites and compare actual
recruitment rates to our current estimates;
2) Evaluate adherence to the study protocol, including application of
eligibility criteria;
3) Assess our ability to follow and collect data for 12 months;
4) Identify and resolve any problems with data quality;
5) Examine adherence to questionnaire completion;
6) Obtain preliminary estimates of increasing severity of IPV and cases of new
abuse (incident cases) among injured women.
Study design
Multi-centre pilot prospective cohort study.
Study burden and risks
Study participant will spend about 30 minutes to complete questionaires at
inclusion and 1, 3, 6, and 12 months later. Patiens will be offered the
posibility to answer the questions by telephone.
Wellington St 293
Hamilton, ON L8L 8E7
CA
Wellington St 293
Hamilton, ON L8L 8E7
CA
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02529267 |
| CCMO | NL58932.075.16 |