Prospective Abuse and Intimate Partner Violence Surgical Evaluation

NCT02529267 | Unknown

• 1 other identifier: PRAISE-2
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone; Dislocations; Spouse Abuse

Keywords

Cohort Studies; intimate partner violence; orthopaedic surgery; epidemiology; outcomes in fracture care

Outcome Measures

Primary Outcomes (4)

• Feasibility - Recruitment rate

  Number of patients recruited at each site during a 12 month period

  12 months

• Feasibility - Proportion of Missed and/or out of window visits

  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)

  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)

  The proportion of case report forms, including patient questionnaires, completed at 12 months.

  12 months

Secondary Outcomes (8)

• Proportion of patients with injury-related complications assessed by central adjudication

  12 months

• Return to function questionnaire

  12 months

• IPV incidence questionnaire

  12 months

• Resource use questionnaire

  12 months

• Quality of life - EQ-5D

  12 months

Study Arms (2)

Experienced abuse

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

Interventions

Standard of care OTHER

Did not experience abuse; Experienced abuse

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women presenting to participating fracture clinics with a fracture or dislocation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8R 3H6, Canada

Location

Related Publications (2)

• 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.

  PMID: 23768757 BACKGROUND

• 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.

  PMID: 29946480 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Joint Dislocations

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Brad Petrisor, MD, MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Sheila Sprague, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

CA (1)