Prospective Abuse and Intimate Partner Violence Surgical Evaluation

NCT ID: NCT02529267

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-06-30

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

Conditions

Fractures, Bone; Dislocations; Spouse Abuse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experienced abuse

Experienced IPV in the past 12 months

Standard of care

Intervention Type: OTHER

Did not experience abuse

Did not experience IPV in the past 12 months.

Standard of care

Intervention Type: OTHER

Interventions

Standard of care

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brad Petrisor, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Sheila Sprague, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 23768757 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29946480 (View on PubMed)

Other Identifiers

PRAISE-2

Identifier Type: -

Identifier Source: org_study_id