Clinical trial NCT02529267: Prospective Abuse and Intimate Partner Violence Surgical Evaluation
Official title: Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractures, Bone
Dislocations
Spouse Abuse
Keywords: Cohort Studies
intimate partner violence
orthopaedic surgery
epidemiology
outcomes in fracture care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Physicians' Services Incorporated Foundation
First posted: 2015-08-20
Enrollment: 250
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women presenting to participating fracture clinics with a fracture or dislocation.

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

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

Primary outcomes:
measure: Feasibility - Recruitment rate
timeFrame: 12 months
measure: Feasibility - Proportion of Missed and/or out of window visits
timeFrame: 12 months
measure: Feasibility - Collection of secondary outcomes (Proportion of included patients followed at 12 months for the primary and secondary outcomes)
timeFrame: 12 months
measure: Feasibility - Completion of data collection (proportion of case report forms, including patient questionnaires, completed at 12 months)
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with injury-related complications assessed by central adjudication
timeFrame: 12 months
measure: Return to function questionnaire
timeFrame: 12 months
measure: IPV incidence questionnaire
timeFrame: 12 months
measure: Resource use questionnaire
timeFrame: 12 months
measure: Quality of life - EQ-5D
timeFrame: 12 months
measure: IPV frequency questionnaire
timeFrame: 12 months
measure: Stage of change questionnaire
timeFrame: 12 months
measure: IPV type questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Brad Petrisor, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Sheila Sprague, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.