AzTrials
AzTrials

Fractures, BonePRAISE-2NCT02529267

Prospective Abuse and Intimate Partner Violence Surgical Evaluation

An observational study of Fractures, Bone and Dislocations, run by McMaster University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Fractures, Bone, Dislocations, Spouse Abuse
How many people
250 participants
Where
1 siteCanada
Study dates
Aug 2015to Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8R 3H6

Other trials in Canada

About this study

Official title: Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study

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.

Read the 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

Being tested
Standard of care
Keywords
Cohort Studies, intimate partner violence, orthopaedic surgery, epidemiology, outcomes in fracture care
Medical subject headings
Fractures, Bone, Joint Dislocations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of careOther

Study groups in NCT02529267
Study groupRoleWhat they receive
Experienced abuseExperienced IPV in the past 12 months
Receives: Other: Standard of care
Did not experience abuseDid not experience IPV in the past 12 months.
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Recruitment rate

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

    Measured: 12 months

  2. Feasibility - Proportion of Missed and/or out of window visits

    Proportion of missed and out of window visits

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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.

    Measured: 12 months

Secondary outcomes (8)

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

    Compare proportion of patients experiencing a composite of injury-related complications between patients who self-report a history of IPV and those who do not. Injury-related complications include non-union, malunion, infection, unplanned secondary procedure, mortality, hardware failure, etc. An independent, blinded adjudicator will determine whether the event is injury-related.

    Measured: 12 months

  2. Return to function questionnaire

    We will use the Return to Function Questionnaire (RTF) to compare the mean time to return to pre-injury function among women who disclose a history of IPV versus those who do not disclose IPV. The RTF is a 4 question tool that was used in a recently completed large FDA-regulated fracture trial.

    Measured: 12 months

  3. IPV incidence questionnaire

    Women's self-reported experience of IPV will be measured using a direct method of screening used by the PRAISE Investigators in 2 previous studies conducted in trauma populations. A participant will be considered to have disclosed IPV if she answers positively to at least 1 of the 3 direct screening questions.

    Measured: 12 months

  4. Resource use questionnaire

    Women's access to and use of health and support services will be measured by directly asking participants to self-report if they have accessed health care services, a social worker, mental health professional, women's shelter, helpline, violence against women website, or legal assistance.

    Measured: 12 months

  5. Quality of life - EQ-5D

    Participants' quality of life will be measured using the EuroQol-5 Dimensions (EQ-5D), a widely used and well-validated quality of life tool. The EQ-5D is a comprehensive, 5-item compact health status classification and health state preference questionnaire.

    Measured: 12 months

  6. IPV frequency questionnaire

    Using 3 questions from the Woman Abuse Screening Tool, which categorizes frequency of different types of violence, we will record and analyze changes in frequency of IPV experienced over time.

    Measured: 12 months

  7. Stage of change questionnaire

    Participants will complete the Domestic Violence Survivor Assessment (DVSA) Short Form questionnaire to determine her stage of change. The stages of change are based on the transtheoretical model of health behavior change applied specifically to survivors of abuse. We developed the DVSA Short Form for the purpose of this study, with the aim of making the self-administered form more accessible.

    Measured: 12 months

  8. IPV type questionnaire

    Using 3 questions from the Woman Abuse Screening Tool, which categorizes types of violence as physical, emotional, and/or sexual abuse, we will record and analyze changes in type of IPV experienced over time.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02529267
Sponsor's protocol ID
PRAISE-2
Acronym
PRAISE-2
Status last verified
Jun 2018
First submitted
7 Aug 2015
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23768757

  • 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.

    PubMed 29946480

Questions about this trial

What is this clinical trial studying?

An observational study of Fractures, Bone and Dislocations, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02529267, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in