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Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)

25 giugno 2018 aggiornato da: McMaster University

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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Effettivo)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8R 3H6
        • McMaster University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Experienced abuse
Experienced IPV in the past 12 months
Altro: Standard di sicurezza
Did not experience abuse
Did not experience IPV in the past 12 months.
Altro: Standard di sicurezza

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility - Recruitment rate
Lasso di tempo: 12 months
Number of patients recruited at each site during a 12 month period
12 months
Feasibility - Proportion of Missed and/or out of window visits
Lasso di tempo: 12 months
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)
Lasso di tempo: 12 months
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)
Lasso di tempo: 12 months
The proportion of case report forms, including patient questionnaires, completed at 12 months.
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients with injury-related complications assessed by central adjudication
Lasso di tempo: 12 months
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.
12 months
Return to function questionnaire
Lasso di tempo: 12 months
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.
12 months
IPV incidence questionnaire
Lasso di tempo: 12 months
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.
12 months
Resource use questionnaire
Lasso di tempo: 12 months
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.
12 months
Quality of life - EQ-5D
Lasso di tempo: 12 months
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.
12 months
IPV frequency questionnaire
Lasso di tempo: 12 months
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.
12 months
Stage of change questionnaire
Lasso di tempo: 12 months
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.
12 months
IPV type questionnaire
Lasso di tempo: 12 months
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.
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

McMaster University

Collaboratori

Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation

Investigatori

  • Investigatore principale: Brad Petrisor, MD, MSc, Hamilton Health Sciences Corporation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2015

Completamento primario (Anticipato)

1 giugno 2019

Completamento dello studio (Anticipato)

1 giugno 2019

Date di iscrizione allo studio

Primo inviato

7 agosto 2015

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2015

Primo Inserito (Stima)

20 agosto 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2018

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRAISE-2

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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