- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02529267
Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)
Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Number of Participants:
250
Primary Research Objectives:
Feasibility
Secondary Research Objective:
The secondary objectives are to determine:
- How a history of IPV affects injury-related complications;
- How a history of IPV affects return to pre-injury function;
- Incident cases of IPV after a musculoskeletal injury, if the injury was not the result of IPV;
- How a history of IPV affects health care and support service use after a musculoskeletal injury;
- How a history of IPV affects health-related quality of life after a musculoskeletal injury;
- How patterns of IPV change over time after a musculoskeletal injury;
- How abused women's stage of change changes over time after a musculoskeletal injury
Diagnosis and Main Inclusion Criteria:
The inclusion criteria are:
- adult females (at least 16 or 18 years of age depending on local ethics requirements);
- 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.
The exclusion criteria are:
- unwilling to or unable to provide consent;
- unable to complete the study questionnaires in a private location, due to safety and confidentiality;
- 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
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Hamilton, Ontario, Canadá, L8R 3H6
- McMaster University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Experienced abuse
Experienced IPV in the past 12 months
|
|
|
Did not experience abuse
Did not experience IPV in the past 12 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility - Recruitment rate
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 12 months
|
The proportion of case report forms, including patient questionnaires, completed at 12 months.
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of patients with injury-related complications assessed by central adjudication
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brad Petrisor, MD, MSc, Hamilton Health Sciences Corporation
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRAISE-2
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