- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07818096
Assessment of Healthcare Professionals' Preparedness to Screen for and Manage Women Experiencing Intimate Partner Violence During the Perinatal Period (PREMIS-PERINAT)
AP-HP has recently opened five hospital-based care units dedicated to supporting women who are victims of violence. Referrals of women to these units rely mainly on healthcare professionals. Despite the recommendations of the French National Authority for Health (HAS), screening for Intimate Partner Violence (IPV) is not systematically performed.
Moreover, although women tend to disclose experiences of violence preferentially to healthcare professionals, these professionals report feeling insufficiently trained to address this issue.
In France, only one national survey assessing knowledge and screening capacities regarding domestic violence has been conducted, and it was limited to midwives. No study has evaluated screening practices and the ability to manage women experiencing IPV.
One questionnaire is available: the PREMIS questionnaire (Physician Readiness to Manage Intimate Partner Violence Survey). This self-administered questionnaire includes 67 items and was developed and validated in a population of healthcare professionals in the United States. It demonstrated good internal consistency, with a Cronbach's alpha coefficient greater than 0.65 for all validated subscales. Its external validity was also tested by comparing questionnaire responses with a field-based observational survey of professional practices, showing good correlation. Stability of responses over time (12 months) was also demonstrated. The questionnaire is able to discriminate between respondents who have received training and those who have not, with a positive correlation between knowledge acquired through experience and the number of hours of personal training. To our knowledge, it is the only validated tool to assess healthcare professionals' preparedness to screen for and manage intimate partner violence. Its French transcultural adaptation was scientifically validated in 2021.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Intimate partner violence (IPV) is defined by the World Health Organization (WHO) as "any behavior within an intimate relationship (current or former partner) that causes physical, sexual, or psychological harm, including physical aggression, sexual coercion, psychological abuse, and controlling behaviors". IPV is common and can take multiple forms.
The frequency and consequences of IPV make it a major public health issue. Globally, it is estimated that one in three women who have been in an intimate relationship experiences or has experienced IPV. In France, in 2021, 1% of women reported having suffered physical and sexual violence, and 4.2% reported psychological violence by an intimate partner. IPV is often repetitive and occurs within relationships where multiple forms of violence coexist, including physical, psychological, and verbal abuse, as well as coercive acts restricting social, educational, health, employment, or financial access. The WHO estimates that women experiencing IPV lose between 1 and 4 years of life expectancy. Physical consequences range from trauma directly caused by violence to increased prevalence of cardiovascular disease, diabetes, musculoskeletal disorders, and mental health conditions. In France in 2023, 93 women were killed by their partner, 18 children died in the same context, and 773 women either committed or attempted suicide following harassment by a current or former partner. The economic cost of domestic violence in France is estimated in the billions of euros per year.
The perinatal period is particularly high-risk for IPV. Pregnancy has been described as a period of increased vulnerability to IPV. Beyond direct physical harm, IPV during pregnancy is associated with adverse pregnancy outcomes, including preterm birth. IPV in pregnancy is frequently associated with other severe and repeated forms of violence and represents a known risk factor for lethality. Children are also affected: exposure to IPV in the household is an aggravating factor, and minors who witness domestic violence are legally recognized as co-victims. IPV during pregnancy is also a risk factor for child physical abuse. In France, victims preferentially disclose experiences of violence to healthcare professionals, and screening by a healthcare professional significantly increases disclosure. Most women consider routine screening by their primary healthcare provider to be beneficial.
International and national initiatives have increasingly emphasized prevention and support for women experiencing violence. Over the past 20 years, there has been growing advocacy for legal, health, and social mobilization against discrimination and violence against women, including:
The UN Convention on the Elimination of All Forms of Discrimination Against Women
The European Parliament Resolution on the elimination of violence against women (2009/2010)
The Council of Europe Convention on preventing and combating violence against women and domestic violence The 2019 French "Grenelle" initiative on domestic violence
Healthcare professionals in France have also increasingly been mobilized over the past decade. Key measures in hospital settings include:
Designation of violence referral officers in emergency departments (2015)
The 2017 IGAS report proposing a model for hospital-based care for women experiencing violence
Measures from the 2019 Grenelle initiative, including agreements for filing complaints within hospitals, collection of forensic evidence without prior complaints, and the development of dedicated care units.
In this context, AP-HP recently opened five hospital units dedicated to supporting women experiencing violence, with referrals largely dependent on healthcare professionals. The French National Authority for Health (HAS) recommends systematic screening for IPV, particularly during pregnancy. However, no studies have evaluated perinatal healthcare professionals' screening practices or preparedness to manage women experiencing IPV using a validated questionnaire. A single national survey conducted among midwives in 2014 reported that only 19% screened systematically for IPV.
While evidence on the benefit of universal screening is limited, a 2015 Cochrane meta-analysis found that routine screening by healthcare professionals is safe and increases disclosure during the perinatal period. International scientific societies also recommend systematic screening. Studies highlight the importance of recognizing women with indicators of potential IPV exposure and of being aware of referral networks for appropriate care.
The PREMIS questionnaire (Physician Readiness to Manage Intimate Partner Violence Survey) is the only scientifically validated tool internationally to assess healthcare professionals' preparedness to identify and manage IPV. Its French translation has recently been validated. This study will use PREMIS to evaluate perinatal healthcare professionals' practices and readiness to care for women experiencing IPV at AP-HP
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Candie GRANGE
- Numer telefonu: +33 01.42.34.87.35
- E-mail: candie.grange@aphp.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Lynda OUSSALAH
- Numer telefonu: +33 01 71 76 08 41
- E-mail: lynda.oussalah@aphp.fr
Lokalizacje studiów
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Île-de-France Region
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Paris, Île-de-France Region, Francja, 75004
- Maison des femmes - Hôtel Dieu
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Licensed perinatal healthcare professionals, including midwives, physicians and residents in obstetrics/gynecology, pediatrics, general practice, psychiatry, psychologists, nurses, and pediatric nurses.
- Currently working in a maternity unit at AP-HP.
- Actively involved in clinical care.
- Willing to participate in the online questionnaire.
Exclusion Criteria:
- None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Healthcare professionals
Healthcare professionals involved in perinatal care at AP-HP, including midwives, obstetricians, nurses, and other staff who may screen for and manage women experiencing intimate partner violence.
Participants complete the PREMIS questionnaire to assess their readiness to identify and respond to IPV during the perinatal period.
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Participants, consisting of perinatal healthcare professionals (midwives, obstetricians, nurses, and related staff) at AP-HP, will complete the PREMIS (Physician Readiness to Manage Intimate Partner Violence Survey) self-administered questionnaire.
The questionnaire evaluates their preparedness to screen for, identify, and manage women experiencing intimate partner violence during the perinatal period.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Conducting routine screening by healthcare professionals.
Ramy czasowe: Day 1
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Based on the responses to the questionnaires, determine the number of healthcare professionals at the APHP who screen pregnant women for domestic violence and the potential impact on this practice of having a specialized care unit for women who are victims of domestic violence.
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Day 1
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Ability of Healthcare Professionals to provide care to women who Are victims of domestic violence during the perinatal period
Ramy czasowe: Day 1
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Questionnaires on professional, social, and demographic characteristics, as well as resources related to the systematic screening for domestic violence by healthcare professionals during the perinatal period
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Day 1
|
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Analysis of Healthcare Professionals' Capacity to Care for Women Who Are Victims of Domestic Violence During the Perinatal Period
Ramy czasowe: Day 1
|
Questionnaires on the determinants of routine screening for domestic violence by perinatal health care professionals
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Day 1
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Identification of professional practices that could be improved through targeted training.
Ramy czasowe: Day 1
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Questionnaires to identify the training needs of healthcare professionals working in the perinatal Period
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Day 1
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Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- APHP250841
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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