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NCT06654427

Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)

Sponsor: The Miriam Hospital

View on ClinicalTrials.gov

Summary

Many pregnant women have experienced trauma, which can make perinatal care stressful and increase the risk of pregnancy-related health conditions. However, obstetric providers can modify procedures to reduce distress and enhance patients' sense of control and safety. Although obstetric providers frequently care for trauma survivors, most are not trained in trauma-informed care (TIC). Additionally, there are no data on feasibility, appropriateness, or acceptability of TIC tools and interventions in the context of obstetrics. The goal of this project is to develop the first, stakeholder-informed obstetric TIC toolkit composed of treatment protocols, clinician training, trauma and violence screening tools, and other resources to help obstetric providers apply TIC practices to all clinical interactions in addition to identifying and providing support for trauma survivors. The obstetric TIC intervention toolkit (OB-TIC) will be developed in collaboration with key stakeholders (pregnant and postpartum patients, nurses, physicians, and administrators) to ensure that it is feasible, acceptable, appropriate, cost-effective, and clinically useful. Current practices and preferences will be characterized in qualitative interviews with stakeholders which will inform the development of OB-TIC in collaboration with a community working group of stakeholders. A pilot implementation trial of OB-TIC will be conducted in two outpatient obstetrics clinics to gather real-world data that will inform the final intervention toolkit, which will be tested on a larger scale in future studies.

Official title: Trauma-Informed Obstetric Care: Development and Implementation of a Stakeholder- Informed Toolkit for Obstetric Providers and Patients

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2025-01-02

Completion Date

2026-06-30

Last Updated

2024-10-23

Healthy Volunteers

Yes

Conditions

Trauma Obstetrics Trauma Pregnancy Related

Interventions

BEHAVIORAL

Obstetric Trauma Informed Care Toolkit

The OB-TIC toolkit will include provider and staff training on trauma- informed care and information on trauma-related perinatal concerns; trauma assessment tools; trauma-informed procedure modifications; clinical language guides; patient-facing resources including birth strategies, referral resources, and education; and clinical language. The OB-TIC intervention will utilize the toolkit to integrate trauma-informed care into clinical practice. Implementation strategies will be assessed to determine the most effective method for integrating OB-TIC content into practice.

Inclusion criteria for pregnant and postpartum patients for individual interviews: * ≥ 18 years old * under the care of an obstetrician or nurse practitioner in the U.S., * English-speaking * have had ≥2 prenatal care encounters, and postpartum if they delivered a surviving infant within the past 12 months * received care at either of the pilot sites during the pilot trial. * Pregnant and postpartum participants will be eligible for the trauma-exposed group if they * report a history of trauma in childhood or adulthood, * are ≥1 year from the time of the traumatic experience * are not currently at-risk for harm from self or others * are willing to discuss experiences related to trauma and are able to do so without experiencing undue distress. * Patient participants will be eligible for the non-trauma group if they deny trauma. * Patients' stratification as White or Women of Color (any racial identity other than non-Hispanic White) will be determined by self-identification in the demographics questionnaire, rather than pre-defined groups, in order to most accurately capture participants' lived experiences. Inclusion criteria for provider participants: * Practicing physicians or nurses * ≥ 6 months of experience in obstetrics * English speaking * Clinician Participants (providers in the participating clinics) will be enrolled in the pilot trial of the obstetric trauma-informed care toolkit intervention. * Clinician participants will be enrolled for group or individual interviews if they consent to do so and meet above criteria. Exclusion Criteria: Patient participants will be excluded from the study interviews if they report * a current unsafe environment (determined by the Assessment of Immediate Safety) * report suicidal ideation (as determined by the PHQ9) * report difficulty discussing experiences related to trauma. Provider participants will be excluded from the study if they do not work at one of the pilot clinics. Provider participants will be excluded from the study interviews if they do not consent to be interviewed.