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

NCT06654427 | Not Yet Recruiting DMC

• 1 other identifier: K23HD107296-01A1
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trauma; Obstetrics Trauma; Pregnancy Related

Keywords

trauma informed care; Obstetrics

Outcome Measures

Primary Outcomes (6)

• Change in Adoption of trauma-screening protocols

  The frequency with which providers assess for past and current trauma/violence will be assessed using chart review of the initial prenatal visit.

  Change in adoption will be assessed in early implementation (2-3 months) and sustainment (6-12 months)

• Evaluation of intervention components for adaptation and scale-up implementation

  Once the OB-TIC toolkit is complete, I will work with my mentorship team to create a survey to assess the most frequently used components of the toolkit. For example, if OB-TIC includes trauma-informed birth strategies, mental health referrals, and a modified exam procedure checklist, the survey would list each of these components and ask clinicians how often each component was used, rate how useful the component was, and whether they made changes to any of the materials.

  Surveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)

• Evaluation of intervention components for adaptation and scale-up implementation

  Once the OB-TIC toolkit is complete, I will work with my mentorship team to create a survey to assess the most frequently used components of the toolkit. For example, if OB-TIC includes trauma-informed birth strategies, mental health referrals, and a modified exam procedure checklist, the survey would list each of these components and ask clinicians how often each component was used, rate how useful the component was, and whether they made changes to any of the materials.

  Surveys to evaluate specific components of the OB-TIC toolkit will be given in sustainment (6-12 months)

• Change in Acceptability of Intervention Measure

  Clinicians will rate acceptability on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .83.

  Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)

• Change in Intervention Appropriateness Measure

  Clinicians will rate appropriateness on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .87.

  Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)

• Change in Feasibility of Intervention Measure

  Clinicians will rate feasibility on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .88.

  Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)

Secondary Outcomes (11)

• Change in Patient health questionnaire (PHQ-9)

  The PHQ9 will be used to assess patient mood changes before (3 months prior) during (9 months) and 3 months after the pilot trial via chart review

• City Birth Trauma Scale

  9-12 months post-intervention

• Change in Appointment Adherence

  Chart review will be used to assess the change in ratio of attended to scheduled appointments before (3 months prior) during (for 9 months of implementation) and after (3 months following the 9 month implementation period) the pilot trial.

• Change in Elective augmentation of delivery

  3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review

• Change Breastfeeding frequency

  3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review

Study Arms (1)

Implementation of OBTIC

EXPERIMENTAL

The OB-TIC intervention toolkit will be pilot tested in outpatient obstetrics clinics. OB-TIC will be implemented for 9 months during which time I will assess providers' and patients' perceptions of acceptability, appropriateness, and feasibility of OB-TIC. Adoption of OB-TIC, attitudes towards TIC, appointment adherence and care choices, maternal-infant health outcomes, and patient mental health will be assessed before, during, and after the pilot.

Behavioral: Obstetric Trauma Informed Care Toolkit

Interventions

Obstetric Trauma Informed Care Toolkit BEHAVIORAL

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.

Also known as: OBTIC, STAR-OB

Implementation of OBTIC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.
• Practicing physicians or nurses
• ≥ 6 months of experience in obstetrics
• English speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Miriam Hospital: lead
• Women and Infants Hospital of Rhode Island: collaborator

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Laura G Ward, Ph.D.

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura G Ward, Ph.D.

CONTACT

401-793-8000; lrollins@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The OBTIC toolkit will be used in an obstetrics clinic for a 9 month period. Baseline will be evaluated 3 months pre-implementation trial and follow-up will be measured 3 months post-implementation trial.

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: October 23, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share