Clinical trial NCT06654427: Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)
Official title: Trauma-Informed Obstetric Care: Development and Implementation of a Stakeholder- Informed Toolkit for Obstetric Providers and Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Obstetrics Trauma
Pregnancy Related
Keywords: trauma informed care
Obstetrics
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2024-10-23
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The goal of this study is to develop a stakeholder-informed toolkit for obstetric providers and patients to support the implementation of trauma-informed care (TIC) in routine clinical practice. Following interviews with providers and pregnant/postpartum participants as well as convening with a community working group of stakeholders, an OBTIC toolkit blueprint will be drafted for testing.

In the pilot implementation phase, all clinicians and administrators at an outpatient obstetrics clinic will participate in the OB-TIC intervention. However, only providers who consent to participate in surveys and interviews will be contacted by the PI to complete surveys (assessment of attitudes related to TIC and usefulness of toolkit components) at the mid-point (month 2) and after completion of the pilot (month 4). Clinicians will also be interviewed as a group (physicians and nurses separately) following a staff meeting; interviews will assess perceived acceptability, feasibility, appropriateness and helpfulness of the toolkit. Additionally, 12-20 postpartum participants, who were treated at the clinic during the pilot, will be recruited for brief semi-structured qualitative interviews and surveys following the completion of the pilot (see detail in 2.5). In order to assess adoption of the trauma screening component of the TIC toolkit, I will conduct chart review of initial prenatal visits at baseline (3 months prior) during (9 months of the pilot trial) and after completion (3 months following completion) of the pilot trial to assess rates of screening. To assess exploratory efficacy outcomes, I will use chart review to collect data on 1) Perinatal care: care engagement (appointment adherence, attendance of postpartum follow-up), and care choices (elective augmentation of delivery); 2) Maternal-infant outcomes: breastfeeding (initiation and continuation), infant birthweight, and post-partum pain; 3) Perinatal mental health: depression (EPDS or PHQ-9), and anxiety (GAD-7). In the sample of patients who elect to participate in IDIs, I will also assess prior trauma exposure (ACE and BTQ), PTSD symptoms (PCL-5 and City Birth Trauma Scale) and experiences of discrimination and safety in care (Personal Discrimination Multi-Item Measure).

Sample sizes for the qualitative components of the study were determined in order to achieve adequate distribution to stratify by key study variables (trauma exposure, race, pregnancy status, provider type). For the pilot implementation trial, the aim of the quantitative aims is to generate data needed to evaluate the feasibility and acceptability of the designed intervention, and to generate estimates of key parameters (variance of outcome measures) to approach power and sample size estimation for an efficacy study.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Adoption of trauma-screening protocols
timeFrame: Change in adoption will be assessed in early implementation (2-3 months) and sustainment (6-12 months)
measure: Evaluation of intervention components for adaptation and scale-up implementation
timeFrame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)
measure: Evaluation of intervention components for adaptation and scale-up implementation
timeFrame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in sustainment (6-12 months)
measure: Change in Acceptability of Intervention Measure
timeFrame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
measure: Change in Intervention Appropriateness Measure
timeFrame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
measure: Change in Feasibility of Intervention Measure
timeFrame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
Secondary outcomes:
measure: Change in Patient health questionnaire (PHQ-9)
timeFrame: 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
measure: City Birth Trauma Scale
timeFrame: 9-12 months post-intervention
measure: Change in Appointment Adherence
timeFrame: 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.
measure: Change in Elective augmentation of delivery
timeFrame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
measure: Change Breastfeeding frequency
timeFrame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
measure: Change in average infant birth-weight
timeFrame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
measure: Change in Post-partum pain ratings
timeFrame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
measure: Change in Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
measure: Posttraumatic stress disorder checklist for DSM-5 (PCL-5)
timeFrame: After completion of the pilot trial (9-12 months after the start of implementation), a subset of patients will be recruited for interviews and completion of surveys
measure: Personal Discrimination Multi- item Measure
timeFrame: After completion of the pilot trial, (9-12 months after the start of implementation) a subset of patients will be recruited for interviews and completion of surveys
measure: Brief Trauma Questionnaire (BTQ)
timeFrame: After completion of the pilot trial, (9-12 months after the start of implementation) a subset of patients will be recruited for interviews and completion of surveys
Other outcomes:
Locations:
Study officials:
affiliation: The Miriam Hospital
name: Laura G Ward, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: