Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654427
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-07-09
Brief Title:
Trauma-Informed Obstetric Care Development and Implementation of a Toolkit for Obstetrics OBTIC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Trauma-Informed Obstetric Care Development and Implementation of a Stakeholder- Informed Toolkit for Obstetric Providers and Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBTIC
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 pregnantpostpartum 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 25 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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None