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Creating VIP Corps to Reduce Maternal Deaths

Primary Purpose

Healthy Participants

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kentucky Violent Death Reporting System
Implementation and Effectiveness of VIP Corps Training
Sponsored by
Ann Coker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Participants focused on measuring Maternal Morbidity, Maternal Mortality, VIP Corps, Pregnancy-associated injuries, Pregnancy-associated deaths

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Students enrolled in a helping professions program and in their senior year 18 years of age through 30 years of age Students whom will have direct interaction with patients or clients that may experience interpersonal violence (IPV) Exclusion Criteria: Students not enrolled in a helping professions program 4 Students under age 18 or over age 30 Students with no direct interaction with patients or clients

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maternal Injury and Death Intervention

Development of a Maternal Injury Surveillance System

Arm Description

For this RCT, our research team has created a VIP Corps online, interactive learning management system training. This VIP Corps online training will be offered to students enrolled in a helping profession and in their last program year. Students are randomized to this experimental intervention arm. This training seeks to provide helping professionals with information and resources to identify, intervene, and prevent maternal injuries from interpersonal violence, substance use/disorder (IPV and SU/D). This training will provide students with the knowledge, skills, and efficacy to intervene and build capacity for prevention of maternal injuries and death due to violence.

Proposal of a novel Maternal Injury Surveillance System (MISS) as a complement to the existing maternal mortality surveillance available within Kentucky Violent Death Reporting System (KVDRS)

Outcomes

Primary Outcome Measures

Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.
Change in knowledge of intimate partner violence (IPV) and attitudes toward those experiencing IPV by condition over time. Knowledge of pregnancy-associated causes of maternal mortality and morbidity created for this randomized controlled trial (RCT). This is a 17-item scale ranging from 0-35 with higher scores indicating greater (accurate) knowledge.
Knowledge and attitudes toward substance use among pregnant and postpartum people.
Change in knowledge of substance use and attitudes toward those using substances or having a substance use disorder by condition over time. Attitudes toward pregnant or postpartum people experiencing: a) intimate partner violence (IPV), substance use, and anxiety or depression. This measure is based on the Domestic Violence Myth Acceptance and expanded to substance use and anxiety or depression. 45 items and 3 subscales. Response options: 1-5 indicating ranging from strongly agree to strongly disagree. Lower scores are desired indicating greater acceptance and increased willingness to address intimate partner violence (IPV), substance use, and anxiety or depression among pregnant or postpartum people.
Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.
Change in knowledge of anxiety or depression and attitudes toward those with anxiety or depression by condition over time. The Violence Against Women Health Care Provider Survey expanded to providers' willingness to ask clients about: a) Intimate partner violence (IPV), b) substance use, and c) anxiety or depression. 41 items querying self-confidence and actions in asking clients about risk factors for maternal morbidity. The response options 1-5 indicate strongly agree to strongly disagree. Higher scores are desired as indicators of greater self confidence and likelihood of actions with clients.

Secondary Outcome Measures

Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.
Change in willingness, perceived efficacy, reports of asking clients about intimate partner violence (IPV) by condition and over time. New Bystander Action Survey developed for this randomized controlled trial (RCT). There are 20 items that measure the opportunity to take action with clients, friends or family members; actions taken, and perceived impact. There are 6 response options ranging from 0 times to more than 12 times (in the past 6 months). More actions and a higher score, are desired as indicators of greater actions to identify risk of maternal morbidity and provide resources to reduce this risk.

Full Information

First Posted
September 29, 2023
Last Updated
October 12, 2023
Sponsor
Ann Coker
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT06089109
Brief Title
Creating VIP Corps to Reduce Maternal Deaths
Official Title
Violence Intervention and Prevention (VIP) Corps to Reduce Maternal Injuries and Deaths Due to Violence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ann Coker
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this observational study is to create and rigorously evaluate a violence intervention and prevention corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students; and to develop a novel maternal injury surveillance system (MISS) to complement an existing maternal violent death registry in Kentucky.
Detailed Description
The participant population defined in this study are undergraduate and professional students within their last educational year in a helping professionals program at the University of Kentucky, ages 18-30. This study will permit the creation of effective programming to train the next generation of health and social service professionals prepared to help reduce Kentucky's maternal mortality and injury rates over time with implementation. Aim 1: Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students. Develop a novel maternal injury surveillance system (MISS) as a complement to an existing maternal violent deaths registry to accurately and reliably enumerate maternal injuries and deaths due to violence. Aim 2: Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening. Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence. Prospectively evaluate the effectiveness of a novel VIP training as the intervention condition relative to an attention control (SU/D and IPV awareness), to increase knowledge of the effects of intimate partner violence (IPV) on health outcomes, report intimate partner violence (IPV) screening behaviors, intimate partner violence (IPV) detection, and to reduce intimate partner violence (IPV) frequency among patients and clients over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
Maternal Morbidity, Maternal Mortality, VIP Corps, Pregnancy-associated injuries, Pregnancy-associated deaths

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maternal Injury and Death Intervention
Arm Type
Experimental
Arm Description
For this RCT, our research team has created a VIP Corps online, interactive learning management system training. This VIP Corps online training will be offered to students enrolled in a helping profession and in their last program year. Students are randomized to this experimental intervention arm. This training seeks to provide helping professionals with information and resources to identify, intervene, and prevent maternal injuries from interpersonal violence, substance use/disorder (IPV and SU/D). This training will provide students with the knowledge, skills, and efficacy to intervene and build capacity for prevention of maternal injuries and death due to violence.
Arm Title
Development of a Maternal Injury Surveillance System
Arm Type
Active Comparator
Arm Description
Proposal of a novel Maternal Injury Surveillance System (MISS) as a complement to the existing maternal mortality surveillance available within Kentucky Violent Death Reporting System (KVDRS)
Intervention Type
Behavioral
Intervention Name(s)
Kentucky Violent Death Reporting System
Intervention Description
The Kentucky Violent Death Reporting System (KYVDRS) addresses the need for accurate surveillance and data analysis by combining data from death certificates, coroner/medical examiner reports, police reports, crime laboratory reports, toxicology reports, and child fatality review team reports.
Intervention Type
Behavioral
Intervention Name(s)
Implementation and Effectiveness of VIP Corps Training
Intervention Description
Implement and evaluate the effectiveness of VIP Corps training aimed at students enrolled in helping professions in their last program year. intervention efficacy to change in students' knowledge, attitudes, and practices of intimate partner violence (IPV) screening, detection, and referrals; participant practices will be the primary, longer-term outcome; while changes in knowledge and attitudes will be short-term outcomes. Secondary outcomes will include changes in detecting symptoms of a) SU/D and b) depression and/or anxiety and providing appropriate resources.
Primary Outcome Measure Information:
Title
Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.
Description
Change in knowledge of intimate partner violence (IPV) and attitudes toward those experiencing IPV by condition over time. Knowledge of pregnancy-associated causes of maternal mortality and morbidity created for this randomized controlled trial (RCT). This is a 17-item scale ranging from 0-35 with higher scores indicating greater (accurate) knowledge.
Time Frame
Year 2 - Year 4
Title
Knowledge and attitudes toward substance use among pregnant and postpartum people.
Description
Change in knowledge of substance use and attitudes toward those using substances or having a substance use disorder by condition over time. Attitudes toward pregnant or postpartum people experiencing: a) intimate partner violence (IPV), substance use, and anxiety or depression. This measure is based on the Domestic Violence Myth Acceptance and expanded to substance use and anxiety or depression. 45 items and 3 subscales. Response options: 1-5 indicating ranging from strongly agree to strongly disagree. Lower scores are desired indicating greater acceptance and increased willingness to address intimate partner violence (IPV), substance use, and anxiety or depression among pregnant or postpartum people.
Time Frame
Year 2 - Year 4
Title
Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.
Description
Change in knowledge of anxiety or depression and attitudes toward those with anxiety or depression by condition over time. The Violence Against Women Health Care Provider Survey expanded to providers' willingness to ask clients about: a) Intimate partner violence (IPV), b) substance use, and c) anxiety or depression. 41 items querying self-confidence and actions in asking clients about risk factors for maternal morbidity. The response options 1-5 indicate strongly agree to strongly disagree. Higher scores are desired as indicators of greater self confidence and likelihood of actions with clients.
Time Frame
Year 2 - Year 4
Secondary Outcome Measure Information:
Title
Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.
Description
Change in willingness, perceived efficacy, reports of asking clients about intimate partner violence (IPV) by condition and over time. New Bystander Action Survey developed for this randomized controlled trial (RCT). There are 20 items that measure the opportunity to take action with clients, friends or family members; actions taken, and perceived impact. There are 6 response options ranging from 0 times to more than 12 times (in the past 6 months). More actions and a higher score, are desired as indicators of greater actions to identify risk of maternal morbidity and provide resources to reduce this risk.
Time Frame
Year 3 - Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Students enrolled in a helping professions program and in their senior year 18 years of age through 30 years of age Students whom will have direct interaction with patients or clients that may experience interpersonal violence (IPV) Exclusion Criteria: Students not enrolled in a helping professions program 4 Students under age 18 or over age 30 Students with no direct interaction with patients or clients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann L Coker, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11064228
Citation
Maiuro RD, Vitaliano PP, Sugg NK, Thompson DC, Rivara FP, Thompson RS. Development of a health care provider survey for domestic violence: psychometric properties. Am J Prev Med. 2000 Nov;19(4):245-52. doi: 10.1016/s0749-3797(00)00230-0.
Results Reference
background
Citation
Peters, J. (2008). Measuring Myths about Domestic Violence: Development and Initial Validation of the Domestic Violence Myth Acceptance Scale. Journal of Aggression, Maltreatment & Trauma, 16(1), 1-21. https://doi.org/10.1080/10926770801917780
Results Reference
background
Links:
URL
https://medicine.uky.edu/departments/obgyn/vip-corps
Description
Official University of Kentucky website pertinent to this study

Learn more about this trial

Creating VIP Corps to Reduce Maternal Deaths

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