Creating VIP Corps to Reduce Maternal Deaths

Violence Intervention and Prevention (VIP) Corps to Reduce Maternal Injuries and Deaths Due to Violence

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Participants
• Intervention / Treatment: Behavioral: Implementation and Effectiveness of VIP Corps Training; Behavioral: Kentucky Violent Death Reporting System

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:

1. Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
2. 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:

1. Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
2. Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 2800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal Injury and Death Intervention; 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.	Behavioral: Implementation and Effectiveness of VIP Corps Training; 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.
Active Comparator: Development of a Maternal Injury Surveillance System; 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)	Behavioral: Kentucky Violent Death Reporting System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Year 2 - Year 4
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.	Year 2 - Year 4
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.	Year 2 - Year 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Year 3 - Year 5

Collaborators and Investigators

• Sponsor: Ann Coker
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Ann L Coker, PhD, University of Kentucky

Publications and helpful links

General Publications

• 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.
• 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

Helpful Links

• Official University of Kentucky website pertinent to this study

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Maternal Mortality; Maternal Morbidity; VIP Corps; Pregnancy-associated injuries; Pregnancy-associated deaths
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 77241; 5 ASTWH210102-02-00 (Other Grant/Funding Number: Department of Health and Human Services)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No