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Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care (eSDM)

Primary Purpose

PTSD, Depression, Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WEB-ED+ Treatment Arm
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PTSD focused on measuring Veteran, Mental Health, War, Shared decision-making, Access to care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans returning from deployment to Iraq or Afghanistan within the prior 5 years who are residing in identified study states.

Exclusion Criteria:

  • Disabilities that would adversely impact ability to independently complete online screening or not allow to talk on telephone.

Sites / Locations

  • Iowa City VA Health Care System, Iowa City, IA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

WEB-ED Only Control Arm

WEB-ED+ Treatment Arm

Arm Description

Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the no intervention control group will receive no further intervention but asked to participate in a subsequent study phase that addresses VA and post-deployment care access

Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the WEB-ED+ Group. WEB-ED+ augments Current WEB-ED in a next step online interface via Pharos. If successful, this enhancement could be integrated into the next iteration of WEB-ED. Enhancements include: An eHealth interface tailored to Veterans' VA and MHV enrollment needs, links for an electronic interface with VA enrollment, MHV and MHV premium status enrollment, and secure messaging guidance. Shared decision making (SDM) interface: Veteran SDM-related educational (e.g., existing YouTube videos) and structured questions about treatment concerns, preferences, and questions and can be accessed through postal and email distribution or Pharos portal. Access to a health coach (the research coordinators) will be available through a toll-free number to assist both Veterans and providers/Transition Patient Advocates.

Outcomes

Primary Outcome Measures

VA mental health treatment engagement validated by VA electronic medical record review.
VA mental health care appointment(s) in any VA clinic with a VA mental health care provider embedded in primary care or within mental health clinics: Both new and follow up

Secondary Outcome Measures

Shared Decision Making Interface between VA clinician and Veteran validated by VA electronic medical record review
Shared decision-making template use (specific to this study) by clinician participants.

Full Information

First Posted
May 10, 2018
Last Updated
June 2, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03539068
Brief Title
Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care
Acronym
eSDM
Official Title
Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
OEF/OIF/OND war Veterans have unique post-deployment care needs that the VA is striving to understand and address. Unfortunately, there is a significant disparity in utilization of mental health (MH) care and VA access as most war Veterans don't seek needed care. New interventions are urgently needed to address disparities in post-deployment MH treatment engagement for war Veterans and to support VA's efforts to provide them with optimal access and care. Online health interventions have been shown to be preferred by OEF/OIF combat Veterans and have the potential to promote access to VA MH care. The investigators' research team has developed a web-based interface (WEB-ED) evolved by feedback from Veterans that screens for common post-deployment MH and readjustment concerns, provides tailored education about positive screens, and facilitates linkage to VA resources. Data from the investigators' prior studies demonstrate WEB-ED can be successfully implemented within VA and activate Veterans to seek needed care. Furthermore, emerging evidence indicates that when patients are educated about their health conditions and treatment alternatives using shared decision-making (SDM), increased treatment participation and adherence, and better health outcomes result. Next steps include: linking Veteran WEB-ED screening results to a VA secure network so that a provider can access the results; and integrating a SDM interface to promote Veteran-Provider partnerships in patient-centered care. This study will improve the investigators' understanding of the most effective methods to reduce barriers to enrollment in VA/MHV and transferring important medical information using My HealtheVet (MHV). Furthermore, it will provide important information regarding how WEB-ED results can enhance the capability of VA providers and transition patient advocates to use Veterans' screening results to triage and engage Veterans in patient-centered MH care and promote VA provider adoption of WEB-ED+ to facilitate patient engagement. Online screening, tailored education, and links to geographically accessible VA resources has been shown to be preferred by Veterans, providing recognition of treatable post-deployment MH concerns, and education that reduces stigma. This study builds upon and augments this prior work with research to understand and evaluate the processes needed to integrate WEB-ED+ into current VHA systems to support efficient care delivery, facilitate patient-centered care, and address unmet need for MH care while also resolving disparities in VA and VA MH care access and engagement for war Veterans. WEB-ED+'s use of shared decision making is a key component for promoting these benefits. WEB-ED+ represents a readily implementable and cost-effective intervention that, with partner collaboration, can be integrated into VA systems through MHV. Findings have important policy implications for several operational partners heavily invested in the improved access and delivery of evidence-based mental health care for war Veterans.
Detailed Description
OEF/OIF/OND war Veterans have unique post-deployment care needs that the VA is striving to understand and address. Unfortunately, there is a significant disparity in utilization of mental health (MH) care and VA access as most war Veterans don't seek needed care. New interventions are urgently needed to address disparities in post-deployment MH treatment engagement for war Veterans and to support VA's efforts to provide them with optimal access and care. Online health interventions have been shown to be preferred by OEF/OIF combat Veterans and have the potential to promote access to VA MH care. The investigators' research team has developed a web-based interface (WEB-ED) evolved by feedback from Veterans that screens for common post-deployment MH and readjustment concerns, provides tailored education about positive screens, and facilitates linkage to VA resources. Data from the investigators' prior studies demonstrate WEB-ED can be successfully implemented within VA and activate Veterans to seek needed care. Furthermore, emerging evidence indicates that when patients are educated about their health conditions and treatment alternatives using shared decision-making (SDM), increased treatment participation and adherence, and better health outcomes result. Next steps include: linking Veteran WEB-ED screening results to a VA secure network so that a provider can access the results; and integrating a SDM interface to promote Veteran-Provider partnerships in patient-centered care. The investigators propose a three phase study to address the investigators' aims. Aim 1 (phase 1) the investigators will gather qualitative information from key VA and Veteran informants to create an enhanced version (WEB-ED+) of the investigators' Current WEB-ED that includes an eHealth and SDM interface. Aim 2 (phase 2) will use a randomized controlled trial (RCT) to test WEB-ED+ vs. Current WEB-ED in promoting VA MH care engagement. Aim 3 (phase 3) the investigators will employ a process evaluation to determine the feasibility and acceptability of WEB-ED+ for both Veterans and VA practitioner and to document the VA processes Veterans use to enroll and engage in VA MH care. This study will improve the investigators' understanding of the most effective methods to reduce barriers to enrollment in VA/MHV and transferring important medical information using My HealtheVet (MHV). Furthermore, it will provide important information regarding how WEB-ED results can enhance the capability of VA providers and transition patient advocates to use Veterans' screening results to triage and engage Veterans in patient-centered MH care and promote VA provider adoption of WEB-ED+ to facilitate patient engagement. Online screening, tailored education, and links to geographically accessible VA resources has been shown to be preferred by Veterans, providing recognition of treatable post-deployment MH concerns, and education that reduces stigma. This study builds upon and augments this prior work with research to understand and evaluate the processes needed to integrate WEB-ED+ into current VHA systems to support efficient care delivery, facilitate patient-centered care, and address unmet need for MH care while also resolving disparities in VA and VA MH care access and engagement for war Veterans. WEB-ED+'s use of shared decision making is a key component for promoting these benefits. WEB-ED+ represents a readily implementable and cost-effective intervention that, with partner collaboration, can be integrated into VA systems through MHV. Findings have important policy implications for several operational partners heavily invested in the improved access and delivery of evidence-based mental health care for war Veterans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Substance Use Disorder, Traumatic Brain Injury
Keywords
Veteran, Mental Health, War, Shared decision-making, Access to care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
RCT- Screening, Shared-decision making intervention with Veteran and Providers using Agency for Healthcare Research and Quality (AHRQ) model
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WEB-ED Only Control Arm
Arm Type
No Intervention
Arm Description
Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the no intervention control group will receive no further intervention but asked to participate in a subsequent study phase that addresses VA and post-deployment care access
Arm Title
WEB-ED+ Treatment Arm
Arm Type
Experimental
Arm Description
Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the WEB-ED+ Group. WEB-ED+ augments Current WEB-ED in a next step online interface via Pharos. If successful, this enhancement could be integrated into the next iteration of WEB-ED. Enhancements include: An eHealth interface tailored to Veterans' VA and MHV enrollment needs, links for an electronic interface with VA enrollment, MHV and MHV premium status enrollment, and secure messaging guidance. Shared decision making (SDM) interface: Veteran SDM-related educational (e.g., existing YouTube videos) and structured questions about treatment concerns, preferences, and questions and can be accessed through postal and email distribution or Pharos portal. Access to a health coach (the research coordinators) will be available through a toll-free number to assist both Veterans and providers/Transition Patient Advocates.
Intervention Type
Behavioral
Intervention Name(s)
WEB-ED+ Treatment Arm
Intervention Description
Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the WEB-ED+ Group. WEB-ED+ augments Current WEB-ED in a next step online interface via Pharos. If successful, this enhancement could be integrated into the next iteration of WEB-ED. Enhancements include: An eHealth interface tailored to Veterans' VA and MHV enrollment needs, links for an electronic interface with VA enrollment, MHV and MHV premium status enrollment, and secure messaging guidance. Shared decision making (SDM) interface: Veteran SDM-related educational (e.g., existing YouTube videos) and structured questions about treatment concerns, preferences, and questions and can be accessed through postal and email distribution or Pharos portal. Access to a health coach (the research coordinators) will be available through a toll-free number to assist both Veterans and providers/Transition Patient Advocates.
Primary Outcome Measure Information:
Title
VA mental health treatment engagement validated by VA electronic medical record review.
Description
VA mental health care appointment(s) in any VA clinic with a VA mental health care provider embedded in primary care or within mental health clinics: Both new and follow up
Time Frame
Within 1 year of Treatment Intervention
Secondary Outcome Measure Information:
Title
Shared Decision Making Interface between VA clinician and Veteran validated by VA electronic medical record review
Description
Shared decision-making template use (specific to this study) by clinician participants.
Time Frame
Within 1 year of Treatment Intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans returning from deployment to Iraq or Afghanistan within the prior 5 years who are residing in identified study states. Exclusion Criteria: Disabilities that would adversely impact ability to independently complete online screening or not allow to talk on telephone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne G. Sadler, PhD RN
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2292
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care

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