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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03539068
Other study ID # IIR 16-096
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date May 31, 2023

Study information

Verified date June 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1586
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Behavioral:
WEB-ED+ Treatment Arm
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.

Locations

Country Name City State
United States Iowa City VA Health Care System, Iowa City, IA Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Within 1 year of Treatment Intervention
Secondary 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. Within 1 year of Treatment Intervention
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