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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03539068
Collaborator
(none)
2,000
1
2
60
33.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WEB-ED+ Treatment Arm
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
RCT- Screening, Shared-decision making intervention with Veteran and Providers using Agency for Healthcare Research and Quality (AHRQ) modelRCT- Screening, Shared-decision making intervention with Veteran and Providers using Agency for Healthcare Research and Quality (AHRQ) model
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: WEB-ED Only Control 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 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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. VA mental health treatment engagement validated by VA electronic medical record review. [Within 1 year of Treatment Intervention]

    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

  1. Shared Decision Making Interface between VA clinician and Veteran validated by VA electronic medical record review [Within 1 year of Treatment Intervention]

    Shared decision-making template use (specific to this study) by clinician participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Iowa City VA Health Care System, Iowa City, IA Iowa City Iowa United States 52246-2208

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Anne G. Sadler, PhD RN, Iowa City VA Health Care System, Iowa City, IA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03539068
Other Study ID Numbers:
  • IIR 16-096
First Posted:
May 29, 2018
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022