CClinicalTrials.gg
CompletedNCT03539068eSDMUpdated Aug 1, 2024Results posted

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

An interventional study of WEB-ED+ Treatment Arm in PTSD, Depression and Substance Use Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,312
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • PTSD
  • Depression
  • Substance Use Disorder
  • Traumatic Brain Injury

Keywords

  • Veteran
  • Mental Health
  • War
  • Shared decision-making
  • Access to care
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 1,312 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Disabilities that would adversely impact ability to independently complete online screening or not allow to talk on telephone.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,312 participants (actual)

Study arms

  • 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 RCT-eligible. RCT-consenters randomly assigned to the WEB-ED+ Treatment are will receive: * eHealth interfaces tailored to Veterans' VA and MHV enrollment needs (links for electronic VA enrollment, MHV and MHV premium status enrollment). * Shared decision making (SDM) interfaces: Patient Decision aids (PTSD, depression, alcohol abuse); SDM educational video; videos). * Access to study staff available through a toll-free number to assist both Veterans and providers, including addressing questions, problem-solving about or assisting with stuck points (e.g. getting screening results to the provider).

    Behavioral: WEB-ED+ Treatment Arm

Interventions

  • BehavioralWEB-ED+ Treatment Arm

    Veterans who screen positive on one or more mental health screens in WEB-ED will be RCT-eligible. RCT-consenters randomly assigned to the WEB-ED+ Treatment are will receive:: * eHealth interfaces tailored to Veterans' VA and MHV enrollment needs (links for electronic VA enrollment, MHV and MHV premium status enrollment). * Shared decision making (SDM) interfaces: Patient Decision aids (PTSD, depression, alcohol abuse); SDM educational video; videos). * Access to study staff available through a toll-free number to assist both Veterans and providers, including addressing questions, problem-solving about or assisting with stuck points (e.g. getting screening results to the provider).

06

What researchers measure

Primary outcomes

  1. VA Mental Health Treatment Engagement Validated by Self Report or 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

    Time frame: Within 1 year of Treatment Intervention

Secondary outcomes

  1. 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 validated by VA electronic medical record review.

    Time frame: Within 1 year of Treatment Intervention

07

Results

Posted Aug 1, 2024

Participant flow

1312 completed WEB-ED, 1234 had positive screens, 996 were excluded for a number of reasons, 316 were consented and randomized.

Participant flow — Overall Study
MilestoneWEB-ED+ Treatment ArmWEB-ED Only Control Arm
Started214102
Completed199102
Not completed150

Outcome measures

PrimaryVA Mental Health Treatment Engagement Validated by Self Report or 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

Time frame:
Within 1 year of Treatment Intervention
Reported as:
Count of participants · Participants
VA Mental Health Treatment Engagement Validated by Self Report or VA Electronic Medical Record Review.
ParticipantsWEB-ED+ Treatment ArmWEB-ED Only Control Arm
VA Mental Health Treatment Engagement Validated by Self Report or VA Electronic Medical Record Review.987
Statistical analysis
  • WEB-ED+ Treatment Arm · Chi-squared · p = <0.00001
SecondaryShared 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 validated by VA electronic medical record review.

Time frame:
Within 1 year of Treatment Intervention
Reported as:
Count of participants · Participants
Shared Decision Making Interface Between VA Clinician and Veteran Validated by VA Electronic Medical Record Review
ParticipantsWEB-ED+ Treatment ArmWEB-ED Only Control Arm
Shared Decision Making Interface Between VA Clinician and Veteran Validated by VA Electronic Medical Record Review894

Adverse events

Collected over Adverse events were collected from the time of study entry until the end of study participation, at WEB-ED completion for baseline, at RCT inclusion, and at final interview (an average of 8 months). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
WEB-ED+ Treatment Arm0/214 (0%)0/214 (0%)0/214 (0%)
WEB-ED Only Control Arm0/102 (0%)0/102 (0%)0/102 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)WEB-ED+ Treatment ArmWEB-ED Only Control ArmTotal
Mean43.99 ± 10.0445.56 ± 11.3344.49 ± 10.48
Sex: Female, Male
Sex: Female, Male(Participants)WEB-ED+ Treatment ArmWEB-ED Only Control ArmTotal
Female10156157
Male11346159
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)WEB-ED+ Treatment ArmWEB-ED Only Control ArmTotal
Race/Ethnicity — White14366209
Race/Ethnicity — African American201434
Race/Ethnicity — Hispanic20323
Race/Ethnicity — Other7613
Race/Ethnicity — Multirace211132
08

Study locations

1 site
  • Iowa City VA Health Care System, Iowa City, IA
    Iowa City, Iowa 52246-2292, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 16, 2022
  • Informed consent form · Dec 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03539068
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
May 29, 2018
Start date
Jun 1, 2018
Primary completion
May 31, 2023
Completion
May 31, 2023
Results posted
Aug 1, 2024
Last update
Aug 1, 2024

Study contacts

Anne G. Sadler, PhD RN
principal investigator · Iowa City VA Health Care System, Iowa City, IA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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