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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03539068
Acronym
eSDM
Enrollment
1312
Registered
2018-05-29
Start date
2018-06-01
Completion date
2023-05-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, PTSD, Substance Use Disorder, Traumatic Brain Injury

Keywords

Veteran, Mental Health, War, Shared decision-making, Access to care

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.

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).

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

RCT- Screening, Shared-decision making intervention with Veteran and Providers using Agency for Healthcare Research and Quality (AHRQ) model

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
VA Mental Health Treatment Engagement Validated by Self Report or VA Electronic Medical Record Review.Within 1 year of Treatment InterventionVA 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

MeasureTime frameDescription
Shared Decision Making Interface Between VA Clinician and Veteran Validated by VA Electronic Medical Record ReviewWithin 1 year of Treatment InterventionShared decision-making template use (specific to this study) by clinician participants validated by VA electronic medical record review.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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).
214
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
102
Total316

Baseline characteristics

CharacteristicWEB-ED+ Treatment ArmWEB-ED Only Control ArmTotal
Age, Continuous43.99 years
STANDARD_DEVIATION 10.04
45.56 years
STANDARD_DEVIATION 11.33
44.49 years
STANDARD_DEVIATION 10.48
Race/Ethnicity, Customized
Race/Ethnicity
African American
20 Participants14 Participants34 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
20 Participants3 Participants23 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Multirace
21 Participants11 Participants32 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
7 Participants6 Participants13 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
143 Participants66 Participants209 Participants
Sex: Female, Male
Female
101 Participants56 Participants157 Participants
Sex: Female, Male
Male
113 Participants46 Participants159 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2140 / 102
other
Total, other adverse events
0 / 2140 / 102
serious
Total, serious adverse events
0 / 2140 / 102

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WEB-ED+ Treatment ArmVA Mental Health Treatment Engagement Validated by Self Report or VA Electronic Medical Record Review.98 Participants
WEB-ED Only Control ArmVA Mental Health Treatment Engagement Validated by Self Report or VA Electronic Medical Record Review.7 Participants
p-value: <0.00001Chi-squared
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 validated by VA electronic medical record review.

Time frame: Within 1 year of Treatment Intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WEB-ED+ Treatment ArmShared Decision Making Interface Between VA Clinician and Veteran Validated by VA Electronic Medical Record Review89 Participants
WEB-ED Only Control ArmShared Decision Making Interface Between VA Clinician and Veteran Validated by VA Electronic Medical Record Review4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026