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Trial record 31 of 209 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT03539068
Recruitment Status : Not yet recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
PTSD Depression Substance Use Disorder Traumatic Brain Injury Behavioral: WEB-ED+ Treatment Arm Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: RCT- Screening, Shared-decision making intervention with Veteran and Providers using Dartmouth 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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.




Primary Outcome Measures :
  1. VA mental health treatment engagement validated by VA electronic medical record review. [ Time Frame: 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 [ Time Frame: Within 1 year of Treatment Intervention ]
    Shared decision-making template use (specific to this study) by clinician participants.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539068


Contacts
Contact: Anne G Sadler, PhD RN (319) 338-0581 ext 5480 Anne.Sadler@va.gov
Contact: Holly J Strehlow, BA (319) 338-0581 ext 7650 Holly.Strehlow@va.gov

Locations
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Not yet recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Bonnie J BootsMiller, PhD    319-887-4938    bonnie.bootsmiller@va.gov   
Contact: John E Holman, MA MA    (319) 338-0581 ext 7507    John.Holman2@va.gov   
Principal Investigator: Anne G. Sadler, PhD RN         
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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03539068     History of Changes
Other Study ID Numbers: IIR 16-096
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Veteran
Mental Health
War
Shared decision-making
Access to care

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Substance-Related Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Chemically-Induced Disorders
Mental Disorders