Trial Outcomes & Findings for Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care (NCT NCT03539068)
NCT ID: NCT03539068
Last Updated: 2024-08-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1312 participants
Primary outcome timeframe
Within 1 year of Treatment Intervention
Results posted on
2024-08-01
Participant Flow
1312 completed WEB-ED, 1234 had positive screens, 996 were excluded for a number of reasons, 316 were consented and randomized.
Participant milestones
| Measure |
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).
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
102
|
|
Overall Study
COMPLETED
|
199
|
102
|
|
Overall Study
NOT COMPLETED
|
15
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Five participants did not report race/ethnicity.
Baseline characteristics by cohort
| Measure |
WEB-ED+ Treatment Arm
n=214 Participants
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).
|
WEB-ED Only Control Arm
n=102 Participants
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
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.99 years
STANDARD_DEVIATION 10.04 • n=214 Participants
|
45.56 years
STANDARD_DEVIATION 11.33 • n=102 Participants
|
44.49 years
STANDARD_DEVIATION 10.48 • n=316 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=214 Participants
|
56 Participants
n=102 Participants
|
157 Participants
n=316 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=214 Participants
|
46 Participants
n=102 Participants
|
159 Participants
n=316 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
143 Participants
n=211 Participants • Five participants did not report race/ethnicity.
|
66 Participants
n=100 Participants • Five participants did not report race/ethnicity.
|
209 Participants
n=311 Participants • Five participants did not report race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
20 Participants
n=211 Participants • Five participants did not report race/ethnicity.
|
14 Participants
n=100 Participants • Five participants did not report race/ethnicity.
|
34 Participants
n=311 Participants • Five participants did not report race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
20 Participants
n=211 Participants • Five participants did not report race/ethnicity.
|
3 Participants
n=100 Participants • Five participants did not report race/ethnicity.
|
23 Participants
n=311 Participants • Five participants did not report race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
7 Participants
n=211 Participants • Five participants did not report race/ethnicity.
|
6 Participants
n=100 Participants • Five participants did not report race/ethnicity.
|
13 Participants
n=311 Participants • Five participants did not report race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multirace
|
21 Participants
n=211 Participants • Five participants did not report race/ethnicity.
|
11 Participants
n=100 Participants • Five participants did not report race/ethnicity.
|
32 Participants
n=311 Participants • Five participants did not report race/ethnicity.
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
WEB-ED+ Treatment Arm
n=199 Participants
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).
|
WEB-ED Only Control Arm
n=102 Participants
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
|
|---|---|---|
|
VA Mental Health Treatment Engagement Validated by Self Report or VA Electronic Medical Record Review.
|
98 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within 1 year of Treatment InterventionShared decision-making template use (specific to this study) by clinician participants validated by VA electronic medical record review.
Outcome measures
| Measure |
WEB-ED+ Treatment Arm
n=199 Participants
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).
|
WEB-ED Only Control Arm
n=102 Participants
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
|
|---|---|---|
|
Shared Decision Making Interface Between VA Clinician and Veteran Validated by VA Electronic Medical Record Review
|
89 Participants
|
4 Participants
|
Adverse Events
WEB-ED+ Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WEB-ED Only Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne G. Sadler, Ph.D., R.N.
Department of Veterans Affairs- Office of Research and Development
Phone: 319-338-0581
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place