Trial Outcomes & Findings for Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care (NCT NCT01710306)
NCT ID: NCT01710306
Last Updated: 2019-02-22
Results Overview
VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record
COMPLETED
NA
171 participants
Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .
2019-02-22
Participant Flow
Participant milestones
| Measure |
Outreach
To evaluate and test differences in VA initiation and use for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. That is, VA usual outreach by existing OEF/OIF/OND transition patient advocates.
|
Study Concierge Nurse Case Manager (NCM)
To evaluate and test differences in VA initiation (did they seek VA care - new or return visit) and for participants who screen positive for PTSD they will be randomly assigned to either: 1)Study nurse case manager (NCM) or outreach as usual..
NCM: Nurse care manager interventions will consist of telephone delivered shared decision protocols with participants compared to OEF/OIF/OND outreach as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
COMPLETED
|
68
|
55
|
|
Overall Study
NOT COMPLETED
|
18
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care
Baseline characteristics by cohort
| Measure |
Outreach
n=86 Participants
To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. That is, VA existing outreach by existing OEF/OIF/OND transition patient advocates.
|
Study Concierge Nurse Case Manager (NCM)
n=85 Participants
To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Mental Health Care Engagement
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record
Outcome measures
| Measure |
Outreach
n=86 Participants
To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
|
Nurse Care Manger Intervention Arm
n=85 Participants
To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
|
|---|---|---|
|
Number of Participants With VA Mental Health Care Engagement
Engaged in Mental Health Care
|
40 Participants
|
30 Participants
|
|
Number of Participants With VA Mental Health Care Engagement
Did Not Engage in Mental Health Care
|
28 Participants
|
28 Participants
|
|
Number of Participants With VA Mental Health Care Engagement
Did Not Complete Participation
|
18 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Outcome measure was assessed at baseline data collectionPopulation: Percentage of participants listed below are those in each arm who had a PAM score indicating a level of taking action (levels 3 and 4).
The Patient Activation Measure (PAM) administered on line to RCT participants yields a patient activation score allowing comparison of patient activation with other populations/studies The PAM-13 item measures patient knowledge, skill, and confidence for medical self-management. It is scored on a scale from 0-100. These scores result in four levels of patient activation that range from 1 to 4 with 1 being the lowest level of patient activation for taking action and 4 the highest level of activation. Specifically: 1=believing the patient role is important. 2=having confidence/knowledge necessary to take action. 3=actually taking action to maintain/improve one's health. 4=maintaining health actions, even under stress. The percentage of participants in each arm who had a PAM score that indicated a level of activation/taking action (levels 3 and 4) will be identified.
Outcome measures
| Measure |
Outreach
n=86 Participants
To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
|
Nurse Care Manger Intervention Arm
n=85 Participants
To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
|
|---|---|---|
|
Patient Activation Measure
|
50 Participants
|
53 Participants
|
Adverse Events
Outreach
Study Concierge Nurse Case Manager (NCM)
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 Veteran's Affairs- Office of Research and Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place