Skip to content

Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care

Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01710306
Enrollment
171
Registered
2012-10-19
Start date
2013-09-01
Completion date
2017-06-30
Last updated
2019-02-22

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

Conditions

PTSD

Keywords

Women, Veterans, PTSD, Access to Care, Shared Decision Making

Brief summary

Women and Reserve/National (RNG) Veterans are among the fastest growing groups of new VA users. While PTSD is prevalent in this group, most women don't access or complete needed treatment. This study will investigate Operation enduring/Iraqi Freedom and New Dawn (OEF/OIF/OND) RNG female war Veterans' perceptions, preferences, barriers and facilitators to accessing VA mental health (MH) and evidence-based PTSD psychotherapy. This information will be used to revise an existing web-based screen that educates participants about their unique post-deployment MH conditions. This web-interface will then be used to randomly assign women who screen positive for PTSD to either 1) a concierge nurse case manager who uses shared decision-making to engage Veterans in EBP or 2) usual outreach to determine what engagement approach women prefer. The investigators' findings will provide VA leaders with key information to understand and improve access to RNG PTSD treatment.

Detailed description

Women and OEF/OIF/OND Reserve/National Guard (RNG) war Veterans are among the fastest growing groups of new VA users. Although PTSD is highly prevalent in this group of Veterans, most choose not to seek care for a variety of reasons. Facilitating access to mental health (MH) services for RNG OEF/OIF/OND female Veterans with post-traumatic stress disorder (PTSD) is challenging and requires new approaches to outreach. Such approaches are urgently needed to mediate the severity of post-deployment MH conditions, alleviate concerns over MH diagnoses, and interrupt the cycle of chronicity found in many with PTSD. This gap between need for and use of VA PTSD services suggests that further research is needed to understand specific barriers to VA mental health (MH) care and VA PTSD evidence-based psychotherapy (EBP). A web-based interface tailored to consumer needs has the potential to promote active engagement by Veterans in their health care. Considering that OEF/OIF combat Veterans enrolled in VA care report a preference to seek readjustment services or information over the internet, such an approach may have important advantages for engaging this group. Furthermore, evidence indicates that when patients are educated about their physical health conditions and treatment alternatives, shared decision-making results in increased treatment participation, better adherence to treatment recommendations, and better health outcomes. Although highly promising, web-based and shared-decision making approaches to facilitating VA MH treatment utilization are in need of further study. In Phase 1 of the project, the investigators will use qualitative methods to assess VA enrolled PTSD positive OEF/OIF/OND RNG female war Veterans' perceptions, preferences and barriers and facilitators to accessing VA MH services and evidence based psychotherapy (EBP) for PTSD. This information will be used to refine the investigators' existing web-based interface to better address these issues. Satisfaction with the revised interface will then be assessed. Phase 2 will focus on comparing the efficacy of two approaches to promoting VHA initiation. Participants who screen positive for PTSD on the web interface will be randomly assigned to: 1) Study concierge nurse case manager (NCM) facilitated shared decision making to assist with VA MH evaluation and treatment; or 2) existing outreach (current standard of care). Follow-up assessments will be conducted at 6 and 12 months to determine whether and where participants sought MH care (from both VA and non-VA resources). This study will provide valuable insights about this population's perceptions of VA MH services and of PTSD EBP, as well as their evolving use of VA and other community resources to address PTSD and other post-deployment MH needs. Furthermore, it will provide important information regarding the efficacy of relatively inexpensive and resource-sparing interventions that can be readily implemented within existing and emerging (e.g., Patient Alight Care Teams \[PACT\]) models of VA care delivery. While the proposed web interface and shared decision-making intervention are currently directed at RNG women Veterans post-deployment, there are clear implications for expansion to other populations and health/MH concerns, as well. Findings have important policy implications for several operational partners heavily invested in the improved access and delivery of evidence-based mental health care for Veterans with PTSD.

Interventions

BEHAVIORALNurse Care Manager (NCM)

Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* R/NG servicewomen who have returned from deployment in service of and/or to Iraq/Afghanistan within the last 60 months.

Exclusion criteria

* Any disability that would impair individuals ability to provide consent and participate in the interview.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With VA Mental Health Care EngagementOutcome 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

Secondary

MeasureTime frameDescription
Patient Activation MeasureOutcome measure was assessed at baseline data collectionThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Outreach
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.
86
Study Concierge Nurse Case Manager (NCM)
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.
85
Total171

Baseline characteristics

CharacteristicOutreachStudy Concierge Nurse Case Manager (NCM)Total
Age, Continuous36.2 years
STANDARD_DEVIATION 8.3
36.5 years
STANDARD_DEVIATION 9.7
36.3 years
STANDARD_DEVIATION 8.9
Mental Health Care Engagement64 Participants63 Participants127 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants15 Participants25 Participants
Race (NIH/OMB)
More than one race
11 Participants18 Participants29 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants4 Participants12 Participants
Race (NIH/OMB)
White
57 Participants48 Participants105 Participants
Sex: Female, Male
Female
86 Participants85 Participants171 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 860 / 85
other
Total, other adverse events
0 / 860 / 85
serious
Total, serious adverse events
0 / 860 / 85

Outcome results

Primary

Number of Participants With VA Mental Health Care Engagement

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

Time frame: Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
OutreachNumber of Participants With VA Mental Health Care EngagementEngaged in Mental Health Care40 Participants
OutreachNumber of Participants With VA Mental Health Care EngagementDid Not Engage in Mental Health Care28 Participants
OutreachNumber of Participants With VA Mental Health Care EngagementDid Not Complete Participation18 Participants
Nurse Care Manger Intervention ArmNumber of Participants With VA Mental Health Care EngagementEngaged in Mental Health Care30 Participants
Nurse Care Manger Intervention ArmNumber of Participants With VA Mental Health Care EngagementDid Not Engage in Mental Health Care28 Participants
Nurse Care Manger Intervention ArmNumber of Participants With VA Mental Health Care EngagementDid Not Complete Participation27 Participants
p-value: 0.1996Chi-squared
Secondary

Patient Activation Measure

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.

Time frame: Outcome measure was assessed at baseline data collection

Population: 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).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OutreachPatient Activation Measure50 Participants
Nurse Care Manger Intervention ArmPatient Activation Measure53 Participants

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