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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710306
• Other study ID #: CRE 12-039
• Status: Completed
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: February 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Nurse Care Manager (NCM)
Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .
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.	Outcome measure was assessed at baseline data collection