Trial record 4 of 440 for:    veterans AND (woman OR women OR female)

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01710306
First received: September 21, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 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. Our findings will provide VA leaders with key information to understand and improve access to RNG PTSD treatment


Condition Intervention Phase
PTSD
Behavioral: Phase 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Information to assist with Phase 2 study screening and intervention in order to understand female war Veterans' perceptions, preferences and barriers to Evidence Base Practice for Post Traumatic Stress Disorder. [ Time Frame: Outcome measures are assessed within 6 months following coding of semi-structured telephone interview data. ] [ Designated as safety issue: Yes ]
    Semi-structured telephone interview data will be thematically coded. There will be no quantitative measures.


Secondary Outcome Measures:
  • To compare efficacy of specific access routes to VA care: concierge nurse case manager using shared decision-making intervention versus VA OEF/OIF/OND outreach. [ Time Frame: Outcome measures are assessed at 6 months following web-based interface. ] [ Designated as safety issue: Yes ]
    Self-report and chart review checklists will assess specific VA mental health care and moreover participation (yes/no) with evidence based therapies and frequency (# of sessions and with what mental health treatment modality).


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Semi-structured telephone interviews
Phase 1 semi-structured telephone interviews are to evaluate the participants' perceptions of and satisfaction with the revised web-based interface and to inform Phase 2 intervention to evaluate and test differences in VA initiation and use for those who screen positive for PTSD by randomly assigned route: 1) Study concierge nurse case manager (NCM) or 2) existing OEF/OIF/OND outreach.
Behavioral: Phase 2
Nurse care manager interventions with shared decision making compared to outreach as usual OEF/OIF/OND outreach.

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 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 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, we 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 EBP for PTSD. This information will be used to refine our 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Semi-structured telephone interview participants will be delimited to OEF/OIF/OND Reserve and National Guard (RNG) servicewomen with PTSD who have returned from deployment in service of and/or to Iraq or Afghanistan within the prior 36 months.
  • Semi-structured telephone interview participants will be composed of women who have had at least one VA encounter within the preceding 18 months.

Exclusion Criteria:

  • Any disability that would impair individuals ability to provide consent and participate in the interview.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710306

Locations
United States, Iowa
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
Sponsors and Collaborators
Investigators
Principal Investigator: Anne G. Sadler, PhD RN VA Medical Center, Iowa City
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01710306     History of Changes
Other Study ID Numbers: CRE 12-039
Study First Received: September 21, 2012
Last Updated: July 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Women
Veterans
PTSD

ClinicalTrials.gov processed this record on October 23, 2014