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PTSDNCT01710306

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

A study testing Nurse Care Manager (NCM) in people with PTSD, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
PTSD
What is being tested?
Nurse Care Manager (NCM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
1 siteUnited States
Study dates
1 Sep 2013to 30 Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa, 52246-2208

Other trials in United States

About this study

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.

Read the 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.

Conditions
PTSD
Being tested
Nurse Care Manager (NCM)
Keywords
Women, Veterans, PTSD, Access to Care, Shared Decision Making
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse Care Manager (NCM)Behavioural

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

Study groups in NCT01710306
Study groupRoleWhat they receive
OutreachNo interventionTo 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 Manager (NCM)ExperimentalTo 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.
Receives: Behavioral: Nurse Care Manager (NCM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (1)
  1. 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.

    Measured: Outcome measure was assessed at baseline data collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2012 (estimated)
  2. Study start1 Sep 2013
  3. Primary completion30 Mar 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01710306
Sponsor's protocol ID
CRE 12-039
Status last verified
Feb 2019
First submitted
21 Sep 2012
Last updated
22 Feb 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nurse Care Manager (NCM) in people with PTSD, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With VA Mental Health Care Engagement (time frame: Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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