NCT01710306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 22, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

3.6 years

First QC Date

September 21, 2012

Results QC Date

September 22, 2017

Last Update Submit

February 21, 2019

Conditions

Keywords

WomenVeteransPTSDAccess to CareShared Decision Making

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

  • Patient Activation Measure

    Outcome measure was assessed at baseline data collection

Study Arms (2)

Outreach

NO INTERVENTION

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 Manager (NCM)

EXPERIMENTAL

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.

Behavioral: Nurse Care Manager (NCM)

Interventions

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

Nurse Care Manager (NCM)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Anne G. Sadler, Ph.D., R.N.
Organization
Department of Veteran's Affairs- Office of Research and Development

Study Officials

  • Anne G. Sadler, PhD RN

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 19, 2012

Study Start

September 1, 2013

Primary Completion

March 30, 2017

Study Completion

June 30, 2017

Last Updated

February 22, 2019

Results First Posted

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations