National Guard Outreach and Linkage to Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01020981
First received: November 24, 2009
Last updated: January 26, 2015
Last verified: January 2015
  Purpose

This project will add an evaluation/research component to an existing peer outreach program, now implemented for over 1100 soldiers in the Michigan Army National Guard. Preliminary work will be completed in three areas. We will conduct semi-structured interviews with soldiers, Buddies, and National Guard leadership and develop and pilot test survey items relevant to implementation. Further, we will develop and pretest survey items relevant to determining soldier symptomatic and functional status. We will also conduct a small feasibility study, fielding the newly developed survey to a representative sample of recently returned National Guard members from Michigan and Indiana, to determine response rates and veteran willingness to allow access to linkable PDHA/PDHRA data and health services data. Finally, we will construct a merged, de-identified longitudinal dataset comprised of Post-Deployment Health Assessment and Reassessment data, Military Health System/TRICARE, and VA services data from National Guard soldiers in Michigan and comparison states of Indiana and Ohio. This will allow a longitudinal assessment of services initiation and retention for the entire Guard populations in these states.


Condition
PTSD
Depression
Reintegration
Veterans Health

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: National Guard Outreach and Linkage to Treatment

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Feasibility-response Rate [ Time Frame: Survey was fielded to Michigan National Guard Service Members on three occasions, March 2011, April 2011, and May 2011. The survey was also fielded to Indiana National Guard Service Members on September 2011, October 2011, and November 2011. ] [ Designated as safety issue: No ]
    Response rate of Soldiers to a mailed survey.


Secondary Outcome Measures:
  • Depressive Symptoms [ Time Frame: Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011). ] [ Designated as safety issue: No ]
    The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

  • PTSD Symptoms [ Time Frame: Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011). ] [ Designated as safety issue: No ]
    The PCL is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The PCL-M is a military version and questions refer to "a stressful military experience". Total possible scores range from 17 to 85. Higher scores indicate more symptoms of PTSD and a cut-off score of 50 is used for indicating a probable diagnosis of combat-related PTSD.


Enrollment: 141
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
Group 2
Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008

Detailed Description:

Background:

Soldiers returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) commonly experience symptoms of PTSD, depressive disorders, and interpersonal difficulties. Forty-two percent of National Guard (NG) soldiers report symptoms suggesting a need for evaluation. Unfortunately, only half with mental health needs initiate treatment in the VA or elsewhere. Stigma remains an important barrier. Proactive peer outreach may successfully address stigma and facilitate appropriate treatment use. In the recently implemented Michigan Guard Buddy*to*Buddy (B2B) program, all returning MIARNG soldiers are assigned a first-tier "Buddy" from their unit who systematically telephones them to "check in" regarding key areas of functioning and symptoms. Soldiers may also be referred to second-tier Buddies, veterans outside the Guard trained in motivational interviewing and supervised by professional staff. The goal of the program is to identify soldiers in need of evaluation and connect them to care in a timely fashion.

We will conduct preliminary work that will allow us to assess the need for and the feasibility of adding a rigorous evaluation/research component to the B2B program.

Objectives:

The goal of this RRP is to assess the need for AND the feasibility of a larger VA study that would use a strong quasi-experimental design (time series analysis with comparison groups) to examine the impact of the B2B program on returning NG veteran mental health treatment initiation, retention, symptoms, and functional outcomes.

Specific RRP aims are to:

  1. Prepare for and initiate a formative evaluation of the Buddy*to*Buddy program in the Michigan Army National Guard (MI ARNG).
  2. Develop and determine the feasibility of a confidential surveys for National Guard veterans in Michigan and Indiana that elicit information regarding B2B processes (in MI ARNG), VA outreach processes, mental health symptoms, substance use, and treatment initiation and retention.
  3. Construct a de-identified linked dataset consisting of PDHA/PDHRA data, Military Treatment Facility/TRICARE service provider use, and VA service use for MI ARNG and NG soldiers in contiguous states of Indiana and Ohio. Conduct preliminary analyses of these data.

Methods:

Preliminary work will be completed in two areas. We will begin a formative evaluation of the implementation of the B2B program, using an augmented qualitative RE-AIM Plus framework, multiple data sources and data collection techniques, and conducting field observations and interviews with program stakeholders. Personnel at all levels, including NG leadership, Buddies, and soldiers, will be part of this process.

We will also develop and refine survey items relevant to understanding B2B implementation and soldier symptom and functional status. We will test procedures for fielding this survey in Michigan and a comparison state, assessing response rates, and using data to inform the design of a larger study of soldier outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

MI, IN, and OH ARNG

Criteria

Inclusion Criteria:

  • Returning MI ARNG member participating in the Buddy-to-Buddy program

Exclusion Criteria:

None

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01020981

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Marcia T. Valenstein, MD VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01020981     History of Changes
Other Study ID Numbers: RRP 09-420
Study First Received: November 24, 2009
Results First Received: November 5, 2014
Last Updated: January 26, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
OEF/OIF
Peer Group
Veterans

ClinicalTrials.gov processed this record on March 31, 2015