MISSION-Vet HUD-VASH Implementation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01430741
First received: July 26, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

A major goal for the Department of Veterans Affairs is to end veteran homelessness by 2015. The VA's largest homelessness initiative is the joint Departments of Housing and Urban Development (HUD) and Veterans Affairs (VA) Supportive Housing program (HUD-VASH), which has been expanded greatly over recent years via the allocation of 30,000 Housing First vouchers between 2008 and 2010 and increased funding to hire 1,000 new program case managers. However, recent expansion has resulted in a number of implementation challenges including delays in the distribution of housing vouchers and dropout among program participants (25% of those housed in HUD-VASH drop out within a year). Much of this dropout can be attributed to untreated issues facing many veterans enrolled in HUD-VASH. The most common among these untreated issues are mental health and substance use disorders. The presence of these disorders is due in large part to the fact that much of HUD-VASH case management focuses on housing placement and maintenance, with limited attention to mental health, substance abuse, and other related psychosocial issues, which when left untreated, negatively impacts voucher distribution and housing stability. This project will test an implementation model-Getting To Outcomes (GTO)-designed to assist in the delivery of an intervention for Veterans with co-occurring mental health and substance use disorders (MISSION-Vet) in the HUD-VASH program. The proposed study will compare implementation of MISSION-Vet currently being planned through VA Office of Patient Care Services to an enhanced approach using the GTO model. Thus, this project can contribute to ending all Veteran homelessness by 2015, a pledge made by President Obama.


Condition Intervention
Co-occurring Disorders
Other: Getting To Outcomes
Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: MISSION-Vet HUD-VASH Implementation Study

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Level of model fidelity as assessed by the MISSION Fidelity Index. [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    We will assess the impact GTO has in facilitating adoption and use with fidelity to MISSION-Vet 12-month service delivery platform.


Secondary Outcome Measures:
  • Assess the effectiveness of MISSION-Vet in regular practice via 3 large HUD-VASH programs. [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    HUD-VASH program data as entered into the VA HOMES data entry system will be used to measure mental health/substance abuse outcomes.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Manual guided, enhanced implementation approach called Getting to Outcomes (GTO), designed specifically to assist in the delivery of evidence-based interventions
Other: Getting To Outcomes
GTO strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. GTO consists of a series of steps practitioners should follow in order to obtain positive results and then provides them with the guidance necessary to complete those steps with quality. According to GTO, "carrying out" an evidence based program includes a series of steps corresponding to three general areas: (1) planning - e.g., developing goals and performance targets, ensuring staff are trained in the evidence based program; (2) implementation - e.g., monitoring program activities, maintaining adherence to an evidence based program model, supervision; and (3) self-evaluation - e.g., tracking patient outcomes, using data to improve program operations.
Other Name: GTO
Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
MISSION-Vet has been developed to target mental health, substance abuse and related issues facing homeless veterans through assertive outreach, psychoeducation and linkages to community-based resources. The core intervention utilized within MISSION-Vet is Critical Time Intervention (CTI), which addresses the situational and motivational barriers related to engagement in care and places a primary focus on housing placement and support. CTI is supplemented with thirteen manual-guided Dual Recovery Therapy (DRT) mental health and substance abuse psychoeducation sessions, delivered by a case manager, to address mental health and substance abuse issues. DRT sessions are intended to assist the veteran with developing more self efficacy and motivation for maintaining sobriety and stability. We have also supplemented CTI by adding Peer Support Technicians (PSTs). PSTs can reduce in-patient utilization, substance abuse, social isolation and other symptoms by role modeling healthy behaviors.
Other Name: MISSION-Vet
Arm 2
Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking for Veterans (MISSION-Vet) integrated co-occurring disorders treatment model - Implemented as Usual (IU)
Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
MISSION-Vet has been developed to target mental health, substance abuse and related issues facing homeless veterans through assertive outreach, psychoeducation and linkages to community-based resources. The core intervention utilized within MISSION-Vet is Critical Time Intervention (CTI), which addresses the situational and motivational barriers related to engagement in care and places a primary focus on housing placement and support. CTI is supplemented with thirteen manual-guided Dual Recovery Therapy (DRT) mental health and substance abuse psychoeducation sessions, delivered by a case manager, to address mental health and substance abuse issues. DRT sessions are intended to assist the veteran with developing more self efficacy and motivation for maintaining sobriety and stability. We have also supplemented CTI by adding Peer Support Technicians (PSTs). PSTs can reduce in-patient utilization, substance abuse, social isolation and other symptoms by role modeling healthy behaviors.
Other Name: MISSION-Vet

Detailed Description:

This project tests an implementation platform-Getting To Outcomes (GTO)-designed to assist in the delivery of an evidence-based intervention for Veterans with co-occurring mental health and substance use disorders (MISSION-Vet) in the HUD-VASH program. This project will be a cluster randomized controlled trial that compares implementation of MISSION-Vet augmented by GTO to MISSION-Vet Implemented as Usual (IU) at three of the largest HUD-VASH programs in the country: VA Central Western Massachusetts Healthcare System (Northampton, MA), VA Capitol Health Care Network (Washington, D.C.), and VA Eastern Colorado Health Care System (Denver, CO). This project will randomly assign 150 HUD-VASH case managers and 1106 Veterans on their caseloads who have received HUD-VASH vouchers and case management services into these two groups on a 1-year rolling admission basis determined by when the Veteran receives a housing voucher. The control group will receive MISSION-Vet in addition to HUD-VASH case management services and the intervention group will receive the same as the control, however the HUD-VASH case manager will have access to GTO implementation support.

To compare case managers implementing MISSION-Vet augmented with GTO to HUD-VASH case managers using IU strategies on the following variables: (1) fidelity to the MISSION-Vet intervention; (2) proportion of time the Veteran is housed; (3) mental health, substance use, and functional outcomes among Veterans; and (4) factors key to the successful deployment of a new treatment as specified by the Reach, Effectiveness, Adoption, Implementation, & Maintenance (RE-AIM) model.

Data will be collected on fidelity to MISSION-Vet in both IU and GTO groups. Data will also be collected on all subjects' substance use, overall mental health functioning, engagement in substance abuse treatment services, the length of time housed, and community participation. We will collect data from individuals at baseline and three time points for up to one year. Our data analysis strategy will be to use a repeated-measures model to test for the significance of the treatment-by-time interaction while accounting for the clustered design of case manager within site.

This study intends to serve a dual function of comparing implementation of MISSION-Vet currently being planned through VA Office of Patient Care Services to an enhanced implementation approach using the GTO model. The proposed research will help to guide policy and practice actions to implement MISSION-Vet with fidelity and effectiveness to achieve maximum outcomes among homeless Veterans.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

VA HUD-VASH case manager at the Northampton, Denver, and Washington D.C. HUD-VASH programs

Exclusion Criteria:

N/A

  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: NCT01430741

Contacts
Contact: Brittany Walker (781) 687-3406 brittany.walker2@va.gov
Contact: Leon Sawh, MPH (781) 687-3576 leon.sawh@va.gov

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO Recruiting
Denver, Colorado, United States, 80220
Contact: Scott Strong    303-399-8020 ext 5689    scott.strong@va.gov   
United States, District of Columbia
VA Central Office - HSR&D, Washington, DC Recruiting
Washington, District of Columbia, United States, 20420
Contact: Fuad Issa    202-636-7676    fuad.issa@va.gov   
United States, Massachusetts
VA New England Health Care System Recruiting
Bedford, Massachusetts, United States, 01730
Contact: Laurie Barrett    (781) 687-2872    laurie.Barrett@va.gov   
Contact: Karen Anderson    (781) 687-2763    Karen.Anderson4@va.gov   
Sub-Investigator: Allen L. Gifford, MD         
Principal Investigator: David A. Smelson, PsyD         
Sub-Investigator: Mark Evan Glickman, PhD         
Sub-Investigator: Marsha Langer Ellison, PhD MSW         
Sub-Investigator: Stephanie Rodrigues, MA PhD         
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Dana Weaver    413-582-3030    dana.weaver@va.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: David A. Smelson, PsyD Edith Nourse Rogers Memorial Veterans Hospital, Bedford
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01430741     History of Changes
Other Study ID Numbers: SDP 11-240
Study First Received: July 26, 2011
Last Updated: May 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Implementation Science
Supportive Housing
Co-occurring disorders
Cluster randomized controlled trial
Hybrid implementation-effectiveness trial

ClinicalTrials.gov processed this record on October 21, 2014