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MISSION-Vet HUD-VASH Implementation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01430741
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : May 30, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Substance Related Disorders Mental Illness Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) Other: Getting To Outcomes Not Applicable

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. The investigators will collect data from individuals at baseline and three time points for up to one year. The investigators' 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MISSION-Vet HUD-VASH Implementation Study
Actual Study Start Date : October 29, 2012
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Implementation as Usual Case Management

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 faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.

Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar

 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
Other Name: MISSION-Vet
Implementation as Usual Veterans

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 faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.

Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar. Staff then deliver MISSION to Veterans.

 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
Other Name: MISSION-Vet
Experimental: Getting to Outcomes Case Management
Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
 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
Other Name: MISSION-Vet
Experimental: Getting to Outcomes Veterans
Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, that guides staff while delivering MISSION to Veterans.
 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
Other Name: MISSION-Vet


Outcome Measures
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Primary Outcome Measures :
  1. MISSION Fidelity Index [ Time Frame: 12-months ]
    The fidelity index assesses the presence or absences of activities within MISSION-Vet - DRT, peer led sessions, self-guided exercises, referrals made, and/or delivery of the workbook, to each participating Veteran. We analyzed fidelity as the percent of adoption of MISSION-Vet. The threshold for fidelity to adopt MISSION-Vet is 1 contact between the case manager and each participating Veteran. There is no composite score, fidelity to MISSION-Vet is if the case manager conducted at least 1 session with a Veteran.This measure was embedded into the VA Electronic Medical Record System. The investigators will assess the impact GTO has in facilitating adoption and use with fidelity to the MISSION-Vet 12-month service delivery platform, in comparison to implementation as usual.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430741


Locations
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United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, District of Columbia
VA Central Office - HSR&D, Washington, DC
Washington, District of Columbia, United States, 20420
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, United States, 01053-9764
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: David A. Smelson, PsyD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Principal Investigator: Matthew J. Chinman, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
More Information
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Publications of Results:
O K, Kline A, Sawh L, Fisher W, Rodrigues S, Kane V, Kuhn J, Ellison ML, Smelson DA. Unemployment and Co-occurring Disorders Among Homeless Veterans. Journal of Dual Diagnosis. 2013 Mar 27; 9(2):134-138.

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01430741    
Other Study ID Numbers: SDP 11-240
First Posted: September 8, 2011    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: June 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Implementation Science
Supportive Housing
Co-occurring disorders
Cluster randomized controlled trial
Hybrid implementation-effectiveness trial
Additional relevant MeSH terms:
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Substance-Related Disorders
Mental Disorders
Chemically-Induced Disorders