- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430741
MISSION-Vet HUD-VASH Implementation Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- VA Eastern Colorado Health Care System, Denver, CO
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District of Columbia
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Washington, District of Columbia, United States, 20420
- VA Central Office - HSR&D, Washington, DC
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Massachusetts
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Bedford, Massachusetts, United States, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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Leeds, Massachusetts, United States, 01053-9764
- VA Central Western Massachusetts Healthcare System, Leeds, MA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
VA HUD-VASH case manager at the Northampton, Denver, and Washington D.C. HUD-VASH programs
Exclusion Criteria:
N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 |
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 Names:
|
Other: 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. |
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 Names:
|
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.
|
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 Names:
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 Names:
|
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.
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12-months
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Collaborators and Investigators
Investigators
- Principal Investigator: David A. Smelson, PsyD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Publications and helpful links
General Publications
- 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.
- Smelson DA, Kline A, Kuhn J, Rodrigues S, O'Connor K, Fisher W, Sawh L, Kane V. A wraparound treatment engagement intervention for homeless veterans with co-occurring disorders. Psychol Serv. 2013 May;10(2):161-7. doi: 10.1037/a0030948. Epub 2012 Dec 17.
- McInnes DK, Sawh L, Petrakis BA, Rao S, Shimada SL, Eyrich-Garg KM, Gifford AL, Anaya HD, Smelson DA. The potential for health-related uses of mobile phones and internet with homeless veterans: results from a multisite survey. Telemed J E Health. 2014 Sep;20(9):801-9. doi: 10.1089/tmj.2013.0329. Epub 2014 Jul 21.
- Smelson DA, Chinman M, McCarthy S, Hannah G, Sawh L, Glickman M. A cluster randomized Hybrid Type III trial testing an implementation support strategy to facilitate the use of an evidence-based practice in VA homeless programs. Implement Sci. 2015 May 28;10:79. doi: 10.1186/s13012-015-0267-4.
- Chinman M, McCarthy S, Hannah G, Byrne TH, Smelson DA. Using Getting To Outcomes to facilitate the use of an evidence-based practice in VA homeless programs: a cluster-randomized trial of an implementation support strategy. Implement Sci. 2017 Mar 9;12(1):34. doi: 10.1186/s13012-017-0565-0.
- Smelson DA, Chinman M, Hannah G, Byrne T, McCarthy S. An evidence-based co-occurring disorder intervention in VA homeless programs: outcomes from a hybrid III trial. BMC Health Serv Res. 2018 May 5;18(1):332. doi: 10.1186/s12913-018-3123-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDP 11-240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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