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MISSION-Vet HUD-VASH Implementation Study

Primary Purpose

Substance Related Disorders, Mental Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
Getting To Outcomes
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
Getting To Outcomes
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Related Disorders focused on measuring Implementation Science, Supportive Housing, Co-occurring disorders, Cluster randomized controlled trial, Hybrid implementation-effectiveness trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Sites / Locations

  • VA Eastern Colorado Health Care System, Denver, CO
  • VA Central Office - HSR&D, Washington, DC
  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
  • VA Central Western Massachusetts Healthcare System, Leeds, MA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Experimental

Experimental

Arm Label

Implementation as Usual Case Management

Implementation as Usual Veterans

Getting to Outcomes Case Management

Getting to Outcomes Veterans

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

MISSION Fidelity Index
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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2011
Last Updated
May 23, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01430741
Brief Title
MISSION-Vet HUD-VASH Implementation Study
Official Title
MISSION-Vet HUD-VASH Implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 29, 2012 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorders, Mental Illness
Keywords
Implementation Science, Supportive Housing, Co-occurring disorders, Cluster randomized controlled trial, Hybrid implementation-effectiveness trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
227 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation as Usual Case Management
Arm Type
Other
Arm Description
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
Arm Title
Implementation as Usual Veterans
Arm Type
Other
Arm Description
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.
Arm Title
Getting to Outcomes Case Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Getting to Outcomes Veterans
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
Other Intervention Name(s)
MISSION-Vet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Getting To Outcomes
Other Intervention Name(s)
GTO
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
Other Intervention Name(s)
MISSION-Vet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Getting To Outcomes
Other Intervention Name(s)
GTO
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)
Other Intervention Name(s)
MISSION-Vet
Intervention Description
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
Primary Outcome Measure Information:
Title
MISSION Fidelity Index
Description
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.
Time Frame
12-months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: VA HUD-VASH case manager at the Northampton, Denver, and Washington D.C. HUD-VASH programs Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Smelson, PsyD
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew J. Chinman, PhD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Eastern Colorado Health Care System, Denver, CO
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
VA Central Office - HSR&D, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20420
Country
United States
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
VA Central Western Massachusetts Healthcare System, Leeds, MA
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01053-9764
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result
PubMed Identifier
23244030
Citation
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.
Results Reference
result
PubMed Identifier
25046280
Citation
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.
Results Reference
result
PubMed Identifier
26018048
Citation
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.
Results Reference
result
PubMed Identifier
28279207
Citation
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.
Results Reference
result
PubMed Identifier
29728148
Citation
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.
Results Reference
result

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MISSION-Vet HUD-VASH Implementation Study

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