MISSION-Vet HUD-VASH Implementation Study

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01430741
• Collaborator: (none)
• Enrollment: 227
• Locations: 4
• Arms: 4
• Actual Duration (Months): 44
• Patients Per Site: 56.8
• Patients Per Site Per Month: 1.3

Study Details

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.

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; Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition); Other: Getting To Outcomes; Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)	N/A

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

• Study Type: Interventional
• 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: Oct 29, 2012
• Actual Primary Completion Date: Sep 30, 2015
• Actual Study Completion Date: Jun 30, 2016

Arms and Interventions

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	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 Names: MISSION-Vet
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.	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 Names: 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 Names: 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 Names: 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 Names: 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 Names: MISSION-Vet

Outcome Measures

Primary Outcome Measures

1. MISSION Fidelity Index [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	VA Eastern Colorado Health Care System, Denver, CO	Denver	Colorado	United States	80220
2	VA Central Office - HSR&D, Washington, DC	Washington	District of Columbia	United States	20420
3	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts	United States	01730
4	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts	United States	01053-9764

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01430741
• Other Study ID Numbers: SDP 11-240
• First Posted: Sep 8, 2011
• Last Update Posted: Jun 29, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Substance-Related Disorders; Mental Disorders

Study Results

Participant Flow

Pre-assignment Detail	All case managers were invited to participate and verbally consented before randomization into the IU or the GTO group. 10 refused to participate.

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO MISSION Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Period Title: Overall Study
STARTED	22	87	47	81
COMPLETED	22	87	37	81
NOT COMPLETED	0	0	10	0

Baseline Characteristics

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet - IU Veterans	Enhanced Implementation Approach GTO Case Management	GTO Veterans	Total
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans	Total of all reporting groups
Overall Participants	22	87	37	81	227
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.7 (10.8)	55.9 (9.5)	52.8 (10.6)
Sex/Gender, Customized (participants) [Number]
Unknown	22 100%	87 100%	37 100%	81 100%	227 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Clinician fidelity to MISSION-Vet using IU or GTO. Only assessed Staff population.

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Measure Participants	22	0	37	0
Number [percentage of MISSION-Vet staff use]	0	68

2. Post-Hoc Outcome

Title	Number of Services Provided by Case Managers and Peers to Veterans
Description	Services provided by Case Managers OR Peers was computed by a count of the number of contacts between case managers OR peers and Veterans. This computed a total of all Veteran contacts, which was the sum of face-to-face contacts with Veterans and contacts on behalf of Veterans (described as Veteran contacts) with other stakeholders (e.g. family, medical providers). Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. We used a linear-mixed effects model to calculate a Least-Squares Mean for each group at the study's end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Measure Participants	0	87	0	81
Least Squares Mean (Standard Error) [Number of Service Contacts]	3.466 (2.824)	3.469 (3.051)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.04
	Comments
	Method	Mixed Models Analysis
	Comments

3. Post-Hoc Outcome

Title	Drug and Alcohol Dependence
Description	Examined monthly alcohol and drug use by Veterans. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Measure Participants	0	87	0	81
Drug Use	1.291 (0.62)	1.786 (0.588)
Alcohol Use	1.668 (0.79)	2.278 (0.752)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.21
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.07
	Comments
	Method	Mixed Models Analysis
	Comments

4. Post-Hoc Outcome

Title	Predicted Values of Veteran Inpatient Hospitalizations for Medical and Mental Health Conditions
Description	Number of inpatient hospitalization for medical and mental health conditions. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an inpatient hospitalization for medical or mental health conditions , and not a count of number of hospitalizations. Specifically, we used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study's end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Measure Participants	0	87	0	81
Medical Inpatient Hospitalizations	-6.597 (1.903)	-6.555 (1.498)
Mental Health Inpatient Hospitalizations	-5.311 (6.008)	-3.825 (5.802)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.14
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.19
	Comments
	Method	Mixed Models Analysis
	Comments

5. Post-Hoc Outcome

Title	Predicted Values of Veteran Emergency Department Visits for Medical and Mental Health Concerns
Description	Number of emergency department visits for medical and for mental health. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an emergency department visit for medical or mental health conditions , and not a count of number of emergency department visits. We used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study's end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Measure Participants	0	87	0	81
Medical Emergency Dept Visits	-4.663 (3.063)	-3.983 (2.923)
Mental Health Emergency Dept Visits	-7.96 (2.312)	-6.792 (1.779)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.24
	Comments
	Method	Mixed Models Analysis
	Comments

6. Post-Hoc Outcome

Title	Estimated Proportion of Veterans Without Negative Housing Exits
Description	We obtained information on negative housing exits from the HUD-VASH Exit form, which is available in HOMES and tracks the dates and reasons for all exits from the program. We measured whether and when a Veteran experienced a negative housing over the period from study enrollment (i.e. the first date of MISSION-Vet for those served by case managers in the GTO group and the date of the first MISSION-Vet session provided to any Veteran at the appropriate study site for this in the comparison group) until the end of the study observation period; the maximum follow-up time was 2.4 years, but only for HUD-VASH Exits. A negative exit was defined as an exit from HUD-VASH that occurred due to non-compliance with case management, eviction, Veteran dissatisfaction with housing, inability to locate Veteran and incarceration. Kaplan-Meier survival curves to calculate an estimate of the proportion of Veterans in each arm/group not experiencing a negative exit from housing at the study's endpoint.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).

Arm/Group Title	MISSION-Vet - IU Case Management	MISSION-Vet IU Veterans	GTO Case Management	GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans.
Measure Participants	0	87	0	81
Number (95% Confidence Interval) [Proportion of Veterans]	0.808	0.884

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MISSION-Vet IU Veterans, GTO Veterans
	Comments	We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.481
	Comments
	Method	Regression, Cox
	Comments

Adverse Events

Arm/Group Title	MISSION-Vet - IU Case Management		MISSION-Vet - IU Veterans		GTO Case Management		GTO Veterans
Arm/Group 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) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services 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, while delivering MISSION services to Veterans
All Cause Mortality
	MISSION-Vet - IU Case Management		MISSION-Vet - IU Veterans		GTO Case Management		GTO Veterans
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	MISSION-Vet - IU Case Management		MISSION-Vet - IU Veterans		GTO Case Management		GTO Veterans
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/87 (0%)		0/37 (0%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	MISSION-Vet - IU Case Management		MISSION-Vet - IU Veterans		GTO Case Management		GTO Veterans
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/87 (0%)		0/37 (0%)		0/81 (0%)

Limitations/Caveats

First peer specialists were not readily available to teams in the IU condition in two of the three sites. Second, HOMES data on case managers reports. Third, we believe the services documented underrepresented the actual amount of services delivered.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.