Substance Related DisordersNCT01430741
MISSION-Vet HUD-VASH Implementation Study
A study testing Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) and Getting To Outcomes in people with Substance Related Disorders and Mental Illness, run by VA Office of Research and Development at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance Related Disorders, Mental Illness
- What is being tested?
- Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) and Getting To Outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Oct 2012to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- VA HUD-VASH case manager at the Northampton, Denver, and Washington D.C. HUD-VASH programs
Who cannot join
- N/A
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
VA Central Office - HSR&D, Washington, DC
Washington D.C., District of Columbia, 20420
About this study
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.
Read the 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.
- Conditions
- Substance Related Disorders, Mental Illness
- Being tested
- Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition), Getting To Outcomes
- Keywords
- Implementation Science, Supportive Housing, Co-occurring disorders, Cluster randomized controlled trial, Hybrid implementation-effectiveness trial
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)Behavioural
Also called MISSION-Vet
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
Getting To OutcomesOther
Also called GTO
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.
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)Behavioural
Also called MISSION-Vet
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
Getting To OutcomesOther
Also called GTO
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.
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)Behavioural
Also called MISSION-Vet
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
| Study group | Role | What they receive |
|---|---|---|
| Implementation as Usual Case Management | Other | 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 Receives: Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) |
| Implementation as Usual Veterans | Other | 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. Receives: Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) |
| Getting to Outcomes Case Management | Experimental | 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. Receives: Other: Getting To Outcomes; Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) |
| Getting to Outcomes Veterans | Experimental | 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. Receives: Other: Getting To Outcomes; Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start29 Oct 2012
- Primary completion30 Sep 2015
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Related DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David A. Smelson, PsyD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MAMatthew J. Chinman, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430741
- Sponsor's protocol ID
- SDP 11-240
- Status last verified
- May 2018
- First submitted
- 26 Jul 2011
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23244030McInnes 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.
PubMed 25046280Smelson 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.
PubMed 26018048Chinman 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.
PubMed 28279207Smelson 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.
PubMed 29728148
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MISSION-Vet HUD-VASH Implementation Study
- ClinicalTrials.gov ID
- NCT01430741
- Acronym / sponsor ID
- SDP 11-240
- Conditions
- Substance Related Disorders, Mental Illness
- Keywords
- Implementation Science, Supportive Housing, Co-occurring disorders, Cluster randomized controlled trial, Hybrid implementation-effectiveness trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 29 Oct 2012 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Implementation as Usual Case Management | Other | Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)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 |
| Implementation as Usual Veterans | Other | Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)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 Case Management | Experimental | Other: Getting To Outcomes, Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)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 Veterans | Experimental | Other: Getting To Outcomes, Behavioral: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- VA HUD-VASH case manager at the Northampton, Denver, and Washington D.C. HUD-VASH programs
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)Also: MISSION-VetMISSION-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 | Behavioural | Implementation as Usual Case Management, Implementation as Usual Veterans |
| Getting To OutcomesAlso: GTOGTO 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 | Getting to Outcomes Case Management |
| Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)Also: MISSION-VetMISSION-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 | Behavioural | Getting to Outcomes Case Management |
| Getting To OutcomesAlso: GTOGTO 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 | Getting to Outcomes Veterans |
| Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)Also: MISSION-VetMISSION-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 | Behavioural | Getting to Outcomes Veterans |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationO 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 publication: PubMed 23244030Smelson 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 publication: PubMed 25046280McInnes 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 publication: PubMed 26018048Smelson 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 publication: PubMed 28279207Chinman 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 publication: PubMed 29728148Smelson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Smelson, PsyD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Matthew J. Chinman, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition) and Getting To Outcomes in people with Substance Related Disorders and Mental Illness, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MISSION Fidelity Index (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01430741, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018; AzTrials last refreshed its copy on 29 Oct 2026.