Co-Occurring DisordersMISSION-HPACTNCT02942979
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking
An observational study of Co-Occurring Disorders and Homelessness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study seeks to implement wrap around services for Veterans suffering from co-occurring mental illness and substance use and who are homeless. It will compare Implementation as Usual of MISSION to Facilitation Implementation of MISSION. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Co-Occurring Disorders, Homelessness, Substance Abuse Disorder
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2016to 1 Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Homeless Veterans in the Greater Los Angeles VA system
Who may be able to join
- meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition diagnostic criteria of International Classification of Diseases, 10th Revision for a current substance abuse or dependence disorder, e.g.:
- alcohol
- marijuana
- cocaine
- or poly substance use and a co-occurring mental illness that includes anxiety, mood, or a psychotic spectrum disorder
- is willing to participate in the service
- is empaneled in HPACT at one of the study sites
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
About this study
Official title: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION) (QUE 15-284)
This study seeks to implement wrap around services for Veterans suffering from co-occurring mental illness and substance use and who are homeless. It will compare Implementation as Usual of MISSION to Facilitation Implementation of MISSION.
Read the detailed description
Background: Homeless Veterans often have multiple health care and psychosocial needs, including assistance with access to housing and health care, as well as support for ongoing treatment engagement. The Department of Veterans Affairs (VA) developed specialized Homeless Patient Alignment Care Teams (HPACT) with the goal of offering an integrated, "one-stop program" to address the Housing and Healthcare needs of Homeless Veterans. However, while 70% of HPACT's Veteran enrollees have co-occurring mental health and substance use disorders (COD), HPACT does not have a uniform, embedded treatment protocol for this subpopulation. One wraparound intervention designed to address the needs of homeless Veterans with COD which is suitable to be integrated into HPACT clinic sites is the evidence-based practice called Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Veterans Edition, or MISSION-Vet. Despite the promise of MISSION-Vet within HPACT clinics, implementation of an evidence based intervention within a busy program like HPACT can be difficult. The current study is being undertaken to identify an appropriate implementation strategy for MISSION-Vet within HPACT. The study will test the implementation platform called Facilitation and compared to implementation as usual (IU).
Aims: (1) Compare the extent to which IU or Facilitation strategies achieve fidelity to the MISSION-Vet intervention as delivered by HPACT homeless provider staff. (2) Compare the effects of Facilitation and IU strategies on the National HPACT Performance Measures. (3) Compare the effects of IU and Facilitation on the permanent housing status. (4) Identify and describe key stakeholders' (patients, providers, staff) experiences with, and perspectives on, the barriers to, and facilitators of implementing MISSION.
Design: Type III Hybrid modified stepped wedge implementation comparing IU to Facilitation across 7 HPACT teams in 3 sites in the greater Los Angeles VA system.
Discussion: Integrating MISSION-Vet within HPACT has the potential to improve the health of thousands of Veterans but, it is crucial to implement the intervention appropriately in order for it to succeed. The lessons learned in this protocol could assist with a larger roll-out of MISSION within HPACT.
- Keywords
- Facilitation, Implementation, Homelessness, Substance Use Disorder, Mental Illness, Co-Occurring Disorders, Veterans, Primary Care
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MISSION Implementation as Usual | Passive implementation or, IU for MISSION-Vet is comprised of a two-hour webinar training, along with key information on how to access and use the MISSION-Vet Treatment Manual and Consumer Workbook. The manual is posted on the web and available inside the VA on the National Center for Homelessness Among Veterans website or at missionmode.org. This passive implementation strategy has been used in previous studies | |
| Facilitation Implementation of MISSION | Facilitation is a comprehensive approach in which implementation experts partner with local staff to support implementation planning and to tailor adoption strategies to the local context. Facilitation gives attention to addressing individual- and organizational-level factors that can influence successful implementation of an evidence based practice with good fidelity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MISSION Sessions Undertaken
Number of MISSION Sessions delivered to Veterans
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 posted24 Oct 2016 (estimated)
- Study start12 Feb 2016
- Primary completion30 Jun 2020
- Study completion1 Sep 2020
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 (3)Papers the sponsor has linked to this study.
- Other trials for Co-Occurring 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- David A. Smelson, PsyD, Principal investigator, VA Bedford HealthCare System, Bedford, MAAllen L. Gifford, MD, Principal investigator, VA Bedford HealthCare System, Bedford, MASonya Emi Gabrielian, MD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942979
- Sponsor's protocol ID
- QUX 16-011
- Other IDs
- QUE 15-284
- Acronym
- MISSION-HPACT
- Status last verified
- Jul 2023
- First submitted
- 17 Oct 2016
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yakovchenko V, McCullough MB, Smith JL, Gabrielian S, Byrne T, Bruzios KE, Koosis E, Smelson DA. Implementing a complex psychosocial intervention for unstably housed Veterans: A realist-informed evaluation case study. Implement Res Pract. 2021 Oct 26;2:26334895211049483. doi: 10.1177/26334895211049483. eCollection 2021 Jan-Dec.
PubMed 37090015Smelson DA, Yakovchenko V, Byrne T, McCullough MB, Smith JL, Bruzios KE, Gabrielian S. Testing implementation facilitation for uptake of an evidence-based psychosocial intervention in VA homeless programs: A hybrid type III trial. PLoS One. 2022 Mar 17;17(3):e0265396. doi: 10.1371/journal.pone.0265396. eCollection 2022.
PubMed 35298514Simmons MM, Gabrielian S, Byrne T, McCullough MB, Smith JL, Taylor TJ, O'Toole TP, Kane V, Yakovchenko V, McInnes DK, Smelson DA. A Hybrid III stepped wedge cluster randomized trial testing an implementation strategy to facilitate the use of an evidence-based practice in VA Homeless Primary Care Treatment Programs. Implement Sci. 2017 Apr 4;12(1):46. doi: 10.1186/s13012-017-0563-2.
PubMed 28376839
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION) (QUE 15-284)
- ClinicalTrials.gov ID
- NCT02942979
- Acronym / sponsor ID
- MISSION-HPACT / QUX 16-011
- Keywords
- Facilitation, Implementation, Homelessness, Substance Use Disorder, Mental Illness, Co-Occurring Disorders, Veterans, Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to implement wrap around services for Veterans suffering from co-occurring mental illness and substance use and who are homeless. It will compare Implementation as Usual of MISSION to Facilitation Implementation of MISSION.
Detailed description
Background: Homeless Veterans often have multiple health care and psychosocial needs, including assistance with access to housing and health care, as well as support for ongoing treatment engagement. The Department of Veterans Affairs (VA) developed specialized Homeless Patient Alignment Care Teams (HPACT) with the goal of offering an integrated, "one-stop program" to address the Housing and Healthcare needs of Homeless Veterans. However, while 70% of HPACT's Veteran enrollees have co-occurring mental health and substance use disorders (COD), HPACT does not have a uniform, embedded treatment protocol for this subpopulation. One wraparound intervention designed to address the needs of homeless Veterans with COD which is suitable to be integrated into HPACT clinic sites is the evidence-based practice called Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Veterans Edition, or MISSION-Vet. Despite the promise of MISSION-Vet within HPACT clinics, implementation of an evidence based intervention within a busy program like HPACT can be difficult. The current study is being undertaken to identify an appropriate implementation strategy for MISSION-Vet within HPACT. The study will test the implementation platform called Facilitation and compared to implementation as usual (IU).
Aims: (1) Compare the extent to which IU or Facilitation strategies achieve fidelity to the MISSION-Vet intervention as delivered by HPACT homeless provider staff. (2) Compare the effects of Facilitation and IU strategies on the National HPACT Performance Measures. (3) Compare the effects of IU and Facilitation on the permanent housing status. (4) Identify and describe key stakeholders' (patients, providers, staff) experiences with, and perspectives on, the barriers to, and facilitators of implementing MISSION.
Design: Type III Hybrid modified stepped wedge implementation comparing IU to Facilitation across 7 HPACT teams in 3 sites in the greater Los Angeles VA system.
Discussion: Integrating MISSION-Vet within HPACT has the potential to improve the health of thousands of Veterans but, it is crucial to implement the intervention appropriately in order for it to succeed. The lessons learned in this protocol could assist with a larger roll-out of MISSION within HPACT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MISSION Implementation as Usual | – | –Passive implementation or, IU for MISSION-Vet is comprised of a two-hour webinar training, along with key information on how to access and use the MISSION-Vet Treatment Manual and Consumer Workbook. The manual is posted on the web and available inside the VA on the National Center for Homelessness Among Veterans website or at missionmode.org. This passive implementation strategy has been used in previous studies |
| Facilitation Implementation of MISSION | – | –Facilitation is a comprehensive approach in which implementation experts partner with local staff to support implementation planning and to tailor adoption strategies to the local context. Facilitation gives attention to addressing individual- and organizational-level factors that can influence successful implementation of an evidence based practice with good fidelity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Homeless Veterans in the Greater Los Angeles VA system
Key inclusion criteria (7 listed)
- meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition diagnostic criteria of International Classification of Diseases, 10th Revision for a current substance abuse or dependence disorder, e.g.:
- or poly substance use and a co-occurring mental illness that includes anxiety, mood, or a psychotic spectrum disorder
- is willing to participate in the service
- is empaneled in HPACT at one of the study sites
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of MISSION Sessions Undertaken
Time frame: 12 months
Number of MISSION Sessions delivered to Veterans
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37090015Yakovchenko V, McCullough MB, Smith JL, Gabrielian S, Byrne T, Bruzios KE, Koosis E, Smelson DA. Implementing a complex psychosocial intervention for unstably housed Veterans: A realist-informed evaluation case study. Implement Res Pract. 2021 Oct 26;2:26334895211049483. doi: 10.1177/26334895211049483. eCollection 2021 Jan-Dec.
- Derived from this study: PubMed 35298514Smelson DA, Yakovchenko V, Byrne T, McCullough MB, Smith JL, Bruzios KE, Gabrielian S. Testing implementation facilitation for uptake of an evidence-based psychosocial intervention in VA homeless programs: A hybrid type III trial. PLoS One. 2022 Mar 17;17(3):e0265396. doi: 10.1371/journal.pone.0265396. eCollection 2022.
- Derived from this study: PubMed 28376839Simmons MM, Gabrielian S, Byrne T, McCullough MB, Smith JL, Taylor TJ, O'Toole TP, Kane V, Yakovchenko V, McInnes DK, Smelson DA. A Hybrid III stepped wedge cluster randomized trial testing an implementation strategy to facilitate the use of an evidence-based practice in VA Homeless Primary Care Treatment Programs. Implement Sci. 2017 Apr 4;12(1):46. doi: 10.1186/s13012-017-0563-2.
- Describes the intervention.Link provided by the sponsor.
- 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
VA Bedford HealthCare System, Bedford, MA
Allen L. Gifford, MD principal investigator
VA Bedford HealthCare System, Bedford, MA
Sonya Emi Gabrielian, MD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Co-Occurring Disorders and Homelessness, run by VA Office of Research and Development at 1 site 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 7 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Nov 2021). 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?
Number of MISSION Sessions Undertaken (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 NCT02942979, which also lists 3 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 21 Jul 2023.