- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942979
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION-HPACT)
Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION) (QUE 15-284)
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Does not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of MISSION Sessions Undertaken
Time Frame: 12 months
|
Number of MISSION Sessions delivered to Veterans
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sonya Emi Gabrielian, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- Principal Investigator: David A. Smelson, PsyD, VA Bedford HealthCare System, Bedford, MA
- Principal Investigator: Allen L. Gifford, MD, VA Bedford HealthCare System, Bedford, MA
Publications and helpful links
General Publications
- Smelson 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.
- Simmons 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUX 16-011
- QUE 15-284 (Other Grant/Funding Number: HSR&D QUERI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Illness
-
McMaster UniversitySt. Joseph's Healthcare HamiltonNot yet recruitingSerious Mental IllnessCanada
-
Vrije Universiteit BrusselMondriaanNot yet recruitingMental Illness PersistentNetherlands
-
Temple UniversityRecruiting
-
Shalvata Mental Health CenterActive, not recruitingSevere Mental IllnessIsrael
-
King's College LondonSouth London and Maudsley NHS Foundation TrustCompletedSevere Mental IllnessUnited Kingdom
-
VA Office of Research and DevelopmentCompleted
-
Oulu University HospitalUniversity of OuluRecruiting
-
University of GroningenLentis Psychiatric Institute; GGZ Friesland; Stichting CosisRecruitingSevere Mental IllnessNetherlands
-
Shalvata Mental Health CenterRecruitingSevere Mental IllnessIsrael
-
VA Office of Research and DevelopmentWithdrawn