Clinical trial NCT02942979: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking
Official title: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION) (QUE 15-284)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Co-Occurring Disorders
Homelessness
Substance Abuse Disorder
Mental Illness
Keywords: Facilitation
Implementation
Homelessness
Substance Use Disorder
Mental Illness
Co-Occurring Disorders
Veterans
Primary Care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2016-10-24
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Homeless Veterans in the Greater Los Angeles VA system

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of MISSION Sessions Undertaken
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: David A. Smelson, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Allen L. Gifford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Sonya Emi Gabrielian, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.