Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION-HPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02942979
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease
Co-Occurring Disorders Homelessness Substance Abuse Disorder Mental Illness

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION) (QUE 15-284)
Actual Study Start Date : February 12, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 1, 2020

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.



Primary Outcome Measures :
  1. MISSION Fidelity [ Time Frame: 12 months ]
    The fidelity index consists of 78 items assessing the presence or absence of certain activities within MISSION-Vet, and will be captured in Veterans' electronic medical records. Together an overall fidelity to the model score will be computed for each Veteran. The presence or absence of the activities together produce the overall score.

  2. Inpatient Service Utilization [ Time Frame: 12 months ]
    The investigators will measure the number of medical, mental health and overall inpatient hospitalization days in each month of the study's observation period.

  3. VA National Homeless Registry [ Time Frame: 12 months ]
    Measures the number of days spent in VA specialized homeless programs (e.g. Grant and Per Diem, Domiciliary Care for Homeless Veterans, Supportive Services for Veteran Families rapid re-housing) for which Veterans meet the statutory definition of homelessness.

  4. Semi-Structured Interviews [ Time Frame: 12 months ]
    Semi-structured interviews will be conducted for a formative (FE). The FE interviews will elicit key stakeholders' experiences with, and perspectives on MISSION-Vet training, barriers and facilitators of implementing MISSION-Vet as well as to identify particular areas to target for Facilitation.

  5. Outpatient Service Utilization [ Time Frame: 12 Months ]
    The investigators will measure engagement in substance abuse services which will be measured by the number of outpatient visits in a VA substance abuse specialty clinic, which will be identified based on clinic stop codes, in each month of the study's observation period.

  6. VA National HOMES Registry [ Time Frame: 12 Months ]
    The investigators will measure of the number of days in VA permanent housing programs for which Veteran is considered housed.

  7. VA National HOMES Registry [ Time Frame: 12 Months ]
    The investigators will measure the number of days residing in the community (i.e. Veteran is in neither VA homeless or VA permanent housing programs) during each month of the study period.

  8. Semi-Structured Interviews [ Time Frame: 12 months ]
    Semi-structured interviews will be conducted for a summative evaluation (SE). Summative evaluation interviews will identify stakeholder's experiences with Facilitation and needed adaptations to MISSION-Vet as well as Veteran experiences with MISISON-Vet.


Secondary Outcome Measures :
  1. Evidence-Base Practice Attitudes Scale [ Time Frame: 12 months ]
    The Evidence-Based Practice Attitudes scale and the Organizational Support for Evidence-Based Practices scale will provide information on potential mediating factors. We will administer this measure to all HPACT staff annually throughout the study period.

  2. Organizational Support for Evidence Based Practice Scale [ Time Frame: 12 months ]
    Will provide information on potential, organization mediating factors.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Homeless Veterans in the Greater Los Angeles VA system
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942979


Contacts
Layout table for location contacts
Contact: David A Smelson, PsyD (781) 687-7778 david.smelson@va.gov

Locations
Layout table for location information
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Recruiting
Bedford, Massachusetts, United States, 01730
Contact: David A Smelson, PsyD    781-687-7778    david.smelson@va.gov   
Principal Investigator: Allen L. Gifford, MD         
Principal Investigator: David A. Smelson, PsyD         
Sponsors and Collaborators
VA Office of Research and Development
US Department of Veterans Affairs
Investigators
Layout table for investigator information
Principal Investigator: David A. Smelson, PsyD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Principal Investigator: Allen L. Gifford, MD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Principal Investigator: Sonya Emi Gabrielian, MD MPH VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02942979     History of Changes
Other Study ID Numbers: QUX 16-011
QUE 15-284 ( Other Identifier: VAHSRD )
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Facilitation
Implementation
Homelessness
Substance Use Disorder
Mental Illness
Co-Occurring Disorders
Veterans
Primary Care

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Substance-Related Disorders
Mental Disorders
Pathologic Processes
Chemically-Induced Disorders