ISRCTN - ISRCTN21059161: Population-based Outreach Services to Reduce Homelessness among Veterans with serious mental illness (SMI)

Plain English Summary

Background and study aims
Homelessness disproportionately affects Veterans with serious mental illness (SMI, e.g., schizophrenia, bipolar disorder). Many Veterans with SMI are at risk of homelessness because of substance use, unstable employment, and incarceration, and are disproportionately represented among Veterans who are chronically homeless. Moreover, Veterans with SMI who drop out of Veterans Affairs (VA) care are more likely to die than those engaged in VA care. A recent VA quality improvement project involving outreach to this population found that Veterans with SMI who reengaged in VA care had a 12-fold decreased risk of mortality compared to Veterans who were not brought back into care. The VA National Center on Homelessness among Veterans has sought to adapt this approach to reengage Veterans who are homeless or are risk of homelessness, starting with the most vulnerable groups (e.g., SMI). In addition, the VA Office of Mental Health Services recommended that the program be implemented in concert with ongoing recovery-oriented initiatives in the VA. This study seeks to test the effectiveness of two different program implementation frameworks to enhance the adoption of a national outreach program for Veterans. Specifically, the study will compare the effectiveness of using Enhanced REP compared to standard REP to enhance the uptake the national Re-Engage directive to implement brief care management program for patients with serious mental illness who have dropped out of care.

Who can participate?
The study includes all VA facilities in the United States and Puerto Rico with Veterans who were directed to implement Re-Engage, with the adaptive implementation intervention phases focusing on facilities that that did not initially implement Re-Engage in response to standard REP alone.

What does the study involve?
This is a four phase study.
Phase 1 Initial Run-in (01/01/2012 - 08/31/13): All VA facilities received standard REP implementation support through national trainings, standardized implementation materials, and technical support. VA administrative databases identified 2738 Veterans with SMI lost to follow-up and lists were disseminated to 158 sites for local recovery coordinators to attempt to reach and re-engage these Veterans in VA healthcare services. All outreach activities were documented on a VA intranet web site to monitor program process and provide feedback reports to regional leaders on a periodic basis.
Phase II (09/01/12 - 03/01/2013): Start of the adaptive treatment design where facilities who did not adequately implement Re-Engage (defined as documented less 80% of the disposition of Veterans lost-to follow-up for a facility) were randomly allocated by geographic region and VA regional network affiliation to receive either Enhanced REP (Facilitation consultations) or continued receipt of standard REP with passive technical assistance and usual feedback reports.
Phase III (03/01/2013 - 08/31/2013): Facilities that were initially randomized to Enhanced REP will return to receiving standard REP support, and facilities initially randomized to receive standard REP and that had not successfully implemented Re-Engage as of the end of Phase II will received Enhanced REP for the next 6 months.
Phase IV - Follow-up (8/31/2013 - 8/31/2014): Outcome monitoring at 18 and 24 months.

What are the possible benefits and risks of participating?
Knowledge gained from this study has the potential to help improve the dissemination and delivery through evaluation of the effectiveness of Faciliation as an program implementation strategy. Moreover, this program will potentially benefit the delivery of VA clinical care services for vulnerable groups of Veterans who could benefit from the application of population-based panel management and brief care management services as found in Re-Engage. There are no known risks to participating sites or Veterans.

Where is the study run from?
The study is run from the Center for Clinical Management Research at the Ann Arbor VA with the support of VA Mental Health Services and the VA Serious Mental Illness Treatment Resource & Evaluation Center.

When is the study starting and how long is it expected to run for?
January 2012 to August 2013.

Who is funding the study?
VA Health Services Research and Development (HSR&D), USA

Who is the main contact?
Principle Investigator: Dr. Amy M. Kilbourne, PhD, MPH (amykilbo@umich.edu)
Study Coordinator: Kristina M. Nord, MSW (kmnord@umich.edu)

Trial website

http://www.hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141701267

Contact information

Type

Scientific

Primary contact

Dr Amy Kilbourne

ORCID ID

Contact details

North Campus Research Complex
VA Center for Clinical Management Research
2800 Plymouth Rd
Bldg 16
Ann Arbor
48109
United States of America
+1 (0)734 845 5046
amykilbo@umich.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VA Health Services Research & Development SDR 11-232

Study information

Scientific title

Population-based Outreach Services to Reduce Homelessness among Veterans with SMI: a four-phase, clustered randomized trial

Acronym

Study hypothesis

The primary implementation outcome is program uptake of the VA Re-Engage clinical outreach program, defined as the percentage of Veterans' with SMI lost to care with an updated documentation of their clinical status, which is a central component of Re-Engage population management. The primary hypothesis is that among facilities not initially responding to use of the Centers for Disease Control and Prevention's Replicating Effective Program (REP) to guide Re-Engage implementation activities, the addition of Facilitation (Enhanced REP) will be associated with increased percentages of documented updates to Veterans' clinical status at 6, 12, 18, and 24 months after program implementation at sites receiving Facilitation versus those continuing to receive standard REP technical assistance. Secondary outcomes include facilities' percentage of Veterans who were provided brief care management, defined as 1) percentage contacted or 2) percentage returning to VA care. Additionally, we seek to explore whether among facilities that initially did not respond to standard REP, the immediate addition of Facilitation (Enhanced REP) is associated with better outcomes than receiving Facilitation after a six month delay.

Ethics approval

Ann Arbor VA Institutional Review Board, 01/02/2012

Study design

Four-phase clustered randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not applicable. The focus of this study is on site-level implementation factors. Patients are identified as part of VA routine care for outreach contacts.

Condition

Serious mental illnesses including schizophrenia, bipolar disorder, and schizoaffective disorder.

Intervention

Standard REP included the initial Implementation phase of Re-Engage, specifically:
1. Training providers in how to conduct the program
2. Technical assistance provided by research staff through regularly scheduled national phone calls and in response to specific requests from providers via email or phone to answer questions, provide information, troubleshoot various aspects of the treatment and its implementation
3. Evaluation of program outcomes provided on an ongoing basis to regional leadership and partners
4. Ongoing partnership support between policy makers and researchers, and
5. Feedback and refinement of processes as needed.

Enhanced REP included the addition of External Facilitation (EF), which has been defined as a process of interactive problem-solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The percentage of Veterans on each VA facility's outreach list whose clinical status has been updated in the Re-Engage web-based clinical registry assessed at the end the 6 month run-in period prior to randomization (08/31/2012) and 12, 18, and 24 months.

Secondary outcome measures

Assessed at 6, 12, 18, and 24 months:
1. The percentage of Veterans that the LRCs successfully contacted among those who were on their lists and still alive and able to be contacted directly
2. The percentage of Veterans who were contacted who re-engaged in VA healthcare services
3. All cause mortality for Veterans based on level of outreach (not contacted, contacted, contacted and re-engaged)
4. Health care utilization including number and length of inpatient hospitalizations, outpatient visits, and emergency department visits as well as use of recovery-oriented VA mental health, housing, and employment services. External Facilitation was delivered via telephone contacts for six months. Individual semi-structured calls with stakeholders lasted about 30 minutes and occurred approximately one to three times per month for each facility to accomplish the following steps: 1) gather information; 2) offer ongoing partnership support; 3) garner regional and local leadership support; 4) identify barriers and facilitators at each site; 5) collaboratively develop action plans; 6) link to resources; and 7) provide feedback on implementation progress.

Overall trial start date

01/09/2011

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

A VA facility was eligible for the current trial if it was included in the national VA Re-Engage program. VA facilities were included in the national Re-Engage program if they were:
1. Within the 50 United States or Puerto Rico
2. Were required, per VA policy to have a mental health provider who filled the role of a Local Recovery Coordinator
3. Had at least one Veteran with serious mental illness who was lost to care (i.e., had been seen at the facility in Fiscal Year 2008 or Fiscal Year 2009, but had no subsequent outpatient visits or an inpatient stay of less than 2 days as of January 2012). There were a total of 158 facilities eligible for Re-Engage, of which 139 were medical centers (i.e., with hospital beds) and 19 were community-based outpatient clinics.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,738 Veterans were initially identified for Re-Engage services and will be the basis for outcome measurement in this study.

Participant exclusion criteria

Sites were not eligible for Re-Engage if they were not required to have a Local Recovery Coordinator or acting point of contact for mental health recovery services.

Recruitment start date

01/09/2011

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

VA Center for Clinical Management Research
Ann Arbor
48109
United States of America

Sponsor information

Organisation

VA Health Services Research & Development (USA)

Sponsor details

810 Vermont Avenue
NW
Washington DC
20420
United States of America

Sponsor type

Government

Website

http://www.hsrd.research.va.gov/about/default.cfm

Funders

Funder type