Condition category
Not Applicable
Date applied
07/08/2012
Date assigned
09/10/2012
Last edited
26/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Homelessness is an increasingly prevalent problem in many countries, and is associated with significant personal and financial costs to society. Mental health problems, including drug use, may precede or be a consequence of homelessness. Research is required to compare the relative effectiveness and costs of different interventions for people who are homeless and who have different levels of health or social needs. This study aims to compare two models of service for people who are homeless, have some form of mental disorder, and require a moderate level of support.

Who can participate?
Up to 200 participants will be recruited through agencies and providers who are in contact with homeless adults (19 years of age or older) in Vancouver BC. Participants must have been homeless in the past year, have a current mental disorder and exhibit moderate challenges with community functioning in order to be enrolled in the study.

What does the study involve?
Participants will be randomly allocated to either: scattered Housing First with Intensive Case Management (ICM); or Treatment As Usual (TAU).
Housing First offers homeless people with mental illness immediate access to independent apartments with a market lease, without any requirements around sobriety or engagement in treatment. Housing First participants are provided access to an array of treatment and social services, but they retain the right to choose their level of participation.
Intensive Case Management (ICM) provides support to people via a case manager working a standard work week and carrying a case load of roughly 20 clients. ICM provides limited direct care and otherwise aims to engage clients with relevant health and social services as indicated (i.e., a brokerage model).
Participants are asked to complete interviews every three months for 24 months. In addition, participants are asked to provide their consent for researchers to receive information from government departments detailing their use of various publicly-funded services, including health, social assistance, and justice. These data will be used to evaluate the impact of each intervention over the two-year trial period, and will be refreshed after completion of the trial in 2013 in order to assess the long-term health and welfare of study participants.

What are the possible benefits and risks of participating?
Benefits to participants include the opportunity for allocation to housing and care, as well as regular meetings with interviewers who may direct participants to appropriate resources in the community based on the participant’s needs. The study results will lead to improvements in long-term housing and support for participants and others as well. Risks include potential disappointment if randomized to Treatment As Usual, as well as the possibility that housing and support could be discontinued in April 2013 when study support for these services terminates.

Where is the study run from?
Simon Fraser University (Canada)

When is the study starting and how long is it expected to run for?
October 2010 to December 2013

Who is funding the study?
Health Canada and The Mental Health Commission of Canada (MHCC)

Who is the main contact?
Karen Fryer
kfryer@sfu.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julian Somers

ORCID ID

Contact details

Faculty of Health Sciences
Simon Fraser University
8888 University Drive
Burnaby
V5A 1S6
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Research demonstration project on homelessness and mental health - Vancouver BC

Acronym

VAHS (Vancouver At Home Study)

Study hypothesis

Individuals assigned to Housing First plus Intensive Case Management will have superior outcomes (i.e., health, quality of life, housing stability, emergency service use, justice system contacts) than individuals assigned to Treatment as Usual.

Ethics approval

1. Research Ethics Board at Simon Fraser University (primary site), 22/06/2009
2. University of British Columbia, 28/07/2009
3. Providence Healthcare, 30/08/2011
4. Vancouver Coastal Health Research Institute, 30/09/2011

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Homelessness, mental illness, substance dependence, comorbid medical

Intervention

Participants will be randomly assigned to either: scattered Housing First with Intensive Case Management (ICM); or Treatment As Usual (TAU).

Housing First (Tsemberis & Eisenberg, 2000) offers homeless people with mental illness immediate access to independent apartments with a market lease, without any requirements around sobriety or engagement in treatment. Housing First participants are provided access to an array of treatment and social services, but they retain the right to choose their level of participation.

Intensive Case Management (ICM) provides support to people via a case manager working a standard work week and carrying a case load of roughly 20 clients. ICM provides limited direct care and otherwise aims to engage clients with relevant health and social services as indicated (i.e., a brokerage model).

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 23/07/2015:
Housing stability and mental health outcomes.

Previous primary outcome measures:
1. Service use changes drawn from administrative data concerning healthcare, social services, and justice system events.
2. Costs related to these events in relation to costs of providing services.
Sources of data for these measures are the government departments responsible for health, justice, and social welfare services. Data will be collected pending participant consent for access. Data will be requested for several years prior to participant enrollment in the Vancouver At Home Study, and will be refreshed following the completion of the 24-month study period in order to monitor longer-term changes in the level and type of service use associated with participants in the years following the completion of the study.

Secondary outcome measures

Current secondary outcome measures as of 23/07/2015:
1. Quality of life
2. Emergency service use and costs
3. Trauma symptoms and harm to self or other
4. Employment
5. Physical health
6. Substance use and related problems

Previous secondary outcome measures:
Numerous questionnaires and additional cross-sectional sources of data include qualitative interviews and physical health examinations with subsets of the total study cohort. These additional measures are gathered to characterize the sample and better understand participant experiences but they are not considered outcome measures.

Overall trial start date

01/01/2009

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Legal adult status (19 years of age or over)
2. Presence of a current mental disorder, and
3. Being absolutely homeless or precariously housed.
3.1. Absolute homelessness was defined as living on the streets or in a shelter for at least two weeks during the past year.
3.2. Precariously housed was defined as living in a rooming house, hotel or other form of transitional housing with at least one episode of absolute homelessness in the past year.

Added 23/07/2015:
4. Moderate needs based on Multnomah Community Assessment Scale.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

This trial (RCT1) includes approx. 200 people. 500 (RCT1 and RCT2 combined)

Participant exclusion criteria

Added 23/07/2015:
1. Not Canadian citizen
2. Current treatment with Case Management or Assertive Community Treatment

Recruitment start date

14/10/2009

Recruitment end date

06/05/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Simon Fraser University
Burnaby
V5A 1S6
Canada

Sponsor information

Organisation

Mental Health Commission of Canada (Canada)

Sponsor details

10301 Southport Lane
SW Suite 800
Calgary
T2W 1S7
Canada

Sponsor type

Government

Website

http://www.mentalhealthcommission.ca

Funders

Funder type

Government

Funder name

Mental Health Commission of Canada (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health Canada (Canada)

Alternative name(s)

Santé Canada

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Protocol (30/09/2013), results (housing stability: 28/02/2016; client questionnaire results: 30/09/2016; service use – administrative data: 31/05/2016)

Intention to publish date

28/02/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24176253
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25492272
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26912081

Publication citations

  1. Results

    Somers JM, Patterson ML, Moniruzzaman A, Currie L, Rezansoff SN, Palepu A, Fryer K, Vancouver At Home: pragmatic randomized trials investigating Housing First for homeless and mentally ill adults., Trials, 2013, 14, 365, doi: 10.1186/1745-6215-14-365.

  2. Results

    Zabkiewicz DM, Patterson M, Wright A, A cross-sectional examination of the mental health of homeless mothers: does the relationship between mothering and mental health vary by duration of homelessness?, BMJ Open, 2014, 4, 12, e006174, doi: 10.1136/bmjopen-2014-006174.

  3. Results

    Somers JM, Moniruzzaman A, Currie L, Rezansoff SN, Russolillo A, Parpouchi M, Accuracy of reported service use in a cohort of people who are chronically homeless and seriously mentally ill, BMC Psychiatry, 2016 , 16, 1, 41, doi: 10.1186/s12888-016-0758-0.

Additional files

Editorial Notes

26/02/2016: Publication reference added.