Introduction Housing First is a complex housing and support intervention for homeless individuals with mental health problems. It has a sufficient knowledge base and interest to warrant a test of wide-scale implementation in various settings. This protocol describes the quantitative design of a Canadian five city, $110 million demonstration project and provides the rationale for key scientific decisions.
Methods A pragmatic, mixed methods, multi-site field trial of the effectiveness of Housing First in Vancouver, Winnipeg, Toronto, Montreal and Moncton, is randomising approximately 2500 participants, stratified by high and moderate need levels, into intervention and treatment as usual groups. Quantitative outcome measures are being collected over a 2-year period and a qualitative process evaluation is being completed. Primary outcomes are housing stability, social functioning and, for the economic analyses, quality of life. Hierarchical linear modelling is the primary data analytic strategy.
Ethics and dissemination Research ethics board approval has been obtained from 11 institutions and a safety and adverse events committee is in place. The results of the multi-site analyses of outcomes at 12 months and 2 years will be reported in a series of core scientific journal papers. Extensive knowledge exchange activities with non-academic audiences will occur throughout the duration of the project.
Trial registration number This study has been registered with the International Standard Randomised Control Trial Number Register and assigned ISRCTN42520374.
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To cite: Goering PN, Streiner DL, Adair C, et al. The At Home/Chez Soi trial protocol: a pragmatic, multi-site, randomised controlled trial of a Housing First intervention for homeless individuals with mental illness in five Canadian cities. BMJ Open 2011;1:e000323. doi:10.1136/bmjopen-2011-000323
Funding This work was supported by a contract from Health Canada administrated by the Mental Health Commission of Canada. Peer review of the grant applications was conducted through the Ontario Mental Health Foundation. Health Canada plays no role in the study design; collection, management, analysis and interpretation of data; writing of the report; or decisions to submit for publication. Some employees of the Mental Health Commission of Canada are research team members and do play a role in all of these activities. Ultimate authority over these issues rests with the university investigators.
Competing interests None.
Ethics approval The Centre for Addiction and Mental Health and 11 other IRBs approved this study.
Contributors PG and JB conceived the study. CA and DS led the design of the quantitative common protocol with the involvement of all authors. SH, EL, TA, JD and JS led the design of site-specific components. All authors, including JK and DZ, participated in the preparation of the manuscript by providing comments on drafts written by PG and DS and reading and approving the final version.
Provenance and peer review Not commissioned; externally peer reviewed.