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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
  1. Paula N Goering1,
  2. David L Streiner2,3,
  3. Carol Adair4,
  4. Tim Aubry5,
  5. Jayne Barker6,
  6. Jino Distasio7,
  7. Stephen W Hwang8,
  8. Janina Komaroff9,
  9. Eric Latimer10,
  10. Julian Somers11,
  11. Denise M Zabkiewicz12
  1. 1Department of Psychiatry, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada
  2. 2Department of Psychiatry, McMaster University, Hamilton, Ontario, Canada
  3. 3University of Toronto, Toronto, Ontario, Canada
  4. 4Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada
  5. 5Centre for Research on Educational and Community Services, University of Ottawa, Ottawa, Ontario, Canada
  6. 6Mental Health Commission of Canada 2008–2011, Calgary, Alberta, Canada
  7. 7Institute of Urban Studies, University of Winnipeg, Winnipeg, Manitoba, Canada
  8. 8St Michaels Hospital, University of Toronto, Toronto, Ontario, Canada
  9. 9Douglas Institute, Conseil des pairs of the Montreal site, Montreal, Quebec, Canada
  10. 10Douglas Institute, McGill University, Montreal, Quebec, Canada
  11. 11Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada
  12. 12Centre for Applied Research in Mental Health and Addiction, Simon Fraser University, Vancouver, British Columbia, Canada
  1. Correspondence to Dr Paula N Goering; paula_goering{at}camh.net

Abstract

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.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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Footnotes

  • 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.