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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

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          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.

          Article summary

          Article focus
          • An evaluation of the cost-effectiveness of Housing First in comparison to treatment as usual for homeless adults with mental illness in five Canadian cities with a 2-year follow-up.

          • Primary outcomes include housing stability, quality of life and social functioning.

          • The correlates of different trajectories and the critical ingredients of the intervention for sub-populations will also be investigated.

          Key messages
          • The first and largest multi-site trial of this complex housing and support intervention will provide information about implementation and outcomes.

          • The addition of site specific intervention arms to a core common protocol will allow investigation of innovative adaptations that are tailored to local context.

          • The inclusion of a broader homeless population receiving a less intensive service model will increase the policy relevance of findings.

          Strengths and limitations of this study
          • A larger sample size (n=2500) and a wider range of outcome variables than in previous trials are strengths of this study.

          • This study utilises a concomitant mixed methods process evaluation that includes fidelity assessments.

          • Variation in sample characteristics and in treatment as usual across five cities may limit opportunities for aggregate analyses.

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          Most cited references20

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          EuroQol: the current state of play.

          R. Brooks (1996)
          The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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            The estimation of a preference-based measure of health from the SF-12.

            The SF-12 is a multidimensional generic measure of health-related quality of life. It has become widely used in clinical trials and routine outcome assessment because of its brevity and psychometric performance, but it cannot be used in economic evaluation in its current form. We sought to derive a preference-based measure of health from the SF-12 for use in economic evaluation and to compare it with the original SF-36 preference-based index. The SF-12 was revised into a 6-dimensional health state classification (SF-6D [SF-12]) based on an item selection process designed to ensure the minimum loss of descriptive information. A sample of 241 states defined by the SF-6D (of 7500) have been valued by a representative sample of 611 members of the UK general population using the standard gamble (SG) technique. Models are estimated of the relationship between the SF-6D (SF-12) and SG values and evaluated in terms of their coefficients, overall fit, and the ability to predict SG values for all health states. The models have produced significant coefficients for levels of the SF-6D (SF-12), which are robust across model specification. The coefficients are similar to those of the SF-36 version and achieve similar levels of fit. There are concerns with some inconsistent estimates and these have been merged to produce the final recommended model. As for the SF-36 model, there is evidence of over prediction of the value of the poorest health states. The SF-12 index provides a useful tool for researchers and policy makers wishing to assess the cost-effectiveness of interventions.
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              Health care and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems.

              Chronically homeless individuals with severe alcohol problems often have multiple medical and psychiatric problems and use costly health and criminal justice services at high rates. To evaluate association of a "Housing First" intervention for chronically homeless individuals with severe alcohol problems with health care use and costs. Quasi-experimental design comparing 95 housed participants (with drinking permitted) with 39 wait-list control participants enrolled between November 2005 and March 2007 in Seattle, Washington. Use and cost of services (jail bookings, days incarcerated, shelter and sobering center use, hospital-based medical services, publicly funded alcohol and drug detoxification and treatment, emergency medical services, and Medicaid-funded services) for Housing First participants relative to wait-list controls. Housing First participants had total costs of $8,175,922 in the year prior to the study, or median costs of $4066 per person per month (interquartile range [IQR], $2067-$8264). Median monthly costs decreased to $1492 (IQR, $337-$5709) and $958 (IQR, $98-$3200) after 6 and 12 months in housing, respectively. Poisson generalized estimating equation regressions using propensity score adjustments showed total cost rate reduction of 53% for housed participants relative to wait-list controls (rate ratio, 0.47; 95% confidence interval, 0.25-0.88) over the first 6 months. Total cost offsets for Housing First participants relative to controls averaged $2449 per person per month after accounting for housing program costs. In this population of chronically homeless individuals with high service use and costs, a Housing First program was associated with a relative decrease in costs after 6 months. These benefits increased to the extent that participants were retained in housing longer.
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                Author and article information

                Journal
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2011
                14 November 2011
                14 November 2011
                : 1
                : 2
                : e000323
                Affiliations
                [1 ]Department of Psychiatry, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada
                [2 ]Department of Psychiatry, McMaster University, Hamilton, Ontario, Canada
                [3 ]University of Toronto, Toronto, Ontario, Canada
                [4 ]Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada
                [5 ]Centre for Research on Educational and Community Services, University of Ottawa, Ottawa, Ontario, Canada
                [6 ]Mental Health Commission of Canada 2008–2011, Calgary, Alberta, Canada
                [7 ]Institute of Urban Studies, University of Winnipeg, Winnipeg, Manitoba, Canada
                [8 ]St Michaels Hospital, University of Toronto, Toronto, Ontario, Canada
                [9 ]Douglas Institute, Conseil des pairs of the Montreal site, Montreal, Quebec, Canada
                [10 ]Douglas Institute, McGill University, Montreal, Quebec, Canada
                [11 ]Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada
                [12 ]Centre for Applied Research in Mental Health and Addiction, Simon Fraser University, Vancouver, British Columbia, Canada
                Author notes
                Correspondence to Dr Paula N Goering; paula_goering@ 123456camh.net
                Article
                bmjopen-2011-000323
                10.1136/bmjopen-2011-000323
                3221290
                22102645
                625cf933-3961-4482-bef5-21a6b014137b
                © 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

                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.

                History
                : 19 August 2011
                : 30 September 2011
                Categories
                Health Services Research
                Protocol
                1506
                1704
                1712
                1725

                Medicine
                Medicine

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