Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial

Trials

Pascal Auquier⁶  Laurent Boyer⁶  Christophe Lançon²  Themis Apostolidis¹  Bruno Falissard⁴  Tim Greacen³  Pauline Rhenter⁶  Benjamin Videau⁶  Christian Laval⁶  Vincent Girard²  Cecile Fortanier⁵  Aurelie Tinland² 

[1] Aix-Marseille Université, LPS EA849, Aix-en-Provence 13621, France;Department of Psychiatry, Sainte-Marguerite University Hospital, Marseille 13009, France;Laboratoire de Recherche, Etablissement Public de Santé Maison Blanche, Paris, France;INSERM U669, Maison de Solenn, University Paris-Sud and University Paris-Descartes, Paris 75679, France;Department of Research and Innovation, Support Unit for clinical research and economic evaluation, Assistance Publique – Hôpitaux de Marseille, Marseille 13385, France;Aix-Marseille University, EA 3279 Research Unit, Marseille 13385, France

关键词: Randomized controlled trial;    Evaluation;    Mental illness;    Bipolar disorder;    Schizophrenia;    Homelessness;    Housing first program;   

Others  :  1093003
DOI  :  10.1186/1745-6215-14-309

 received in 2013-03-29, accepted in 2013-09-10,  发布年份 2013

【 摘 要 】

Background

Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France.

Method and design

A prospective randomized trial was designed to assess the impact of a Housing First intervention on health outcomes and costs over a period of 24 months on homeless people with severe mental illness, compared to Treatment-As-Usual. The study is being conducted in four cities in France: Lille, Marseille, Paris and Toulouse. The inclusion criteria are as follows: over 18 years of age, absolutely homeless or in precarious housing, and possessing a ‘high’ level of need: diagnosis of schizophrenia or bipolar disorder and moderate to severe disability according to the Multnomah Community Ability Scale (score ≤ 62) and at least one of the following three criteria: 1) having been hospitalized for mental illness two or more times in any one year during the preceding five years; 2) co-morbid alcohol or substance use; and 3) having been recently arrested or incarcerated. Participants will be randomized to receiving the Housing First intervention or Treatment-As-Usual. The Housing First intervention provides immediate access to independent housing and community care. The primary outcome criterion is the use of high-cost health services (that is,, number of hospital admissions and number of emergency department visits) during the 24-month follow-up period. Secondary outcome measures include health outcomes, social functioning, housing stability and contact with police services. An evaluation of the cost-effectiveness and cost-utility of Housing First will also be conducted. A total of 300 individuals per group will be included.

Discussion

This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context.

Trial registration

The current clinical trial number is NCT01570712

【 授权许可】

   
2013 Tinland et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Rossi PH, Wright JD, Fisher GA, Willis G: The urban homeless: estimating composition and size. Science 1987, 235:1336-1341.
• [2]OECD: Divided We stand: Why Inequality Keeps Rising. OECD Publishing; 2011. http://www.oecd.org/els/soc/dividedwestandwhyinequalitykeepsrising.htm webcite
• [3]Frankish CJ, Hwang SW, Quantz D: Homelessness and health in Canada: research lessons and priorities. Can J Public Health 2005, 96(Suppl 2):S23-S29.
• [4]Moore G, Manias E, Gerdtz MF: Complex health service needs for people who are homeless. Aust Health Rev 2011, 35:480-485.
• [5]Henry JM, Boyer L, Belzeaux R, Baumstarck-Barrau K, Samuelian JC: Mental disorders among homeless people admitted to a French psychiatric emergency service. Psychiatr Serv 2010, 61:264-271.
• [6]Kleindorfer DO, Lindsell C, Broderick J, Flaherty ML, Woo D, Alwell K, Moomaw CJ, Ewing I, Schneider A, Kissela BM: Impact of socioeconomic status on stroke incidence: a population-based study. Ann Neurol 2006, 60:480-484.
• [7]Wardle J, Steptoe A: Socioeconomic differences in attitudes and beliefs about healthy lifestyles. J Epidemiol Community Health 2003, 57:440-443.
• [8]Breakey WR, Fischer PJ, Kramer M, Nestadt G, Romanoski AJ, Ross A, Royall RM, Stine OC: Health and mental health problems of homeless men and women in Baltimore. JAMA 1989, 262:1352-1357.
• [9]Fazel S, Khosla V, Doll H, Geddes J: The prevalence of mental disorders among the homeless in western countries: systematic review and meta-regression analysis. PLoS Med 2008, 5:e225.
• [10]Folsom D, Jeste DV: Schizophrenia in homeless persons: a systematic review of the literature. Acta Psychiatr Scand 2002, 105:404-413.
• [11]Folsom DP, McCahill M, Bartels SJ, Lindamer LA, Ganiats TG, Jeste DV: Medical comorbidity and receipt of medical care by older homeless people with schizophrenia or depression. Psychiatr Serv 2002, 53:1456-1460.
• [12]Shinn M, Baumohl J, Hopper K: The prevention of homelessness revisited. Anal Soc Issues Public Policy 2001, 1:95-127.
• [13]Kuhn R, Culhane DP: Applying cluster analysis to test a typology of homelessness by pattern of shelter utilization: results from the analysis of administrative data. Am J Community Psychol 1998, 26:207-232.
• [14]Goering PN, Streiner DL, Adair C, Aubry T, Barker J, Distasio J, Hwang SW, Komaroff J, Latimer E, Somers J, Zabkiewicz DM: The At Home/Chez Soi trial protocol: a pragmatic, multi-site, randomized controlled trial of a Housing First intervention for homeless individuals with mental illness in five Canadian cities. BMJ Open 2011, 1:e000323.
• [15]Fitzpatrick-Lewis D, Ganann R, Krishnaratne S, Ciliska D, Kouyoumdjian F, Hwang SW: Effectiveness of interventions to improve the health and housing status of homeless people: a rapid systematic review. BMC Public Health 2011, 11:638. BioMed Central Full Text
• [16]Hwang SW, Tolomiczenko G, Kouyoumdjian FG, Garner RE: Interventions to improve the health of the homeless: a systematic review. Am J Prev Med 2005, 29:311-319.
• [17]Sahlin I: The Staircase of Transition. European Observatory on Homelessness, National report from Sweden 1997. Lund: Department of Sociology; 1998.
• [18]Tsemberis S, Gulcur L, Nakae M: Housing first, consumer choice, and harm reduction for homeless individuals with a dual diagnosis. Am J Public Health 2004, 94:651-656.
• [19]Padgett DK, Stanhope V, Henwood BF, Stefancic A: Substance use outcomes among homeless clients with serious mental illness: comparing housing first with treatment first programs. Community Ment Health J 2011, 47:227-232.
• [20]Greenwood RM, Schaefer-McDaniel NJ, Winkel G, Tsemberis SJ: Decreasing psychiatric symptoms by increasing choice in services for adults with histories of homelessness. Am J Community Psychol 2005, 36:223-238.
• [21]Stefancic A, Tsemberis S: Housing first for long-term shelter dwellers with psychiatric disabilities in a suburban county: a four-year study of housing access and retention. J Prim Prev 2007, 28:265-279.
• [22]Clifasefi SL, Malone DK, Collins SE: Exposure to project-based housing first is associated with reduced jail time and bookings. Int J Drug Policy 2012, 24(4):291-296. doi: 10.1016/j.drugpo.2012.10.002. Epub 2012 Nov 2
• [23]Larimer ME, Malone DK, Garner MD, Atkins DC, Burlingham B, Lonczak HS, Tanzer K, Ginzler J, Clifasefi SL, Hobson WG, Marlatt GA: Health care and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems. JAMA 2009, 301:1349-1357.
• [24]Rosenheck R, Kasprow W, Frisman L, Liu-Mares W: Cost-effectiveness of supported housing for homeless persons with mental illness. Arch Gen Psychiatry 2003, 60:940-951.
• [25]Atherton I, Nicholls CM: ‘Housing First’ as a means of addressing multiple needs and homelessness. Eur J Homelessness 2008, 2:289-303.
• [26]Rodwin VG: The health care system under French national health insurance: lessons for health reform in the United States. Am J Public Health 2003, 93:31-37.
• [27]Verdoux H: The current state of adult mental health care in France. Eur Arch Psychiatry Clin Neurosci 2007, 257:64-70.
• [28]Duflo E: Scaling up and evaluation. In Accelerating Development. Edited by Francois B, Boris P. Oxford, UK and Washington, DC: Oxford University Press and World Bank; 2004.
• [29]Duflo E, Kremer M: Use of randomization in the evaluation of development effectiveness. In Evaluating Development Effectiveness (World Bank Series on Evaluation and Development, Volume 7. Edited by Osvaldo F, Ingram GK, Pitman GK. New Brunswick, NJ: Transaction Publishers; 2004:205-232.
• [30]Girard V, Estecahandy P, Chauvin P: Rapport. La santé des personnes sans chez soi - Plaidoyer et propositions pour un accompagnement des personnes à un rétablissement social et citoyen, Ministère de la santé et des sports. Paris: For French Government; 2010:236.
• [31]APA: DSM-IV. Diagnostic and Statistical Manual of Mental Disorders, Text revised. 4th edition. Washington, DC: American Psychiatric Association; 2000.
• [32]Barker S, Barron N, McFarland BH, Bigelow DA: A community ability scale for chronically mentally ill consumers: part I, Reliability and validity. Community Ment Health J 1994, 30:363-383.
• [33]Barker S, Barron N, McFarland BH, Bigelow DA, Carnahan T: A community ability scale for chronically mentally ill consumers: part II, applications. Community Ment Health J 1994, 30:459-472.
• [34]Jeste DV, Saks E: Decisional capacity in mental illness and substance use disorders: empirical database and policy implications. Behav Sci Law 2006, 24:607-628.
• [35]Girard V, Sarradon-Eck A, Payan N, Bonin JP, Perrot S, Vialars V, Boyer L, Tinland A, Simeoni MC: The analysis of a mobile mental health outreach team activity: from psychiatric emergencies on the street to practice of hospitalization at home for homeless people. Presse Med 2012, 41:e226-e237.
• [36]Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: The mini-international neuropsychiatric interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998, 59(Suppl 20):22-33. Quiz 34–57
• [37]Daly J, Willis K, Small R, Green J, Welch N, Kealy M, Hughes E: A hierarchy of evidence for assessing qualitative health research. J Clin Epidemiol 2007, 60:43-49.
• [38]Fitzpatrick R, Boulton M: Qualitative methods for assessing health care. Qual Health Care 1994, 3:107-113.
• [39]Fitzpatrick R, Boulton M: Qualitative research. Lancet 1996, 348:127-128.
• [40]Morrissey JP, Domino ME, Cuddeback GS: Assessing the effectiveness of recovery-oriented ACT in reducing state psychiatric hospital use. Psychiatr Serv 2012, 64(4):303-311. doi: 10.1176/appi.ps.201200095
• [41]Conrad KJ, Yagelka JR, Matters MD, Rich AR, Williams V, Buchanan M: Reliability and validity of a modified Colorado symptom index in a national homeless sample. Ment Health Serv Res 2001, 3:141-153.
• [42]Guy W: Clinical Global Impression, ECDEU assessment manual for psychopharmacology (revised). National Institute of Mental Health; 1976:217-221. http://archive.org/details/ecdeuassessmentm1933guyw webcite
• [43]Leucht S, Engel RR: The relative sensitivity of the clinical global impressions scale and the brief psychiatric rating scale in antipsychotic drug trials. Neuropsychopharmacology 2006, 31:406-412.
• [44]Leucht S, Kane JM, Etschel E, Kissling W, Hamann J, Engel RR: Linking the PANSS, BPRS, and CGI: clinical implications. Neuropsychopharmacology 2006, 31:2318-2325.
• [45]Thompson K, Kulkarni J, Sergejew AA: Reliability and validity of a new medication adherence rating scale (MARS) for the psychoses. Schizophr Res 2000, 42:241-247.
• [46]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care 1992, 30:473-483.
• [47]Boyer L, Simeoni MC, Loundou A, D’Amato T, Reine G, Lancon C, Auquier P: The development of the S-QoL 18: a shortened quality of life questionnaire for patients with schizophrenia. Schizophr Res 2010, 121:241-250.
• [48]Auquier P, Simeoni MC, Sapin C, Reine G, Aghababian V, Cramer J, Lancon C: Development and validation of a patient-based health-related quality of life questionnaire in schizophrenia: the S-QoL. Schizophr Res 2003, 63:137-149.
• [49]Group TE: EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
• [50]Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L: Examining the factor structure of the recovery assessment scale. Schizophr Bull 2004, 30:1035-1041.
• [51]Knapp M, Mangalore R, Simon J: The global costs of schizophrenia. Schizophr Bull 2004, 30:279-293.
• [52]Mangalore R, Knapp M: Cost of schizophrenia in England. J Ment Health Policy Econ 2007, 10:23-41.
• [53]van Roijen L, Essink-Bot ML, Koopmanschap MA, Bonsel G, Rutten FF: Labor and health status in economic evaluation of health care, the health and labor questionnaire. Int J Technol Assess Health Care 1996, 12:405-415.
• [54]Sadowski LS, Kee RA, VanderWeele TJ, Buchanan D: Effect of a housing and case management program on emergency department visits and hospitalizations among chronically ill homeless adults: a randomized trial. JAMA 2009, 301:1771-1778.
• [55]HAS: A Methodological Guide: Choices in Methods for Economic Evaluation. Haute Autorité de santé: Department of Economics and Public Health Assessment; 2012.
• [56]CES: Methodological Recommendations: French Guidelines for the Economic Evaluation of Health Care Technologies. Paris . France: The French Health Economists Association; 2004.
• [57]Koopmanschap MA, Rutten FF: A practical guide for calculating indirect costs of disease. Pharmacoeconomics 1996, 10:460-466.
• [58]Koopmanschap MA, Rutten FF, van Ineveld BM, van Roijen L: The friction cost method for measuring indirect costs of disease. J Health Econ 1995, 14:171-189.
• [59]Roe D, Mashiach-Eizenberg M, Lysaker PH: The relation between objective and subjective domains of recovery among persons with schizophrenia-related disorders. Schizophr Res 2011, 131:133-138.
• [60]WMA: Declaration of Helsinki. 6th edition. Edinburgh: World Medical Association; 2008.
• [61]Hwang SW, Stergiopoulos V, O’Campo P, Gozdzik A: Ending homelessness among people with mental illness: the At Home/Chez Soi randomized trial of a housing first intervention in Toronto. BMC Public Health 2012, 12:787. BioMed Central Full Text
• [62]Macpherson H: Pragmatic clinical trials. Complement Ther Med 2004, 12:136-140.
• [63]Banerjee AV, Duflo E: The experimental approach to development economics. Ann Rev Econ 2009, 1:151-178.
• [64]Heckman JJ: Randomization and social policy evaluation. In Evaluating Welfare and Training Programs. Edited by Charles M, Garfinkel I. Cambridge, MA: Harvard University Press; 1992.
• [65]Bradley EH, Curry LA, Devers KJ: Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res 2007, 42:1758-1772.
• [66]Curry LA, Nembhard IM, Bradley EH: Qualitative and mixed methods provide unique contributions to outcomes research. Circulation 2009, 119:1442-1452.