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BMC Psychiatry
Published in: BMC Psychiatry 1/2013

Open Access 01-12-2013 | Study protocol

Effectiveness and efficiency of assertive outreach for Schizophrenia in Germany: study protocol on a pragmatic quasi-experimental controlled trial

Authors: Anke Bramesfeld, Jörn Moock, Kirsten Kopke, Dorothea Büchtemann, Denise Kästner, Jeanett Radisch, Wulf Rössler

Published in: BMC Psychiatry | Issue 1/2013

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Abstract

Background

A model of assertive outreach (AO) in which office-based psychiatrists collaborate with ambulatory nursing services for providing intensive home-treatment is currently being implemented in rural areas of Lower Saxony, Germany. The costs of the model are reimbursed by some of the statutory health insurance companies active in Lower Saxony. Effectiveness and efficiency of this model for patients suffering from schizophrenia is evaluated in a pragmatic and prospective trial.

Methods

Quasi-experimental controlled trial: patients receiving the intervention are all those receiving AO; controls are patients not eligible for AO based on their health insurance affiliation. Eligibility criteria: clinical diagnosis of schizophrenia (ICD-10 F.20), aged at least 18 years and being moderately to severely impaired in global functioning. Primary outcome: admission and days spent in psychiatric inpatient care; secondary outcomes: clinical and functional status; patient satisfaction with chronic care; health care costs. Follow-up time: 6 and 12 months.

Discussion

The study faces many challenges typical to pragmatic trials such as the rejection of randomisation by service providers, the quality of treatment as usual (TAU) to which the intervention will be compared, and the impairment of the study subjects. Solutions of how to deal with these challenges are presented and discussed in detail.

Trial registration

International Standard Randomised Controlled Trial Number: http://ISRCTN34900108, German Clinical Trial Register: http://DRKS00003351
Literature
1.
WHO/ OMS: Rapport sur la santé dans le monde, La santé mentale: Nouvelle conception, nouveaux éspoirs. 2001, Genève: Organisation Mondial de la Santé, 2001-
2.
WHO: Mental Health Declaration for Europe Facing the Challenges, Building Solutions, Helsinki 12–15.January 2005 edn. 2005, Helsinki
3.
Bachrach L: Continuity of care for chronic mental patients: a conceptual analysis. Am J Psychiatry. 1981, 138: 1449-1456.CrossRefPubMed
4.
Adair C, McDougall G, Mitton C, Joyce A, Wild T, Gordon A: Continuity of care and health outcomes among persons with severe mental illness. Psychiatr Serv. 2005, 56: 1061-1069. 10.1176/appi.ps.56.9.1061.CrossRefPubMed
5.
Dixon L: Assertive community treatment: twenty-five years of gold. Psychiatr Serv. 2000, 51: 759-765. 10.1176/appi.ps.51.6.759.CrossRefPubMed
6.
Burns T, Catty J, Wright C: De-constructing home-based care for mental illness: can one identify the effective ingredients?. Acta Psychiatr Scand Suppl. 2006, 429: 33-35.CrossRefPubMed
7.
Catty J, Burns T, Knapp M, Watt H, Wright C, Henderson J: Home treatment for mental health problems: a systematic review. Psychol Med. 2002, 32: 383-401.CrossRefPubMed
8.
Burns T, Raftery J, Beadsmoore A, McGuigan S, Dickson M: A controlled trial of home-based acute psychiatric services. II: treatment patterns and costs. Br J Psychiatry. 1993, 163: 55-61. 10.1192/bjp.163.1.55.CrossRefPubMed
9.
Burns T, Beadsmoore A, Bhat AV, Oliver A, Mathers C: A controlled trial of home-based acute psychiatric services. I: clinical and social outcome. Br J Psychiatry. 1993, 163: 49-54. 10.1192/bjp.163.1.49.CrossRefPubMed
10.
Sytema S, Wunderink L, Bloemers W, Roorda L, Wiersma D: Assertive community treatment in the Netherlands: a randomized controlled trial. Acta Psychiatr Scand. 2007, 116: 105-112. 10.1111/j.1600-0447.2007.01021.x.CrossRefPubMed
11.
Bhugra D, Ayonrinde O, Butler G, Leese M, Thornicroft G: A randomised controlled trial of assertive outreach vs. treatment as usual for black people with severe mental illness. Epidemiol Psychiatr Sci. 2011, 20: 83-89. 10.1017/S2045796011000151.CrossRefPubMed
12.
Salize H-J, Rössler W, Becker T: Mental health care in Germany. Eur Arch Psychiatry Clin Neurosci. 2007, 257: 92-103. 10.1007/s00406-006-0696-9.CrossRefPubMed
13.
Winter JP, Calsyn RJ: The Dartmouth Assertive Community Treatment Scale (DACTS). A generalizability study. Eval Rev. 2000, 24: 319-338. 10.1177/0193841X0002400304.CrossRefPubMed
14.
Saß H, Wittchen H, Zaudig M: Skala zur Globalbeurteilung des Funktionsniveaus für DSM-IV. Diagnostisches und statistisches Manual psychischer Störungen. Edited by: Saß H, Wittchen H, Zaudig M. 1996, Göttingen: Hogrefe,
15.
Overall J, Gorham D: The brief psychiatric rating scale. Psychol Rep. 1962, 10: 799-812. 10.2466/pr0.1962.10.3.799.CrossRef
16.
Wagner GG: Wie die 11er-Skala in das SOEP kam - Ein Beitrag zu den Problemen und Möglichkeiten multidisziplinärer Forschung und zugleich eine Fußnote zum Design der SOEP-Stichprobe. Arbeitsmarkt- und Sozialpolitikforschung im Wandel: Festschrift für Christof Helberger zum 65. Geburtstag. Edited by: Schwarze J, Räbiger J, Thiede R. 2007, Hamburg: Verlag Dr. Kovac, 41-62.
17.
Üstün TB, Kostanjesek N, Chatterji S, Rehm J: Measuring Health and Disability: Manual for WHO Disability Assessment Schedule (WHODAS 2.0). 2010, Geneva: WHO
18.
Mueser KT, Drake R, Clark R, McHugo G, Mercer-McFadden C, Ackerson TH: Toolkit for evaluating substance abuse in persons with severe mental illness. 1995, Cambridge, MA: Center at Human Services Research Institute
19.
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. 10.1016/S0920-9964(99)00130-9.CrossRefPubMed
20.
Gugiu PC, Coryn C, Clark R, Kuehn A: Development and evaluation of the short version of the patient assessment of chronic illness care instrument. Chronic Illn. 2009, 5: 268-276. 10.1177/1742395309348072.CrossRefPubMed
21.
Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B: Client socio-demographic and service receipt inventory–European version: development of an instrument for international research. EPSILON study 5. European psychiatric services: inputs linked to outcome domains and needs. Br J Psychiatry Suppl. 2000, 39: s28-s33.CrossRefPubMed
22.
Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer M: German adaptation of the client sociodemographic and service receipt inventory - an instrument for the cost of mental health care. Psychiatr Prax. 2001, 28 (Suppl 2): S84-S90.CrossRefPubMed
23.
Kilian R, Roick C, Matschinger H, Bernert S, Mory C, Angermeyer MC: The analysis of the cost structures of the treatment of schizophrenia by means of standardized assessment instruments. Psychiatr Prax. 2001, 28 (Suppl 2): S102-S108.CrossRefPubMed
24.
Rosemann T, Laux G, Droesemeyer S, Gensichen J, Szecsenyi J: Evaluation of a culturally adapted German version of the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire in a sample of osteoarthritis patients. J Eval Clin Pract. 2007, 13: 806-813. 10.1111/j.1365-2753.2007.00786.x.CrossRefPubMed
25.
Gensichen J, Muth C, Butzlaff M, Rosemann T, Raspe H, Müller de Cornejo G: Die Zukunft ist chronisch: das Chronic Care-Modell in der deutschen Primärversorgung. Übergreifende Behandlungsprinzipien einer proaktiven Versorgung für chronische Kranke. Zeitschr ärztl Fortb Qual Gesundheitswesen. 2006, 100: 365-374.
26.
Gensichen J, von Korff M, Peitz M, Muth C, Beyer M, Guthlin C: Case management for depression by health care assistants in small primary care practices: a cluster randomized trial. Ann Intern Med. 2009, 151: 369-378.CrossRefPubMed
27.
Kilian R, Matschinger H, Becker T, Angermeyer MC: A longitudinal analysis of the impact of social and clinical characteristics on the costs of schizophrenia treatment. Acta Psychiatr Scand. 2003, 107: 351-360. 10.1034/j.1600-0447.2003.00072.x.CrossRefPubMed
28.
Puschner B, Steffen S, Gaebel W, Freyberger H, Klein HE, Steinert T: Needs-oriented discharge planning and monitoring for high utilisers of psychiatric services (NODPAM): design and methods. BMC Health Serv Res. 2008, 8: 152-10.1186/1472-6963-8-152.CrossRefPubMedPubMedCentral
29.
Hedeker D, Gibbons RD, Waternaux C: Sample size estimation for longitudinal designs with attrition: comparing time-related contrasts between two groups. J Educ Behav Stat. 1999, 24: 70-93.CrossRef
30.
Des Jarlais DC, Lyles C, Crepaz N: Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004, 94: 361-366. 10.2105/AJPH.94.3.361.CrossRefPubMedPubMedCentral
31.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
32.
Seekles W, van Straten A, Beekman A, van Marwijk H, Cuijpers P: Stepped care for depression and anxiety: from primary care to specialized mental health care: a randomised controlled trial testing the effectiveness of a stepped care program among primary care patients with mood or anxiety disorders. BMC Health Serv Res. 2009, 9: 90-10.1186/1472-6963-9-90.CrossRefPubMedPubMedCentral
33.
Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R: Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003, 3: 28-10.1186/1471-2288-3-28.CrossRefPubMedPubMedCentral
34.
Wright C, Catty J, Watt H, Burns T: A systematic review of home treatment services–classification and sustainability. Soc Psychiatry Psychiatr Epidemiol. 2004, 39: 789-796.CrossRefPubMed
35.
Burns T: End of the road for treatment-as-usual studies?. Br J Psychiatry. 2009, 195: 5-6. 10.1192/bjp.bp.108.062968.CrossRefPubMed
36.
Simon G, Fleck M, Lucas R, Bushnell D, LIDO Group: Prevalence and predictors of depression treatment in an international primary care study. Am J Psychiatry. 2004, 161: 1626-1634. 10.1176/appi.ajp.161.9.1626.CrossRefPubMed
Metadata
Title
Effectiveness and efficiency of assertive outreach for Schizophrenia in Germany: study protocol on a pragmatic quasi-experimental controlled trial
Authors
Anke Bramesfeld
Jörn Moock
Kirsten Kopke
Dorothea Büchtemann
Denise Kästner
Jeanett Radisch
Wulf Rössler
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2013
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-13-56

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