Top

Published in:

Open Access 01-12-2020 | Care | Study protocol

Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial

Authors: Annabel Sandra Mueller-Stierlin, Friedrich Meixner, Anne Kohlmann, Mara Schumacher, Anke Hänsel, Melanie Pouwels, Nicole Bias, Sabrina Hartl, Jessica Reichstein, Elke Prestin, Nils Greve, Thomas Becker, Reinhold Kilian

Published in: Trials | Issue 1/2020

Abstract

Background

The community-based mental health care programme GBV is based on the British Community Mental Health Teams and the Dutch Flexible Assertive Community Treatment model. In addition, the programme offers crisis-intervention services. A special feature of this integrated care programme is the initial standardised assessment process regarding empowerment, unmet care needs, and psychosocial functioning, used to verify the need for such a comprehensive form of care. The project evaluates the assessment process and analyses the effectiveness and cost-effectiveness of GBV compared to treatment as usual.

Methods

This randomised, controlled study includes five assessments over 2 years. In twelve regions in Germany, 1000 patients with severely impaired psychosocial functioning and unmet care needs will be recruited. Study eligibility relies on an indication for GBV based on the results of the initial assessment. The primary outcome is improved self-reported empowerment. Further outcomes include improved treatment satisfaction and subjective quality of life, reductions in patients’ unmet needs and illness-related clinical and social impairment, and an improved cost-effectiveness ratio of the resources used (from the perspectives of both statutory health insurance and the national economy). In addition, the GBV’s effects on the burden and quality of life of informal caregivers of patients will be investigated.

Discussion

The study’s results are expected to provide information on whether the community-based mental health care programme GBV contributes to improving mental health care provision in Germany. In addition, the study will show whether the GBV successfully overcomes the weaknesses that former research has identified regarding a German integrated care programme. Such improvement is particularly expected with respect to the semi-structured assessment within GBV.

Trial registration

German Clinical Trial Register, DRKS00019086. Registered on 3 January 2020.

Gühne U, Weinmann S, Riedel-Heller SG, Becker T. S3-Leitlinie Psychosoziale Therapien bei schweren psychischen Erkrankungen. Berlin: Springer; 2019.CrossRef

World Health Organization. WHO mental health action plan 2013 - 2020. 2012.

OECD. Health at a Glance 2019. Paris: OECD Publishing; 2019.CrossRef

Salize H-J, Roessler W, Becker T. Mental health care in Germany: current state and trends. Eur Arch Psychiatry Clin Neurosci. 2007;257:92–103. https://doi.org/10.1007/s00406-006-0696-9 .CrossRefPubMed

Brieger P. Psychiatrische Versorgung in Deutschland – ein Überblick. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2019;62:121–7. https://doi.org/10.1007/s00103-018-2861-5 .CrossRefPubMed

Karow A, Bock T, Daubmann A, Meigel-Schleiff C, Lange B, Lange M, et al. The Hamburg-model of integrated care for patients with psychosis: part 2. Results of the clinical course over 2- and 4-years of treatment. Psychiatr Prax. 2014;41:266–73. https://doi.org/10.1055/s-0033-1349496 .CrossRefPubMed

Karow A, Reimer J, Koenig H-H, Heider D, Bock T, Huber CG, et al. Cost-effectiveness of 12-month therapeutic assertive community treatment as part of integrated care versus standard care in patients with schizophrenia treated with quetiapine immediate release (ACCESS trial). J Clin Psychiatry. 2012;73:e402–8. https://doi.org/10.4088/JCP.11%20m06875.

Lambert M, Bock T, Daubmann A, Meigel-Schleiff C, Lange B, Lange M, et al. The Hamburg-model of integrated care for patients with psychosis: part 1. Rationale, treatment concept and results of the pre-study. Psychiatr Prax. 2014;41:257–65. https://doi.org/10.1055/s-0033-1349497 .CrossRefPubMed

Fischer F, Hoffmann K, Mönter N, Walle M, Beneke R, Negenborn S, et al. Kostenevaluation eines Modells der Integrierten Versorgung für schwer psychisch Kranke. Gesundheitswesen. 2014;76:86–95. https://doi.org/10.1055/s-0033-1343438 .CrossRefPubMed

10.

Mueller-Stierlin AS, Helmbrecht MJ, Herder K, Prinz S, Rosenfeld N, Walendzik J, et al. Does one size really fit all? The effectiveness of a non-diagnosis-specific integrated mental health care program in Germany in a prospective, parallel-group controlled multi-centre trial. BMC Psychiatry. 2017;17:283. https://doi.org/10.1186/s12888-017-1441-9 .CrossRefPubMedPubMedCentral

11.

Kaestner D, Buechtemann D, Warnke I, Radisch J, Baumgardt J, Giersberg S, et al. Clinical and functional outcome of assertive outreach for patients with schizophrenic disorder: results of a quasi-experimental controlled trial. Eur Psychiatry. 2015;30:736–42. https://doi.org/10.1016/j.eurpsy.2015.04.003 .CrossRef

12.

Greve N. Gemeindepsychiatrische Basisversorgung - ein dickes Brett. Soziale Psychiatrie. 2019;1:4–6.

13.

Greve N, Heuchemer P. Die Gemeindepsychiatrische Basisversorgung. Psychosoziale Umschau. 2019;2:47–8.

14.

Kilian R, Becker T, Schleuning G, Welschehold M, Hertle C, Matschinger H, Hörand S. Die Entwicklung eines standardisierten Verfahrens zur Messung von Empowerment im Prozess der psychiatrischen Behandlung von Patienten mit schweren psychischen Erkrankungen. Ulm; 2012. http://forschung-patientenorientierung.de/files/abschlussbericht_01gx0743.pdf.

15.

Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5:233–7.CrossRef

16.

Schmidt J, Lamprecht F, Wittmann WW. Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. Psychother Psychosom Med Psychol. 1989;39:248–55.PubMed

17.

Angermeyer MC, Kilian R, Matschinger H. WHOQOL-100 und WHOQOL-BREF: Handbuch für die deutschsprachigen Versionen der WHO-Instrumente zur internationalen Erfassung von Lebensqualität. Göttingen: Hogrefe; 2000.

18.

Kilian R, Bernert S, Matschinger H, Mory C, Roick C, Angermeyer MC. Die standardisierte Erfassung des Behandlungs- und Unterstützungsbedarfs bei schweren psychischen Erkrankungen - Entwicklung und Erprobung der deutschsprachigen Version des Camberwell Assessment of Need-EU. Psychiatr Prax. 2001;28(Suppl 2):S79–83. https://doi.org/10.1055/s-2001-17789 .CrossRefPubMed

19.

Phelan M, Slade M, Thornicroft G, Dunn G, Holloway F, Wykes T, et al. The Camberwell Assessment of Need: the validity and reliability of an instrument to assess the needs of people with severe mental illness. Br J Psychiatry. 1995;167:589–95.CrossRef

20.

Andreas S, Harfst T, Dirmaier J, Kawski S, Koch U, Schulz H. A psychometric evaluation of the German version of the ‘Health of the Nation Outcome Scales, HoNOS-D’: on the feasibility and reliability of clinician-performed measurements of severity in patients with mental disorders. Psychopathology. 2007;40:116–25. https://doi.org/10.1159/000098492 .CrossRefPubMed

21.

Kawski S, Andreas S, Harfst T, Dirmaier J, Koch U, Schulz H. Die “Health of the Nation Outcome Scales”: Entwicklung und erste psychometrische Analysen einer deutschen Version (HoNOS-D). Psychother Psychosom Med Psychol. 2004;54:AB49 (abstract). https://doi.org/10.1055/s-2004-822511 .CrossRef

22.

Wing JK, Lelliott P, Beevor AS, Trauer T, Slade M, Thornicroft G. HoNOS update. Br J Psychiatry. 2000;176:392–5. https://doi.org/10.1192/bjp.176.4.392 .CrossRef

23.

McClelland R, Trimble P, Fox ML, Stevenson MR, Bell B. Validation of an outcome scale for use in adult psychiatric practice. Qual Health Care. 2000;9:98–105.CrossRef

24.

Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer MC. Die deutsche Version des Client Sociodemographic and Service Receipt Inventory – Ein Instrument zur Erfassung psychiatrischer Versorgungskosten. Psychiatr Prax. 2001;28(Suppl 2):S84–90. https://doi.org/10.1055/s-2001-17790 .CrossRefPubMed

25.

Brooks RG, Rabin R, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective: Evidence from the EuroQol BIOMED Research Programme. Dordrcht: Kluwer; 2003.

26.

Bernert S, Kilian R, Matschinger H, Mory C, Roick C, Angermeyer MC. Die Erfassung der Belastung der Angehörigen psychisch erkrankter Menschen: Die deutsche Version des Involvement Evaluation Questionnaires (IEQ-EU). Psychiatr Prax. 2001;28(Suppl 2):97–101. https://doi.org/10.1055/s-2001-17792 .CrossRef

27.

Rohlmann F, Muche R, Goldschmidt L. Randomisierung in klinischen Studien.Praktische Umsetzung mit dem Randomisationsprogramm ROM. In: Schweizer B, Großmann C, Meule M, Gaus W, editors. Tagungsband zur 8. DVMD-Tagung in Ulm. Ulm: Universitätsverlag Ulm; 2004. p. 168–71.

28.

Panzirsch M, Frasch K, Kilian R. Empowerment und Stigma als Mediatorvariablen zwischen Krankheitsschwere und Lebensqualität bei Patienten mit einer affektiven Erkrankung. Psychiatr Prax. 2019;46:439–44. https://doi.org/10.1055/a-1002-0508 .CrossRefPubMed

29.

Rubin DB. Multiple Imputation for Nonresponse in Surveys. Hoboken: Wiley-Interscience; 2004. ISBN: 978-0-471-65574-9.

Title: Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial
Authors: Annabel Sandra Mueller-Stierlin
Friedrich Meixner
Anne Kohlmann
Mara Schumacher
Anke Hänsel
Melanie Pouwels
Nicole Bias
Sabrina Hartl
Jessica Reichstein
Elke Prestin
Nils Greve
Thomas Becker
Reinhold Kilian
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Care
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04492-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2020

Prospective evaluation of hydroxychloroquine in pediatric interstitial lung diseases: Study protocol for an investigator-initiated, randomized controlled, parallel-group clinical trial

Early recognition and response to increases in surgical site infections using optimized statistical process control charts—the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design

The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan

Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?—a systematic review

The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion—study protocol for a randomized controlled trial

The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial