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. 2022 Sep 24;23(1):807.
doi: 10.1186/s13063-022-06749-0.

Structured implementation of digital, systematically updated guideline recommendations for enhanced adherence in schizophrenia (SISYPHOS)-protocol of a cluster-randomized trial

Carolin Lorenz  1 , Gabriele Gaigl  2 , Duygu Güler  2 , Theresa Halms  2 , Naiiri Khorikian-Ghazari  2 , Astrid Röh  2 , Marco Schneider  3 , Elias Wagner  3 , Thomas Schneider-Axmann  2   3 , Angelika Kapfhammer  4 , Marisa Flick  5 , Charline Pielenz  5 , Eva Salveridou-Hof  5 , Peter Falkai  3 , Wolfgang Gaebel  5 , Alkomiet Hasan #  2 , Stefan Leucht #  4
Affiliations

Structured implementation of digital, systematically updated guideline recommendations for enhanced adherence in schizophrenia (SISYPHOS)-protocol of a cluster-randomized trial

Carolin Lorenz et al. Trials. .

Abstract

Background: Despite high acceptance rates in the field, the implementation of the 2019 published German evidence and consensus-based S3 guideline is unsatisfactory. This study aims to assess the superiority of an adaptive online version with a better visualization of the recommendations in terms of guideline conformity, application of shared decision making, and digital health expertise compared to the classic pdf print version of the guideline.

Methods: The study is a multicenter, controlled, cluster-randomized trial with two arms: one arm investigating the implementation of the German schizophrenia guideline in form of a digital format (intervention group using the evidence ecosystem MAGICapp), the other arm in form of the classic print pdf version (control group). Physicians and psychologists working in specialized hospitals will be included in the study. The guideline-knowledge before and after the intervention is defined as primary outcome measure. Secondary endpoints include digital health expertise and application of shared decision making.

Discussion: This is the first study evaluating if an adaptive-digital version of the schizophrenia guideline is superior to the classic pdf print version. Therefore, the guideline is digitally prepared in the evidence-ecosystem MAGICapp, which covers the whole process of the development of a living guideline. We intend to use the results of the cluster-randomized trial for developing the German S3 guideline for schizophrenia in form of a living guideline in future.

Trial registration: The study is registered (10 May 2022) in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00028895 .

Keywords: Cluster-randomized controlled trial; Guideline; Implementation; Living guideline; MAGICapp; Schizophrenia.

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Conflict of interest statement

C. Lorenz: none. G. Gaigl: none. D. Güler: none. T. Halms: none. N. Khorikian-Ghazari: none. A. Röh: none. M. Schneider: none. E. Wagner: none. T. Schneider-Axmann: none. A. Kapfhammer: none. M. Flick: none. C. Pielenz: none. E. Salveridou-Hof: none. P. Falkai received research support/honoraria for lectures or advisory activities from: Abbott, Boehringer-Ingelheim, Janssen, Essex, Lundbeck, Otsuka, Recordati, Richter, Servier and Takeda. He holds a payed position as chairman of the Psychiatric Department of the University Munich and is full professor at the Psychiatric Department of the University Munich. He has received and is currently receiving grants from several national and international foundations and institutions, e.g., from the “German Science Foundation,” the “German Ministry of Science,” and the “German Ministry of Health.” W. Gaebel is a member of the Lundbeck International Neuroscience Foundation. A. Hasan has been invited to scientific meetings by Lundbeck, Janssen-Cilag, and Pfizer, and he received paid speakerships from Janssen, Recordati, Otsuka, and Lundbeck. He was a member of Roche, Otsuka, Lundbeck, Rovi, Recordati, and Janssen advisory boards. S. Leucht reported personal fees from Alkermes, Angelini Pharma, Eisai, Gedeon Richter, Janssen Pharmaceuticals, Johnson & Johnson, Lundbeck, Medichem, Merck Sharp & Dohme, Otsuka Pharmaceutical, Casen Recordati, Rovi, Sandoz, Sanofi, Sunovion, Teva Pharmaceuticals, Boehringer Ingelheim, and LTS Lohmann.

Figures

Fig. 1
Fig. 1
Study design
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References

    1. SIGN guideline. Management of schizophrenia. https://www.sign.ac.uk/our-guidelines/management-of-schizophrenia/. Accessed 13 June 2022.
    1. DGPPN, 2019. S3-Leitlinie Schizophrenie]. Dtsch. Gesellschaft für Psychiatr. Psychother. Psychosom. und Nervenheilkd. https://www.awmf.org/leitlinien/detail/ll/038-009.html. Accessed 13 June 2022.
    1. NICE guidelines. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/ni.... Accessed 13 June 2022.
    1. Girlanda F, et al. The evidence-practice gap in specialist mental healthcare: systematic review and meta-analysis of guideline implementation studies. Br J Psychiatry. 2017;210(1):24–30. doi: 10.1192/bjp.bp.115.179093. - DOI - PubMed
    1. Waldorff FB, et al. Implementation of a clinical dementia guideline. A controlled study on the effect of a multifaceted strategy. Scand J Prim Health Care. 2003;21(3):142–147. doi: 10.1080/02813430310005136. - DOI - PubMed

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