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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Schizophrenia | Study protocol

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

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

Published in: Trials | Issue 1/2022

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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.
Appendix
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Metadata
Title
Structured implementation of digital, systematically updated guideline recommendations for enhanced adherence in schizophrenia (SISYPHOS)—protocol of a cluster-randomized trial
Authors
Carolin Lorenz
Gabriele Gaigl
Duygu Güler
Theresa Halms
Naiiri Khorikian-Ghazari
Astrid Röh
Marco Schneider
Elias Wagner
Thomas Schneider-Axmann
Angelika Kapfhammer
Marisa Flick
Charline Pielenz
Eva Salveridou-Hof
Peter Falkai
Wolfgang Gaebel
Alkomiet Hasan
Stefan Leucht
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Schizophrenia
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06749-0

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