TY - JOUR
T1 - Structured implementation of digital, systematically updated guideline recommendations for enhanced adherence in schizophrenia (SISYPHOS)—protocol of a cluster-randomized trial
AU - Lorenz, Carolin
AU - Gaigl, Gabriele
AU - Güler, Duygu
AU - Halms, Theresa
AU - Khorikian-Ghazari, Naiiri
AU - Röh, Astrid
AU - Schneider, Marco
AU - Wagner, Elias
AU - Schneider-Axmann, Thomas
AU - Kapfhammer, Angelika
AU - Flick, Marisa
AU - Pielenz, Charline
AU - Salveridou-Hof, Eva
AU - Falkai, Peter
AU - Gaebel, Wolfgang
AU - Hasan, Alkomiet
AU - Leucht, Stefan
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Cluster-randomized controlled trial
KW - Guideline
KW - Implementation
KW - Living guideline
KW - MAGICapp
KW - Schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=85138457790&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06749-0
DO - 10.1186/s13063-022-06749-0
M3 - Article
C2 - 36153555
AN - SCOPUS:85138457790
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 807
ER -