VISIT STROKE: non-inferiority of telemedicine-based neurological consultation for post-acute stroke patients - protocol of a prospective observational controlled multi-center study.


Journal

BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677

Informations de publication

Date de publication:
17 Oct 2024
Historique:
received: 17 04 2024
accepted: 24 09 2024
medline: 17 10 2024
pubmed: 17 10 2024
entrez: 16 10 2024
Statut: epublish

Résumé

Telemedicine provides specialized medical expertise in underserved areas where neurological expertise is frequently not available on a daily basis for hospitalized stroke patients. While tele-consultations are well established in acute stroke assessment, the value of telemedicine-based ward-rounds in the subsequent in-patient stroke management is unknown. Four telemedicine stroke networks in Germany, implemented in eight out of 16 federal states, participate in this prospective observational multi-center study. We plan to enroll 523 patients hospitalized due to acute (suspected or confirmed) stroke or transient ischemic attack. Each recruited patient will receive both a tele-consultation and an on-site consultation at the same day within the first three days after hospital admission. We will test non-inferiority of telemedicine-based assessments in ward-rounds in terms of quality of medical assessment and recommendations for hospitalized stroke patients. The correctness of the medical assessment and recommendation is defined as positive evaluation (binary, correct vs. in-correct) of six out of six predefined quality indicators by at least two out of three blinded independent raters. The non-inferiority margin for the difference in proportions of correct assessments is set to 5%-points. If non-inferiority of telemedicine-based ward-rounds compared to on-site ward-rounds by a neurologist were demonstrated, telemedicine-based neurological consultation for post-acute stroke patients may contribute to deliver evidence-based high-quality stroke care more easily in underserved regions. DRKS - DRKS00028671 ( https://drks.de/search/de/trial/DRKS00028671 ; registration date 09-27-2022).

Sections du résumé

BACKGROUND BACKGROUND
Telemedicine provides specialized medical expertise in underserved areas where neurological expertise is frequently not available on a daily basis for hospitalized stroke patients. While tele-consultations are well established in acute stroke assessment, the value of telemedicine-based ward-rounds in the subsequent in-patient stroke management is unknown.
METHODS METHODS
Four telemedicine stroke networks in Germany, implemented in eight out of 16 federal states, participate in this prospective observational multi-center study. We plan to enroll 523 patients hospitalized due to acute (suspected or confirmed) stroke or transient ischemic attack. Each recruited patient will receive both a tele-consultation and an on-site consultation at the same day within the first three days after hospital admission. We will test non-inferiority of telemedicine-based assessments in ward-rounds in terms of quality of medical assessment and recommendations for hospitalized stroke patients. The correctness of the medical assessment and recommendation is defined as positive evaluation (binary, correct vs. in-correct) of six out of six predefined quality indicators by at least two out of three blinded independent raters. The non-inferiority margin for the difference in proportions of correct assessments is set to 5%-points.
DISCUSSION CONCLUSIONS
If non-inferiority of telemedicine-based ward-rounds compared to on-site ward-rounds by a neurologist were demonstrated, telemedicine-based neurological consultation for post-acute stroke patients may contribute to deliver evidence-based high-quality stroke care more easily in underserved regions.
TRIAL REGISTRATION BACKGROUND
DRKS - DRKS00028671 ( https://drks.de/search/de/trial/DRKS00028671 ; registration date 09-27-2022).

Identifiants

pubmed: 39415153
doi: 10.1186/s12913-024-11651-3
pii: 10.1186/s12913-024-11651-3
doi:

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

1246

Informations de copyright

© 2024. The Author(s).

Références

Cutting S, Conners JJ, Lee VH, Song S, Prabhakaran S. Telestroke in an urban setting. Telemed J E Health. 2014;20:855–7.
doi: 10.1089/tmj.2013.0348 pubmed: 24968197 pmcid: 4148054
Audebert HJ, Schenkel J, Heuschmann PU, Bogdahn U, Haberl RL. Effects of the implementation of a telemedical stroke network: the Telemedic Pilot Project for Integrative Stroke Care (TEMPiS) in Bavaria, Germany. Lancet Neurol. 2006;5:742–8.
doi: 10.1016/S1474-4422(06)70527-0 pubmed: 16914402
Barlinn J, Winzer S, Worthmann H, Urbanek C, Häusler KG, Günther A, et al. Telemedicine in stroke—pertinent to stroke care in Germany. Nervenarzt. 2021;92:593–601.
doi: 10.1007/s00115-021-01137-6 pubmed: 34046722 pmcid: 8184549
Liman TG, Winter B, Waldschmidt C, Zerbe N, Hufnagl P, Audebert HJ, et al. Telestroke ambulances in prehospital stroke management: concept and pilot feasibility study. Stroke. 2012;43:2086–90.
doi: 10.1161/STROKEAHA.112.657270 pubmed: 22693132
Lazarus G, Permana AP, Nugroho SW, Audrey J, Wijaya DN, Widyahening IS. Telestroke strategies to enhance acute stroke management in rural settings: a systematic review and meta-analysis. Brain Behav. 2020;10:e01787.
Audebert HJ, Kukla C, Vatankhah B, Gotzler B, Schenkel J, Hofer S, et al. Comparison of tissue plasminogen activator administration management between telestroke network hospitals and academic stroke centers: the telemedical pilot project for integrative stroke care in Bavaria/Germany. Stroke. 2006;37:1822–7.
doi: 10.1161/01.STR.0000226741.20629.b2 pubmed: 16763192
Audebert HJ, Kukla C, Von Claranau SC, Kühn J, Vatankhah B, Schenkel J, et al. Telemedicine for safe and extended use of thrombolysis in stroke: the Telemedic Pilot Project for Integrative Stroke Care (TEMPiS) in Bavaria. Stroke. 2005;36:287–91.
doi: 10.1161/01.STR.0000153015.57892.66 pubmed: 15625294
Schwab S, Vatankhah B, Kukla C, Hauchwitz M, Bogdahn U, Fürst A, et al. Long-term outcome after thrombolysis in telemedical stroke care. Neurology. 2007;69:898–903.
doi: 10.1212/01.wnl.0000269671.08423.14 pubmed: 17724293
Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, et al. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008;7:787–95.
doi: 10.1016/S1474-4422(08)70171-6 pubmed: 18676180 pmcid: 2744128
Erdur H, Weber JE, Angermaier A, Kinze S, Sotoodeh A, Gorski C, et al. A Managed Care System with Telemedicine Support for Neurological emergencies. Ann Neurol. 2023;93:511–21.
doi: 10.1002/ana.26556 pubmed: 36401341
Markus H. Personalising secondary prevention: different treatments for different strokes. Pract Neurol. 2020;20:34–8.
pubmed: 31484793
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inf. 2009;42:377–81.
doi: 10.1016/j.jbi.2008.08.010
Nam J. Establishing equivalence of two treatments and sample size requirements in matched-pairs design - PubMed. Biometrics. 1997;53:1422–30.
doi: 10.2307/2533508 pubmed: 9423257
Tango T. Equivalence test and confidence interval for the difference in proportions for the paired-sample design. Stat Med. 1998;17:891–908.
doi: 10.1002/(SICI)1097-0258(19980430)17:8<891::AID-SIM780>3.0.CO;2-B pubmed: 9595618
Liu J, Hsueh H, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002;21:231–45.
doi: 10.1002/sim.1012 pubmed: 11782062
Gangadharan S, Tomari S, Levi CR, Weaver N, Holliday E, Bajorek B, et al. Rural versus metropolitan comparison of processes of care in the community-based management of TIA and minor stroke in Australia (an analysis from the INSIST study). Aust J Rural Health. 2023;31:272–84.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200.
doi: 10.7326/0003-4819-158-3-201302050-00583 pubmed: 23295957 pmcid: 5114123

Auteurs

Juliane Herm (J)

Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. juliane.herm@charite.de.
Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany. juliane.herm@charite.de.
Department of Neurology, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. juliane.herm@charite.de.

Hebun Erdur (H)

Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany.
Klinik für Neurologie, Asklepios Fachklinikum Teupitz, Teupitz, Germany.

Annette Aigner (A)

Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Johannes Hengelbrock (J)

Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Anselm Angermaier (A)

Department of Neurology, University Medicine Greifswald, Greifswald, Germany.

Agnes Flöel (A)

Department of Neurology, University Medicine Greifswald, Greifswald, Germany.
German Center for Neurodegenerative Diseases, partner site, Rostock, Greifswald, Germany.

Annegret Hille (A)

Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.

Claudia Gorski (C)

Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.

Stephan Kinze (S)

Unfallkrankenhaus Berlin, Berlin, Germany.

Ingo Schmehl (I)

Unfallkrankenhaus Berlin, Berlin, Germany.

Gordian J Hubert (GJ)

TEMPiS telestroke center, Department of Neurology, München Klinik gGmbH, Munich, Germany.

Hanni Wiestler (H)

TEMPiS telestroke center, Department of Neurology, München Klinik gGmbH, Munich, Germany.

Timo Siepmann (T)

Dresden Neurovascular Center, Department of Neurology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.

Martin Arndt (M)

Dresden Neurovascular Center, Department of Neurology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.

Christoph Gumbinger (C)

Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.

Miriam Heyse (M)

Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.

Joachim E Weber (JE)

Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany.
Clinical Research Unit, Berlin Institute of Health, Berlin, Germany.

Heinrich J Audebert (HJ)

Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH