Optimizing home-based long-term intensive care for neurological patients with neurorehabilitation outreach teams – protocol of a multicenter, parallel-group randomized controlled trial (OptiNIV-Study)
Thomas Platz,
Thomas Kohlmann,
Steffen Fleßa,
Bernadette Einhäupl,
Martha Koppelow,
Lina Willacker,
Hans-Jürgen Gdynia,
Esther Henning,
Jürgen Herzog,
Friedemann Müller,
Dennis A. Nowak,
Romy Pletz,
Felix Schlachetzki,
Tobias Schmidt-Wilcke,
Michael Schüttler,
Andreas Straube,
Rebekka Süss,
Volker Ziegler,
Andreas Bender
Affiliations
Thomas Platz
Neurorehabilitation Research Group, Faculty of Medicine, University of Greifswald, Universitätsmedizin Greifswald
Thomas Kohlmann
Institut für Community Medicine, Abt. Methoden der Community Medicine, Universitätsmedizin Greifswald
Steffen Fleßa
Lehrstuhl für Allgemeine Betriebswirtschaftslehre und Gesundheitsmanagement, University Greifswald
Bernadette Einhäupl
Department of Neurology, University Hospital, Ludwig-Maximilians-University Munich
Martha Koppelow
Neurorehabilitation Research Group, Faculty of Medicine, University of Greifswald, Universitätsmedizin Greifswald
Lina Willacker
Department of Neurology, University Hospital, Ludwig-Maximilians-University Munich
Hans-Jürgen Gdynia
m&i-Fachklinik Enzensberg
Esther Henning
Institut für Community Medicine, Abt. Methoden der Community Medicine, Universitätsmedizin Greifswald
Jürgen Herzog
Schön Klinik München Schwabing
Friedemann Müller
Schön Klinik Bad Aibling Harthausen
Dennis A. Nowak
VAMED Klinik Kipfenberg
Romy Pletz
Neurorehabilitation Research Group, Faculty of Medicine, University of Greifswald, Universitätsmedizin Greifswald
Felix Schlachetzki
Klinik für Neurologie der Universität Regensburg am Medbo Bezirksklinikum, Zentrum für Vaskuläre Neurologie und Intensivmedizin
Tobias Schmidt-Wilcke
Neurologisches Zentrum am Bezirksklinikum Mainkofen
Michael Schüttler
Schön Klinik Bad Staffelstein
Andreas Straube
Department of Neurology, University Hospital, Ludwig-Maximilians-University Munich
Rebekka Süss
Lehrstuhl für Allgemeine Betriebswirtschaftslehre und Gesundheitsmanagement, University Greifswald
Volker Ziegler
Klinik für Neurologische Frührehabilitation, Rhön-Klinikum
Andreas Bender
Department of Neurology, University Hospital, Ludwig-Maximilians-University Munich
Abstract Background Even with high standards of acute care and neurological early rehabilitation (NER) a substantial number of patients with neurological conditions still need mechanical ventilation and/or airway protection by tracheal cannulas when discharged and hence home-based specialised intensive care nursing (HSICN). It may be possible to improve the home care situation with structured specialized long-term neurorehabilitation support and following up patients with neurorehabilitation teams. Consequently, more people might recover over an extended period to a degree that they were no longer dependent on HSICN. Methods This healthcare project and clinical trial implements a new specialised neurorehabilitation outreach service for people being discharged from NER with the need for HSICN. The multicentre, open, parallel-group RCT compares the effects of one year post-discharge specialized outpatient follow-up to usual care in people receiving HSICN. Participants will randomly be assigned to receive the new form of healthcare (intervention) or the standard healthcare (control) on a 2:1 basis. Primary outcome is the rate of weaning from mechanical ventilation and/or decannulation (primary outcome) after one year, secondary outcomes include both clinical and economic measures. 173 participants are required to corroborate a difference of 30 vs. 10% weaning success rate statistically with 80% power at a 5% significance level allowing for 15% attrition. Discussion The OptiNIV-Study will implement a new specialised neurorehabilitation outreach service and will determine its weaning success rates, other clinical outcomes, and cost-effectiveness compared to usual care for people in need for mechanical ventilation and/or tracheal cannula and hence HSICN after discharge from NER. Trial registration The trial OptiNIV has been registered in the German Clinical Trials Register (DRKS) since 18.01.2022 with the ID DRKS00027326 .
