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)

Platz, Thomas ; Kohlmann, Thomas ; Fleßa, Steffen ; Einhäupl, Bernadette ; Koppelow, Martha ; Willacker, Lina ; Gdynia, Hans-Jürgen ; Henning, Esther ; Herzog, Jürgen ; Müller, Friedemann ; Nowak, Dennis A. ; Pletz, Romy ; Schlachetzki, Felix ; Schmidt-Wilcke, Tobias ; Schüttler, Michael ; Straube, Andreas ; Süss, Rebekka ; Ziegler, Volker ; Bender, Andreas

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Details

Item type:	Article
Höhe Gebühr (aus OpenAPC):	1960.79
Institution der Zahlung:	Greifswald U
Journal or Publication Title:	BMC Neurology
Publisher:	BMC
Place of Publication:	LONDON
Volume:	22
Number of Issue or Book Chapter:	1
Date:	2022
Institutions:	Medicine > Lehrstuhl für Neurologie
Identification Number:	Value Type 10.1186/s12883-022-02814-y DOI
Keywords:	; Neurorehabilitation; Weaning; Clinical trial; Protocol; Healthcare
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	57654

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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 ...

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.

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