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 and Kohlmann, Thomas and Flessa, Steffen and Einhaeupl, Bernadette and Koppelow, Martha and Willacker, Lina and Gdynia, Hans-Juergen and Henning, Esther and Herzog, Juergen and Mueller, Friedemann and Nowak, Dennis A. and Pletz, Romy and Schlachetzki, Felix and Schmidt-Wilcke, Tobias and Schuettler, Michael and Straube, Andreas and Suess, Rebekka and Ziegler, Volker and Bender, Andreas (2022) 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). BMC NEUROLOGY, 22 (1): 290. ISSN , 1471-2377

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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 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.

Item Type: Article
Uncontrolled Keywords: ; Neurorehabilitation; Weaning; Clinical trial; Protocol; Healthcare
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Neurologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 01 Feb 2024 07:29
Last Modified: 01 Feb 2024 07:29
URI: https://pred.uni-regensburg.de/id/eprint/58516

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