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. 2022 Aug 4;22(1):290.
doi: 10.1186/s12883-022-02814-y.

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  1   2 , Thomas Kohlmann  3 , Steffen Fleßa  4 , Bernadette Einhäupl  5 , Martha Koppelow  6 , Lina Willacker  5 , Hans-Jürgen Gdynia  7 , Esther Henning  3 , Jürgen Herzog  8 , Friedemann Müller  9 , Dennis A Nowak  10 , Romy Pletz  6 , Felix Schlachetzki  11 , Tobias Schmidt-Wilcke  12 , Michael Schüttler  13 , Andreas Straube  5 , Rebekka Süss  4 , Volker Ziegler  14 , Andreas Bender  5   15
Affiliations

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 et al. BMC Neurol. .

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 .

Keywords: Clinical trial; Healthcare; Neurorehabilitation; Protocol; Weaning.

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Conflict of interest statement

The authors declare that they have no competing interests. Furthermore, no competing interests are known for the other participating centres.

Figures

Fig. 1
Fig. 1
The 12 participating centres of the trial, the study coordination centre in Munich, and the scientific evaluation centres in Greifswald. ■ Study coordination centre: Department of Neurology, University Hospital, Ludwig-Maximilians-University Munich. ○ Regional Outreach Centres, ROC: Schoen Clinic Bad Aibling Harthausen; Therapy Centre Burgau; Clinic for Neurology of the University of Regensburg at medbo district hospital; Clinic for Neurological Early Rehabilitation/Intensive Care, Rhön-Klinikum, Campus Bad Neustadt. △ Participating Neurological Early Rehabilitation centre, NER: Juliusspital Würzburg, VAMED Klinik Kipfenberg, Schoen Clinic Bad Staffelstein, m&i Fachklinik Enzensberg, m&i Fachklinik Herzogenaurach, m&i Fachklinik Bad Heilbrunn, Neurological Centre at the Bezirksklinikum Mainkofen. ● Independent scientific evaluation centres in Greifswald: Greifswald University Medical Center; University of Greifswald. Source maps offered by Maxim Grebeshkov were obtained from Inmagine Lab Pte. Ltd ("123RF") with a license to use and adapt it
Fig. 2
Fig. 2
Flow chart: Trial course of control and intervention group in the OptiNIV trial. Abbreviations: NR = Neurorehabilitation; FEES = fiberoptic endoscopic evaluation of swallowing; BGA = blood gas analysis
See this image and copyright information in PMC

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