BMC Neurology (Aug 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)

  • 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

DOI
https://doi.org/10.1186/s12883-022-02814-y
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 11

Abstract

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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. Trial registration The trial OptiNIV has been registered in the German Clinical Trials Register (DRKS) since 18.01.2022 with the ID DRKS00027326 .

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