Trial document




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  DRKS00027326

Trial Description

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Title

Optimization of post-hospital intensive care for neurological patients

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Trial Acronym

OptiNIV

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URL of the Trial

https://www.medizin.uni-greifswald.de/optiniv/index.php?id=375

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Brief Summary in Lay Language

Neurological intensive care patients who cannot be weaned from ventilation or tracheal cannula (TC) in the context of inpatient early rehabilitation treatment are increasingly frequently discharged to out-of-hospital intensive care (AIP) ("ventilator shared-care units"), which generates annual costs of approximately €4 billion at the expense of the SHI system. The aim of the new form of care is to improve the long-term recovery potential of patients, so that more patients can be weaned off ventilation/TC after 1 year. In addition, the psychological situation (e.g. anxiety, quality of life) and satisfaction with the treatment of relatives and responsible AIP staff will be investigated.
Methodological approach:
The new form of care consists of outpatient specialist teams (stationed at neurological early rehabilitation clinics) of physicians/therapists who regularly visit the AIP patients at home, perform examinations and coordinate the therapeutic concept. After approximately 10 months, a structured inpatient assessment and, if necessary, inpatient treatment for ventilator weaning/decanulation takes place. The evaluation will be performed in the context of a randomized clinical trial in comparison to patients in standard care (6 study visits per patient). A health economics subproject is investigating the cost-effectiveness of the new treatment pathway.
Implementation potential:
The new form of care could be extended to all of Germany with the participation of existing neurorehabilitation structures, lead to an improvement in quality of life, and save costs in the triple-digit millions annually.

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Brief Summary in Scientific Language

Currently, about 30,000 people in Germany are dependent on mechanical ventilation or permanent access to the trachea (tracheal cannula, TC) even after inpatient intensive care treatment. These patients are cared for by out-of-hospital intensive care (AIP) and are associated with high costs. However, neurological patients in particular, e.g. after a stroke, might have a great potential to recover in the long term and to be successfully weaned from ventilation/TK. However, this recovery potential is currently only partially exploited due to the lack of coordinating rehabilitative structures and processes in the outpatient setting. OptiNIV aims to remedy this situation.

The project develops and evaluates new diagnostic and treatment pathways at the interface of inpatient, neurorehabilitative and AIP care. Outpatient expert teams regularly care for and treat patients at home. Study centers at focal neurological early rehabilitation clinics coordinate treatment interventions and provide case management. A multidisciplinary assessment identifies the individual weaning potential of the patients. Weaning from mechanical ventilation/TK then takes place during inpatient neurological interval rehabilitation, if necessary.

The one-year study of 173 neurological AIP patients is designed to determine the success of their weaning from mechanical ventilation/TK. For this purpose, the intervention group (115 patients receiving the new form of care) will be compared with a control group (58 patients receiving the existing standard care). In addition, the researchers will analyze the costs of the new treatment pathway compared to standard care. The project is funded for three and a half years with approximately 5.3 million euros.

If successful, fewer patients will need to be mechanically ventilated or fitted with a tracheostomy tube and cared for in AIP after the project is completed. This can potentially lead to an improvement in quality of life and social participation.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Project data are only shared within the cooperation partners of the project.
Primary data (from the clinics as well as questionnaires) and secondary data (health insurance data) are pseudonymized and forwarded to evaluators at the University of Greifswald and the University Hospital. A linkage of the primary and secondary data can only take place in the intermediary trustee office.

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Organizational Data

  •   DRKS00027326
  •   2022/01/18
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  •   yes
  •   Approved
  •   21-1090, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1272-3048 
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Health Condition or Problem studied

  •   G00-G99 -  Diseases of the nervous system
  •   Z99.0 -  Dependence on aspirator
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Interventions/Observational Groups

  •   Intervention group: receives new form of care with additional assessments, team conferences, and feedback, and if possible, inpatient assessment and interval rehabilitation as a follow-up.
  •   Control group: receives existing standard form of care of out-of-hospital intensive care without additional examinations, team conferences and feedback of the new form of care and without the possibility of an inpatient assessment and/or interval rehabilitation in the follow-up. However, study visits occur at the same times during the course as in the experimental group.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of patients in the intervention group compared to the control group who could be weaned from mechanical ventilation and/or TC one year after the start of treatment in the AIP

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Secondary Outcome

Clinical factors (standardized scores using questionnaires and clinical scales, respectively):
TC and ventilatory status and modalities.
Mortality
Neurological status
Activities of daily living (ATL)
Quality of life (QOL)/depression, anxiety
Relative burden
Care situation
Satisfaction with care situation (use of AIP / living arrangements)
Utilization of health care (medication, remedies, hospital treatment)
Complications/side effects

Additional health economic factors: Indirect and direct costs of the intervention Analysis of pseudonymized AOK routine data Cost-benefit analysis of the new form of treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2022/02/28
  •   173
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age of majority
- Health insured with AOK Bayern
- Inpatient treatment in the neurological early rehabilitation with neurological rehabilitation diagnosis
- Presence of mechanical ventilation and/or TC.
- Acute onset of illness < 6 months
- Planned discharge to AIP in Bavaria
- Existing informed consent for study participation

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Exclusion Criteria

- Palliative treatment/life expectancy according to medical assessment < 12 months
- Weaning/decanulation medically ruled out (e.g., high cervical spinal cord injury, laryngeal tumor)
- Pre-existing AIP
- Progressive neuromuscular disease (e.g. Muscular dystrophy, ALS)
- AIP by a team already providing care to other study participants

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Addresses

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    • Klinikum der Universität München
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Neurologische Klinik, Klinikum der Universität München
    • Mr.  Prof. Dr.  Andreas  Bender 
    • Fraunhoferstr. 20
    • 82152  Planegg
    • Germany
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    • Neurologische Klinik, Klinikum der Universität München
    • Mr.  Prof. Dr.  Andreas  Bender 
    • Fraunhoferstr. 20
    • 82152  Planegg
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Postfach 120606
    • 10596  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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