{
  "abstract": "Introduction Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.Method and analysis This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.Ethics and dissemination This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.Trial registration number This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).",
  "authors": [
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine (CCM | CVK), Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Andreas Edel"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine (CCM | CVK), Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Susanne Jöbges"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine (CCM | CVK), Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Bjoern Weiss"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine (CCM | CVK), Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Nicolas Paul"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine (CCM | CVK), Charité - Universitätsmedizin Berlin, Berlin, BE, Germany",
        "Department of Nephrology and Intensive Medical Care, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Maike Lucia Lyall"
    },
    {
      "affiliations": [
        "Department of Nephrology and Intensive Medical Care, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Clemens Hoffmann"
    },
    {
      "affiliations": [
        "Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Stephen Schüürhuis"
    },
    {
      "affiliations": [
        "Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany",
        "Institute of Medical Informatics, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Sophie K K Piper"
    },
    {
      "affiliations": [
        "Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Frank Konietschke"
    },
    {
      "affiliations": [
        "Department of Health Care Management, Technical University of Berlin, Berlin, BE, Germany"
      ],
      "name": "Elke Berger"
    },
    {
      "affiliations": [
        "Department of Health Care Management, Technical University of Berlin, Berlin, BE, Germany"
      ],
      "name": "Reinhard Busse"
    },
    {
      "affiliations": [
        "BARMER, Wuppertal, NRW, Germany"
      ],
      "name": "Ursula Marschall"
    },
    {
      "affiliations": [
        "Fraunhofer Institute for Open Communication Systems FOKUS, Berlin, BE, Germany"
      ],
      "name": "Ben Kraufmann"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine and Critical Care Medicine with Sleep Medicine, Charite Universitatsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Martin Witzenrath"
    },
    {
      "affiliations": [
        "Department of Nephrology and Intensive Medical Care, Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Kai-Uwe Eckardt"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine (CCM | CVK), Charité - Universitätsmedizin Berlin, Berlin, BE, Germany"
      ],
      "name": "Claudia Spies"
    }
  ],
  "title": "Development of intersectoral medical care for patients with ‘chronic critical illness’: protocol for a telemedicine interventional study with a pre-post design in out-of-hospital intensive care facilities (E=MC²)",
  "uid": "1cd743b8-941c-50a3-8b6b-254181376a4f"
}