{
  "abstract": "Introduction Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.Methods and analysis The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.Ethics and dissemination This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.Trial registration number NCT04926597.",
  "authors": [
    {
      "affiliations": [
        "Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau AG, Aarau, Switzerland"
      ],
      "name": "Carla Wunderle"
    },
    {
      "affiliations": [
        "Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau AG, Aarau, Switzerland",
        "Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland",
        "Faculty of Life Sciences, University of Vienna, Vienna, Austria"
      ],
      "name": "Pascal Tribolet"
    },
    {
      "affiliations": [
        "Department of Medicine Huddinge, Karolinska Institute, Stockholm, Sweden"
      ],
      "name": "Nina Kaegi-Braun"
    },
    {
      "affiliations": [
        "Medical University Department, Kantonsspital Aarau, Aarau, Switzerland",
        "Department of Nutritional Science, Justus Liebig University Giessen, Giessen, Germany"
      ],
      "name": "Valerie Haller"
    },
    {
      "affiliations": [
        "Department of Medicine, Spital Emmental, Burgdorf, Switzerland"
      ],
      "name": "Robert Escher"
    },
    {
      "affiliations": [
        "Division of Diabetes, Endocrinology, Nutritional Medicine, and Metabolism, Bern University Hospital, Bern, Switzerland"
      ],
      "name": "Drahomir Aujesky"
    },
    {
      "affiliations": [
        "Department of Endocrinology, Kantonsspital Münsterlingen, Münsterlingen, Switzerland"
      ],
      "name": "Gisele Trennepohl Da Costa Heinen"
    },
    {
      "affiliations": [
        "Department of General Internal Medicine / Family Medicine and Emergency Medicine, HOCH Health Eastern Switzerland, St. Gallen, Switzerland"
      ],
      "name": "Michael Brändle"
    },
    {
      "affiliations": [
        "Medical Department, Spital Lachen AG, Lachen, Switzerland"
      ],
      "name": "Thomas Bregenzer"
    },
    {
      "affiliations": [
        "Medical Department, Luzerner Kantonsspital, Lucerne, Switzerland"
      ],
      "name": "Christoph Henzen"
    },
    {
      "affiliations": [
        "Medical Department, Spital Thun, Thun, Switzerland"
      ],
      "name": "Thomas Zehnder"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Critical Care Medicine, Klinik Hirslanden, Zürich, Switzerland"
      ],
      "name": "Susanne Schait"
    },
    {
      "affiliations": [
        "Department of Nursing and Allied Health Care Professions, University Hospital Zurich, Zürich, Switzerland"
      ],
      "name": "Christina Gassmann"
    },
    {
      "affiliations": [
        "Clinic for Visceral, Thoracic, Vascular Surgery, and Angiology, Stadtspital Zürich Triemli, Zürich, Switzerland"
      ],
      "name": "Maja Dorfschmid"
    },
    {
      "affiliations": [
        "Department of Endocrinology and Nutrition, Complejo Asistencial Universitario de León, Leon, Spain"
      ],
      "name": "María D Ballesteros-Pomar"
    },
    {
      "affiliations": [
        "Departamento de Medicina, Hospital General Universitario Gregorio Marañón, Madrid, Spain"
      ],
      "name": "Cristina Cuerda"
    },
    {
      "affiliations": [
        "Nutritional Support Unit, University Hospital Vall d’Hebron, Madrid, Spain"
      ],
      "name": "Rosa Burgos"
    },
    {
      "affiliations": [
        "Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid and Health Research Institute of Valladolid (IBioVALL), Valladolid, Spain",
        "Centro de Investigación Biomedica en Red (CIBEROBN) de la Obesidad y Nutrición, Universidad de Valladolid, Valladolid, Spain"
      ],
      "name": "Daniel De Luis"
    },
    {
      "affiliations": [
        "Servicio de Endocrinología y Nutrición, ospital Regional Universitario e instituto de investigación biomédica de Málaga, Malaga, Spain",
        "Departamento de Medicina y Dermatología, Universidad de Málaga, Málaga, Spain",
        "Centro de Investigación Biomédica en Red (CIBER) de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Málaga, Spain"
      ],
      "name": "Gabriel Olveira"
    },
    {
      "affiliations": [
        "Centro de Investigación Biomédica en Red sobre Fragilidad y Envejecimiento Saludable (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain",
        "Servicio de Geriatría, Hospital Universitario de Getafe, Getafe, Spain"
      ],
      "name": "Leocardio Rodriguez-Mañas"
    },
    {
      "affiliations": [
        "Division of Diabetes, Endocrinology, Nutritional Medicine, and Metabolism, Inselspital Universitatsspital Bern, Bern, Switzerland"
      ],
      "name": "Zeno Stanga"
    },
    {
      "affiliations": [
        "Medical University Department, Kantonsspital Aarau AG, Aarau, Switzerland",
        "Medical Faculty, University of Basel, Basel, Switzerland"
      ],
      "name": "Beat Mueller"
    },
    {
      "affiliations": [
        "Medical University Department, Kantonsspital Aarau, Aarau, Switzerland",
        "Medical Faculty, University of Basel, Basel, Switzerland"
      ],
      "name": "Philipp Schuetz"
    }
  ],
  "title": "Design and rationale of the EFFORTII project: a multicentric randomised-controlled trial on the impact of continued nutritional therapy at hospital discharge",
  "uid": "d78208f6-5abb-5631-b8d8-d2ae61dfb622"
}