Enhancing Palliative Care in Intensive Care Units (EPIC) Trial Design of the Health Economic Substudy
Author(s)
Michaela Carla Barbier, PhD1, Spyridon Mentzelopoulos, Prof.2, Andreas Edel, Dr.3, Martin Neukirchen, Prof.4, Katerina Rusinova, MD, PhD5, Jochen Dutzman, Priv.-Doz. Dr.6, Akiva Nachshon, Dr.7, Edoardo De Robertis, Prof.8, Sophie Piper, PhD9, Susanne Joebges, Dr.3, Claudia Spies, Prof.3, Victoria Metaxa, Dr.10, Christiane S. Hartog, Prof. Dr. med.11, Matthias Schwenkglenks, Prof.1.
1Institute of Pharmaceutical Medicine (ECPM) and Health Economics Facility, Department of Public Health, University of Basel, Basel, Switzerland, 2First Department of Intensive Care Medicine, National and Kapodistrian University of Athens Medical School, Evaggelismos Hospital, Athens, Greece, 3Department of Anaesthesiogy and Intensive Care Medicine, Charité Universtitätsmedizin, Berlin, corporate member of Freie Universität Berlin und Humboldt-Universität zu Berlin, Berlin, Germany, 4Interdisciplinary Centre for Palliative Medicine, Medical Faculty, disciplinary Centre for Palliative Medicine, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, Duesseldorf, Germany, 5Department of Palliative Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prag, Czech Republic, 6Department of Internal Medicine III, University Hospital Halle, Halle (Saale), Germany, 7General Intensive Care Unit, Department of Anesthesia, Critical Care and Pain Medicine, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel, 8Section of Anaesthesia Analgesia and Intensive Care. Department of Medicine and Surgery. University of Perugia, Perurgia, Italy, 9Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Informatics and Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, Berlin, Germany, 10Department of Critical Care, King’s College Hospital NHS Foundation Trust, London, United Kingdom, 11TP21 Berlin and Charité Universitätsmedizin Berlin, Berlin, Germany.
1Institute of Pharmaceutical Medicine (ECPM) and Health Economics Facility, Department of Public Health, University of Basel, Basel, Switzerland, 2First Department of Intensive Care Medicine, National and Kapodistrian University of Athens Medical School, Evaggelismos Hospital, Athens, Greece, 3Department of Anaesthesiogy and Intensive Care Medicine, Charité Universtitätsmedizin, Berlin, corporate member of Freie Universität Berlin und Humboldt-Universität zu Berlin, Berlin, Germany, 4Interdisciplinary Centre for Palliative Medicine, Medical Faculty, disciplinary Centre for Palliative Medicine, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, Duesseldorf, Germany, 5Department of Palliative Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prag, Czech Republic, 6Department of Internal Medicine III, University Hospital Halle, Halle (Saale), Germany, 7General Intensive Care Unit, Department of Anesthesia, Critical Care and Pain Medicine, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel, 8Section of Anaesthesia Analgesia and Intensive Care. Department of Medicine and Surgery. University of Perugia, Perurgia, Italy, 9Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Informatics and Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, Berlin, Germany, 10Department of Critical Care, King’s College Hospital NHS Foundation Trust, London, United Kingdom, 11TP21 Berlin and Charité Universitätsmedizin Berlin, Berlin, Germany.
OBJECTIVES: The trial aims to assess whether blended learning and integration of specialized palliative care into intensive care via telemedical consultations reduces intensive care unit (ICU) length of stay and improves care for critically ill non-cancer patients. We present the design of the health economic sub-study.
METHODS: A European, stepped-wedge cluster randomised trial is being conducted in 5 countries. Enrolment has started in October 2024. N=2001 patients are anticipated. Data collection items were determined through literature review, expert consultations within our consortium and with the financial departments of participating centres, tailored to the trial-specific international setting and observation period. Cost and value for money of the complex intervention compared to standard care will be studied from healthcare system, societal and institutional perspectives. Given the challenges of interpreting standard cost-effectiveness metrics (costs per quality-adjusted life year gained) in palliative care, costs will also be related to other trial outcomes in a cost-consequence analysis.
RESULTS: Health-related quality-of-life will be assessed using the EQ-5D-5L questionnaire, completed by patients or proxies. Retrospective and current-day EQ-5D-5L measurements will cover the period from 14 days before ICU admission to 3 months post ICU discharge.
Data on healthcare resource use and productivity losses through informal care will be sourced from clinical information systems or self-reports, and combined with unit costs from public sources. In addition, cost and reimbursement data, including flat-fee reimbursement codes where applicable, will be provided by hospital administrations. Intervention-related costs will be estimated using time requirements for specific tasks and salary estimates for relevant staff categories.
CONCLUSIONS: We have implemented a pragmatic, feasible strategy for health economic data collection in a complex trial setting. Ensuring data quality and completeness requires continuous monitoring to identify needs for corrective action. The economic findings may help identify barriers to palliative care integration and facilitate larger-scale implementation.
METHODS: A European, stepped-wedge cluster randomised trial is being conducted in 5 countries. Enrolment has started in October 2024. N=2001 patients are anticipated. Data collection items were determined through literature review, expert consultations within our consortium and with the financial departments of participating centres, tailored to the trial-specific international setting and observation period. Cost and value for money of the complex intervention compared to standard care will be studied from healthcare system, societal and institutional perspectives. Given the challenges of interpreting standard cost-effectiveness metrics (costs per quality-adjusted life year gained) in palliative care, costs will also be related to other trial outcomes in a cost-consequence analysis.
RESULTS: Health-related quality-of-life will be assessed using the EQ-5D-5L questionnaire, completed by patients or proxies. Retrospective and current-day EQ-5D-5L measurements will cover the period from 14 days before ICU admission to 3 months post ICU discharge.
Data on healthcare resource use and productivity losses through informal care will be sourced from clinical information systems or self-reports, and combined with unit costs from public sources. In addition, cost and reimbursement data, including flat-fee reimbursement codes where applicable, will be provided by hospital administrations. Intervention-related costs will be estimated using time requirements for specific tasks and salary estimates for relevant staff categories.
CONCLUSIONS: We have implemented a pragmatic, feasible strategy for health economic data collection in a complex trial setting. Ensuring data quality and completeness requires continuous monitoring to identify needs for corrective action. The economic findings may help identify barriers to palliative care integration and facilitate larger-scale implementation.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE412
Topic
Economic Evaluation, Patient-Centered Research, Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas