Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes
Introduction Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of cr...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e036096.full |
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| author | Ulrich Mansmann Claudia Spies Ursula Marschall Reinhard Busse Christine Adrion Bjoern Weiss Nicolas Paul Elke Berger Jörg Caumanns Simone Rosseau |
| author_facet | Ulrich Mansmann Claudia Spies Ursula Marschall Reinhard Busse Christine Adrion Bjoern Weiss Nicolas Paul Elke Berger Jörg Caumanns Simone Rosseau |
| author_sort | Ulrich Mansmann |
| collection | DOAJ |
| description | Introduction Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients’ long-term outcomes if adhered to.Methods and analysis The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient’s ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.Ethics and dissemination This protocol was approved by the ethics committee of the Charité—Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).Trial registration number ClinicalTrials.gov Registry (NCT03671447). |
| format | Article |
| id | doaj-art-77c693b8ef704e4bbaf05bca8db9496c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-77c693b8ef704e4bbaf05bca8db9496c2025-01-09T07:45:10ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-036096Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomesUlrich Mansmann0Claudia Spies1Ursula Marschall2Reinhard Busse3Christine Adrion4Bjoern Weiss5Nicolas Paul6Elke Berger7Jörg Caumanns8Simone Rosseau9Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University (LMU), Munich, GermanyDepartment of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité—Universitätsmedizin Berlin, Berlin, GermanyBARMER, Wuppertal, GermanyDepartment of Health Care Management, Technical University Berlin, Berlin, GermanyInstitute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University (LMU), Munich, GermanyDepartment of Anesthesiology and Operative Intensive Care Medicine, Charité—Universitätsmedizin Berlin, Berlin, GermanyDepartment of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, GermanyDepartment of Health Care Management, Technical University of Berlin, Berlin, GermanyFraunhofer Institute for Open Communication Systems, Berlin, GermanyWeaning and Ventilation Centre, Ernst von Bergmann Klinikum, Bad Belzig, GermanyIntroduction Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients’ long-term outcomes if adhered to.Methods and analysis The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient’s ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.Ethics and dissemination This protocol was approved by the ethics committee of the Charité—Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).Trial registration number ClinicalTrials.gov Registry (NCT03671447).https://bmjopen.bmj.com/content/10/9/e036096.full |
| spellingShingle | Ulrich Mansmann Claudia Spies Ursula Marschall Reinhard Busse Christine Adrion Bjoern Weiss Nicolas Paul Elke Berger Jörg Caumanns Simone Rosseau Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes BMJ Open |
| title | Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes |
| title_full | Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes |
| title_fullStr | Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes |
| title_full_unstemmed | Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes |
| title_short | Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes |
| title_sort | enhanced recovery after intensive care eric study protocol for a german stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes |
| url | https://bmjopen.bmj.com/content/10/9/e036096.full |
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