Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial

BMC Anesthesiology

Research

Christoph Fisser¹  Maximilian V. Malfertheiner²  Konrad Schmidt³  Claudia Hasenpusch⁴  Karl Philipp Drewitz⁴  Christian J. Apfelbacher⁵  Christine Bernardi⁶  Vreni Brunnthaler⁷  Katharina Pielmeier⁸  Magdalena Rohr⁹  Susanne Brandstetter^1,10 

[1] Department of Internal Medicine II, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany;Department of Internal Medicine II, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany;Klinik Donaustauf, Ludwigstr. 68, 93093, Donaustauf, Germany;Institute of General Practice and Family Medicine, Charité – Universitätsmedizin Berlin, Charitéplatz 1, 10098, Berlin, Germany;Institute of General Practice and Family Medicine, Jena University Hospital, Bachstr. 18, 07743, Jena, Germany;Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany;Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany;Family Medicine and Primary Care, Lee Kong Chian School of Medicine, Nanyang Technological University, 50 Nanyang Avenue, 639798, Singapore, Singapore;Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Dr.-Gessler-Str. 17, 93051, Regensburg, Germany;Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Dr.-Gessler-Str. 17, 93051, Regensburg, Germany;Caritas-Krankenhaus St. Josef, Landshuter Str. 65, 93053, Regensburg, Germany;Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Dr.-Gessler-Str. 17, 93051, Regensburg, Germany;Department of Internal Medicine II, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany;Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Dr.-Gessler-Str. 17, 93051, Regensburg, Germany;University Children’s Hospital Regensburg, University of Regensburg, Klinik St. Hedwig, Steinmetzstr. 1-3, 93049, Regensburg, Germany;University Children’s Hospital Regensburg, University of Regensburg, Klinik St. Hedwig, Steinmetzstr. 1-3, 93049, Regensburg, Germany;

关键词: Complex intervention;    Critical care;    ICU follow-up clinic;    Mechanical ventilation;    Pilot study;    Post-intensive care syndrome (PICS);   

DOI  :  10.1186/s12871-023-02255-1

 received in 2022-11-21, accepted in 2023-08-24,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundICU survivors often suffer from prolonged physical and mental impairments resulting in the so called “Post-Intensive Care Syndrome” (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care.MethodsThis pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT’s primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire.ResultsThe pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median).ConclusionThe participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic.Trial registrationClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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