Antonio Ojeda1, Andrea Calvo2, Tomas Cuñat1, Ricard Mellado Artigas3, Oscar Comino-Trinidad4, Jorge Aliaga4, Marilyn Arias4, Maribel Ahuir5, Carlos Ferrando3,6, Christian Dürsteler1. 1. Pain Medicine Section, Department of Anaesthesiology, Critical Care and Pain Treatment, Hospital Clínic de Barcelona, Barcelona, Spain. 2. Surgical Intensive Care Unit, Department of Anesthesiology, Critical Care and Pain Treatment, Hospital Clínic, Institut d'investigació August Pi i Sunyer, 08036, Barcelona, Spain. macalvo@clinic.cat. 3. Surgical Intensive Care Unit, Department of Anesthesiology, Critical Care and Pain Treatment, Hospital Clínic, Institut d'investigació August Pi i Sunyer, 08036, Barcelona, Spain. 4. Department of Anaesthesiology, Critical Care and Pain Treatment, Hospital Clínic de Barcelona, Barcelona, Spain. 5. Department of clinical Psychology, Clinical Neuroscience Institute, Hospital Clínic de Barcelona, Barcelona, Spain. 6. CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
Abstract
BACKGROUND:Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge. METHODS: The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm). DISCUSSION: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic. TRIAL REGISTRATION: This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors' institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov ( NCT04394169 ).
RCT Entities:
BACKGROUND:Critically illpatients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge. METHODS: The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm). DISCUSSION: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic. TRIAL REGISTRATION: This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors' institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov ( NCT04394169 ).
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Authors: Antonio Ojeda; Andrea Calvo; Tomas Cuñat; Ricard Mellado-Artigas; Oscar Comino-Trinidad; Jorge Aliaga; Marilyn Arias; Carlos Ferrando; Graciela Martinez-Pallí; Christian Dürsteler Journal: Eur J Pain Date: 2021-12-15 Impact factor: 3.651