Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial

A. Ojeda , A. Calvo , T. Cuñat , R. Mellado-Artigas , A. Costas-Carrera , M.M. Sánchez-Rodriguez , O. Comino-Trinidad , J. Aliaga , M. Arias , G. Martínez-Pallí , C. Dürsteler , C. Ferrando
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Abstract

Background

Critical COVID-19 survivors are at risk of developing Post-intensive Care Syndrome (PICS) and Chronic ICU-Related Pain (CIRP). We determined whether a specific care program improves the quality of life (QoL) of patients at risk of developing PICS and CIRP after COVID-19.

Methods

The PAIN-COVID trial was a parallel-group, single-centre, single-blinded, randomized controlled trial. The intervention consisted of a follow up program, patient education on PICS and pain, and a psychological intervention based on Rehm’s self-control model in patients with abnormal depression scores (≥8) in the Hospital Anxiety and Depression Scale (HADS) at the baseline visit. QoL was evaluated with the 5-level EQ 5D (EQ 5D 5 L), mood disorders with the HADS, post-traumatic stress disorder (PTSD) with the PCL-5 checklist, and pain with the Brief Pain Inventory short form, the Douleur Neuropathique 4 questionnaire, and the Pain Catastrophizing Scale. The primary outcome was to determine if the program was superior to standard-of-care on the EQ visual analogue scale (VAS) at 6 months after the baseline visit. The secondary outcomes were EQ VAS at 3 months, and EQ index, CIRP incidence and characteristics, and anxiety, depression, and PTSD at 3 and 6 months after baseline visits.

Conclusions

This program was not superior to standard care in improving QoL in critical COVID-19 survivors as measured by the EQ VAS. However, our data can help establish better strategies for the study and management of PICS and CIRP in this population.

Trial registration

# NCT04394169, registered on 5/19/2020.

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针对 COVID-19 感染后重症监护室后综合征和慢性疼痛的精神因素的特定随访计划的效果:PAIN-COVID 随机临床试验的结果。
背景:COVID-19危重症幸存者有患重症监护后综合征(PICS)和慢性重症监护病房相关疼痛(CIRP)的风险。我们确定了一项特定护理计划是否能改善 COVID-19 病后有可能患重症监护后综合征和慢性重症监护相关疼痛的患者的生活质量(QoL):PAIN-COVID 试验是一项平行组、单中心、单盲、随机对照试验。干预措施包括随访计划、PICS和疼痛方面的患者教育,以及基于雷姆自我控制模型的心理干预,干预对象为基线访问时医院焦虑抑郁量表(HADS)中抑郁评分异常(>=8)的患者。质量生活以 5 级 EQ 5D (EQ 5D 5 L) 进行评估,情绪障碍以 HADS 进行评估,创伤后应激障碍(PTSD)以 PCL-5 核对表进行评估,疼痛以简明疼痛量表简表、Douleur Neuropathique 4 问卷和疼痛灾难化量表进行评估。主要结果是确定该计划在基线访问后 6 个月的 EQ 视觉模拟量表(VAS)上是否优于标准护理。次要结果是 3 个月后的 EQ VAS,基线访问后 3 个月和 6 个月的 EQ 指数、CIRP 发生率和特征,以及焦虑、抑郁和创伤后应激障碍:结论:根据 EQ VAS 测量,该计划在改善 COVID-19 危重症幸存者的 QoL 方面并不优于标准护理。然而,我们的数据有助于为研究和管理该人群中的 PICS 和 CIRP 制定更好的策略:# NCT04394169,注册日期:2020年5月19日。
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