PDF(Pubmed)
Abstract：
ICU 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.
This 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.
The 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).
The 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.
ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.
This 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.
The 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).
The 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.
ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.
摘要：
背景：ICU幸存者经常遭受长期的身体和精神损伤，导致所谓的“后重症监护综合征”（PICS）。迄今为止，德国尚未充分解决特别是受PICS影响的前ICU患者的后续护理问题。这项研究的目的是评估一项实用的随机试验（RCT）的可行性，该试验将重症监护病房（ICU）随访临床干预与常规护理进行比较。
方法：这项在德国大学医院进行的初步研究评估了实用RCT的可行性。患者以1：1的比例分配到ICU随访临床干预或常规护理。这种随访诊所的概念以前是在与患者的参与过程中发展起来的，近亲,卫生保健专业人员和研究人员。我们进行了过程评估并确定了可接受性，保真度，测量仪器的完整性和实用性作为可行性结果。在ICU出院后6个月，通过Short-Form-12自我报告问卷的物理成分量表评估RCT的主要结局（与健康相关的生活质量）。
结果：试点研究于2020年6月至2021年5月进行，干预组和对照组分别有21名和20名参与者。与可行性相关的主要发现是85%的同意率(N=48)，62%的保真率，34%的流失率(N=41)和77%的结果测量完整性。主要有效性结果（与健康相关的生活质量）可以在完成研究的93％的参与者中进行测量（N=27）。大多数参与者（85％）需要后续问卷（实用性）的帮助。ICU住院时间中位数为13天，85%(N=41)接受机械通气，中位序贯器官衰竭评估评分为9分.计划对所有研究参与者进行6个月的随访评估，并在197天后对66％（N=41）的参与者进行评估（中位数）。
结论：ICU随访诊所的参与式干预和实用的试点RCT似乎都是可行的。我们建议对ICU随访诊所的有效性进行实用的RCT。
背景：ClinicalTrials.govUSNLM，NCT04186468，提交：02/12/2019，注册：04/12/2019，https://clinicaltrials.gov/ct2/show/NCT04186468。
方法：这项在德国大学医院进行的初步研究评估了实用RCT的可行性。患者以1：1的比例分配到ICU随访临床干预或常规护理。这种随访诊所的概念以前是在与患者的参与过程中发展起来的，近亲,卫生保健专业人员和研究人员。我们进行了过程评估并确定了可接受性，保真度，测量仪器的完整性和实用性作为可行性结果。在ICU出院后6个月，通过Short-Form-12自我报告问卷的物理成分量表评估RCT的主要结局（与健康相关的生活质量）。
结果：试点研究于2020年6月至2021年5月进行，干预组和对照组分别有21名和20名参与者。与可行性相关的主要发现是85%的同意率(N=48)，62%的保真率，34%的流失率(N=41)和77%的结果测量完整性。主要有效性结果（与健康相关的生活质量）可以在完成研究的93％的参与者中进行测量（N=27）。大多数参与者（85％）需要后续问卷（实用性）的帮助。ICU住院时间中位数为13天，85%(N=41)接受机械通气，中位序贯器官衰竭评估评分为9分.计划对所有研究参与者进行6个月的随访评估，并在197天后对66％（N=41）的参与者进行评估（中位数）。
结论：ICU随访诊所的参与式干预和实用的试点RCT似乎都是可行的。我们建议对ICU随访诊所的有效性进行实用的RCT。
背景：ClinicalTrials.govUSNLM，NCT04186468，提交：02/12/2019，注册：04/12/2019，https://clinicaltrials.gov/ct2/show/NCT04186468。
