Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Dr.-Gessler-Str. 17, 93051, Regensburg, Germany.
BMC Anesthesiol. 2023 Oct 14;23(1):344. doi: 10.1186/s12871-023-02255-1.
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.
重症监护病房（ICU）幸存者常遭受长期身心损伤，导致所谓的“重症监护后综合征”（PICS）。在德国，目前对受 PICS 影响的前 ICU 患者的后续护理尚未得到充分重视。本研究旨在评估一项比较 ICU 随访诊所干预与常规护理的实用随机对照试验（RCT）的可行性。
本研究在德国一家大学医院进行，评估了一项实用 RCT 的可行性。患者以 1:1 的比例随机分配至 ICU 随访诊所干预组或常规护理组。该随访诊所的概念是在一个由患者、亲属、医疗保健专业人员和研究人员参与的参与性过程中预先制定的。我们进行了过程评估，并确定了可接受性、忠实度、测量工具的完整性和实用性作为可行性结果。RCT 的主要结局（健康相关生活质量）在 ICU 出院后 6 个月通过简短形式 12 项自我报告问卷的生理成分量表进行评估。
该试点研究于 2020 年 6 月至 2021 年 5 月进行，干预组和对照组各有 21 名和 20 名参与者。与可行性相关的主要发现包括 85%的同意率（N=48）、62%的忠实度、34%的脱落率（N=41）和 77%的结局测量完整性。主要有效性结局（健康相关生活质量）可在完成研究的 93%的参与者（N=27）中测量。大多数参与者（85%）需要协助进行随访问卷（实用性）。ICU 住院时间中位数为 13 天，85%（N=41）接受机械通气，中位数序贯器官衰竭评估评分 9 分。所有研究参与者均计划进行 6 个月随访评估，并在 197 天后（中位数）对 66%（N=41）的参与者进行评估。
参与式制定的 ICU 随访诊所干预和实用的试点 RCT 似乎都具有可行性。我们建议开展一项关于 ICU 随访诊所有效性的实用 RCT。
美国国立卫生研究院临床试验数据库（ClinicalTrials.gov US NLM），NCT04186468，提交日期：2019 年 2 月 12 日，注册日期：2019 年 4 月 12 日，网址：https://clinicaltrials.gov/ct2/show/NCT04186468。
