Rohr M, Brandstetter S, Bernardi C, Fisser C, Drewitz K P, Brunnthaler V, Schmidt K, Malfertheiner M V, Apfelbacher C J
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.
Pilot Feasibility Stud. 2021 Mar 30;7(1):90. doi: 10.1186/s40814-021-00796-1.
Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy.
METHODS/DESIGN: Design: Pilot RCT with intervention and control (usual care) arms plus mixed-methods process evaluation.
100 ICU patients (50 per arm) of three ICUs in a university hospital (Regensburg, Germany), ≥ 18 years with an ICU stay of > 5 days, a sequential organ failure assessment (SOFA) score > 5 during the ICU stay and a life expectancy of more than 6 months.
The intervention will contain three components: information, consultation and networking. Information will be available in form of an intensive care guide for patients and next of kin at the ICU and phone support during follow-up. For consultation, patients will visit the ICU follow-up clinic at least once during the first 6 months after discharge from ICU. During these visits, patients will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The networking part (e.g. special referral letter from the ICU follow-up clinic) aims to provide a network of outpatient care providers for former ICU patients. Feasibility Outcomes: Qualitative and quantitative evaluation will be used to explore reasons for non-participation and the intervention´s acceptability to patients and caregivers. Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the physical component score (PCS) of the Short-Form 12 Questionnaire (SF-12). Secondary outcomes encompass further patient-reported outcomes. All outcomes are assessed at 6 months after discharge from ICU.
The PINA study will determine feasibility and potential efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multi-centre RCT.
ClinicalTrials.gov , NCT04186468 . Submitted 2 December 2019.
重症监护病房（ICU）幸存者常患有认知、身体和精神方面的损伤，即所谓的重症监护后综合征（PICS）。ICU随访门诊可能会改善这些患者的后续护理。目前缺乏证据表明哪种ICU随访门诊的概念是有效的，或者是否有效。在PINA研究中，已制定了一个ICU随访门诊的概念，并将在一项试点随机对照试验（RCT）中进行测试，主要目的是评估其可行性，此外还评估其潜在疗效。
方法/设计：设计：设有干预组和对照组（常规护理）的试点随机对照试验以及混合方法的过程评估。
德国雷根斯堡一所大学医院的三个ICU中的100名患者（每组50名），年龄≥18岁，在ICU的住院时间>5天，ICU住院期间序贯器官衰竭评估（SOFA）评分>5，预期寿命超过6个月。
干预措施包括三个部分：信息提供、咨询和建立联系。信息将以针对患者及其家属的重症监护指南的形式在ICU提供，并在随访期间提供电话支持。为了进行咨询，患者将在从ICU出院后的前6个月内至少到ICU随访门诊就诊一次。在这些就诊期间，将对患者进行PICS症状筛查，如有需要，转诊至专科医生处进行进一步治疗。建立联系部分（例如ICU随访门诊的特殊转诊信）旨在为以前的ICU患者提供门诊护理提供者网络。可行性结果：将采用定性和定量评估来探究不参与的原因以及患者和护理人员对干预措施的接受程度。疗效结果：健康相关生活质量（HRQOL）将通过简短健康调查问卷（SF-12）的身体成分评分（PCS）作为主要结局进行评估。次要结局包括更多患者报告的结局。所有结局均在从ICU出院后6个月进行评估。
PINA研究将在试点随机对照试验中确定一种复杂干预措施对加强ICU幸存者后续护理的可行性和潜在疗效。该试点研究是ICU后续护理领域进一步研究的重要一步，尤其是对于实施一项务实的多中心随机对照试验而言。
ClinicalTrials.gov，NCT04186468。于2019年12月2日提交。
