评估成人重症监护病房中灵活家庭探视模式预防谵妄有效性和安全性的研究方案：一项整群随机交叉试验（重症监护病房探视研究）
Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study).
作者信息
Rosa Regis Goulart, Falavigna Maicon, Robinson Caroline Cabral, da Silva Daiana Barbosa, Kochhann Renata, de Moura Rafaela Moraes, Santos Mariana Martins Siqueira, Sganzerla Daniel, Giordani Natalia Elis, Eugênio Cláudia, Ribeiro Tarissa, Cavalcanti Alexandre Biasi, Bozza Fernando, Azevedo Luciano Cesar Pontes, Machado Flávia Ribeiro, Salluh Jorge Ibrain Figueira, Pellegrini José Augusto Santos, Moraes Rafael Barberena, Hochegger Taís, Amaral Alexandre, Teles José Mario Meira, da Luz Lucas Gobetti, Barbosa Mirceli Goulart, Birriel Daniella Cunha, Ferraz Iris de Lima, Nobre Vandack, Valentim Helen Martins, Corrêa E Castro Livia, Duarte Péricles Almeida Delfino, Tregnago Rogério, Barilli Sofia Louise Santin, Brandão Nilton, Giannini Alberto, Teixeira Cassiano
机构信息
Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
Institute for Education and Research, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
出版信息
BMJ Open. 2018 Apr 13;8(4):e021193. doi: 10.1136/bmjopen-2017-021193.
INTRODUCTION
Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals.
METHODS AND ANALYSIS
A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals.
ETHICS AND DISSEMINATION
The study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through conferences and peer-reviewed journals.
TRIAL REGISTRATION
NCT02932358.
引言
灵活的重症监护病房（ICU）探视时间被认为是改善以患者和家庭为中心的护理的一种方式。然而，评估灵活家庭探视模式（FFVM）效果的随机试验很少。本研究旨在比较FFVM与限制性家庭探视模式（RFVM）在预防ICU患者谵妄方面的有效性和安全性，并分析其对家庭成员和ICU专业人员的潜在影响。
方法与分析
将进行一项涉及成年ICU患者、家庭成员和ICU专业人员的整群随机交叉试验。40个采用RFVM（每天探视时间<4.5小时）的巴西内科-外科ICU将以1:1的比例随机分配到RFVM组（按照当地政策进行探视）或FFVM组（每天连续探视12小时）。在纳入并随访25例患者后，每个ICU将切换到另一种探视模式，直至每个地点再纳入并随访25例患者。主要结局将是ICU患者谵妄的累积发生率，每天使用ICU意识模糊评估方法测量两次。次要结局指标将包括谵妄的每日风险、无呼吸机天数、任何ICU获得性感染、患者的ICU住院时间和医院死亡率；家庭成员的焦虑和抑郁症状及满意度；以及ICU专业人员倦怠症状的患病率。三级结局将包括患者对抗精神病药物和/或机械约束的需求、无昏迷天数、侵入性设备的意外丢失以及ICU获得性肺炎、尿路感染或血流感染；家庭成员对参与患者护理的自我认知；以及ICU专业人员的满意度。
伦理与传播
研究方案已获得所有参与机构的研究伦理委员会批准。我们旨在通过会议和同行评审期刊传播研究结果。
试验注册
NCT02932358。
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