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).
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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, ICU Visits Study Group Investigators and the BRICNet
Аннотация
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.