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Table 1 Eligibility criteria

From: Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study)

 

Inclusion criteria

Exclusion criteria

Cluster

Adult medical-surgical ICUs of public and philanthropic hospitals with at least six beds; restrictive policy of ICU visiting hours (< 4.5 h/day)

Structural or organizational impediments to flexible family visitation, according to the Brazilian resolution of minimal operational requirements for ICUsa

Patients

ICU patients aged ≥18 years

Coma (RASS − 4 or − 5) lasting > 96 h from the moment of first evaluation for recruitment; delirium at baseline (positive CAM-ICU); cerebral death; aphasia; severe hearing deficit; predicted ICU length of stay < 48 h; exclusive palliative treatment at ICU admission; unavailability of a family member to participate in the flexible family visits; unlikelihood to survive > 24 h; prisoner status; readmission to the ICU after enrollment in the study

Family members

Closest family member of a patient enrolled in the study

Family members who do not speak Portuguese or have serious difficulty in answering the self-applied questionnaires (e.g., due to illiteracy or severe visual or hearing limitations); having another family member already enrolled in the study

ICU professionals

Bedside ICU professionals (physicians, nurses, nursing technicians, and physiotherapists) who assist patients during daytime for at least 20 h/week at the enrolled ICU

ICU professionals who have a planned leave of absence of > 15 days during phase 1 of the study

  1. CAM-ICU Confusion Assessment Method for the Intensive Care Unit, ICU intensive care unit, RASS Richmond Agitation-Sedation Scale
  2. aAvailable from: http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2010/res0007_24_02_2010.html. Accessed 26 Aug 2017