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)

Sganzerla, Daniel; Teixeira, Cassiano; Robinson, Caroline Cabral; Kochhann, Renata; Santos, Mariana Martins Siqueira; de Moura, Rafaela Moraes; Barbosa, Mirceli Goulart; da Silva, Daiana Barbosa; Ribeiro, Tarissa; Eugênio, Cláudia; Schneider, Daniel; Mariani, Débora; Jeffman, Rodrigo Wiltgen; Bozza, Fernando; Cavalcanti, Alexandre Biasi; Azevedo, Luciano Cesar Pontes; Machado, Flávia Ribeiro; Salluh, Jorge Ibrain; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Damiani, Lucas Petri; da Silva, Nilton Brandão; Falavigna, Maicon; Rosa, Regis Goulart

doi:10.1186/s13063-018-3006-8

Trials

Table 3 Study outcomes

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)

Outcomes	FFVM	RFVM	Type of effect estimate	Effect estimate (CI)	p value^a
Primary
Cumulative incidence of delirium:^b n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
Secondary
Patients
Daily hazard of delirium:^b mean (SD)	xx.x (xx.x)	xx.x (xx.x)	HR	x.xx (x.xx-x.xx)**	x.xx
Any ICU-acquired infection:^c n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
Proportion of ventilator free-days: mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)**	x.xx
ICU length of stay: mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)**	x.xx
Hospital mortality: n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)**	x.xx
Family members
HADS anxiety score: mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)***	x.xx
HADS depression score: mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)***	x.xx
CCFNI satisfaction score: mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)***	x.xx
ICU professionals
Burnout syndrome:^d n/total n (%)	x/x (xx.x)	x/x (xx.x)	PR	x.xx (x.xx-x.xx)*	x.xx
Tertiary
Patients
Need for antipsychotic agents: n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
Need for mechanical restraints: n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
Unplanned loss of invasive devices: n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
Proportion of coma-free days: mean (SD)	xx.x (xx.x)	xx. (xx.x)	MD	x.xx (x.xx-x.xx)*	x.xx
ICU-acquired pneumonia:^c n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
ICU-acquired UTI:^c n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
ICU-acquired BSI:^c n/total n (%)	x/x (xx.x)	x/x (xx.x)	RR	x.xx (x.xx-x.xx)*	x.xx
Family members
Self-perception of involvement in patient care
Score:^e mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)*	x.xx
ICU professionals
Satisfaction of ICU professionals with the ICU visiting policy score:^f mean (SD)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)*	x.xx

BSI bloodstream infection, CCFNI Critical Care Family Needs Inventory, CI confidence interval, FFVM flexible family visitation model, HADS Hospital Anxiety and Depression Scale, HR hazard ratio, ICU intensive care unit, MD mean difference, PR prevalence ratio, RFVM restrictive family visitation model, RR risk ratio, SD standard deviation, UTI urinary tract infection
^aAdjusted for multiple comparisons with Bonferroni correction when appropriate
^bAccording to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) criteria
^cAccording to the Centers for Disease Control and Prevention (CDC) criteria
^dMaslach Burnout Inventory (MBI) total score > − 9
^eThe self-perception of involvement in patient care score varies from 0 (no involvement) to 27 (maximum degree of involvement)
^fThe satisfaction of ICU professionals with the ICU visiting policy score varies from 0 (unsatisfied) to 4 (very satisfied)
^*95% confidence interval
^**99% confidence interval
^***98.3% confidence interval

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ISSN: 1745-6215

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