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. 2019 Oct 21;180(1):17–25. doi: 10.1001/jamainternmed.2019.4446

Table 2. Primary Outcomes Between Groupsa.

Study Population Incidence of Delirium, No./Total (%) RR (95% CI) P Value
t-HELP Usual Care
Intention to treat 4/152 (2.6) 25/129 (19.4) 0.14 (0.05-0.38) <.001
0.06 (0.02-0.23)b
0.07 (0.02-0.26)c
Per protocol 4/132 (3.0) 25/115 (21.7) 0.14 (0.05-0.39) <.001
0.07 (0.02-0.28)b
0.07 (0.02-0.28)c
Sensitivity analysisd 12/152 (7.9) 25/129 (19.4) 0.41 (0.21-0.78) .006
0.32 (0.14-0.73)b .007
0.16 (0.06-0.44)c <.001

Abbreviations: RR, relative risk; t-HELP, Tailored, Family-Involved Hospital Elder Life Program.

a

The intention-to-treat group included all participants randomized without exclusions, analyzed according to their original treatment group assignment. The per-protocol group excluded participants who withdrew or were lost to follow-up.

b

Adjusted for age, sex, and cluster (nursing unit); treated as random-effect factor in the models.

c

Adjusted for age, sex, and type of surgical procedure; treated as random-effect factor in the models.

d

Recoding missing values owing to study withdrawals as delirium positive for the t-HELP group or delirium negative for the usual care group.