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.
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.
Adjusted for age, sex, and cluster (nursing unit); treated as random-effect factor in the models.
Adjusted for age, sex, and type of surgical procedure; treated as random-effect factor in the models.
Recoding missing values owing to study withdrawals as delirium positive for the t-HELP group or delirium negative for the usual care group.