Leanne M. Boehm, Matthew F. Mart, Marianna LaNoue, Shu-Fen Siao, Brenda T. Pun, David L. Bowton, Matthew C. Exline, Michelle N. Gong, Robert D. Hite, Catherine L. Hough, Robert C. Hyzy, Babar A. Khan, Robert L. Owens, Margaret A. Pisani, Peter Rock, Gregory A. Schmidt, James C. Jackson, E. Wesley Ely, Timothy D. Girard, Nathan E. Brummel
PURPOSE: There is limited information on the relationship between multidisciplinary bundle compliance and long-term outcomes. We explored the association between bundle compliance and outcomes at 3 and 12 months after hospital discharge. METHODS: We conducted secondary analyses of a randomized controlled trial comparing haloperidol, ziprasidone, and placebo for delirium in patients with critical illness. From 2011 to 2017, adult patients with respiratory failure and/or shock were recruited from 16 US medical centers. Participants received a daily ABCDE bundle during their critical illness. We assessed cognition, disability, mental health, quality of life, and survival over 12 months of follow-up. We analyzed data using linear mixed effects regression and Cox proportional hazards models. RESULTS: Among 566 participants, 418 survived to hospital discharge, 304 were assessed for 3-month outcomes, and 251 for 12-month outcomes. Median proportional bundle compliance was 97%, indicating high overall fidelity. After adjusting for covariates, greater proportional bundle compliance was associated with better functional independence and health-related quality of life, as evidenced by lower 12-month Functional Activity Questionnaire scores (β = - 9.6, CI = - 19.6, - 1.7, p = 0.04) and higher 12-month EuroQol-5D scores (β = 0.5, CI = 0.1, 0.9, p = 0.01). Greater bundle compliance was not associated with better long-term cognition, mental health, or survival. CONCLUSION: In this multi-site cohort with high-fidelity bundle compliance, greater bundle compliance was associated with less disability in instrumental activities of daily living and better health-related quality of life at 12 months, though associations were inconsistent and absent across other domains. Future research should evaluate integrated bundle care with post-discharge interventions to optimize long-term recovery. TRIAL REGISTRATION: The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA Study (MIND-USA), NCT01211522, https://clinicaltrials.gov/ct2/show/NCT01211522 .