Structured Mobilization for Critically Ill Patients: A Pragmatic Cluster-randomized Trial

Rationale: Small trials and professional recommendations support mobilization interventions to improve recovery among critically ill patients, but their real-world effectiveness is unknown. Objective: To evaluate a low-cost, multifaceted mobilization intervention. Methods: We conducted a stepped-wedge cluster-randomized trial across 12 ICUs with diverse case mixes. The primary and secondary samples included patients mechanically ventilated for ⩾48 hours who were ambulatory before admission, and all patients with ICU stays ⩾48 hours, respectively. The mobilization intervention included 1) designation and posting of daily mobilization goals; 2) interprofessional closed-loop communication coordinated by each ICU's facilitator; and 3) performance feedback. Measurements and Main Results: From March 4, 2019 through March 15, 2020, 848 and 1,069 patients were enrolled in the usual care and intervention phases in the primary sample, respectively. The intervention did not increase the primary outcome, patient's maximal Intensive Care Mobility Scale (range, 0-10) score within 48 hours before ICU discharge (estimated mean difference, 0.16; 95% confidence interval, -0.31 to 0.63; P = 0.51). More patients in the intervention (37.2%) than usual care (30.7%) groups achieved the prespecified secondary outcome of ability to stand before ICU discharge (odds ratio, 1.48; 95% confidence interval, 1.02 to 2.15; P = 0.04). Similar results were observed among the 7,115 patients in the secondary sample. The percentage of days on which patients received physical therapy mediated 90.1% of the intervention effect on standing. ICU mortality (31.5% vs. 29.0%), falls (0.7% vs. 0.4%), and unplanned extubations (2.0% vs. 1.8%) were similar between groups (all P > 0.3). Conclusions: A low-cost, multifaceted mobilization intervention did not improve overall mobility but improved patients' odds of standing and was safe. Clinical trial registered with www.clinicaltrials.gov (NCT03863470).