PROtocol-based MObilizaTION on intensive care units: Design of a cluster randomized pilot study

Abstract

Background: Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Hypothesis: Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). Methods: A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Expected results: Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.