Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial

The STAND trial aims to measure the effect of an early goal-directed mobilization algorithm
versus usual care for ICU patients with acute respiratory failure in the medical and surgical
ICUs across University of Pennsylvania Health System (UPHS) with respect to patient-centered
outcomes of patient physical function and cognition as well as multiple secondary clinical
outcomes. To achieve this goal, the investigators will conduct a 54-week stepped-wedge,
cluster randomized, trial to test the intervention during the course of providing usual care
among a large and diverse population of patients admitted to 12 ICUs across 4 hospitals
within UPHS. The intervention is an early mobilization protocol implemented during a
patient's stay in the ICU. It involves three steps: 1) the clinical team will set a
standardized mobility goal for each patient during morning rounds and display the goal on the
patient's door; 2) a facilitator will be established in the ICU to communicate mobility goals
and activities across clinical personnel shifts; 3) patient mobility scores will be displayed
to clinical and administrative staff in the ICU via the ICU board. Approximately 1,500 adult
patients with continuous mechanical ventilation for ≥48 hours (without interruption) and
baseline independent ambulatory status will be enrolled. Participating ICUs will be
randomized into 6 clusters of 2 ICUs each. Each ICU contributes a minimum of 12 weeks of data
under the usual care control condition prior to implementing the early mobilization
intervention. Then, using the stepped-wedge design, all ICUs will implement the intervention
in 6-week intervals with the order and timing of implementation determined by random
assignment. By the end of the trial, all ICUs will have utilized the intervention for at
least 12 weeks. The primary outcome is peak patient activity level as measure by the ICU
mobility score (IMS) at ICU discharge. Secondary outcomes include an array of clinical
outcomes.

Inclusion Criteria:

- Age ≥18 years old; AND

- Admission to 1 of 12 participating ICUs; AND

- Continuous mechanical ventilation for ≥ 48 hours (without interruption); AND

- Baseline independent ambulatory status

Exclusion Criteria:

- Admitting diagnosis of any of the following conditions:

- Cardiopulmonary arrest

- Raised intracranial pressure

- Acute neurological admission diagnosis

- Subarachnoid hemorrhage

- Ischemic stroke