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

University of Pennsylvania

Status: Completed

Conditions: Critical Illness; Acute Respiratory Failure

Treatments: Behavioral: Early mobilization intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03863470

831966

Details and patient eligibility

About

This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. The investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to ICU and hospital length of stay and duration of mechanical ventilation compared to usual care.

Full description

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.

Enrollment: 1,917 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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1,917 participants in 2 patient groups

Pre-Intervention (Control)

No Intervention group

Description:

There is no trial-driven approach to care. All hospitals contribute a minimum of 12 weeks of outcomes data prior to adopting the intervention. Pre-specified outcomes data will be electronically extracted for patients meeting eligibility criteria but there will be no attempt to influence delivery of usual care within the ICU. The length of the control phase will differ for each ICU cluster, depending on the sequence in which ICU-clusters are assigned to switch to the intervention phase.

Early mobilization intervention

Active Comparator group

Description:

The clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door. A facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts. Patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board.

Treatment:

Behavioral: Early mobilization intervention