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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Critical Illness, Acute Respiratory Failure

Intervention / Treatment
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* Behavioral: Early mobilization intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Intervention (Control)<br>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. | |
| Active Comparator: Early mobilization intervention<br>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. | Behavioral: Early mobilization intervention<br>* The intervention consists of 3 components: 1) A simplified mobilization goal (using the Surgical Optimal Mobility Score) will be defined during daily morning ward rounds and displayed on the doors of patients' rooms; 2) a facilitator will communicate to the care team regarding mobility goals; 3) clinicians will receive feedback on patient's mobility as mobility scores will be made available electronically on the ICU board - a dashboard for monitoring patient care in the ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak hour patient activity level | Peak hour patient activity level as measured by the ICU mobility score (IMS) at ICU discharge. IMS score ranges from 0 to 10. | Within 48 hours of ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | ICU Mortality | From ICU admission to ICU discharge, approximately 3 days | 
| ICU length of stay | ICU length of stay (days) | From ICU admission to ICU discharge, approximately 3 days | 
| Hospital length of stay | Hospital length of stay (days) | From hospital admission to hospital discharge, approximately 5 days | 
| Duration of mechanical ventilation | Duration of time spent on continuous mechanical ventilation (hours) | From hospital admission to hospital discharge, approximately 5 days | 
| Duration of time spent in deep sedation | Duration of time spent in deep sedation (hours) | From hospital admission to hospital discharge, approximately 5 days | 
| Neurological function | Composite measure of delirium and coma free days | From hospital admission to hospital discharge, approximately 5 days | 
| Richmond Agitation-Sedation Scale (RASS) | RASS score at time of first spontaneous breathing trial. RASS score ranges from -5 (unarousable) to +4 (combative); A score of 0 = alert and calm. | From hospital admission to hospital discharge, approximately 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early ICU mobility