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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Acute Respiratory Failure
• Intervention / Treatment: Behavioral: Early mobilization intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1917
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
    • West Chester, Pennsylvania, United States, 19380
      • Chester County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Pre-Intervention (Control); 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; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: William Schweickert, MD, University of Pennsylvania School of Medicine - Pulmonary, Allergy, and Critical Care; Principal Investigator: Scott D Halpern, MD PhD, University of Pennsylvania School of Medicine - PAIR Center; Principal Investigator: Juliane Jablonski, DNP RN, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2019
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Early ICU mobility
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Respiratory Insufficiency; Critical Illness; Respiratory Distress Syndrome
• Other Study ID Numbers: 831966

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No