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

NCT03863470 | Completed DMC

• 1 other identifier: 831966
• Study Type: interventional
• Target: 1,917
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Critical Illness; Acute Respiratory Failure

Keywords

Early ICU mobility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• ICU mortality

  From ICU admission to ICU discharge, approximately 3 days

• ICU length of stay

  From ICU admission to ICU discharge, approximately 3 days

• Hospital length of stay

  From hospital admission to hospital discharge, approximately 5 days

• Duration of mechanical ventilation

  From hospital admission to hospital discharge, approximately 5 days

• Duration of time spent in deep sedation

  From hospital admission to hospital discharge, approximately 5 days

Study Arms (2)

Pre-Intervention (Control)

NO INTERVENTION

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

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

Interventions

Early mobilization intervention BEHAVIORAL

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

Early mobilization intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Admitting diagnosis of any of the following conditions:
• Cardiopulmonary arrest
• Raised intracranial pressure
• Acute neurological admission diagnosis
• Subarachnoid hemorrhage
• Ischemic stroke

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (4)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (1)

• Schweickert WD, Jablonski J, Bayes B, Chowdhury M, Whitman C, Tian J, Blette B, Tran T, Halpern SD. Structured Mobilization for Critically Ill Patients: A Pragmatic Cluster-randomized Trial. Am J Respir Crit Care Med. 2023 Jul 1;208(1):49-58. doi: 10.1164/rccm.202209-1763OC.

  PMID: 36996413 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: March 4, 2019
• Primary Completion: March 15, 2020
• Study Completion: July 30, 2020
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)