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Completed

NCT Number: NCT03863470

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Peak hour patient activity level

    Time frame: Within 48 hours of ICU discharge

    Peak hour patient activity level as measured by the ICU mobility score (IMS) at ICU discharge. IMS score ranges from 0 to 10.

Secondary outcomes

  1. ICU mortality

    Time frame: From ICU admission to ICU discharge, approximately 3 days

    ICU Mortality

  2. ICU length of stay

    Time frame: From ICU admission to ICU discharge, approximately 3 days

    ICU length of stay (days)

  3. Hospital length of stay

    Time frame: From hospital admission to hospital discharge, approximately 5 days

    Hospital length of stay (days)

  4. Duration of mechanical ventilation

    Time frame: From hospital admission to hospital discharge, approximately 5 days

    Duration of time spent on continuous mechanical ventilation (hours)

  5. Duration of time spent in deep sedation

    Time frame: From hospital admission to hospital discharge, approximately 5 days

    Duration of time spent in deep sedation (hours)

  6. Neurological function

    Time frame: From hospital admission to hospital discharge, approximately 5 days

    Composite measure of delirium and coma free days

  7. Richmond Agitation-Sedation Scale (RASS)

    Time frame: From hospital admission to hospital discharge, approximately 5 days

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: STAND

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2019
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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