Clinical trial NCT03863470: Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial
Official title: Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Acute Respiratory Failure
Keywords: Early ICU mobility
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 1917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak hour patient activity level
timeFrame: Within 48 hours of ICU discharge
Secondary outcomes:
measure: ICU mortality
timeFrame: From ICU admission to ICU discharge, approximately 3 days
measure: ICU length of stay
timeFrame: From ICU admission to ICU discharge, approximately 3 days
measure: Hospital length of stay
timeFrame: From hospital admission to hospital discharge, approximately 5 days
measure: Duration of mechanical ventilation
timeFrame: From hospital admission to hospital discharge, approximately 5 days
measure: Duration of time spent in deep sedation
timeFrame: From hospital admission to hospital discharge, approximately 5 days
measure: Neurological function
timeFrame: From hospital admission to hospital discharge, approximately 5 days
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: From hospital admission to hospital discharge, approximately 5 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania School of Medicine - Pulmonary, Allergy, and Critical Care
name: William Schweickert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania School of Medicine - PAIR Center
name: Scott D Halpern, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Juliane Jablonski, DNP RN
role: PRINCIPAL_INVESTIGATOR
References: